Sectors

Activity 1.3 under Result 1: Development of accreditation schemes and guidelines to assist TURKAK personnel making accreditation assessment and decisions for notification purposes for 20 selected sectors.

 

1.Personal Protective Equipment Regulation – (EU) 2016/425

This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules on the free movement of PPE in the European Union.

The requirements of this regulation have been implemented in Turkey through “Kişisel Koruyucu Donanım Yönetmeliği” published in the Turkish Official Journal, Resmi Gazete, number 30761, 1 May 2019.

Turkish conformity assessment bodies wishing to become notified bodies under this regulation have to work to the requirements in the Turkish implementation of the regulation.

 

Definitions and scope

Personal protective equipment (PPE) is equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety. PPE is divided into three categories where category I covers equipment used in the least hazardous situations and category III covers equipment in the most hazardous situations.

Examples of PPE category I are gloves protecting against superficial mechanical hazards, gloves for dishwashing, clothing protecting against weather conditions for professional use, sunglasses for non-professional use.

Examples of PPE category II are eye and face protectors, Helmets, H-VIS clothing.

Examples of PPE category III are respiratory protective devices, hearing protectors, equipment protecting against fall from a height, equipment protecting against drowning, clothing, gloves and shoes protecting against chemical hazards, PPEs for firefighters.

 

Exceptions

PPE Regulation 2016/425 does not apply to PPE which is:

  1. Specifically designed for use by the armed forces or in the maintenance of law and order.
  2. Designed to be used for self-defence, with the exception of PPE intended for sporting activities.
  3. Designed for private use to protect against atmospheric conditions that are not of an extreme nature, damp and water during dishwashing.
  4. For exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States.
  5. For head, face or eye protection of users that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.

 

Other legislation related to PPE

Depending on the type of product, PPE may also be covered by one or more of the following directives:

  • Pressure Equipment Directive (PED) 2014/68/EU: Applies to a limited number of PPE
  • Electromagnetic Compatibility (EMC) Directive 2014/30/EU: Applies to PPE incorporating electrical and electronic devices
  • Radio Equipment Directive (RED) 2014/53/EU: Applies to PPE incorporating radio equipment
  • Toys Directive 2009/48/EC: PPE for children is covered by the PPE Regulation but any limitations of the PPE Regulation fall under the Toys Directive.
  • Equipment and Protective Systems intended for use in Potentially Explosive Atmospheres (ATEX) Directive 2014/34/EU: Equipment covered by the PPE Regulation is specifically excluded from the ATEX.
  • Medical Devices Directive (MDD) 93/42/EEC: Applies with specific interpretations
  • Marine Equipment Directive (MED) 2014/90/EU: Safety equipment covered by MED does not fulfil the role of PPE.

 

Notification and accreditation

Any CAB established in Turkey which wishes to be a notified body within the scope of the PPE directive may apply for accreditation under this directive. Accreditation under this directive is the only route to becoming a Turkish notified body for the PPE directive.

An accreditation for notification purposes may be granted to CABs by TURKAK only in the scope of PPEs classified to category II and III. The notifying authority in Turkey for this regulation is the Ministry of Family, Work and Social Services (Aile, Çalışma ve Sosyal Hizmetler Bakanlığı). Bodies accredited under this directive may use the accreditation to apply to the Ministry of Industry and Technology for appointment and continuation of appointment as notified bodies under the Pressure Equipment Directive within their accredited scopes.

 

Modules and conformity assessment procedures

The following table shows the modules that apply to the various categories of products and the harmonised standards to be used for the conformity assessment procedures.

 

ModuleHarmonized standards for conformity assessment proceduresRisk category of PPE
BISO/IEC 17065*Category II
C2ISO/IEC 17065 or

ISO/IEC 17025 + EN ISO 17065 p. 4.1, 7.5, 7.6

Category III

 

 

DISO/IEC 17065 or

ISO/IEC 17021-1 +

ISO/IEC 17020 p. 6.1.2, 6.1.3, 6.1.6 to 6.1.10

Category III

 

 

Please note that TURKAK’s policy for the harmonised standards to be used for the modules can be found in the information in the following links.

https://www.turkak.org.tr/duyurular/ea-217-dokumani-revizyonu-sonrasi-onaylanma-amacli-akreditasyon-kapsaminda-uygulanacak-akreditasyon-standartlari-ile-ilgili-gecis-sureci.html

Ek: Direktif/Modüllere göre Uygulanacak Akreditasyon Standardları Listesi

 

2.Machinery Directive – 2006/42/EC

The Machinery Directive defines only the essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery.

This directive has been implemented in Turkish legislation through “Makina Emniyeti Yönetmeliği” and published in the Turkish Official Journal, Resmi Gazete number 27158, 3 March 2009.

Turkish conformity assessment bodies wishing to become notified bodies under this directive have to work to the requirements in the Turkish implementation of the directive.

 

Definitions and scope

The definition of machinery focuses on assemblies, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application. However, the full definition must be clearly understood by CABs and manufacturers. Therefore, for a detailed description of what is meant by machinery within the scope of this directive, the original text of the directive should be used.

This Directive applies to the following products:

(a) machinery;

(b) interchangeable equipment;

(c) safety components;

(d) lifting accessories;

(e) chains, ropes and webbing;

(f) removable mechanical transmission devices;

(g) partly completed machinery.

 

Exemptions

Most of the exceptions to the scope of this directive are covered by other harmonized legislation, are manufactured specially for research, fall under legislation for nuclear powerplants or fall under the jurisdiction of the military forces/Ministry of Defense.

The following are excluded from the scope of this Directive:

  • safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;
  • specific equipment for use in fairgrounds and/or amusement parks;
  • machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;
  • weapons, including firearms;
  • the following means of transport:
  • agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,
  • motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers, with the exclusion of machinery mounted on these vehicles,
  • vehicles covered by Directive 2002/24/EC of the Euro- pean Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles, with the exclusion of machinery mounted on these vehicles,
  • motor vehicles exclusively intended for competition, and
  • means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;
  • seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;
  • machinery specially designed and constructed for military or police purposes;
  • machinery specially designed and constructed for research purposes for temporary use in laboratories;
  • mine winding gear;
  • machinery intended to move performers during artistic performances;
  • electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (LVD):
  • household appliances intended for domestic use, — audio and video equipment,

— Information technology equipment,

— Ordinary office machinery,

  • low-voltage switchgear and control gear,
  • electric motors;
  • the following types of high-voltage electrical equipment:
  • switch gear and control gear,

 

Other legislation related to the Machinery directive

Depending on the type of product, machinery may also be covered by one or more of the following directives:

  • Low Voltage Directive
  • Electromagnetic compatibility Directive
  • Radio Equipment Directive (RED) 2014/53/EU
  • Pressure Equipment Directive
  • Equipment for use in Explosive Atmospheres Directive (ATEX)
  • Noise Emission of Outdoor Equipment Directive (OND)

 

In a few cases machinery may be covered by other Directives than the most obvious ones listed above, for example, Powered furniture (in MD scope) may interface with, for example, a powered Dental chair or dental machinery which may be in scope of the Medical Equipment Directive. Outboard motors are in the scope of the Machinery Directive, but the boat they are attached to is not.

 

Notification and accreditation

Any CAB established in Turkey which wishes to notified body within the scope of the Machinery directive may apply for accreditation under this directive. Accreditation under this directive is the only route to becoming a Turkish notified body for the Machinery directive.

The notifying authority in Turkey for this regulation is the Ministry of Industry and Trade (Sanayi ve Ticaret Bakanlığı). Bodies accredited under this directive may use the accreditation to apply to the Ministry of Industry and Technology for appointment and continuation of appointment as notified bodies under the Machınery Directive within their accredited scopes.

 

Modules and conformity assessment procedures

 

The vast majority of machinery does not require Notified Body involvement. Only the very limited categories of more dangerous equipment listed in Annex IV of the directive require notified body involvement if they do not meet the requirements of all relevant harmonized standards. Notified bodies do not have a role outside Annex IV in the Machinery Directive. Notified bodies cannot issue EC Type Examination certificates for equipment that is not in Annex IV.

Declaration of Conformity versus Declaration of Incorporation

The Declaration of Incorporation is a peculiarity of the Machinery Directive. It allows for the possibility that a machine is placed on the market incomplete and therefore not in full conformity with all the essential health and safety requirements (EHSR), because it will be incorporated into another machine before it is put into service. An example is a robot, which is unsafe until it is incorporated into a manufacturing system with guard fences, laser proximity scanner etc. The robot is placed on the market with a Declaration of Incorporation. The final Installation is issued with a Declaration of Conformity.

A Declaration of Incorporation states which EHSRs the equipment meets and also that the equipment into which it is incorporated must not be placed into service in the EU until the whole, finished machine has been assessed for CE conformity.

There can be confusion over whether an equipment is a complete machinery or a component for incorporation. Most Annex IV machinery is likely to be supplied as complete machinery with a Declaration of Conformity so this issue will only rarely arise within the scope of activity of notified bodies.

Please note that TURKAK’s policy for the harmonised standards to be used for the conformity assessment procedures can be found in the information in the following links.

https://www.turkak.org.tr/duyurular/ea-217-dokumani-revizyonu-sonrasi-onaylanma-amacli-akreditasyon-kapsaminda-uygulanacak-akreditasyon-standartlari-ile-ilgili-gecis-sureci.html

Ek: Direktif/Modüllere göre Uygulanacak Akreditasyon Standardları Listesi

 

3.Equipment and Protective Systems for use in potentially explosive atmospheres (recast) ATEX – 2014/34/EU

The ATEX directive lays down uniform, EU-wide rules on the sale and putting into service of equipment and protective systems intended for use in potentially explosive atmospheres. It seeks to ensure that products fulfil certain requirements to ensure a high level of protection of the health and safety of persons, especially workers, and, where appropriate, the protection of domestic animals and property.

This directive has been implemented in Turkish legislation through “Muhtemel Patlayıcı Ortamda Kullanılan Teçhizat ve Koruyucu Sistemler ile ilgili yönetmelik” published in the Turkish Official Journal, Resmi Gazete number 29758, 30 June 2016.

Turkish conformity assessment bodies wishing to become notified bodies under this directive have to work to the requirements in the Turkish implementation of the directive.

 

Definitions and scope

The ATEX directive covers equipment and protective systems intended for use in potentially explosive atmospheres, and safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres.

It applies to a wide range of products, including equipment used on fixed offshore oil and gas platforms, in petrochemical plants, mines, flour mills (airborne flour particles are highly flammable) and other areas where a potentially explosive atmosphere may be present.

Furthermore, safety and controlling devices may be relevant concerning their functional safety. The equipment in the scope may be of electrical and/or mechanical nature. ATEX may apply to products in addition to other Directives, such as the Low Voltage and Machinery Directives (e.g. controlling devices under ATEX may also be electrical equipment, and a machine may include a protective system within the scope of ATEX).

In the scope of this directive,

  • ‘Equipment’ means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy and/or the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
  • ‘Protective systems’ means devices other than components of equipment which are intended to halt incipient explosions immediately and/or to limit the effective range of an explosion and which are separately made available on the market for use as autonomous systems;
  • ‘Explosive atmosphere’ means a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture;
  • ‘Potentially explosive atmosphere’ means an atmosphere which could become explosive due to local and operational conditions.

 

Exemptions

Certain equipment is excluded from the scope of ATEX, such as (see also the ATEX 2014/34/EU Guidelines, 2nd edition 2017):

  • Medical devices intended for use in a medical environment.
  • Equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances.
  • Equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas.
  • Personal protective equipment covered by Directive 89/686/EEC.
  • Seagoing vessels and mobile offshore units together with equipment on board such vessels or units.
  • Means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water. Vehicles intended for use in a potentially explosive atmosphere are not excluded.

 

Other legislation related to the ATEX directive

The scope of the ATEX directive is focused on equipment and protective systems to be used in potentially explosive environments. However, these products may be electrical, they may be machines or other product groups. This means that the products and systems in question may first have to meet the requirements associated with their basic functions and that the ATEX directive regulates their use in potentially explosive atmospheres. In short, ATEX may apply in addition to other Directives, such as the Low Voltage Directive, Machinery Directive and others (e.g. controlling devices under ATEX may also be electrical equipment, and a machine may include a protective system within the scope of ATEX).

 

Notification and accreditation

Any CAB established in Turkey which wishes to notified body within the scope of the ATEX directive may apply for accreditation under this directive. Accreditation under this directive is the only route to becoming a Turkish notified body for the ATEX directive.

Bodies accredited under this directive may use the accreditation to apply to the Ministry of Industry and Technology for appointment and continuation of appointment as notified bodies under the ATEX Directive within their accredited scopes.

 

Modules and conformity assessment procedures

The following products are within the possible scope of activity for notified bodies according to the classification in the directive:

Group I electrical

Group I non-electrical

Group II gas electrical

Group II dust electrical

Group II gas non-electrical

Group II dust non-electrical

The modules that may be used and how they are to be used are given in the annexes of the directive. These modules are A, B, C1, D, E, F and G.

Please note that TURKAK’s policy for the harmonised standards to be used for the modules has been submitted to the relevant ministries and can be found in the information in the following links.

https://www.turkak.org.tr/duyurular/ea-217-dokumani-revizyonu-sonrasi-onaylanma-amacli-akreditasyon-kapsaminda-uygulanacak-akreditasyon-standartlari-ile-ilgili-gecis-sureci.html

Ek: Direktif/Modüllere göre Uygulanacak Akreditasyon Standardları Listesi

 

4.Pressure Equipment Directive – 2014/68/EU

The Pressure Equipment Directive applies to the design, manufacture and conformity assessment of stationary pressure equipment with a maximum allowable pressure greater than 0,5 bar. It aims to guarantee free movement of the products in its scope while ensuring a high level of safety.

The implementation of the Directive is supported by a set of PED Guidelines and guidance documents. These guidelines are not legally binding – instead, they help to ensure that the directive is applied consistently. Unless otherwise indicated, they represent the unanimous opinion of the Working Group Pressure composed of representatives of the national authorities of the Member States.

The list of references of harmonized standards and of European Approvals Materials are published Official Journal of the European Union.

This directive has been implemented in Turkish legislation through “Basınçlı Ekipmanlar Yönetmeliği” and published in the Turkish Official Journal, Resmi Gazete number 30349, 3 March 2018.

Turkish conformity assessment bodies wishing to become notified bodies under this directive have to work to the requirements in the Turkish implementation of the directive.

 

Definitions and scope

The Pressure Equipment Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.

For the purposes of this Directive, the following definitions apply:

  • ‘pressure equipment’ means vessels, piping, safety accessories and pressure accessories, including, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings, supports, lifting lugs;
  • ‘vessel’ means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment; a vessel may be composed of more than one chamber;
  • ‘piping’ means piping components intended for the transport of fluids, when connected together for integration into a pressure system; piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate; heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping;
  • ‘safety accessories’ means devices designed to protect pressure equipment against the allowable limits being exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices;
  • ‘pressure accessories’ means devices with an operational function and having pressure-bearing housings;
  • ‘assemblies’ means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole;

 

Exemptions

This Directive does not apply to:

  • pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from an installation (onshore or offshore) starting from and including the last isolation device located within the confines of the installation, including all the annexed equipment designed specifically for pipelines; this exclusion shall not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;
  • networks for the supply, distribution and discharge of water and associated equipment and headraces such as penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories;
  • simple pressure vessels covered by Directive 2014/29/EU of the European Parliament and of the Council;
  • aerosol dispensers covered by Council Directive 75/324/EEC;
  • equipment intended for the functioning of vehicles defined by the following legal acts:
  • Directive 2007/46/EC of the European Parliament and of the Council;
  • Regulation (EU) No 167/2013 of the European Parliament and of the Council;
  • Regulation (EU) No 168/2013 of the European Parliament and of the Council;
  • equipment classified as no higher than category I under Article 13 of this Directive and covered by one of the following Directives:
  • Directive 2006/42/EC of the European Parliament and of the Council;
  • Directive 2014/33/EU of the European Parliament and of the Council;
  • Directive 2014/35/EU of the European Parliament and of the Council;
  • Council Directive 93/42/EEC;
  • Directive 2009/142/EC of the European Parliament and of the Council;
  • Directive 2014/34/EU of the European Parliament and of the Council;
  • equipment covered by point (b) of Article 346(1) TFEU;
  • items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;
  • well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage which is intended to contain and/or control well pressure; this shall comprise the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;
  • equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other operational characteristics and for which pressure is not a significant design factor; such equipment may include:
  • engines including turbines and internal combustion engines;
  • steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;
  • blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaust-gas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, re-melting, de-gassing and casting of steel, iron and non-ferrous metals;
  • enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;
  • pressurised pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;
  • ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof;
  • pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment;
  • exhaust and inlet silencers;
  • bottles or cans for carbonated drinks for final consumption;
  • vessels designed for the transport and distribution of drinks having a PS·V of not more than 500 bar·L and a maximum allowable pressure not exceeding 7 bar;
  • equipment covered by Directive 2008/68/EC and Directive 2010/35/EU and equipment covered by the International Maritime Dangerous Goods Code and the Convention on International Civil Aviation;
  • radiators and pipes in warm water heating systems;
  • vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.

 

Other legislation related to the Pressure Equipment directive

It can be the case that some PE and assemblies are also subject to other EU product legislation. The common examples are:

  • Directive 2006/42/EC Machinery
  • Directive 2014/34/EU ATEX
  • Directive 2014/35/EU LVD
  • Directive 2009/142/EC GAD

 

Notification and accreditation

Any CAB established in Turkey which wishes to notified body within the scope of the Pressure Equipment directive may apply for accreditation under this directive. Accreditation under this directive is the only route to becoming a Turkish notified body for the Pressure Equipment directive.

Bodies accredited under this directive may use the accreditation to apply to the Ministry of Industry and Technology for appointment and continuation of appointment as notified bodies under the Pressure Equipment Directive within their accredited scopes.

 

Modules and conformity assessment procedures

PED Art.14 specifies the possible conformity assessment modules according to the classification of the PE based on the application of Art.13 and Annex II.

 

PE CategoryConformity Assessment Procedure/Modules
IA
IIA2, D1, E1
IIIB(design type) + D, B(design type) + F, B(production type) + E, B(production type) + C2, H
IVB(production type) + D, B(production type) + F, G, H1

 

A peculiarity of the PED is the concept of “global conformity assessment” for assemblies.

In addition to product conformity assessment, PED also requires participation of CABs in the following;

 

  • Joining procedure and personnel approvals
  • NDT operator approvals
  • European approval of materials

 

Please note that TURKAK’s policy for the harmonised standards to be used for the modules can be found in the information in the following links.

https://www.turkak.org.tr/duyurular/ea-217-dokumani-revizyonu-sonrasi-onaylanma-amacli-akreditasyon-kapsaminda-uygulanacak-akreditasyon-standartlari-ile-ilgili-gecis-sureci.html

Ek: Direktif/Modüllere göre Uygulanacak Akreditasyon Standardları Listesi

 

5.Construction Products Regulation – (EU) 305/2011

This Regulation lays down conditions for the placing or making available on the market of construction products by establishing harmonised rules on how to express the performance of construction products in relation to their essential characteristics and on the use of CE marking on those products.

This directive has been implemented in Turkish legislation through “Yapı Malzemeleri Yönetmeliği” and published in the Turkish Official Journal, Resmi Gazete number 28703, 10 Temmuz 2013.

Turkish conformity assessment bodies wishing to become notified bodies under this Regulation have to work to the requirements in the Turkish implementation of the Regulation.

 

Definitions and scope

For the purposes of this Regulation the following definitions apply:

  • ‘construction product’ means any product or kit which is produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works
  • ‘kit’ means a construction product placed on the market by a single manufacturer as a set of at least two separate components that need to be put together to be incorporated in the construction works
  • ‘construction works’ means buildings and civil engineering works

 

Exemptions

The CPR does not list any specific exceptions to its scope.

 

Notification and accreditation

Any CAB established in Turkey which wishes to notified body within the scope of the Machinery directive may apply for accreditation under this directive. Accreditation under this directive is the only route to becoming a Turkish notified body for the Construction Products Regulation.

The notifying authority for this regulation is the Ministry of Environment and Urbanisation- Bodies accredited under this regulation may use the accreditation to apply to the Ministry of Environment and Urbanisation (Çevre ve Şehircilik Bakanlığı) for appointment and continuation of appointment as notified bodies and designation as technical assessment bodies under the Construction Products Regulation within their accredited scopes.

 

Modules and related harmonized standards used for conformity assessment processes

The CPR has a conformity assessment structure that does not follow the traditional modules of the new approach directives. The conformity assessment bodies involved within the scope of the CPR are Notified certifications bodies for Assessment and Verification of Constancy of Performance and designated Technical Assessment Bodies (TAB) performing European Technical Assessment. Technical assessment bodies may or may not be notified as designated bodies to the NANDO database depending on the tasks they perform and depending on the choice of the designating national authority.

CPR Annex V Assessment and verification of constancy of performance (AVCP) requires the involvement of notified bodies which may offer one or more of the following tasks:

(1) Product certification body

(2) Factory production control certification body

(3) Testing laboratory

 

The CPR provides five different Assessment and Verification of Constancy of Performance (AVCP) systems,

  • System 1+: Involves notified body
  • System 1: Involves notified body
  • System 2+: Involves notified body
  • System 3: Does not involve notified body
  • System 4: Does not involve notified body

 

Please note that TURKAK’s policy for the harmonised standards to be used for the modules can be found in the information in the following links.

https://www.turkak.org.tr/duyurular/ea-217-dokumani-revizyonu-sonrasi-onaylanma-amacli-akreditasyon-kapsaminda-uygulanacak-akreditasyon-standartlari-ile-ilgili-gecis-sureci.html

Ek: Direktif/Modüllere göre Uygulanacak Akreditasyon Standardları Listesi

 

6.ISO 20287:2018 – Biotechnology – Biobanking

ISO 20387:2018 “Biotechnology – Biobanking – General requirements for biobanking”, specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.

It should be noted that some of the activities of a biobank are similar to those of other conformity assessment bodies such as medical, medical reference, biological and calibration laboratories.

 

Definitions and scope

ISO 20387:2018 is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.

The following definitions are an excerpt from ISO 20387: 2018. For a full list please refer to the standard.

  • ‘Biobank’ is a legal entity or part of a legal entity that performs biobanking.
  • ‘Biobanking’ is the process of acquisitioning and storing, together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data.
  • ‘Biological material’ is any substance derived or part obtained from an organic entity such as a human, animal, plant, microorganism(s) or multicellular organism(s) that is(are) neither animal nor plant (e.g. brown seaweed, fungi).

 

Exemptions

ISO 20387:2018 is not applicable to biological material intended for food/feed production laboratories undertaking analysis for food/feed production and/or therapeutic use.

 

Other legislation related to Biobanking

National and regional regulations or requirements have to be applied in biobanks (human, animals, fungus, plants and microorganisms). It is the responsibility of the biobanking organisation to identify and implement the national and regional legal requirements. At the moment there are not any guidance or implementation documents issued by the Turkish authorities on the management and activities of biobanks.

 

Accreditation

Biobanking organisations established in Turkey may apply for accreditation by TURKAK according to ISO 20387:2018.

 

7.Recreational Craft and Personal Watercraft Directive – 2013/53/EU

The directive lays down requirements for manufacturers, importers and distributors of watercraft and builds on legislation adopted in 2003 which included limits on engine exhaust emissions (CO, HC, NOx and particulates) and noise levels to reflect technological developments that have resulted in improved environmental performance.

Other essential requirements include minimization of the risk of falling overboard and easy reboarding; good all-round visibility for the operator; sufficient structure, stability and buoyancy and emergency stopping device for all tiller-controlled outboard propulsion engines.

This directive has been implemented in Turkish legislation through “Gezi Tekneleri ve Kişisel Deniz Taşıtları Yönetmeliği” and published in the Turkish Official Journal, Resmi Gazete number 30057, 5 May 2017.

Turkish conformity assessment bodies wishing to become notified bodies under this directive have to work to the requirements in the Turkish implementation of the directive.

 

Definitions and scope

For the purposes of this Directive the following definitions shall apply:

  • ‘watercraft’ means any recreational craft or personal water­craft.
  • ‘recreational craft’ means any watercraft of any type, excluding personal watercraft, intended for sports and leisure purposes of hull length from 2,5 m to 24 m, regardless of the means of propulsion.
  • ‘personal watercraft’ means a watercraft intended for sports and leisure purposes of less than 4 m in hull length which uses a propulsion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting, standing or kneeling on, rather than within the confines of, a hull.
  • ‘watercraft built for own use’ means a watercraft predomi­nantly built by its future user for his own use.
  • ‘propulsion engine’ means any spark or compression ignition, internal combustion engine used directly or indi­rectly for propulsion purposes.

 

The following products are within the scope of this directive:

  1. Recreational craft and partly completed recreational craft;
  2. Personal watercraft and partly completed personal watercraft;
  3. Components listed in Annex II when placed on the Union market separately, hereinafter referred to as ‘components’;
  4. Propulsion engines which are installed or specifically intended for installation on or in watercraft;
  5. Propulsion engines installed on or in watercraft that are subject to a major engine modification;
  6. Watercraft that are subject to major craft conversion.

 

Exemptions

The following products are exempted from the scope of this directive.

 

Products exempted with regard to design and construction requirements set out in Part A of Annex I to the directive

  1. Watercraft intended solely for racing, including rowing racing boats and training rowing boats, labelled as such by the manufacturer;
  2. Canoes and kayaks designed to be propelled solely by human power, gondolas and pedalos;
  • Surfboards designed solely to be propelled by wind and to be operated by a person or persons standing;
  1. Surfboards;
  2. Original historical watercraft and individual replicas thereof designed before 1950, built predominantly with the original materials and labelled as such by the manufacturer;
  3. Experimental watercraft, provided that they are not placed on the Union market;
  • Watercraft built for own use, provided that they are not subsequently placed on the Union market during a period of five years from the putting into service of the watercraft;
  • Watercraft specifically intended to be crewed and to carry passengers for commercial purposes, without prejudice to paragraph 3, regardless of the number of passengers;
  1. Submersibles;
  2. Air cushion vehicles;
  3. Hydrofoils;
  • External combustion steam powered watercraft, fueled by coal, coke, wood, oil or gas;
  • Amphibious vehicles, i.e. wheeled or track-laying motor vehicles, which are able to operate both on water and on solid land;

Products exempted with regard to exhaust emission set out in Part B of

  1. Propulsion engines installed or specifically intended for installation on the following products:
  • watercraft intended solely for racing and labelled as such by the manufacturer;
  • experimental watercraft, provided that they are not placed on the Union market;
  • submersibles;
  • air cushion vehicles;
  • hydrofoils;
  • Amphibious vehicles, i.e. wheeled or track-laying motor vehicles, which are able to operate both on water and on solid land.
  1. Engines, which are based on a pre-1950 design, not produced in series and fitted on watercraft referred to in points (v) or (vii) of cl. 1.2.1 of the directive.
  • Propulsion engines built for own use provided that they are not subsequently placed on the Union market during a period of five years from the putting into service of the watercraft.

 

Products exempted with regard to noise emission

  1. All watercraft referred in cl. 1.2.2 of the directive;
  2. Watercraft built for own use, provided that they are not subsequently placed on the Union market during a period of five years from the putting into service of the watercraft.

 

Other legislation related to the Recreational Craft and Personal Watercraft directive

In addition to the requirements as laid down in the RCD, other national, international and/or EU legislation may be applicable to the above-mentioned products or parts thereof.

Therefore, the manufacturer of the products covered by this directive should take due care to determine if any other Directive or legislation does apply. Non-exhaustive list of other EU Directives that may apply:

  • EMC Directive 2013/40/EU
  • Machinery Directive 2006742/EU
  • Energy Efficiency Directive 2012/27/EU
  • Low voltage directive (LVD) (2014/35/EU)
  • Radio equipment directive 2014/53/EU

 

Notification and accreditation

Any CAB established in Turkey which wishes to notified body within the scope of the Recreational Craft and Personal Watercraft directive may apply for accreditation under this directive. Accreditation under this directive is the only route to becoming a Turkish notified body for the Recreational Craft and Personal Watercraft directive.

The notifying authority for this directive is the Ministry of Transport, Maritime Affairs and Communication (Ulaştırma, Denizcilik ve Haberleşme Bakanlığı). Bodies accredited under this directive may use the accreditation to apply to the Ministry of Transport, Maritime Affairs and Communication for appointment and continuation of appointment as notified bodies under this directive within their accredited scopes.

 

Modules and related harmonized standards used for conformity assessment processes

The following table gives an overview of the applicable modules

 

Design category

 (see Annex I)

Applicable modules depending on length and use of harmonised standard
2.5m £ hull length <12m12m £ hull length < 24m
AA1, B+C, B+D, B+E, B+F, G or HB+C, B+D, B+E, B+F,
G or H
B
CWhere harmonised standards are used for stability and buoyancy (ER 3.2 & 3.3):

A, A1, B+C, B+D, B+E, B+F, G or H

Where harmonised standards are not used for stability and buoyancy (ER 3.2 & 3.3):

A1, B+C, B+D, B+E, B+F, G or H

DA, A1, B+C, B+D, B+E, B+F, G or H

 

Please note that TURKAK’s policy for the harmonised standards to be used for the modules can be found in the information in the following links.

https://www.turkak.org.tr/duyurular/ea-217-dokumani-revizyonu-sonrasi-onaylanma-amacli-akreditasyon-kapsaminda-uygulanacak-akreditasyon-standartlari-ile-ilgili-gecis-sureci.html

Ek: Direktif/Modüllere göre Uygulanacak Akreditasyon Standardları Listesi

 

8.Interoperability of the Rail System Directive – (EU) 2016/797

The Interoperability of Rail System Directive (IOD) establishes the conditions to be met to achieve interoperability within the Union rail system in a manner compatible with Directive (EU) 2016/798 in order to define an optimal level of technical harmonisation, to make it possible to facilitate, improve and develop rail transport services within the Union and with third countries and to contribute to the completion of the single European railway area and the progressive achievement of the internal market. Those conditions concern the design, construction, placing in service, upgrading, renewal, operation and maintenance of the parts of that system as well as the professional qualifications of, and health and safety conditions applying to, the staff who contribute to its operation and maintenance.

The directive is one of three legislative acts covering the technical aspects of the fourth railway package which aims to revitalise the rail sector and deliver a better quality of service and more choice to passengers. It works alongside the Regulation (EU) 2016/796 on the European Agency for Railways and Directive (EU) 2016/798 on railway safety.

Following the outbreak of the COVID-19 pandemic in 2020, the directive was amended by Directive (EU) 2020/700 to extend the deadline for incorporating the content of the directive into EU countries’ national law.

The directive is to be enacted in Turkish law according to the Railway Systems Interoperability Regulation (‘RSIR’). It is currently available in draft form.

Turkish conformity assessment bodies wishing to become notified bodies under this directive have to work to the requirements in the Turkish implementation of the directive.

 

Definitions and scope

Annex I of the directive describes the elements of the EU rail system and Annex II describes the product groups of the EU rail system, called Subsystems. For each Subsystem, there is a Technical Specification for Interoperability (TSI); each TSI defines and describes certain Interoperability Constituents.

It is important to note that the subsystems themselves are also subject to assessment and certification, as well as the interoperability constituents. Rail projects at subsystem level can be worth several 100 million euros (eg a new fleet of trains) or even several billion euros (eg a major infrastructure improvement project). Such projects can take several years to complete. This makes the IOD different from a typical ’Global Approach’ directive according to Regulation 765/2008/EC.

For the purposes of this directive:

  • ‘Union rail system’ means the elements listed in Annex I of the directive.
  • ‘interoperability’ means the ability of a rail system to allow the safe and uninterrupted movement of trains which accomplish the required levels of performance.
  • ‘vehicle’ means a railway vehicle suitable for circulation on wheels on railway lines, with or without traction; a vehicle is composed of one or more structural and functional subsystems.
  • ‘network’ means the lines, stations, terminals, and all kinds of fixed equipment needed to ensure safe and continuous operation of the Union rail system.
  • ‘subsystems’ means the structural or functional parts of the Union rail system, as set out in Annex II;
  • ‘mobile subsystem’ means the rolling stock subsystem and the on-board control-command and signaling subsystem.
  • ‘interoperability constituents’ means any elementary component, group of components, subassembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem, upon which the interoperability of the rail system depends directly or indirectly, including both tangible objects and intangible objects.
  • ‘product’ means a product obtained through a manufacturing process, including interoperability constituents and subsystems.

The following are descriptions of some of the concepts used in the directive:

 

ERA – EU Agency for Railways

ERA is the EU authority charged with the following tasks:

  • Promote a harmonised approach to railway safety
  • Devise the technical and legal framework in order to enable removing technical barriers, and acting as the system authority for ERTMS (European Rail Traffic Management System) and telematics applications
  • Improve accessibility and use of railway system information
  • Act as the European Authority under the 4th Railway Package issuing vehicle (type) authorisations and single safety certificates, while improving the competitive position of the railway sector.

 

NB-Rail Coordination Group

The European Commission has set up the NB-Rail Coordination Group in accordance with the principles of (EU) 2016/797 Art 44, (EC) No 765/2008 Art R30 & R17(11) and the Blue Guide 2016 (5.2.2 & 5.2.4).

In line with the above, main purpose of the NB-Rail Coordination Group is to discuss matters relating to the application

  • of the relevant TSIs
  • of the procedures for assessing conformity or suitability for the use of interoperability constituents,
  • of the procedures for the verification of subsystems.

TSI

This is the abbreviation for Technical Specifications for Interoperability.

RFU

NB-Rail issues Recommendations for Use (RFU)  to ensure a uniform application of the current technical provisions of the IOD scheme.

Infrastructure [INF]

The infrastructure subsystem concerns the civil engineering structure that supports the track (embankments, cuttings, bridges, tunnels, etc), the track and pointwork (switches and crossings), passenger station elements including accessibility features (platforms, toilets, information systems, etc), fixed installations for servicing trains. Interoperability Constituents for the infrastructure subsystem include the sleepers, rails and track fixings.

The characteristics of the infrastructure within each Member State is published within a register of infrastructure.

Energy [ENE]

The energy subsystem concerns the electrification power supply system for the trains, including the gantries / masts supporting the overhead wires and the trackside electricity consumption measuring and charging system. The Interoperability Constituent for the energy subsystem is the overhead contact line (wire).

Control-command and signalling [CCS]

The CCS subsystem concerns specialised equipment both on and beside the track and onboard trains and is described in two parts:

Trackside: The fixed signalling and radio equipment (include balises / loops, radio in-fill) and their functional and safety level requirements to command and control movements of trains authorised to travel on the network.

On-board: The mobile signalling and radio equipment (including Driver-Machine Interface units, antenna, radio units) and their functional and safety level requirements to monitor and intervene with (where necessary) the safe movement of trains.

The Interoperability Constituents in the CCS subsystem are defined in groups of individual components.

The major feature of the CCS subsystem is the definition of the European Rail Traffic Management System (ERTMS), comprising the European Train Control System (ETCS) and a mobile communication system for the railways (GSM-R), referred to as the Class A train protection system. Existing (legacy) signalling and radio systems are referred to as the Class B train protection systems and are the responsibility of the relevant Member State.

Rolling stock [RST]

The rolling stock subsystem concerns the rail vehicles, including structural bodywork, running gear (bogies, wheelsets, suspension, etc.), electric current collection devices, traction and energy conversion units, brakes, couplings, passenger-related items (including accessibility features for persons with reduced mobility) and load carrying requirements for freight wagons. Interoperability Constituents for the rolling stock subsystem include the wheels / axles, couplings, head / marker / tail lamps, pantographs (current collection device), drivers seat, etc.

There are separate TSIs for Locomotives and Passenger vehicles (LOC&PAS), either individual or as a trainset in fixed formation; and freight wagons (WAG). There is a further TSI covering noise requirements for rolling stock.

All rolling stock is assigned a European Vehicle Number (EVN) within the European Vehicle Register, according to Appendix H of the OPE TSI.

Persons of Reduced Mobility [PRM]

The PRM TSI concerns the accessibility requirements for trains and stations to achieve one of the general principles of the United Nations Convention on the Rights of Persons with Disabilities. This includes doors and entrances, visual information, lighting, toilets, wheelchair spaces, handrailse and boarding aids. Interoperability Constituents for the rolling stock subsystem include displays, ramps, lifts, door controls, toilets, call-for-aid device, etc

Safety in Rail Tunnels [SRT]

The SRT TSI concerns the specific technical features to reduce the risks associated with the operation of trains through tunnels, including the risk of fire (however caused). This includes fire resistance, fire detection, escape walkways, emergency communication, evacuation requirements, etc.in the most cost-efficient way. There are no Interoperability Constituents specified in the SRT TSI.

 

Exemptions

This Directive does not apply to:

  • metros,
  • trams and light rail vehicles, and infrastructure used exclusively by those vehicles,
  • networks that are functionally separate from the rest of the Union rail system and intended only for the operation of local, urban or suburban passenger services, as well as undertakings operating solely on those networks.

 

Member States may exclude the following from the scope of the measures implementing this Directive:

  • privately owned railway infrastructure, including sidings, used by its owner or by an operator for the purpose of their respective freight activities or for the transport of persons for non-commercial purposes, and vehicles used exclusively on such infrastructure.
  • infrastructure and vehicles reserved for a strictly local, historical or touristic use.
  • light rail infrastructure occasionally used by heavy rail vehicles under the operational conditions of the light rail system, where it is necessary for the purposes of connectivity of those vehicles only; and
  • vehicles primarily used on light rail infrastructure but equipped with some heavy rail components necessary to enable transit to be effected on a confined and limited section of heavy rail infrastructure for connectivity purposes only.

 

In the case of tram-trains operating in the Union rail system, where there are no TSIs that apply to those tram-trains, the following apply:

  • Member States concerned shall ensure that national rules or other relevant accessible measures are adopted in order to ensure that such tram-trains meet the relevant essential requirements.
  • Member States may adopt national rules in order to specify the authorisation procedure applicable to such tram-trains. The authority issuing the vehicle authorisation shall consult the relevant national safety authority in order to ensure that mixed operation of tram-trains and heavy rail trains meet all essential requirements as well as relevant common safety targets (‘CSTs’).
  • by way of derogation from Article 21 of the directive, in the case of cross-border operation, the relevant competent authorities shall cooperate with a view to issuing the vehicle authorisations.

 

Other legislation related to the Interoperability of the Rail System directive

The following other EU directives may apply to IOD subsystems and interoperability constituents:

 

Electromagnetic Compatibility (EMC) Directive 2014/30/EU

The EMC Directive ensures that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance. This is relevant to the rail industry sector, particularly for modern signalling systems which relies on a high safety integrity level interface between the trains and trackside equipment.

 

Pressure Equipment Directive (PED) 2014/68/EU

Inland Transport of Dangerous Goods Directive 2008/68/EC

The PED and Dangerous Goods Directives can apply to the rail industry sector, particularly for the rail wagons designed to carry dangerous goods and / or pressurised cargos (eg tank wagons).

 

Machinery Directive 2006/42/EC

The Machinery Directive sets out the essential health and safety requirements for workers using powered machinery. This is relevant to the rail industry sector, particularly for track maintenance machines which can operate on the rail network.

 

A non-exhaustive list of other EU Directives that my apply is as follows:

  • EMC Directive 2013/40/EU
  • Machinery Directive 2006742/EU
  • Energy Efficiency Directive 2012/27/EU
  • Low voltage directive (LVD) (2014/35/EU)
  • Radio equipment directive 2014/53/EU

 

Notification and accreditation

Any CAB established in Turkey which wishes to be a notified body within the scope of this directive may apply for accreditation under this directive. Accreditation under this directive is the only route to becoming a Turkish notified body for the Interoperability of the Rail System directive.

Bodies accredited under this directive may use the accreditation to apply to the Ministry of Transport and Infrastructure for appointment and continuation of appointment as notified bodies under this Directive within their accredited scopes.

 

Modules and related harmonized standards used for conformity assessment processes

For the IOD, the standard A-H conformity assessment procedures (modules) contained in Annex II of Decision 768/2008/EC, have been adapted and the conformity assessment modules to be used by IOD notified bodies are set out in EU decision document 2010/713/EU. This contains two types of conformity assessment modules: modules with the prefix ‘C’ (such as CB) are for the Interoperability Constituents; modules with the prefix ‘S’ (such as SB) are for the Subsystems. Each TSI defines which modules apply to that subsystem.

IOD notified bodies undertake conformity assessment, including EC-type examination, of new, upgraded or renewed Interoperability Constituents and Subsystems for all structural and transverse subsystems of the EU rail system according to 2010/713/EU, using the relevant TSI(s) as the principal assessment criteria. For structural subsystems the IOD notified body issues a certificate of verification intended for the applicant (client) who in turn draws up the ‘EC’ declaration of verification to support the EU authorisation process for placing into service, according to Annex IV of the IOD.

For larger, subsystem projects, the IOD notified body may issue an ‘Intermediate Statement of Verification’ (ISV) to recognise that the project has reached a key stage (for example testing of the subsystem under controlled conditions prior to full service introduction).

NB-Rail issues Recommendations for Use (RFU) to ensure a uniform application of the current technical provisions of the IOD scheme. RFUs relevant to the work of the IOD notified bodies include RFU-STR-001 ‘Content of EC Certificates’ and RFU-STR-011 ‘Content of Notified Body File’.

ERA Management Board Decision No.156 includes the issue of Technical Document MNB-Assessment Scheme 000MRA 1044. The purpose of this document is to provide confidence that CABs have the correct procedures and competence to perform IOD NoBo activities within the EU railway legal framework and provides clarification, guidance and examples specific to the IOD scheme for the various clauses of ISO/IEC 17065:2012.

Regulation 402/2013/EC concerning the Common Safety Method for Risk Evaluation and Assessment (‘CSM-RA’) sets out the approach to risk assessment within the EU rail industry sector.

Please note that TURKAK’s policy for the harmonised standards to be used for the modules can be found in the information in the following links.

https://www.turkak.org.tr/duyurular/ea-217-dokumani-revizyonu-sonrasi-onaylanma-amacli-akreditasyon-kapsaminda-uygulanacak-akreditasyon-standartlari-ile-ilgili-gecis-sureci.html

Ek: Direktif/Modüllere göre Uygulanacak Akreditasyon Standardları Listesi

 

9.Measuring Instruments Directive – 2014/32/EU

The Measuring Instrument Directive lays down uniform, EU-wide rules on the sale and putting into use of measuring instruments (MIs). MIs are important for trade, consumers and industry as they ensure the accuracy of measurements and help the transparency and fairness of commercial transactions.

The directive aims to:

  • establish the essential requirements that instruments or systems with a measurement function have to satisfy.
  • introduce simpler, clearer and more-consistent rules and ensure traceability.
  • reduce administrative burdens for manufacturers, importers and distributors.
  • ensure that instruments compliant with the essential requirements can circulate freely within the EU.

Benefits should include:

  • compliant and more-accurate measuring instruments on the EU market and increased levels of public trust in them.
  • fewer non-compliant instruments and distortions of competition on the market arising from different enforcement practices.
  • protection of the public from wrong measurements.
  • increased room for technological innovation, by adopting a modern regulatory approach.

 

This directive has been implemented in Turkish legislation “Ölçü Aletleri Yönetmeliği” and published in the Turkish Official Journal, Resmi Gazete number 29757, 29 June 2016.

Turkish conformity assessment bodies wishing to become notified bodies under this directive have to work to the requirements in the Turkish implementation of the directive.

 

Definitions and scope

Legally controlled measuring instruments are used for a variety of measurement tasks in the areas of public health and safety and of fair trading.

The directive applies to:

  • utility meters (water meters, gas meters and volume-conversion devices, active electrical energy meters and thermal energy meters);
  • measuring systems for the continuous and dynamic measurement of quantities of liquids other than water (e.g. petrol pumps);
  • automatic weighing instruments (e.g. rail weighbridges or automatic packaging lines);
  • taximeters;
  • material measures and dimensional measuring instruments (e.g. for metalworking or woodworking); and
  • exhaust gas analysers (e.g. to check engine performance).

 

The directive applies to all MIs that are new to the EU market when they are placed on that market or put into use, that is that they are:

  • new MIs made by a manufacturer established in the EU; or
  • MIs imported from a non-EU country, whether they are new or second hand.

It applies to all forms of supply of MIs, including distance selling.

 

Exemptions

There are no exclusions for the scheme as it covers the above instruments regardless of whether or not they have been prescribed in Turkey for measuring tasks where they consider it justified for reasons of public interest, health, safety and order, the protection of the environment or consumers and for levying of taxes and duties and fair trading.

 

Other legislation related to the Measuring Instruments directive

It can be the case that some MID and assemblies are also subject to other EU product legislation. The manufacture shall identify all the relevant directives that apply, common examples are:

  • Directive 2014/30/EU on electromagnetic compatibility
  • Directive 2014/35/EU on low voltage equipment

 

Notification and accreditation

Any CAB established in Turkey which wishes to be a notified body within the scope of this directive may apply for accreditation under this directive. Accreditation under this directive is the only route to becoming a Turkish notified body for the Measuring Instrument directive.

The notifying authority for the MID is the Ministry of Industry and Trade (Sanayi ve Ticaret Bakanlığı). Bodies accredited under this directive may use the accreditation to apply to the Ministry of Industry and Trade (Sanayi ve Ticaret Bakanlığı) for appointment and continuation of appointment as notified bodies under this Directive within their accredited scopes.

 

Modules and conformity assessment procedures

Modules and conformity assessment procedures relevant for the MID are given in the following table.

 

MI TypeConformity Assessment Procedures (Modules)
MI-001 – Water metersB followed by either D or F; or H1
MI-002 – Gas meters & Volume conversion devicesB followed by either D or F; or H1
MI-003 – Active electrical energy metersB followed by either D or F; or H1
MI-004 – Thermal energy metersB followed by either D or F; or H1
MI-005 – Measuring systems for the continuous and dynamic measurement of quantities of liquids other than waterB followed by either D or F; or G or H1
MI-006 – Automatic weighing instruments

– mechanical systems

 

– electromechanical systems

 

– electronic or systems containing software

 

B followed by D, E or F; or D1 or F1 or G or H1

 

B followed by either D, E or F; or G or H1

 

B followed by either D or F; or G or H1

MI-007 Taxi metersB followed by either D or F; or H1
MI-008 – Material measures

– length

 

Capacity serving measures

 

B followed by D; or D1 or F1 or G or H

 

B followed by either D or E; or A2 or D1 or E1 or F1 or H

MI-009 – Dimensional measuring instruments

– For mechanical or electromechanical instruments

 

For electronic instruments or instruments containing software

 

 

B followed by either D, E or F; or D1 or E1 or F1 or G or H or H1

 

B followed by either D or F; or G or H1

MI-010 – Exhaust gas analysersB followed by either D or F; or H1

 

 

Please note that TURKAK’s policy for the harmonised standards to be used for the modules can be found in the information in the following links.

 

https://www.turkak.org.tr/duyurular/ea-217-dokumani-revizyonu-sonrasi-onaylanma-amacli-akreditasyon-kapsaminda-uygulanacak-akreditasyon-standartlari-ile-ilgili-gecis-sureci.html

Ek: Direktif/Modüllere göre Uygulanacak Akreditasyon Standardları Listesi

 

10.Cableway Installations Regulation (EU) 2016/424

This Regulation lays down rules on the making available on the market and the free movement of subsystems and safety components for cableway installations. It also contains rules on the design, construction and entry into service of new cableway installations.

It sets out rules on the essential safety requirements, design, construction and entry into service of new cableways carrying passengers. These ensure passenger safety and enable the equipment to be sold and used throughout the EU.

The legislation applies to new cableway installations, to modifications to existing cableway installations which require authorisation and to subsystems and safety components for cableways installations. They must all meet the essential safety requirements contained in Annex II of the regulation. Annex II contains essential requirements that cover all aspects of cableway installations, including maintenance and operability, ranging from dimensions and assembly to towing and control devices.

The national person or authority responsible for cableway installations must carry out a comprehensive safety analysis of each planned installation and include the results in a safety report.

This directive has been implemented in Turkish legislation through “Kablolu Taşıma Tesisatı Yönetmeliği” and published in the Turkish Official Journal, Resmi Gazete number 30258, 2 December 2017.

Turkish conformity assessment bodies wishing to become notified bodies under this directive have to work to the requirements in the Turkish implementation of the directive.

 

Definitions and scope

For the purposes of this directive the following definitions apply.

  • ‘cableway installation’ means a whole on-site system, consisting of infrastructure and subsystems, which is designed, constructed, assembled and put into service with the objective of transporting persons, where the traction is provided by cables positioned along the line of travel.
  • ‘subsystem’ means a system listed in Annex I of the directive, or a combination thereof, intended to be incorporated into a cableway installation.
  • ‘infrastructure’ means a station structure or a structure along the line specifically designed for each cableway installation and constructed on-site, which takes into account the layout and the data of the system and which is needed for the construction and the operation of the cableway installation, including the foundations.
  • ‘safety component’ means any component of equipment or any device intended to be incorporated into a subsystem or a cableway installation for the purpose of ensuring a safety function, the failure of which endangers the safety or health of passengers, operating personnel or third parties.

 

The legislation covers

  • cable cars, funiculars and chairlifts carrying people, particularly in high-altitude tourist resorts, urban transport and sport facilities.
  • funicular railways and other installations with vehicles mounted on wheels or on other suspension devices where traction is provided by one or more cables.
  • cable cars where the cabins are lifted and/or displaced by one or more carrier cables; this category also includes gondolas and chair lifts.
  • drag lifts, where users with appropriate equipment are dragged by means of a cable.

 

Traction by cable and passenger transport are the 2 essential criteria determining whether a cableway installation is covered by the legislation.

The following describes the various components of cableways covered by the directive:

Infrastructure:

– steel structure of stations (maintaining the mechanical equipment)

– steel structure of the line (maintaining the mechanical line equipment)

– building constructions (foundations) for stations and line towers

– other building construction for surrounding infrastructure (operator rooms, electrical equipment rooms, rooms for public areas, washrooms, cafes, etc.)

Subsystems:
Subsystem 1: Ropes and rope connections

Safety components

– carrying-hauling rope

– Rope splice

 

Subsystem 2: Drives and brakes

Safety components

– Drive pulley with gear rim

– Drive pulley bearing

– Drive frame

– Brake caliper for safety and service brake

– Hydraulic centre for brake

 

Subsystem 3: Mechanical equipment

Subsystem 3.1: Rope winding gear

Safety components

– Hydraulic cylinder

– Load measuring pin

– Hydraulic clamping system

 

Subsystem 3.2: station machinery

Safety components

Subsystem 3.2 a: Station controls – rope deflection

– Clamping force testing device (mechanical part)

– Vertical rope deflection

– Horizontal rope deflection

– Coupling point complete

Subsystem 3.2 b: diverting group

– Deflecting pulley

– Bearing of deflecting pulley

– Deflection frame

Subsystem 3.2 c: anti-crossing device stations

– Drive-through protection

 

Subsystem 3.3: line engineering

Safety components

– Load-bearing roller battery 550

– Roller battery, holding down 420

– counter roller battery 550/420

 

Subsystem 4: carriers

Safety components

– Vehicle Cabin

– Suspension Vehicle

– Maintenance vehicle

– Rope clamp

 

Subsystem 5: Electrotechnical installations

Safety components

– Electrotechnical installations for cableways in circulating operation

 

Subsystem 6: Rescue equipment

Safety components

– Crawler cranes

 

Exemptions

The legislation does not apply to:

  • lifts covered by Directive 2014/33/EU.
  • cableway installations that are categorised by Member States as historic, cultural or heritage installations, that entered into service before 1 January 1986 and that are still in operation, and that have not had any significant changes in design or construction, including subsystems and safety components specifically designed for them.
  • installations intended for agricultural or forestry purposes.
  • cableway installations for the service of mountain shelters and huts intended only for the transport of goods and specifically designated persons.
  • on-site or mobile equipment exclusively designed for leisure and amusement purposes and not as a means for transporting persons.
  • mining installations or other industrial on-site installations used for industrial activities.
  • installations in which the users or their carriers are waterborne.

 

Notification and accreditation

Any CAB established in Turkey which wishes to be a notified body within the scope of this directive may apply for accreditation under this directive. Accreditation under this directive is the only route to becoming a Turkish notified body for the Cableway directive.

The notifying authority for the Cableway directive is the Ministry of Industry and Trade (Sanayi ve Ticaret Bakanlığı). Bodies accredited under this directive may use the accreditation to apply to the Ministry of Industry and Trade (Sanayi ve Ticaret Bakanlığı) for appointment and continuation of appointment as notified bodies under this Directive within their accredited scopes.

 

Modules and related harmonized standards used for conformity assessment processes

The modules applicable under the Cableway directive are Module B, D, F, G and H1.

In order to place a subsystem or safety component of a cableway on the market, the following common system of combination of modules is possible:

 

DesignProduction
Modul BModul D
Modul F
Modul G
Module H1

 

Please note that TURKAK’s policy for the harmonised standards to be used for the modules can be found in the information in the following links.

https://www.turkak.org.tr/duyurular/ea-217-dokumani-revizyonu-sonrasi-onaylanma-amacli-akreditasyon-kapsaminda-uygulanacak-akreditasyon-standartlari-ile-ilgili-gecis-sureci.html

Ek: Direktif/Modüllere göre Uygulanacak Akreditasyon Standardları Listesi

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