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Personal Protective Equipment Directive

Personal Protective Equipment Regulation (EU) 2016/425

 

New PPE Regulation (EU) 2016/425 has been entered into force in Turkey as of May 2019.

Our Institution has been designated as a notified body with the number of 1783, and has been published on the list of European Union Notified Bodies (NANDO)  with its scope on the website.

SCOPE EXTENSION:

The new service scope of our Institution was published on the European Commission New Approach Notified and Designated Bodies (NANDO) website as of 31.12.2020.

TSE SERVICE SCOPE VE RELATED HARMONISED STANDARDS

Equipment providing foot, leg and anti-slip protection

EN 50321 Electrically insulating footwear for working on low voltage installation

EN ISO 20345 Safety footwear

EN ISO 20346 Protective footwear

EN ISO 20347 Occupational footwear                    

EN 14404+A1 Knee protectors for work in the kneeling position

EN 15090 Footwear for firefighters

Equipment providing head protection

EN 397+A1 Industrial safety helmets

EN 812 Industrial bump caps

Equipment providing hand and arm protection

EN 388 Protective gloves against mechanical risks

EN 407 Protective gloves against thermal risks (heat and/or fire)

EN 420 + A1 Protective gloves general requirements and test methods

Equipment providing general body protection (clothing)

EN ISO 20471 High visibility clothing-test methods and requirements

EN 343+A1/AC Protective clothing-Protection against rain

EN 14605+A1 Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB[4])

EN 14126 +A1 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents

EN 13034+A1 Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

EN ISO 13982-1 Protective clothing for use against solid particulates - Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates (type 5 clothing)

Equipment providing eye and face protection

EN 166 Personal eye protection - Specifications

Equipment providing respiratory system protection

EN 149+A1 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking

 

 

1. PPE CERTIFICATION APPLICATION DOCUMENTS

EU Type Examination Procedures (Module B)  for Category II Products

IConformity Assesment Application Form and Agreement (must be filled 2 copies)

II- Information Form

III- Prepayment Receipt (3000 USD)

IV- Technical File (Regulation Annex III)

1- Description of Products

2-Samples of Label

3-Consumer Infomation Notice (User Manual)

4-Organisation Chart

5-Manufacturing Prosess

6-List of Suppliers

7-Test Reports

8-Conformity Assessment Reports

9-Declaration of Conformity

10-Risk assessment

11- Pictures and technical drawings of the product

12- Internal control documents (Module C)

V- Samples representing the PPE intended to be produced ( The notified body may request additional samples if necessary for the testing program)

VI- To inform us for ammendments: Technical File Ammendment Form

 

2. CHANGES IN NEW PPE REGULATION

Essential information about the ammendments introduced by the New Regulation can be obtained from the link below.

PPE NEW REGULATION CHANGES

PPE Transfer Application Form for EU Type Examination Certificate

3. You can check Turkish Standard Institution’s full designated scope, which is publicly accessible and downloadable on the NANDO website.

NANDO

4. Guidance document for risk assessment can be found in the link below.

Risk Assesment Guidance

Please communicate with us for your questions and our fees.

 

Service Program

Responsible for Personal Protective Equipment Directive

Ahmet Yavuz ÇEKİRGE

Tel: 90 - 312 416 64 44
Fax: 90 - 312 416 62 82
aycekirge@tse.org.tr

 


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