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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.

 

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. TSE PRODUCT SCOPE AND RELATED HARMONIZED STANDARDS

You can access our PPE product groups and related harmonized standards that we provide service under the Regulation from the link below.

TSE PPE SERVICE SCOPE

3. 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

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

NANDO

5. 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

 


Documents (3)

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