CE Marking
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
I- Conformity 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.
3. CHANGES IN NEW PPE REGULATION
Essential information about the ammendments introduced by the New Regulation can be obtained from the link below.
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.
5. Guidance document for risk assessment can be found in the link below.
Please communicate with us for your questions and our fees.
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