Respiratory protection device CE certification

Introduction to CE certification of PPE respiratory protection devices

Respiratory protective equipment belongs to PPE personal protective equipment, and for this type of product to obtain CE certification, it must comply with the requirements of the EU Personal Protective Equipment PPE Regulation (EU) 2016/425 (replacing the original)

There is a directive: 89/686/EEC, which requires CE certification based on the corresponding risk level (Class I, Class I, Class I) and standards.

Respiratory protective devices generally belong to PPE Class III products, and the certification modes that can be used are B+C2 or B+D, where:

Module B: EU Form Check

Module C2: Internal production control+random interval supervision product inspection

Module D: Consistency assurance in the production process

The meaning of adding CE marking to respiratory protection devices

1. Any product must be affixed with CE marking before entering the EU market and use

Products involving multiple directives, CE marking indicates that the product meets the requirements of all applicable directives

3. CE marking must be affixed by the manufacturer and their authorized representative in the European Union

The affixing of the CE mark must follow a fixed format and specific requirements

The 5 CE markings require clear visibility and easy identification on the product, with shelves affixed to the product packaging or random documents