CE Mark Access Certificate Is A Condition For Exporting Personal Protective Masks To EU

Recently, TESTEX Swiss Textile Testing Co., Ltd. conducted an on-site audit of module C2 (internal quality control + random supervision and random inspection) certification of en 149 filter half mask mask for particle inhalation of respiratory protective device. After obtaining the relevant certification certificate, it means that the personal protective masks produced by the company can be legally sold in the EU.

What kind of certification should be obtained for personal protective masks exported to EU before they can be circulated in the local market? What is the specific workflow of these certifications? For personal protective mask manufacturers, it is necessary to understand the following requirements for the export of products to the EU market.

Access system of CE mark

CE mark is no stranger to most manufacturers of protective equipment. It is understood that the EU CE certification is actually a CE mark access system. CE marking system is the EU's way to supervise products entering the EU market. Products with CE mark show that the products meet the requirements of EU regulations on safety, health and environmental protection, and can be legally marketed in 27 EU Member States, European Free Trade Association (Norway, Switzerland, Iceland, and Lichtenstein), as well as Britain and Turkey.

According to EU regulations, different products adopt different evaluation methods to affix CE mark. There are mainly two ways: most products can be pasted with CE mark if the manufacturer adopts self declaration of conformity; some products with relatively higher risk need to be authorized by the European Union, i.e. notified organization The CE mark can only be pasted after the conformity assessment.

Personal protective equipment needs to be evaluated

According to the relevant regulations, the CE mark can only be applied to personal protective equipment (PPE) such as masks after conformity assessment by the notified body. PPE mainly refers to the product designed to protect employees from serious industrial injury or disease caused by exposure to chemical radiation, electric equipment, human equipment, mechanical equipment or in some dangerous workplaces. According to the classification principle of product design complexity and protection level, PPE can be divided into three categories: class I refers to low-risk personal protective equipment; class II refers to medium risk personal protective equipment except class I and III; class III refers to high-risk personal protective equipment. The mask belongs to the product with high risk coefficient and is classified as class III.

The European Union divides masks into two categories according to their use: medical masks and personal protective masks. Among them, personal protective masks do not belong to medical devices, but should meet the requirements of EU personal protective equipment regulations eu2016 / 425 (PPE). The authorized notification body shall carry out CE certification and issue certificate, and the corresponding standard is en 149.

One of two certification methods for protective masks

According to the regulations of eu2016 / 425 (PPE), the protective masks must obtain the certificate of module B (type inspection and certification) + module C2 (internal quality control + random supervision and random inspection of products) or module D (quality control of production process) before they can be legally sold in the EU. In short, you must choose either module B + module C2 or module B + module D.

The overall certification process mainly includes five steps: application, verification, evaluation, certificate issuance, supervision and inspection. The main work of each stage is as follows: the first stage is the application stage, in which the enterprise provides application forms, technical documents, en 149 test reports and 50 masks; the second is to verify the application stage, to verify the documents and samples, and to issue payment documents; the third is to evaluate the documents and sample samples for en 149 project sampling; the fourth is to issue the certificate stage: the organization issues the module The fifth stage is the supervision and inspection stage: the organization first carries out on-site audit, samples the masks for testing, and then issues the module C2 certificate and supervision report.

From the perspective of time cycle, the time for quality spot check, data evaluation and issuance of module B certificate is 4-6 weeks. The certification period of modulec2 is about 8 weeks.

Audit methods in extraordinary times

As a modern enterprise specializing in the production of medical devices, sanitary products and personal protective products, Suzhou Xinyi Dadian Network Technology Co., Ltd. has three production bases, covering an area of more than 10000 square meters, 3000 square meters of 300000 clean rooms and 4000 square meters of 100000 clean rooms. The company is equipped with 30 domestic most advanced kn95 mask production lines, with a daily output of 3 million kn95 masks.

Due to the epidemic situation, the mode of remote video participation of European auditors and on-site visit of local auditors were adopted, and the final summary meeting was jointly held.

TESTEX Swiss Textile Testing Co., Ltd. said that the main purpose of on-site audit is to carry out module C2 on-site audit according to the requirements of CE certification. It is hoped that through face-to-face communication, certified enterprises can further understand en149 standard and guide enterprises to use certificates and marks correctly. The on-site audit includes two parts: factory audit and product sampling. The audit focuses on consistency inspection, focusing on the consistency of certified products through inspection of procurement, production, inspection, mark use, packaging and sales.

TESTEX Swiss Textile Testing Co., Ltd

It is understood that TESTEX Swiss Textile Testing Co., Ltd., established in 1846, is a well-known textile testing and certification agency with a long history all over the world. Oeti Institute of Austria is a wholly-owned subsidiary of TESTEX Swiss Textile Testing Co., Ltd. in 2013. It was founded in 1967. It was first engaged in carpet research. Its EU notification body number is 0534. At present, it can carry out certification of some PPE class II and class III standards. The certification mode of en 149 standard is to issue the certificate of module B first, and then issue the certificate of module C2 after on-site audit and sampling.