Recently, more than one country in Europe has revealed that Chinese products have substandard quality problems. On March 28, some Dutch media reported that the country’s government announced a recall of hundreds of thousands of masks imported from China that had been distributed to hospitals, pointing out that their quality was substandard. Regarding product quality issues, we believe that they should be dealt with on a case-by-case basis and faced calmly.
Faced with the new coronavirus epidemic sweeping the world, China, which took the lead in controlling the epidemic, has become the global anti- One of the main suppliers of urgently needed medical supplies due to the epidemic. Theoretically, there are two possibilities for the quality of some of China’s foreign aid and exported medical products not meeting standards: on the one hand, due to the large and urgent foreign orders, some Chinese manufacturers have temporarily switched production in an emergency and have not been specialized in this industry for a long time; On the one hand, it is a problem caused by the inconsistency of relevant standards in various countries.
How to effectively avoid such problems from happening again?
In fact, as the EU single market gradually improves and more and more product safety directives come into effect, in the market of the European Economic Area (including the 27 EU member states and the European Free Trade Area member states) , most products involving safety, sanitation, environmental protection and consumer protection (such as electronics, machinery, medical equipment, toys, personal protective equipment, communications, pressure equipment, etc.) have been compulsorily included in the “must carry CE” mark, otherwise they will not be allowed to enter the EU market.”
CE certificate has triple added value
R Passport: ensuring that our certified products can flow smoothly in the European market
R touchstone: improve product quality through EU standard testing and certification
R amulet: join the ranks of world-class products and reduce international disputes
Products with the CE mark indicate that they comply with the basic requirements stipulated in the EU directives. However, it is not necessary to have a CE certificate to enter the EU market. What’s going on?
There are tens of millions of CE instructions, and non-professionals cannot understand them at all. During the emergency period of responding to the epidemic, companies that have not been involved in international trade before are easily led astray by some testing agencies or intermediaries, wasting money and time in exchange for an invalid CE certificate.
What are the CE directives applicable to masks?
The applicable directive for protective masks (non-medical) is: EN149:2001+A1:2009. The medical grade mask directive is EN14683. If this is not visible on the certificate, it means it does not meet the requirements.
In addition, CE certificates and test reports can be checked on the European Commission’s official website (website: https://ec.europa.eu)
Step 1: Open the homepage of the website and select the language interface you need;
Step 2: Enter the content you want to search in the search bar, such as: “Certificate “Testing agency”, “instructions”, etc. You can find the results you want according to the instructions.
What are the CE directives applicable to protective clothing?
Protective clothing is a personal protective equipment. The English name is Personal Protective Equipment, or PPE for short. It is used to protect employees from exposure to chemical radiation, electrical equipment, human equipment, mechanical equipment or in some dangerous workplaces. Products designed to prevent serious work-related injuries or illnesses.
The European Union’s personal protective equipment safety directive is 89/686/EEC. This directive contains many related standards. For example, the EN340 standard is for general personal protective clothing. Safety requirements, that is to say, work clothes products exported to the EU must meet the relevant content stipulated in the EN340 standard from the design point of view.
According to the provisions of the PPE Directive, PPE products are divided into three categories according to the complexity of the PPE product design and the level of protection.
The first category is PPE products with simple design, aiming at minimum protection, including ordinary cold-proof clothing for professional use and ordinary medical protective clothing. Generally speaking, these products account for 10% of PPE products. 10% of the total product volume, and can directly affix the CE mark through self-declaration.
The second category of products involves a wide range of products, including the above-mentioned protective equipment for protecting against chemical radiation, electric equipment, human equipment, mechanical equipment or in some hazardous workplaces. This type of product It accounts for about 80% of the total PPE products, and it is strictly required that the Notified Body designated by the EU must help companies complete EC type testing and issue a certificate before the CE mark can be affixed to the product.
The third category of products is PPE products with complex designs used to protect against fatal hazards or that can cause serious health problems, including Anti-static clothing, anti-high temperature clothing, anti-freeze clothing, chemical resistance clothing, anti-ionization clothing and complete isolation clothing, etc. These products account for 10% of the total PPE products. Due to the high safety factor involved in such products, the products In addition to the need for EC type testing of products by a notified body, the directive also clearly stipulates that factories should have an “EC quality control system for final products” approved by a notified body.
Pictures from the Internet
How to obtain CE certification?
The focus of Personal Protective Equipment (PPE) is on quality, this type of clothing provides the wearer with personal protection and safety during daily (occupational) use. TESTEX is a recognized conformity assessment body for personal protective clothing. Its registered Swiss certification number is SCESp 0096, its EU notified body number is 1726, and it performs Type II and Type III type inspections.
Personal protective equipment that wants to be sold in the European market must comply with applicable safety requirements and standards. In Switzerland, the use of the CE mark to distinguish tested and certified clothing is optional; in the EU, such clothing must be accompanied by the CE conformity mark. The relevant legal requirements must be taken into account here (Production Safety Regulation PrSV/EU Directive 89/686/EEC).
TESTEX is a neutral and independent testing organization. Both technical documents and testing standards comply with EU Directive 89/686/EEC Appendix III (PrSV, Appendix 3) and others. Relevant test standards. TESTEX guarantees that its tested and certified PPE products comply with legal requirements and provide adequate protection for consumers when used reasonably.
How many steps are needed to obtain CE certification?
1. Apply and submit models
Manufacturers, dealers, etc. submit application forms (download link testex) and model numbers as well as the ones specified in EN ISO 13688:2013 Manufacturer’s documents to apply for type inspection. TESTEX provides comprehensive documentation to make certification as efficient as possible and assist with the necessary preparations.
2. Submit supplier certificate and test report
Including from All existing test reports, harmless certificates or certificates from the supplier. According to the specific standard requirements, a test report from an accredited testing agency must be provided, confirming the required values in the report. TESTEX can conduct relevant testing and issue reports according to needs.
3. Assessment and certification
In order to ensure that all applicants receive Consistent evaluation, TESTEX testing agency complies with PrSV, Appendix 3 (Annex II of EU Directive 89/686/EEC) and relevant European standards, and operates in strict accordance with the requirement list.
In this case, it is important to separate testing and certification – these two steps must be performed by independent departments or companies. TESTEX has an independent in-house textile testing department and can also arrange for its OETI affiliates or other recognized agencies to conduct these tests. This flexibility enables TESTEX to ensure that orders are processed in a timely manner according to the customer’s wishes.
4. PPE type certificate
In addition to the evaluation report, the customer also You will also receive a PPE type certificate, which will allow the tested product to be circulated on the market for the next 5 years.
5. Declaration of Conformity
Manufacturers and distributors must Confirm that on the basis of the type inspection certificate, its PPE products are consistent with the relevant prototype samples and comply with PrSV, Appendix 3 (Annex II of EU Directive 89/686/EEC) and relevant European standards.
TESTEX (https://testex/cn/) was founded in 1846 as OEKO-TEX® International Textile He is one of the most important members of the Leather Ecological Testing and Research Association, and is also the official representative organization in China designated by OEKO-TEX®. It is committed to providing the most professional ecological textile products and sustainable textile production to the Chinese customer base more efficiently. Series certification services
OEKO-TEX® series certification:
Standard 100 certification for European environmentally friendly textiles
Product label MADE IN GREEN with traceable and transparent supply chain
Environmentally friendly natural leather LEATHER STANDARD
Ecological dye certification ECO PASSPORT
Sustainable textile STeP certification that meets the development needs of the times, etc.
Also includes:
UV STANDARD 801 UV protection certification
CE certification for PPE protective clothing
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