GST epidemic prevention materials special compliance services-masks

China

Species

The market demand

Time

Medical and

Personal protective

Common testing standards:

Gb19083-2010 technical requirements for medical protective masks

Yy0469-2011 technical requirements for surgical masks for medical use

GB/T 32610-2016 technical specification for daily protective masks

GB 2626-2006 respiratory protection self-absorption filter anti-particulate respirator

Common test items:

1. Physical and chemical indicators

2. Microbial indicators

3. Toxicological allergic index

2 weeks

USA

Species

The market demand

Time

medical

Common surgical masks belong to class II medical devices in the us FDA, which requires FDA factory registration and 510 (k) application before marketing. The application process is as follows:

1. Conduct product testing

2. Prepare 510k technical documents and submit them to FDA for review

3. Obtain a 510k approval letter from FDA

4. Complete the factory registration and device listing.

6-10 months

Personal protective

A NIOSH certification is required and certification applications must be carried out in accordance with NIOSH guidelines.The certification is carried out by NIOSH's NPPTL laboratory.

The process is as follows:

1. Send samples to NIOSH lab for testing

2. Submit technical materials for document review

3. NIOSH certification

2-3 months

European

Species

The market demand

Time

medical

The European standard for surgical masks is EN14683, which is required to meet the requirements of the European Union (EU) 2017/745 (new version of MDR for medical devices).

Certification process:

1. Prepare technical documents

2. Provide test reports

3. Provide a declaration of compliance

4. Appoint an authorized representative of the European Union to complete the registration.

2-3 months

Personal protective

According to standard EN149, the requirements of the eu (E U) 2016/42 personal protective equipment directive (PPE) need to be met.

Certification process:

1. Type test report of the product

2. Review of technical documents

3. Factory quality system review

4. Issue a CE certificate.

1 to 2 months