Medical Supplies

Standards

Respirator / face Mask Standards


WARNING - No FDA certificates exist


Beware of "FDA certificates"! In this hectic trade of emergency supplies and PPE (personal protection equipment) many traders offer "FDA certified products" - and many buyers even ask for it. 

Note: All FDA certifications are fake. 


The FDA is an American law-enforcing government agency. They do not certify or state their approval of anybody's medical device (exporters to the US can self-register themselves in the FDA database, but there is no control of quality whatsoever).


CE MARK IS NOT A STANDARD 


The CE mark does not tell eg. about the filtering capability of a mask, it is a registration process needed to enter the EU market. 



CHINESE MASK STANDARDS


1. Testing of Masks, Classification

2. European Standards EN and FFP


April 4, 2020


At present, the accreditation granted by CNAS to laboratories for testing of mask includes Chinese standards and EN standards.


1. Classification and applicable standards of masks in China

Testing standards and their applicable scope of masks are as follows:

a) GB 19083-2010 is for medical protective masks (GB refers to mandatory national standard);


b) GB 2626 -2006 is for industrial protective masks;


c) YY 0469-2011 is for medical surgical masks (YY refers to mandatory standard in pharmaceutical industry);


d) YY/T 0969-2013 is for disposable medical masks (YY/T refers to recommended standard in pharmaceutical industry);


e) GB/T 32610-2016 is for civil masks (GB/T refers to recommended national standard).


Testing standards and their applicable scope

Classification Standard, Applicable Scope:


Medical protective mask

GB 19083-2010

Filter particulate matter in the air, and block the droplets, blood, body fluids, secretions,   etc. in the medical working environment


Industrial protective masks

GB 2626-2006

Protection from various types of particulate matter


Medical surgical masks

YY 0469-2011

Used by clinical medical staff in the process of invasive operation


Disposable medical masks

YY/T 0969-2013

Used in general medical environments to block the pollutants exhaled and sprayed from the mouth and nose


Not suitable for medical protective masks or medical surgical masks.

Civil   masks

GB/T   32610-2016

Filter   particulate matter in the air pollution environment in daily life


2. European EN standards and China national standards


According to EN 149 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking, three categories are listed as FFP1, FFP2 and FFP3, and the last two are recognized as mainstream medical products. Chinese GB 2626 is similar to it.


According to EN 14683 Surgical Masks—Requirements and test methods, surgical masks are classified into three types, TYPE I, TYPE II and TYPE IIR. TYPE I is applied to patients and ordinary people, while TYPE II and TYPE IIR are applied to medical staff. 

The Chinese standards GB 19083, YY 0469-2011 and YY/T 0969-2013 cover the classification and requirements described in EN 14683.


Source CNAS (April 4, 2020)


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