Introduction to CE certification of respirator

2020-06-06 21:22:52 nsn

1、 EU's access requirements for respirators and other anti epidemic products

(1) Mask

The European Union divides the masks into two categories according to their use: medical masks and personal protective masks.

1. Medical mask

The medical mask shall be affixed with CE mark in accordance with EU medical device directive 93 / 42 / EEC (MDD) or EU medical device regulation eu2017 / 745 (MDR), and the corresponding standard is en14683. According to the aseptic or non aseptic state of the mask products, the conformity assessment mode adopted is also different.

(1) Sterile medical mask: it must be CE certified by an authorized notified body.

(2) Non sterile medical mask: enterprises only need to make CE self-compliance declaration, and do not need to pass the certification of the notified body. After preparing the corresponding documents, test reports and other data, you can complete the declaration of conformity by yourself.

2. Personal protective mask

Personal protective masks do not belong to medical devices, but they need to meet the requirements of EU regulations on personal protective equipment eu2016 / 425 (PPE). The authorized notified body shall carry out CE certification and issue a certificate, and the corresponding standard is en149.

Mask level introduction:

Grade 95: minimum filtration efficiency ≥ 95%

Grade 99: minimum filtration efficiency ≥ 99%

Grade 100: minimum filtration efficiency ≥ 99.97%

Grade 97: infrequent, minimum filtration efficiency ≥ 97%

european union:

FFP2 / 3 Mask [Edit] according to EU standard (protective mask en 149:2001) (medical mask en 14683),

FFP2 mask (medium filtration efficiency mask, filtering 94% particles) is similar to N95 mask in non oil particle filtration,

The higher standard ffp3 (high efficiency filter mask) can filter 99% particles, with higher protection level.

Different from NIOSH's standards, EU standards need to filter oil (paraffin oil mist) and non oil (sodium chloride) particles at the same time. EU standards actually cover a wider range.

Other common European suffixes: "R" can be reused, "NR" can not be reused, "d" can pass dolomite blocking test (that is, the respiratory resistance increases slowly after the mask absorbs dust).