CE certification for PPE products of protective clothing

2020-06-06 21:20:16 nsn

PPE personal protection product testing standards and methods

Protective clothing

The protective clothing is also divided into medical protective clothing and personal protective clothing, and the management requirements are basically similar to those of masks. Medical protective clothing is managed according to medical devices. Sterile medical protective clothing shall obtain CE certification according to EU medical device directive 93 / 42 / EEC (MDD) or EU medical device regulation eu2017 / 745 (MDR). Non sterile medical protective clothing only needs CE self declaration. Personal protective clothing shall be CE certified in accordance with the EU personal protective equipment regulation eu2016 / 425 (PPE).

PPE is the abbreviation of personal protective equipment. The term "PPE" refers to any device or appliance worn or held by an individual for the purpose of preventing one or more health and safety hazards. It is mainly used to protect employees from serious work injury or disease caused by exposure to chemical radiation, electric equipment, human equipment, mechanical equipment or in some dangerous workplaces.

PPE includes products:

a. Some types of PPE with simple design may not require EC type test when the designer thinks that the user can evaluate the protection level to prevent their lowest risk. This minimum risk refers to those risks whose functions are gradual and can be detected by users in a timely and safe manner.

Such PPE shall be limited to those intended to protect the wearer from:

--Mechanical action on the epidermis (gardening gloves, thimbles, etc.);

--Cleaning materials with small effect and easy to remove (gloves for anti dilution detergent solution, etc.);

--Danger encountered when processing hot workpieces, which will not put the user at a temperature above 50 ℃ or make the user suffer from dangerous collision (such as some professional gloves, aprons, etc.);

--It is used for protection (helmet, seasonal clothing, shoes and socks, etc.) under neither special nor extremely harsh atmospheric environment;

--Minor collisions and vibrations (light helmets, gloves, light shoes and socks, etc.) that do not injure vital parts of the body or cause irreparable damage;

--Sunshine (sunglasses).

b. - PPE designed to prevent a fatal hazard or a hazard that may be serious and irreparable to health, the designer estimates that the user has no time to detect the instantaneous effect of such hazard, in which case, at the manufacturer's option, one of the two procedures described in Article 11 shall be used. Such PPE shall be limited to:

--Filter breathing device for protecting solid or liquid aerosol or irritating, dangerous, toxic or radiation toxic gas;

--A respiratory protection device for complete isolation from the atmosphere, including a respiratory protection device for diving;

--PPE with limited protection for chemical corrosion or ionizing radiation;

--First aid equipment used in high temperature environment with the effect of temperature over 100 ℃ and possibly characterized by infrared radiation, flame or a large amount of sprayed molten material;

--First aid equipment used in low temperature environment with the effect of - 50 ℃;

--PPE for preventing falling from high place;

--It is used to prevent electric shock hazard and voltage hazard or to insulate PPE in high voltage operation.

PPE product classification and certification mode:

Class risk level consistency assessment procedure

I simple designed PPE with minimum protection (10% of PPE) self certification

All PPE excluding class I and III (80% of PPE) shall be tested by independent laboratory

III. PPE of complex design (10% of PPE) for protection against fatal hazard or irrecoverable damage to serious health is inspected by independent laboratory + manufacturing process quality insurance