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Commission Implementing Decision (,EU,) 2020/668 of 18 May 2020 on the harmonised standards for personal ,protective, equipment drafted in support of Regulation (,EU,) 2016/425 of the ,European, Parliament and of the Council - OJ L 156, 19 May 2020, p. 13–19
Brussels 20 March 2020 - In response to the coronavirus outbreak, CEN, the ,European, Committee for Standardization, and CENELEC, the ,European, Committee for Electrotechnical Standardization, agreed, in collaboration with all their Members and after the urgent request from the ,European, Commission, to make freely available a series of ,European, standards (ENs) for ,medical, devices and personal ...
The ,EU, MDR 2017/745 has 4 main categories for ,Medical, Devices ,classification,:. Class I; Class IIa; Class IIb; Class III; This goes from the products with low risk (Class I) to the products with high risk (Class III). You can find this on the MDR 2017/745 (to be precise – Chapter V Section 1 Article 51). But if you want to be more specific, we can say that there are 3 sub-classes under class I.
For a level one ,classification,, a material must pass water impact penetration with a result lower than 4.5 grams; material with a result higher than 4.5 grams is considered to be ,non,-,protective,. The second ,classification, level is determined by using a test called AATCC 127 – Hydrostatic Head Test, which measures the material’s resistance to water penetration under increasing pressure.
PPE standards are changing, with one of the biggest shake ups in over 20 years in PPE Regulation (,EU,) 2016/425. As with the PPE Directive, under the Regulation it will not change that ,medical, products that are PPE will have to meet both Health and Safety requirements.
The term ‘personal ,protective, equipment’ (PPE) refers to a vast group of products (e.g. safety helmets, safety footwear and harnesses, eye ,protection,, gloves, high-visibility ,clothing,, etc.) designed with the aim to protect users against low-, medium- and high-level hazards.
apply to ,protective clothing, in terms of ergonomics, innoc-uousness, ageing, size designation, compatibility and marking, as well as the information to be supplied by the manufacturer with the ,protective clothing,. This ,European, standard is a reference standard that is referred to in all other specific ,protective clothing, standards.
EN 14126:2003 is the standard to determine whether ,protective clothing, offers necessary ,protection, against infective agents, which prescribes the requirements for materials, seams and garments. For ,protective clothing, which passes EN 14126:2003, wording “-B” will be added behind “TYPE” ,classification,, namely “TYPE 3-B”, “TYPE 4-B” and “TYPE 5-B”.