为应对COVID-19,欧洲标准化委员会(CEN)和欧洲电工标准化委员会(CENELEC)向公众免费提供了一系列医疗设备和个人防护设备标准。主要包括欧洲标准化委员会(CEN)制定的11项标准以及与ISO共同制定的3项标准,涵盖了普通过滤口罩、医用手套和防护服等防护设备(见下表)。
序号 |
标准号 |
标准名称 |
1 |
EN 149:2001 + A1:2009 |
Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking |
2 |
EN 14683:2019 |
Medical face masks - Requirements and test methods |
3 |
EN 166:2001 |
Personal eye-protection - Specifications |
4 |
EN 14126:2003 + AC 2004 |
Protective clothing - Performance requirements and tests methods for protective clothing against infective agents |
5 |
EN 14605:2009 + A1:2009 |
Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) |
6 |
EN 13795-1:2019 |
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns |
7 |
EN 13795-2:2019 |
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits |
8 |
EN 455-1:2000 |
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
9 |
EN 455-2:2015 |
Medical gloves for single use - Part 2: Requirements and testing for physical properties |
10 |
EN 455-3:2015 |
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
11 |
EN 455-4:2009 |
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination |
12 |
EN ISO 374-5:2016 |
Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016) |
13 |
EN ISO 13688:2013 |
Protective clothing - General requirements (ISO 13688:2013) |
14 |
EN ISO 10993-1:2009 + AC 2010 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) |
以上标准可登录欧洲标准化委员会网站https://ec.europa.eu/commission/presscorner/detail/en/ip_20_502免费下载。