[EN] Свободный доступ к ряду европейских стандартов

В связи с кризисом COVID-19, Европейская Комиссия выступила с инициативой организовать свободный доступ к перечню европейских стандартов для определенных медицинских изделий и средств индивидуальной защиты, и сейчас они доступны для бесплатной загрузки на веб-сайтах национальных членов CEN.

Сам перечень включает 11 стандартов, разработанных Европейским комитетом по стандартизации (CEN), и 3 дополнительных, разработанных совместно с ISO:

1. EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles — Requirements, testing, marking
2. EN 14683:2019 EN Medical face masks — Requirements and test method
3. EN 166:2001 Personal eye-protection – Specifications
4. EN 14126:2003 Protective clothing — Performance requirements and tests methods for protective clothing against infective agents
5. EN 14605:2009 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
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 drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods
8. EN 455-1:2000 Medical gloves for single use — Part 1: Requirements and testing for freedom from holes (MDD)
9. EN 455-2:2015 Medical gloves for single use — Part 2: Requirements and testing for physical properties (MMD)
10. EN 455-3:2015 Medical gloves for single use — Part 3: Requirements and testing for biological evaluation (MDD)
11. EN 455-4:2009 EN Medical gloves for single use — Part 4: Requirements and testing for shelf life determination (MDD)
    Дополнительно:
12. EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms — Part 5: Terminology and performance requirements for micro-organisms risks
13. EN ISO 13688:2013 Protective clothing — General requirements
14. EN ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process