27.03.2020
Meditsiiniseadmeid ja isikukaitsevahendeid käsitlevad standardid
Koroonaviiruse puhangu kontekstis on Euroopa standardiorganisatsioonid teinud tasuta kättesaadavaks mitmed meditsiiniseadmeid ja isikukaitsevahendeid käsitlevad standardid:
- EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as 'FFP masks')
- EN 14683:2019 EN Medical face masks - Requirements and test method
- EN 166:2001 Personal eye-protection – Specifications
- EN 14126:2003 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
- 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
- EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
- 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
- EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)
- EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)
- EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)
- EN 455-4:2009 EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)
- EN ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
- EN ISO 13688:2013 Protective clothing - General requirements
- EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
