EU standards for protective equipment – available now for free
In light of the COVID-19 crisis, some of the European standards for certain medical devices and personal protective equipment can now be downloaded for free. This includes the 11 standards developed by the European Committee for Standardization (CEN) and 3 additional ones developed jointly with ISO.
Providing free access to these standards during the Coronavirus outbreak enables companies that produce filtering masks, medical gloves, gowns, and other protective supplies to speed up the manufacturing process and enter the EU market quicker to help those in need.
Here is the list of CEN standards available for free download:
- EN 149 + A1:2009 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking (commonly referred to as ‘FFP masks’)
- EN 14683:2019 + AC:2019 Medical face masks – Requirements and test method
- EN 166:2003 Personal eye-protection – Specifications
- EN 14126:2003 Protective clothing – Performance requirements and tests methods for protective clothing against infective agents
- EN 14605 + 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])
- 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 455-1:2001 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 374-5:2016 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
To learn which documents are needed to comply with EU MDR, download this free white paper: EU MDR Checklist of Mandatory Documents.
Advisera is Exemplar Global Certified TPECS Provider for the IS, QM, EM, TL and AU Competency Units.
ITIL® is a registered trade mark of AXELOS Limited. Used under licence of AXELOS Limited. All rights reserved.
DNV GL Business Assurance is one of the leading providers of accredited management systems certification.
