Standards made freely availalable for coronavirus

Standards for personal protective equipment, medical devices, business continuity management and crisismanagement

The rapid spread of the coronavirus (Covid-19) worldwide requires exceptional measures for governments, companies and consumers alike. The standardization world naturally wants to contribute to facilitating solutions to combat the shortages of medical devices. After consultation with the European Commission, the European standardization organizations, united in the European institute CEN-CENELEC, have decided to release various standards for personal protective equipment, medical devices, business continuity management and crisis management.

After (free) registration in NEN Connect, you can temporarily view the following standards for your own use. All you need is a valid emailaddress and name.

New:

  • NEN-spec 1-1:2020-11-09 nl Community masks
    - Part 1: Guidance for design, use and maintenance in the context of COVID-19

  • NEN-spec 1-2:2020-11-09 nl Community masks
    - Part 2: Requirements for producers and importers in the context of COVID-19

  • NEN-spec 2:2020 versie 1.1 nl Ergonomics
    - Ergonomic requirements for the surface and layout of office workplaces in the context of COVID-19
    This NEN-spec provides recommendations for the surface and furnishing of various spaces in an office building in the context of the COVID-19 measures.

  • NEN-spec 3:2020 versie 1 nl Single use medical devices 
    -  Guidelines for reprocessing during COVID-19
    NEN-spec 3 describes the steps that must be taken to reach an informed decision about the reprocessing and reuse of single-use medical devices.
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Why register?
The fact that standards are freely available does not mean that the standards are free of copyright. For that reason, you must register.

An added bonus is that you can also use many functionalities. For example, you can be automatically informed via 'Recently changed' whether a standard has been corrected (C1), changed (A1) or whether a new edition has been released. You will always be up to date.

Respiratory protective devices

  • NEN-EN 149:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
  • NEN-EN 166:2001 Personal eye-protection – Specifications

Non-medical community masks

  • NEN-spec 1:2020 versie 1 nl&nbspNon-medical community masks - Guidance for design, manufacturing process, use and maintenance in the context of COVID-19
  • CWA 17553:2020 Community face coverings - Guide to minimum requirements, methods of testing and use

Protective clothing

  • CWA 17553:2020 Community face coverings - Guide to minimum requirements, methods of testing and use
  • NEN-EN 14126:2003+AC:2004 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
  • NEN-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])
  • NEN EN ISO 10993-1:2009  AC:2010  Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • NEN EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
  • NEN EN ISO 13688:2013 EN Protective clothing - General requirements

Surgical clothing, drapes and gloves

  • NEN-EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
  • NEN-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
  • NEN-EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)
  • NEN-EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)
  • NEN-EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)
  • NEN-EN 455-4:2009 EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)
  • NEN-EN 14683:2019 EN Medical face masks - Requirements and test methods

Business Continuity Management en Crisismanagement

Medical devices

  • NEN-EN-ISO 5356-1:2015 en Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
  • ISO 10651-3:1997 en Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators
  • NEN-EN-ISO 10651-4:2009 en Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators
  • NEN-EN-ISO 13485:2016 en Medical devices - Quality management systems - Requirements for regulatory purposes
  • NEN-EN-ISO 13485:2016/C11:2017 en Medical devices - Quality management systems - Requirements for regulatory purposes
  • NEN-EN-ISO 13485:2016/C12:2018 en Medical devices - Quality management systems - Requirements for regulatory purposes
  • NEN-EN-ISO 13485:2016 nl Medical devices - Quality management systems - Requirements for regulatory purposes
  • NEN-EN-ISO 13485:2016/C11:2017 nl Medical devices - Quality management systems - Requirements for regulatory purposes
  • NPR-ISO/TS 16976-8:2013 en Respiratory protective devices - Human factors - Part 8: Ergonomic factors
  • NEN-EN-ISO 17510:2020 en Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
  • NEN-ISO 10651-5:2006 en Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
  • NEN-EN-ISO 18082:2014 en Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
  • NEN-EN-ISO 18082:2014/A1:2017 en Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
  • NEN-EN-ISO 80601-2-12:2020 en Medische elektrische toestellen - Deel 2-12: Bijzondere eisen voor de basisveiligheid en essentiële eigenschappen van ventilatoren voor intensieve verpleging
  • ISO 80601-2-70:2015 en Medische elektrische toestellen - Deel 2-70: Bijzondere eisen voor algemene veiligheid en essentiële prestatie van beademingsapparatuur voor slaapapneutherapie
  • NEN-EN-ISO 80601-2-79:2019 en Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
  • NEN-EN-ISO 80601-2-80:2019 en Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency