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DIN makes medical equipment standards available free of charge until further notice

To beat the challenges of the corona crisis, DIN has agreed with the European Commission to make various standards on medical equipment available free of charge until further notice. The aim is to tackle the growing shortage of protective masks, gloves and other products faced by many European countries. Providing free access to the standards will facilitate the work of the many companies wishing to reconvert their production lines in order to manufacture the equipment that is so urgently needed. Using standards can help ensure the safety of medical devices and personal protective equipment and provide support and practical guidance to the manufacturers involved in their production. Further information on the topic and a supplementary consulting offer can be found at DIN.

Why is a charge usually made for standards?

Standards are products for which a fee is charged in principle. Users of standards enjoy a range of benefits: these include increased efficiency, cost savings, easier market access and reduced product liability risk. In Germany, standardization is a form of self-regulation by industry. This ensures that the standards users themselves determine which standards are in line with the market. By purchasing standards, standards users also ensure that DIN, as a non-profit association, can continue to organize its standards work on a private-basis independently and efficiently.

Who develops standards?

Standards are developed by those who subsequently use them. The broad participation of all stakeholders, a transparent development process and the consensus principle ensure the wide acceptance of DIN Standards. Anyone can submit a proposal for a new standard. All those interested in a specific standards topic can participate and contribute their expertise. Before a standard is officially adopted, a draft version is published so that the public can make comments. Experts working on a standard must come to agreement on its content. To ensure they reflect the state of the art, standards are regularly reviewed by experts at least every five years.

You can find the German standards here.

Publication 2009-08

DIN EN 149 -special edition
Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking; German version EN 149:2001+A1:2009

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2002-04

DIN EN 166 - special edition
Personal eye-protection - Specifications; German version EN 166:2001

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2010-03

DIN EN 420 - special edition
Protective gloves - General requirements and test methods; German version EN 420:2003+A1:2009

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2001-01

DIN EN 455-1 - special edition
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes; German version EN 455-1:2000

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2015-07

DIN EN 455-2 - special edition
Medical gloves for single use - Part 2: Requirements and testing for physical properties; German version EN 455-2:2015

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2015-07

DIN EN 455-3 - special edition
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfung für die biologische Bewertung; Deutsche Fassung EN 455-3:2015

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2009-10

DIN EN 455-4 - special edition
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination; German version EN 455-4:2009

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2019-06

DIN EN 13795-1 - special edition
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns; German version EN 13795-1:2019

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2019-06

DIN EN 13795-2 - special edition
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits; German version EN 13795-2:2019

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2004-01

DIN EN 14126 - special edition
Protective clothing - Performance requirements and test methods for protective clothing against infective agents; German version EN 14126:2003

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2009-08

DIN EN 14605 - special edition
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]); German version EN 14605:2005+A1:2009

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2019-10

DIN EN 14683 - special edition
Medical face masks - Requirements and test methods; German version EN 14683:2019+AC:2019

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2018-10

DIN EN ISO 374-1 - special edition
Protective gloves against dangerous chemicals and micro-organisms - Part 1: Terminology and performance requirements for chemical risks (ISO 374-1:2016 + Amd. 1:2018); German version EN ISO 374-1:2016 + A1:2018

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2017-03

DIN EN ISO 374-5 special edition
Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016); German version EN ISO 374-5:2016

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2015-06

DIN EN ISO 5356-1 - special edition
Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015); German version EN ISO 5356-1:2015

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2009-08

DIN EN ISO 10651-4 - special edition
Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015); German version EN ISO 5356-1:2015

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2010-04

DIN EN ISO 10993-1 - special edition
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2016-08

DIN EN ISO 13485 - special edition
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2013-12

DIN EN ISO 13688 - special edition
Protective clothing - General requirements (ISO 13688:2013); German version EN ISO 13688:2013

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2020-05

DIN EN ISO 17510 - special edition
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015); German version EN ISO 17510:2020

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2017-12

DIN EN ISO 18082 - special edition
Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014 + Amd. 1:2017); German version EN ISO 18082:2014 + A1:2017

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2020-05

DIN EN ISO 18562-1 - special edition
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017); German version EN ISO 18562-1:2020

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2020-05

DIN EN ISO 18562-2 - special edition
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2017)

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2020-05

DIN EN ISO 18562-3 - special edition
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO 18562-3:2017); German version EN ISO 18562-3:2020

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2020-05

DIN EN ISO 18562-4 - special edition
Biocompatibility evaluation of breathing gas pathways in healthcare application - Part 4: Tests for leachables in condensate (ISO 18562-4:2017); German version EN ISO 18562-4:2020

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2020-02

DIN EN ISO 80601-2-79 - special edition
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018); German version EN ISO 80601-2-79:2019

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2020-02

DIN EN ISO 80601-2-80 - special edition
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018); German version EN ISO 80601-2-80:2019

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 1997-01

ISO 10651-3 - special edition
Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2006-02

ISO 10651-5 special edition
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2019-07

ISO 19223 - special edition
Lung ventilators and related equipment - Vocabulary and semantics

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2019-08

ISO 20395 - special edition
Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2019-10

ISO 22301 - special edition
Security and resilience - Business continuity management systems - Requirements

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2017-03

ISO 22316 - special edition
Security and resilience - Organizational resilience - Principles and attributes

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2018-10

ISO 22395 - special edition
Security and resilience - Community resilience - Guidelines for supporting vulnerable persons in an emergency

Free of charge

Publication 2020-02

ISO 80601-2-12 - special edition
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2011-08

ISO 80601-2-13 - special edition
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2015-01

ISO 80601-2-70 - special edition
Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2017-05

ISO 80601-2-74 - special edition
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge

Publication 2013-06

ISO/TS 16976-8 - special edition
Respiratory protective devices - Human factors - Part 8: Ergonomic factors

To help overcome the challenge of coronavirus, DIN is making this version of the standard available free of charge until further notice.

Free of charge