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2020-03-30

COVID-19: DIN makes standards for medical equipment available

Persönliche Schutzausrüstung
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Members of the European standards organizations CEN and CENELEC support the fight against coronavirus

The European standards organizations CEN and CENELEC have decided, in agreement with all their Members (including DIN, the German Institute for Standardization) and in agreement with the European Commission, to make freely available a series of European standards (ENs) for medical devices and personal protective equipment, in a move to support the fight against the COVID-19 pandemic.

The aim is to tackle the severe shortage of protective masks, gloves and other products currently 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. The standards are aimed purely at professional users.

Thierry Breton, the European Commissioner for the Internal Market, welcomes the initiative thus: “In our battle against the coronavirus we need to act with urgency, solidarity and in a coordinated manner. We need audacity and innovative ways of producing the equipment we need. I am encouraging manufacturers to evaluate the possibilities of increasing and diversifying production, building on positive examples such as textile and shoe manufacturers starting to produce masks and gowns. I will do everything possible to support their efforts. I am pleased to announce that following contacts with the Commission, today CEN and CENELEC agreed to make freely available the standards needed for such companies to be able to produce masks and other protective equipment. This agreement has immediate effect.”

Rüdiger Marquardt, Member of DIN’s Executive Board, adds: “Standards are of utmost importance in ensuring the safety of medical devices and personal protective equipment and providing support and guidance to the manufacturers who produce them. Together with other national standardizations, CEN and CENELEC, DIN is committed to supporting the efforts of the European Commission in the fight against coronavirus.”

The International Organization for Standardization (ISO) will also make relevant standards on medical equipment freely available. The current editions of the standards are available free of charge until further notice. These standards describe the key requirements to be met by filter masks, medical gloves and protective clothing.

Interested companies and organizations can download the standards (in German) from the webshop of Beuth Verlag at www.beuth.de/go/kostenlose-normen.

The english versions of this standards can be found here: www.beuth.de/en/special-editions-standards-for-medical-equipments

The following standards are available:

Protective masks

DIN EN 149:2009-08: Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking

DIN EN 14683:2019-10: Medical face masks - Requirements and test methods


Eye protection

DIN EN 166:2002-04: Personal eye-protection – Specifications


Protective clothing

DIN EN 14126:2004-01: Protective clothing - Performance requirements and tests methods for protective clothing against infective agents

DIN EN 14605:2009-08: 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])

DIN EN ISO 13688:2013-12 Protective clothing - General requirements (ISO 13688:2013)

DIN EN 13795-1:2019-06: Surgical clothing and drapes - Requirements and test methods – Part 1: Surgical drapes and gowns

DIN EN 13795-2:2019-06: Surgical clothing and drapes - Requirements and test methods – Part 2: Clean air suits


Gloves

DIN EN 455-1:2001-01 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes

DIN EN 455-2:2015-07: Medical gloves for single use – Part 2: Requirements and testing for physical properties

DIN EN 455-3:2015-07: Medical gloves for single use – Part 3: Requirements and testing for biological evaluation

DIN EN 455-4:2009-10: Medical gloves for single use – Part 4: Requirements and testing for shelf life determination

DIN EN 420:2010-03: Protective gloves - General requirements and test methods

DIN EN ISO 374-1:2018-10 Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance requirements for chemical risks

DIN EN ISO 374-5:2017-03: Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)


Medical devices

DIN EN ISO 10993-1:2010-04: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)


Safety and resilience

DIN EN ISO 22301:2019-10: Security and resilience - Business continuity management systems - Requirements (ISO/DIS 22301:2019)

ISO 22395: 2018-10: Security and resilience - Community resilience - Guidelines for supporting vulnerable persons in an emergency

ISO 22320: 2018-11: Security and resilience - Emergency management - Guidelines for incident management

ISO 22316 2017-03: Security and resilience - Organizational resilience - Principles and attributes


Risk management

ISO 31000: 2018-02: Risk management - Guidelines

The US SDOs Association for the Advancement of Medical Instrumentation (AAMI) and ASTM have also made further standards freely available:

Contact

DIN e. V.

Julian Pinnig

Saatwinkler Damm 42/43
13627 Berlin

Tel.: +49 30 2601-2812

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