2nd April 2020
In response to the coronavirus emergency, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), the International Organization for Standardization (ISO) and the Association for the Advancement of Medical Instrumentation (AAMI), have all agreed to make freely available a series of European, American and International Standards for use in response to COVID-19.
To further support this initiative, the National Standards Authority of Ireland (NSAI) and SAI Global have developed the COVID-19 Response Package which will provide access at no cost to organisations involved in the fight against COVID-19. The response package includes a series of Irish, American, European and International Standards for medical devices and personal protective equipment.
Geraldine Larkin, CEO of the NSAI said:
The world’s major standardisation organisations have been encouraging manufacturers to increase and diversify production, building on positive examples such as textile and shoe manufacturers starting to produce masks and gowns. NSAI are honoured to stand in solidarity with this initiative, making freely available the standards which will enable companies to produce face masks and other protective equipment.”
The suite of 21 standards (listed below) cover common filtering masks, medical gloves and protective clothing. They can be viewed via i2i, a secure cloud-based platform, and at Standards.ie.
By providing free access to these standards, it will assist both EU and third-country companies which, are reconverting their production lines to quickly manufacture these critical items assisting in the fight against the coronavirus pandemic. The use of these standards will enable companies that adopt them easier access to the market for such fundamental medical and protection equipment, thus providing those in need with essential medical equipment.
Normally, standards must be purchased and used in line with the intellectual property right rules, as the copyright of the standards lies with the organisations, which have developed the standards. The derogation from this business model is a strong international response, based on a sense of social responsibility and solidarity, to address the shortage problem of protective equipment deriving from the Covid-19 epidemics.
Access the Standards via i2i, a cloud-based, communal platform for viewing your Standards
For more info, contact firstname.lastname@example.org
Brónagh Kelly - email@example.com - 0863651329
Deirdre Farrelly - firstname.lastname@example.org - 086 869 0774
List of available standards
- I.S. EN 149:2009 - Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
- I.S. EN 166:2001 - Personal eye-protection – Specifications
- I.S. EN 14126:2003+AC:2004 - Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
- I.S. 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  and PB )
- I.S. EN 13795-1:2019 - Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
- I.S. 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
- I.S. EN 455-1:2000 - Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)
- I.S. EN 455-2:2015 - Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)
- I.S. EN 455-3:2015 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)
- I.S. EN 455-4:2009 - EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)
- I.S. EN 14683:2019 - EN Medical face masks - Requirements and test methods
- I.S. EN ISO 10993-1:2009+ AC:2010* - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
- I.S. EN ISO 374-5:2016 - Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)
- I.S. EN ISO 13688:2013 - EN Protective clothing - General requirements (ISO 13688:2013)
- I.S. ISO 31000:2018 - Risk management Guidelines
- ISO 22395:2018 - Security and resilience — Community resilience — Guidelines for supporting vulnerable persons in an emergency
- ISO 22320:2018 - Security and resilience — Emergency management — Guidelines for incident management
- ISO 22316:2017 - Security and resilience — Organizational resilience — Principles and attributes
- AAMI PB70:2012 - Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
- AAMI TIR11:2005/(R)2015 - Selection and use of protective apparel and surgical drapes in health care facilities
- AAMI TIR68:2018 - Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
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