Standards for medical supplies made freely available

In response to the COVID-19 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 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 COVID-19 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 info@nsai.ie

ENDS

Media Contact

Brónagh Kelly - bronagh.kelly@nsai.ie - 0863651329

Deirdre Farrelly - deirdre.farrelly@nsai.ie - 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 [3] and PB [4]).

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.