Standards made available free of cost to

combat COVID-19

Please find the list of standards made available free of cost by the respective standards organizations
to support the global efforts in dealing with COVID-19 Crisis.

Laboratories may make use of this information.

1.ISO (Please visit www.iso.org/covid19)

 ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms -

Part 5: Terminology and performance requirements for micro-organisms risk
 ISO 10651-3:1997, Lung ventilators for medical use — Part 3: Particular requirements for
emergency and transport ventilators
 ISO 10651-4:2002, Lung ventilators — Part 4: Particular requirements for operator-
powered resuscitators
 ISO 10651-5:2006, Lung ventilators for medical use — Particular requirements for basic
safety and essential performance — Part 5: Gas-powered emergency resuscitators
 ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process
 ISO 13485:2016, Medical devices — Quality management systems - Requirements for
regulatory purposes
 ISO 13688:2013, Protective clothing – General requirements
 ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and
application accessories
 ISO 18082:2014, Anaesthetic and respiratory equipment — Dimensions of non-
interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
[Including ISO 18082:2014/AMD 1:2017, AMENDMENT 1]
 ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare
applications — Part 1: Evaluation and testing within a risk management process
 ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare
applications — Part 2: Tests for emissions of particulate matter
 ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare
applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
 ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare
applications — Part 4: Tests for leachables in condensate
 ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics
 ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of
quantification methods for nucleic acid target sequences — qPCR and dPCR
 ISO 22301:2019, Security and resilience – Business continuity management systems –
Requirements
 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
 ISO 31000:2018, Risk management – Guidelines
 ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1:
Cones and sockets
 ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements
for basic safety and essential performance of critical care ventilators
 ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular requirements
for basic safety and essential performance of an anaesthetic workstation [Including: ISO
80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018,
AMENDMENT 2]
 ISO 80601-2-70:2015, Medical electrical equipment — Part 2-70: Particular requirements
for basic safety and essential performance of sleep apnoea breathing therapy equipment
 ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements
for basic safety and essential performance of respiratory humidifying equipment
 ISO 80601-2-79:2018, Medical electrical equipment — Part 2-79: Particular requirements
for basic safety and essential performance of ventilatory support equipment for
ventilatory impairment
 ISO 80601-2-80:2018, Medical electrical equipment — Part 2-80: Particular requirements
for basic safety and essential performance of ventilatory support equipment for
ventilatory insufficiency
 ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8:
Ergonomic factors

2. CEN – CENELEC (Please visit

https://www.cencenelec.eu/News/Press_Relea
ses/Pages/PR-2020-003.aspx)

 EN 149:2001 + A1:2009 Respiratory protective devices – Filtering half masks to protect

against particles - Requirements, testing, marking (commonly referred to as ‘FFP masks’)
 EN 14683:2019 Medical face masks - Requirements and test methods
 EN 166:2001 Personal eye-protection – Specifications
 EN 14126:2003 + AC 2004 Protective clothing - Performance requirements and tests
methods for protective clothing against infective agents
 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
 EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1:
Surgical drapes and gowns
 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
 EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for
freedom from holes (MDD)
 EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for
physical properties (MMD)
 EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for
biological evaluation (MDD)
 EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf
life determination (MDD)
 EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms -
Part 5: Terminology and performance requirements for micro-organisms risks
 EN ISO 13688:2013 Protective clothing - General requirements
 EN ISO 10993-1:2009 + AC 2010 Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process

3. Bureau of Indian Standards (BIS) (Please visit

https://www.bsbedge.com/IndianStandardson
Covid19)

 IS 4148: 1989 Surgical Rubber Gloves - Specification

 IS 5983: 1980 Eye-protectors
 IS 8521: Part 1: 1977 Specification for Industrial Safety Faceshields - Part I : With Plastics
Visor
 IS 9473: 2002 Respiratory Protective Devices - Filtering Half Masks to Protect Against
Particles - Specification
 IS/ISO 10651: Part 3: 1997 Lung Ventilators for Medical Use - Part 3 Particular
Requirements for Emergency and Transport Ventilators
 IS/ISO 10651: Part 4: 2002 Lung Ventilators for Medical Use-Particular Requirements for
Basic Safety and Essential Performance - Part 4 Particular Requirements for Operator-
Powered Resuscitators
 IS/ISO 10651: Part 5: 2006 Lung Ventilators for Medical Use- Particular Requirements for
Basic Safety and Essential Performance - Part 5 Gas-Powered Emergency Resuscitators
 IS/ISO 10651: Part 6: 2004 Lung Ventilators for Medical Use-Particular Requirements for
Basic Safety and Essential Performance - Part 6 Home-Care Ventilatory Support Devices
 IS 13422: 1992 Disposable surgical rubber gloves - Specification
 IS 15354: Part 1: 2018 Single-Use Medical Examination Gloves - Part 1 Specification for
Gloves Made from Rubber Latex or Rubber Solution
 IS 16289: 2014 Medical Textiles Surgical Face Masks Specification
 IS 17334: 2019 Medical Textiles-Surgical Gowns and Surgical Drapes-Specification
 IS/ISO 80601: Part 2: Sec 12: 2011 Medical Electrical Equipment - Part 2-12 Particular
Requirements for Basic Safety and Essential Performance of Critical Care Ventilators
 IS/ISO 80601: Part 2: Sec 56: 2017 Medical Electrical Equipment - Part 2 Particular
 Requirements for Basic Safety and Essential Performance - Section 56 Clinical
thermometers for body temperature measurement

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and NABL claims no authenticity in the above data. Users need to follow the respective guidelines on
the copyright and other information as mentioned in the respective websites.