Freebie Friday - Free ISO Standards to Help You During the COVID-19 Crisis

Posted by Craig Thornton

To support global efforts in dealing with COVID-19, ISO have opened up their store for you to view some of their PPE, Risk Management, Business Continuity and Medical standards.

Please share this widely with your colleagues.

Some of these are great standards. Particularly ISO 13485 for Medical Devices and ISO 22301 for Business Continuity and ISO 31000 for Risk Management.

PPE

ISO 13688:2013, Protective clothing – General requirements

ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risk

ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors

 

Risk Management

ISO 31000:2018, Risk management – Guidelines

 

Business Continuity

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

 

Medical

ISO 13485:2016, Medical devices — Quality management systems - Requirements for regulatory purposes

ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics

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 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 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

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

Complementary Standards

The IEC (International Electrotechnical Commission) have made some complementary standards freely available too. 

Click here to get these complementary standards.

IEC 60601-1:2005+AMD1:2012 CSV, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1-6:2010+AMD1:2013 CSV, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-8:2006+AMD1:2012 CSV, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

 

Tags: ISO, Compliance, Integrated QHSE, ISO Certification, Freebie Friday