Air Collective Forum

List of ISO certifications for ventilators

From OSCMS:

Standards relating to ventilator use, operations and design

  • ASTM F 1100-90 (Standard Specifications for Ventilators Intended for Use in Critical Care) (Withdrawn without replacement in 2004)
  • ASTM F 1246-91 (Standard Specification for Electrically Powered Home Care Ventilators, Part 1-Positive-Pressure Ventilators and Ventilator Circuits) (LINK)
  • IEC 6061-2-12(Standard for Critical Care Ventilators)
  • ISO 80601-2-12:2020 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
  • ICS 11.040.10 (ANAESTHETIC, RESPIRATORY AND REANIMATION EQUIPMENT INCLUDING MEDICAL GAS INSTALLATIONS)
  • 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 19223:2019 (Lung ventilators and related equipment — Vocabulary and semantics)
  • ISO/TR 21954:2018 (Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator)
  • ISO 80601-2-72:2015
  • Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
  • 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/DIS 80601-2-87 (Medical electrical equipment — Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators)
  • ISO/FDIS 80601-2-84 (Medical electrical equipment — Part 2-84: Particular requirements for basic safety and essential performance of ventilators for the emergency medical services environment)

Connectors for Respiratory Devices

ISO/AWI 27427 Nebulizing systems and components (Under Development)

ISO/AWI TR 22175 Connectors for respiratory devices (Under Development)

Related Technical Committees

ISO/TC 121/SC 2 - Airways and related equipment (Link)

See Free ISO IEC ASTM CEN International Technical Standards

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A post was split to a new topic: Chilean government launched an Ambubag ventilator design challenge

ISO and IEC ventilator standards are now free.

https://www.iso.org/covid19

https://webstore.iec.ch/webstore/webstore.nsf/xpFAQ.xsp?OpenXPage&id=GFOT-BNAEXA

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