ISO 10651-4:2023
Lung ventilators — Part 4: Particular requirements for user-powered resuscitators

Standard No.

ISO 10651-4:2023

Release Date

2023

Published By

International Organization for Standardization (ISO)

Latest

ISO 10651-4:2023

Scope

This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range. Example user-powered resuscitators include: — self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations. — flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source. This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator. Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment. This document is also applicable to point-of-use packaging. This document does not specify the requirements for: — gas-powered emergency resuscitators, which are given in ISO 10651-5; — electrically-powered resuscitators; — gas powered resuscitators for professional healthcare facilities; and — anaesthetic reservoir bags, which are given in ISO 5362. NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D. NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.

ISO 10651-4:2023 Referenced Document

• IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
• IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
• IEC Guide 115:2021 Application of uncertainty of measurement to conformity assessment activities in the electrotechnical sector
• ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 11195:2018 Gas mixers for medical use - Stand-alone gas mixers
• ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• ISO 14971:2019 Medical devices — Application of risk management to medical devices
• ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
• ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
• ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
• ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer
• ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
• ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
• ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets

ISO 10651-4:2023 history

• 2023 ISO 10651-4:2023 Lung ventilators — Part 4: Particular requirements for user-powered resuscitators
• 2002 ISO 10651-4:2002 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators