BS EN ISO 10651-4:2023
Lung ventilators - Particular requirements for user-powered resuscitators

Standard No.

BS EN ISO 10651-4:2023

Release Date

2023

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 10651-4:2023

Scope

1   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

BS EN 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

BS EN ISO 10651-4:2023 history

• 2023 BS EN ISO 10651-4:2023 Lung ventilators - Particular requirements for user-powered resuscitators
• 2009 BS EN ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
• 0000 BS EN ISO 10651-4:2002