ISO 10651-4:2023
Lung ventilators — Part 4: Particular requirements for user-powered resuscitators
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:
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for testing of a resuscitator
4.1 Risk management process
4.2 Type tests
4.3 Test conditions
4.4 Gas flowrate, volume and leakage specifications
4.5 Testing errors
4.6 Environmental conditions in the end user environment
4.6.1 Transport and storage conditions
4.6.2 Operating conditions
4.6.3 Shelf-life
4.6.4 Expected lifetime
5 Information supplied by the manufacturer
5.1 General
5.2 Additional marking requirements
5.3 Additional instructions for use requirements
6 Connectors and ports
6.1 General
6.2 Patient-connection port
6.3 Expiratory port connector for breathing gases
6.4 Face mask connectors
6.5 Intake connectors
6.6 Bag refill valve connector
6.7 Oxygen inlet connection
6.8 Pressure monitor connector
7 Operational requirements
7.1 Dismantling and reassembly
7.2 Resuscitator performance after contamination with vomitus
7.3 Mechanical strength
7.4 Resistance to separation from an axial load
7.4.1 Multiple patient multiple use resuscitators
7.4.2 Single use and single patient multiple use resuscitators
7.5 Immersion in water
7.6 Bag refill valve
7.7 Compatibility with substances
8 Ventilatory requirements
8.1 Delivered oxygen concentration
8.1.1 Non-spontaneously breathing patient
8.1.2 Spontaneously breathing patient
8.2 Expiratory resistance
8.3 Inspiratory resistance
8.4 Gas source excessive flow
8.5 Resuscitator deadspace
8.6 Ventilation performance
8.6.1 Minimum guaranteed tidal volume (VT) — one hand
8.6.2 Minimum guaranteed tidal volume for B 2,5 kg
8.6.3 Maximum deliverable tidal volume — two hands
8.6.4 Maximum limited pressure
9 Additional requirements for resuscitator parts and accessories
9.1 General
9.2 Labelling
9.3 Breathing system filters
9.4 Stand-alone gas mixer
10 Processing requirements for a resuscitator and its accessories that are reusable
11 Biocompatibility
12 Usability
Annex A (informative) Particular guidance and rationale
Annex B (informative) Guide to marking and labelling requirements for resuscitators and their accessories
Annex C (informative) Symbols on marking
Annex D (informative) Reference to the IMDRF essential principles and labelling guidances
Annex E (informative) Reference to the essential principles
Annex F (informative) Reference to the general safety and performance requirements
Bibliography
Terminology — Alphabetized index of defined terms
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for testing of a resuscitator
4.1 Risk management process
4.2 Type tests
4.3 Test conditions
4.4 Gas flowrate, volume and leakage specifications
4.5 Testing errors
4.6 Environmental conditions in the end user environment
4.6.1 Transport and storage conditions
4.6.2 Operating conditions
4.6.3 Shelf-life
4.6.4 Expected lifetime
5 Information supplied by the manufacturer
5.1 General
5.2 Additional marking requirements
5.3 Additional instructions for use requirements
6 Connectors and ports
6.1 General
6.2 Patient-connection port
6.3 Expiratory port connector for breathing gases
6.4 Face mask connectors
6.5 Intake connectors
6.6 Bag refill valve connector
6.7 Oxygen inlet connection
6.8 Pressure monitor connector
7 Operational requirements
7.1 Dismantling and reassembly
7.2 Resuscitator performance after contamination with vomitus
7.3 Mechanical strength
7.4 Resistance to separation from an axial load
7.4.1 Multiple patient multiple use resuscitators
7.4.2 Single use and single patient multiple use resuscitators
7.5 Immersion in water
7.6 Bag refill valve
7.7 Compatibility with substances
8 Ventilatory requirements
8.1 Delivered oxygen concentration
8.1.1 Non-spontaneously breathing patient
8.1.2 Spontaneously breathing patient
8.2 Expiratory resistance
8.3 Inspiratory resistance
8.4 Gas source excessive flow
8.5 Resuscitator deadspace
8.6 Ventilation performance
8.6.1 Minimum guaranteed tidal volume (VT) — one hand
8.6.2 Minimum guaranteed tidal volume for B 2,5 kg
8.6.3 Maximum deliverable tidal volume — two hands
8.6.4 Maximum limited pressure
9 Additional requirements for resuscitator parts and accessories
9.1 General
9.2 Labelling
9.3 Breathing system filters
9.4 Stand-alone gas mixer
10 Processing requirements for a resuscitator and its accessories that are reusable
11 Biocompatibility
12 Usability
Annex A (informative) Particular guidance and rationale
Annex B (informative) Guide to marking and labelling requirements for resuscitators and their accessories
Annex C (informative) Symbols on marking
Annex D (informative) Reference to the IMDRF essential principles and labelling guidances
Annex E (informative) Reference to the essential principles
Annex F (informative) Reference to the general safety and performance requirements
Bibliography
Terminology — Alphabetized index of defined terms