ISO 15002:2023
Flow control devices for connection to a medical gas supply system
This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a) a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b) the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c) to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)
Foreword Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 4.1 Risk management 4.2 Usability 4.3 Materials 4.4 Oxygen compatibility 4.5 Environmental conditions 5 Design requirements 5.1 General 5.2 Gas inlets 5.3 Outlet connectors 5.4 Mechanical strength 5.5 Leakage 5.6 Flow indication 5.7 Accuracy 5.8 Stability of indicated flow 5.9 Continuous increase in flow 5.10 Security of components 5.11 Flow controls and flow selectors 6 Packaging 7 Information supplied by the manufacturer 7.1 General 7.2 Marking 7.3 Instructions for use Annex A (informative) Rationale Annex B (informative) Examples of flow control devices and gas supply inlets Annex C (normative) Test methods Annex D (informative) Hazard identification for risk assessment Bibliography Approval and test specification - Medical electrical equipment - Particular requirements for safety - Cardiac defibrillators Medical electrical equipment, Part 2.20: Particular requirements for the basic safety and essential performance of infant transport incubators Transportable gas container valves, Valves with taper stems for use with breathing apparatus
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Medical electrical equipment - Part 2.21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Risk management
4.2 Usability
4.3 Materials
4.4 Oxygen compatibility
4.5 Environmental conditions
5 Design requirements
5.1 General
5.2 Gas inlets
5.3 Outlet connectors
5.4 Mechanical strength
5.5 Leakage
5.6 Flow indication
5.7 Accuracy
5.8 Stability of indicated flow
5.9 Continuous increase in flow
5.10 Security of components
5.11 Flow controls and flow selectors
6 Packaging
7 Information supplied by the manufacturer
7.1 General
7.2 Marking
7.3 Instructions for use
Annex A (informative) Rationale
Annex B (informative) Examples of flow control devices and gas supply inlets
Annex C (normative) Test methods
Annex D (informative) Hazard identification for risk assessment
Bibliography