Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices

Amended by

ISO 10524-1:2018/Amd 1:2023

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

02-01-2018

Publisher

International Organization for Standardization

ISO 10524-1:2018 specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools.

Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.

ISO 10524-1:2018 applies to pressure regulators:

a) intended to be connected to cylinders by the operator;

b) with integral flow-metering devices intended to be connected to cylinders by the operator;

c) that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators).

A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable or pre-set.

pressure regulators are intended to be fitted to refillable cylinders with a working pressure up to 30 000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the medical gas delivered.

Committee	ISO/TC 121/SC 6
DevelopmentNote	Supersedes ISO 10524. (02/2006) Supersedes ISO/DIS 10524-1. (02/2018)
DocumentType	Standard
Pages	33
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 10524-1:2006

Standards	Relationship
DS/EN ISO 10524-1:2019	Identical
DS/ISO 10524-1:2018	Identical
IS 18361 : Part 1 : 2023	Identical
DIN EN ISO 10524-1:2019-08	Identical
SN EN ISO 10524-1:2019	Identical
EN ISO 10524-1:2006	Identical
I.S. EN ISO 10524-1:2019	Identical
EN ISO 10524-1:2019	Identical
UNE-EN ISO 10524-1:2019	Identical
UNI EN ISO 10524-1:2019	Identical
SS-EN ISO 10524-1:2019	Identical
SS-EN ISO 10524-1 : 2018	Identical
NF EN ISO 10524-1 : 2006	Identical
NS-EN ISO 10524-1:2019	Identical
PN-EN ISO 10524-1 : 2019	Identical
ÖNORM EN ISO 10524-1: 2019 07 15	Identical
BS EN ISO 10524-1:2019	Identical
NEN-EN-ISO 10524-1:2019	Identical

CGA E 18 : 2015	MEDICAL GAS VALVE INTEGRATED PRESSURE REGULATORS
CGSB 24.2 : M86	IDENTIFICATION OF MEDICAL GAS CONTAINERS, PIPELINES AND VALVES
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 15001:2010	Anaesthetic and respiratory equipment Compatibility with oxygen
CGA C 9 : 2013	STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE
ISO 5145:2014	Cylinder valve outlets for gases and gas mixtures Selection and dimensioning
ISO 32:1977	Gas cylinders for medical use — Marking for identification of content
ISO 10297:2014	Gas cylinders — Cylinder valves — Specification and type testing
ASTM G 175 : 2013 : REDLINE	Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV	Degrees of protection provided by enclosures (IP Code)
ISO 10156:2017	Gas cylinders — Gases and gas mixtures — Determination of fire potential and oxidizing ability for the selection of cylinder valve outlets
EN 1089-3:2011	Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding
ISO 407:2004	Small medical gas cylinders Pin-index yoke-type valve connections
ISO/TR 7470:1988	Valve outlets for gas cylinders — List of provisions which are either standardized or in use
ISO 9170-1:2017	Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
AS 4484:2016	Gas cylinders for industrial, scientific, medical and refrigerant use - Labelling and colour coding
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
EN 837-1:1996/AC:1998	PRESSURE GAUGES - BOURDON TUBE PRESSURE GAUGES - DIMENSIONS, METROLOGY, REQUIREMENTS AND TESTING
ISO 4135:2001	Anaesthetic and respiratory equipment Vocabulary
EN 13544-2:2002+A1:2009	Respiratory therapy equipment - Part 2: Tubing and connectors
ISO 7396-1:2016	Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum