ISO 10524-1:2018 PDF

Scope: This document 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. This document 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 30000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the medical gas delivered.

ISO 10524-1:2018 Referenced Document

EN 13544-2 Respiratory therapy equipment - Part 2: Tubing and connectors
EN 837-1 Pressure gauges - Part 1: Bourdon tube pressure gauges - Dimensions, metrology, requirements and testing
IEC 60601-1 Medical electrical equipment - ALL PARTS
ISO 10297:2014 Gas cylinders - Cylinder valves - Specification and type testing
ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
ISO 15001:2010 Anaesthetic and respiratory equipment - Compatibility with oxygen
ISO 32 Gas cylinders for medical use; Marking for identification of content
ISO 407 Small medical gas cylinders — Pin-index yoke-type valve connections*， 2023-07-26 Update
ISO 5145 Gas cylinders - Cylinder valve outlets for gases and gas mixtures - Selection and dimensioning
ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update
ISO 9170-1 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum

2023 ISO 10524-1:2018/Amd 1:2023 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices — Amendment 1
2018 ISO 10524-1:2018 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices
2006 ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices