ISO 10524-3-2019 PDF

Full title and description

Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (VIPRs). This International Standard specifies requirements for design, type testing and marking of cylinder valves with integrated pressure regulators used for administration of medical gases and for gases used to drive surgical tools, covering refillable cylinders with working pressures up to 30 000 kPa (300 bar).

Abstract

This document defines the design, performance (type) testing and marking requirements for valves with integrated pressure regulators (VIPRs) intended for medical gas applications, including examples such as oxygen, medical air and oxygen/nitrous oxide mixtures. It applies to VIPRs that are pressure pre-set and that provide a pressure outlet and/or pre-set flow outlet(s) for cylinders intended to be filled in cylinder filling facilities or on self-filling systems (including some homecare use cases).

General information

• Status: Published.
• Publication date: January 2019.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: Edition 2 (2019).
• Number of pages: 41 pages.

(General bibliographic and lifecycle information as recorded by ISO for ISO 10524-3:2019.)

Scope

Applies to cylinder valves with integrated pressure regulators (VIPRs) intended for the administration of medical gases or gases used to drive surgical tools, mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar). The standard covers pressure pre-set VIPRs provided with pressure and/or pre-set flow outlets and sets out requirements for their design, type testing and marking.

Key topics and requirements

• Definitions and terminology for VIPRs (valves with integrated pressure regulators).
• Design requirements to ensure safe connection, operation and prevention of hazardous gas release.
• Type testing procedures to verify performance, durability and safety (including pressure and leak tests).
• Marking and information requirements for traceability, gas identification and safe use.
• Operating pressure range and limits (applies to refillable cylinders up to 30 000 kPa / 300 bar).
• Requirements for pre-set pressure and/or pre-set flow outlet provisions.

Typical use and users

Used by medical device manufacturers (especially manufacturers of cylinder valves and pressure-regulating assemblies), hospital procurement and biomedical engineering teams, testing and certification laboratories, regulators and notified bodies, and maintenance/service organizations responsible for medical gas supply equipment. It is relevant for manufacturers of cylinders and VIPRs, homecare equipment suppliers where refillable cylinder use applies, and organizations involved in conformity assessment.

Related standards

ISO 10524 is a multi-part series addressing pressure regulators for use with medical gases. Closely related parts include ISO 10524-1 (pressure regulators and pressure regulators with flow‑metering devices) and ISO 10524-4 (low-pressure regulators); other parts of the series and regional/adopted versions may also apply when specifying or testing medical-gas pressure regulation equipment.

Keywords

VIPR, cylinder valve, pressure regulator, medical gas, oxygen, medical air, pre-set flow, type testing, marking, ISO 10524, medical gas equipment.

FAQ

Q: What is this standard?

A: ISO 10524-3:2019 specifies requirements for cylinder valves with integrated pressure regulators (VIPRs) used with medical gases, covering design, type testing and marking for refillable cylinders up to 30 000 kPa (300 bar).

Q: What does it cover?

A: It covers pressure pre-set VIPRs that provide pressure and/or pre-set flow outlets, including performance and safety testing, required markings and information for safe use and traceability.

Q: Who typically uses it?

A: Manufacturers of VIPRs and cylinders, hospital biomedical engineers and procurement teams, conformity assessment and testing laboratories, regulatory bodies and service/maintenance providers for medical gas systems.

Q: Is it current or superseded?

A: ISO 10524-3:2019 is the published (2019) edition. ISO records indicate the 2019 edition is published and that further revisions or a DIS (draft) may be in development; users who require the very latest lifecycle status should check ISO or their national standards body for updates or subsequent revisions.

Q: Is it part of a series?

A: Yes — ISO 10524 is a series of documents covering pressure regulators for medical gases (multiple parts such as Part 1, Part 2, Part 3 and Part 4) that together address different regulator types and pressure ranges.

Q: What are the key keywords?

A: VIPR, cylinder valve, pressure regulator, medical gas, oxygen, medical air, pre-set flow, type testing, marking, ISO 10524.