EN ISO 10524-4:2008 PDF

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

Title (English):

EN ISO 10524-4:2008

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 40
Publication date:: June 1, 2008
Edition:: CEN EN 10524 edition 2 version 1
ICS:: 11.040.10

Document language:

enru

Delivery time:1–7 days

Price:89 €

Description (English):

ISO 10524-4:2008 applies to the types of low-pressure regulators listed below and intended to be used with the following medical gases in the treatment, management, diagnostic evaluation and care of patients: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air. The types of low-pressure regulators covered by ISO 10524-4:2008 are as follows: low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; low-pressure regulators intended to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3; operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pipeline system complying with ISO 7396-1.

Technical details

Technical committee: CEN/TC 215 - Respiratory and anaesthetic equipment
SKU: EN ISO 10524-4:2008

Abstract

Overview

EN ISO 10524-4:2008 - "Pressure regulators for use with medical gases - Part 4: Low‑pressure regulators" (CEN adoption of ISO 10524-4:2008) specifies requirements and test methods for low-pressure regulators used with medical gases. The standard covers regulators used in patient care, anaesthesia and for driving surgical tools, and applies to gases such as oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures, air/nitrogen for surgical tools, and oxygen‑enriched air.

Key topics and technical requirements

Scope and types covered
- Regulators connected to terminal units of medical gas pipeline systems (ISO 7396-1).
- Regulators with integral flow‑metering devices.
- Regulators connected to terminal units attached to higher‑stage pressure regulators (ISO 10524-1 / ISO 10524-3).
- Operator‑adjustable low‑pressure regulators integral to pipeline systems for air/nitrogen driving tools.
Safety and performance priorities
- Mechanical strength, controlled relief of excess pressure, resistance to ignition.
- Low leakage and gas specificity to prevent cross‑contamination.
- Material suitability and cleanliness for medical environments.
Accuracy and stability
- Requirements for flowmeters, flowgauges and fixed orifice performance (accuracy, stability).
Testing and verification
- Defined test methods for outlet pressure, leakage, mechanical strength, flow accuracy/stability, loosening torque, and durability of markings/colour coding.
Marking, colour coding and documentation
- Mandatory marking, packaging, colour coding guidance (with Annex for reported national/regional deviations), and information to be supplied by manufacturers.
Supporting information
- Annexes include typical regulator examples, rationale for requirements, regional colour coding deviations, and environmental aspects.

Applications and users

Intended for:
- Manufacturers designing and producing low‑pressure medical gas regulators and integrated flow devices.
- Biomedical engineers / hospital estates specifying, installing and maintaining medical gas terminal equipment.
- Test laboratories and conformity assessors performing verification and type testing against EN ISO 10524‑4.
- Procurement and regulatory teams ensuring medical devices meet applicable safety and EU Medical Device Directive (93/42/EEC) expectations.
Practical uses:
- Reducing pipeline pressure to safe working levels for patient devices.
- Integrating flow control or metering at bedside or equipment interfaces.
- Ensuring consistent performance, safety and traceability in hospital gas systems.

Related standards

ISO 10524 series (Parts 1–3) - other pressure regulator types.
ISO 7396-1 - medical gas pipeline systems (terminal unit interface).
CEN adoption aligns with EU directives and national implementation requirements.

Keywords: EN ISO 10524-4:2008, low-pressure regulators, medical gases, medical gas pipeline, flowmeter, ISO 7396-1, pressure regulators.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and technical requirements

Scope and types covered
- Regulators connected to terminal units of medical gas pipeline systems (ISO 7396-1).
- Regulators with integral flow‑metering devices.
- Regulators connected to terminal units attached to higher‑stage pressure regulators (ISO 10524-1 / ISO 10524-3).
- Operator‑adjustable low‑pressure regulators integral to pipeline systems for air/nitrogen driving tools.
Safety and performance priorities
- Mechanical strength, controlled relief of excess pressure, resistance to ignition.
- Low leakage and gas specificity to prevent cross‑contamination.
- Material suitability and cleanliness for medical environments.
Accuracy and stability
- Requirements for flowmeters, flowgauges and fixed orifice performance (accuracy, stability).
Testing and verification
- Defined test methods for outlet pressure, leakage, mechanical strength, flow accuracy/stability, loosening torque, and durability of markings/colour coding.
Marking, colour coding and documentation
- Mandatory marking, packaging, colour coding guidance (with Annex for reported national/regional deviations), and information to be supplied by manufacturers.
Supporting information
- Annexes include typical regulator examples, rationale for requirements, regional colour coding deviations, and environmental aspects.

Applications and users

Intended for:
- Manufacturers designing and producing low‑pressure medical gas regulators and integrated flow devices.
- Biomedical engineers / hospital estates specifying, installing and maintaining medical gas terminal equipment.
- Test laboratories and conformity assessors performing verification and type testing against EN ISO 10524‑4.
- Procurement and regulatory teams ensuring medical devices meet applicable safety and EU Medical Device Directive (93/42/EEC) expectations.
Practical uses:
- Reducing pipeline pressure to safe working levels for patient devices.
- Integrating flow control or metering at bedside or equipment interfaces.
- Ensuring consistent performance, safety and traceability in hospital gas systems.

Related standards

ISO 10524 series (Parts 1–3) - other pressure regulator types.
ISO 7396-1 - medical gas pipeline systems (terminal unit interface).
CEN adoption aligns with EU directives and national implementation requirements.

Keywords: EN ISO 10524-4:2008, low-pressure regulators, medical gases, medical gas pipeline, flowmeter, ISO 7396-1, pressure regulators.

EN ISO 10524-4:2008 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

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Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)