EN ISO 15002:2008/prA2

Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 2 (ISO 15002:2008/DAM 2:2020)

Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen von Rohrleitungssystemen für medizinische Gase (ISO 15002:2008/DAM 2:2020)

Dispositifs de mesure de débit pour raccordement aux prises murales des systèmes de distribution de gaz médicaux - Amendement 2 (ISO 15002:2008/DAM 2:2020)

Pretočni merilniki za priključitev na končne dele napeljav za medicinske pline - Dopolnilo A2 (ISO 15002:2008/DAM 2:2020)

General Information

• Status: Not Published
• Publication Date: 15-Nov-2021
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 4098 - Decision to abandon - Enquiry
• Start Date: 23-Nov-2022
• Completion Date: 14-Apr-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 15002:2008/oprA2:2020 - Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 2 (ISO 15002:2008/DAM 2:2020)

Relations

• Amends: EN ISO 15002:2008 - Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
• Effective Date: 13-Jun-2018

Overview

EN ISO 15002:2008/prA2 (Amendment 2 to ISO 15002:2008/DAM 2:2020) clarifies marking and functional requirements for flow-metering devices used at terminal units of medical gas pipeline systems. The amendment removes certain restrictive text from Amendment 1 and replaces it with requirements that prioritize clear device marking, functional testing and safe operation across a range of clinical settings. The document is circulated as a draft amendment by ISO/TC 121/SC 6 and is intended to enhance patient safety and regulatory compliance for medical gas flow-metering.

Key Topics

• Marking of maximum flow: Flowmeters that can be adjusted to deliver flows greater than the scale indication must be clearly marked with the maximum flow deliverable at the specified pipeline pressure (see 7.1.1). This marking requirement supports clear labeling and reduces the risk of inadvertent high flows.
• Removal of prior flow restriction text: Amendment 2 removes text from Amendment 1 that attempted to restrict maximum deliverable flow values; instead the focus is on transparent marking and verification.
• Scale and indicator updates: Additions to clauses on scales and flow controls require that flow control devices cannot be set above the maximum setting and must be designed so they cannot be positioned where no flow occurs between settings.
• Between-setting flow limits: The amendment replaces prior between-setting limits and requires that a device set between adjacent flow settings shall not generate a flow exceeding 150% of the higher adjacent setting; compliance is to be verified by functional testing.
• Compliance checks: The document specifies both visual inspection (for marking and scale signs) and functional testing (for mechanism behavior and flow limits) as verification methods.

Applications

This amendment applies to manufacturers, test laboratories, healthcare facilities, and standards bodies involved with:

• Medical gas pipeline systems and wall terminal equipment
• Design and labeling of flow-metering devices and flow controls
• Risk mitigation for neonatal, paediatric and adult patients sensitive to high flows
• Conformity assessment, procurement specifications and clinical equipment management

Benefits include clearer device labeling, reduced risk of excessive flow delivery to vulnerable patients, and more consistent functional verification procedures.

Related Standards

• ISO 15002:2008 (base standard for flow‑metering devices connected to terminal units of medical gas systems)
• ISO/TC 121 guidance and subsequent amendments or corrigenda

For authoritative interpretation, refer to the full draft amendment text and national standards bodies. The amendment emphasizes practical controls: clear maximum-flow marking, robust design to prevent unsafe settings, and routine verification via visual inspection and functional testing to ensure patient safety and regulatory compliance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2020
Pretočni merilniki za priključitev na končne dele napeljav za medicinske pline -
Dopolnilo A2 (ISO 15002:2008/DAM 2:2020)
Flow-metering devices for connection to terminal units of medical gas pipeline systems -
Amendment 2 (ISO 15002:2008/DAM 2:2020)
Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen von
Rohrleitungssystemen für medizinische Gase (ISO 15002:2008/DAM 2:2020)
Dispositifs de mesure de débit pour raccordement aux prises murales des systèmes de
distribution de gaz médicaux - Amendement 2 (ISO 15002:2008/DAM 2:2020)
Ta slovenski standard je istoveten z: EN ISO 15002:2008/prA2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT AMENDMENT
ISO 15002:2008/DAM 2
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-01-03 2020-03-27
Flow-metering devices for connection to terminal units of
medical gas pipeline systems
AMENDMENT 2
Dispositifs de mesure de débit pour raccordement aux prises murales des systèmes de distribution de gaz
médicaux
AMENDEMENT 2
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 15002:2008/DAM 2:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020

ISO 15002:2008/DAM 2:2020(E)
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ISO 15002:2008/DAM 2:2020(E)
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