Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/DAM 1:2025)

Anästhesie- und Beatmungsgeräte - Begriffe - Änderung 1 (ISO 4135:2022/DAM 1:2025)

Matériel d'anesthésie et de réanimation respiratoire - Vocabulaire - Amendement 1 (ISO 4135:2022/DAM 1:2025)

Anestezijska in dihalna oprema - Slovar - Dopolnilo A1 (ISO 4135:2022/DAM 1:2025)

General Information

Status
Not Published
Publication Date
07-Apr-2027
Current Stage
4060 - Closure of enquiry - Enquiry
Start Date
05-Dec-2025
Completion Date
05-Dec-2025

Relations

Effective Date
16-Jul-2025

Overview

EN ISO 4135:2022/prA1 (Anaesthetic and respiratory equipment - Vocabulary - Amendment 1, ISO 4135:2022/DAM 1:2025) is a draft amendment to the ISO vocabulary for anaesthetic and respiratory equipment published via CEN. This amendment clarifies and extends terminology related to medical oxygen, introducing new defined gas categories such as oxygen 90+ and updating the entry for oxygen 93. The document is circulated for comment and intended to harmonize terminology used by manufacturers, regulators and healthcare providers.

Key topics and technical requirements

  • New and revised definitions
    • Oxygen 90+: a defined gas mixture with explicit compositional limits, including minimum oxygen (O2) volume fraction ≥ 90% and maximum limits for argon, nitrogen, CO2, CO, NOx, SO2, and oils (as provided in the amendment). This definition is intended for consistent use in device and system specifications.
    • Oxygen 93: retains status as a medicinal gas (manufactured often by pressure‑swing adsorption concentrators) and deprecates the term “oxygen‑enriched air.”
  • Removal of water vapour specification: the draft removes a previously proposed maximum water vapour content from the oxygen 90+ definition, with rationale that moisture limits are product‑specific requirements and belong in product or pipeline standards rather than in a vocabulary entry.
  • Usage notes: the amendment includes explanatory notes clarifying that the oxygen 90+ specification is production‑method agnostic and intended to be compatible with existing pharmacopoeia monographs (several WHO, Ph. Eur., US Ph. and JP monographs are referenced).

Practical applications and users

  • Medical device manufacturers: ventilators, anaesthesia delivery systems, respiratory care devices and medical gas supply equipment can use the defined terms to ensure consistent labelling, interfaces and compatibility with medical oxygen supplies.
  • Healthcare providers and procurement: hospitals and clinics benefit from clear terminology when specifying oxygen supply sources (on‑site concentrators vs. cylinder or pipeline supplies).
  • Regulators and standards committees: supports consistent regulatory language and technical requirements referenced in product standards or national regulations.
  • Standards writers and test laboratories: helps align test methods, conformity assessments and product requirements with an agreed vocabulary.

Related standards

  • ISO 4135:2022 (base vocabulary standard) - this amendment
  • Pharmacopoeia monographs referenced in the amendment (Ph. Eur., US Ph., JP, WHO)
  • Product and pipeline standards for medical gas distribution and medical devices (for application‑specific requirements such as moisture limits)

Keywords: EN ISO 4135:2022/prA1, anaesthetic and respiratory equipment vocabulary, oxygen 90+, oxygen 93, medical oxygen specification, ISO 4135 amendment, medical device compatibility, pressure‑swing adsorption.

Draft

EN ISO 4135:2022/oprA1:2025

English language
5 pages
Preview
Preview
e-Library read for
1 day

Frequently Asked Questions

EN ISO 4135:2022/prA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/DAM 1:2025)". This standard covers: Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/DAM 1:2025)

Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/DAM 1:2025)

EN ISO 4135:2022/prA1 is classified under the following ICS (International Classification for Standards) categories: 01.040.11 - Health care technology (Vocabularies); 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

EN ISO 4135:2022/prA1 has the following relationships with other standards: It is inter standard links to EN ISO 4135:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN ISO 4135:2022/prA1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-november-2025
Anestezijska in dihalna oprema - Slovar - Dopolnilo A1 (ISO 4135:2022/DAM
1:2025)
Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO
4135:2022/DAM 1:2025)
Anästhesie- und Beatmungsgeräte - Begriffe - Änderung 1 (ISO 4135:2022/DAM 1:2025)
Matériel d'anesthésie et de réanimation respiratoire - Vocabulaire - Amendement 1 (ISO
4135:2022/DAM 1:2025)
Ta slovenski standard je istoveten z: EN ISO 4135:2022/prA1
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
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 4135:2022/
DAM 1
ISO/TC 121/SC 4
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Vocabulary
Voting begins on:
AMENDMENT 1
2025-09-12
Matériel d'anesthésie et de réanimation respiratoire — Voting terminates on:
Vocabulaire 2025-12-05
AMENDEMENT 1
ICS: 11.040.10; 01.040.11
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO 4135:2022/DAM 1:2025(en)
DRAFT
ISO 4135:2022/DAM 1:2025(en)
Amendment
ISO 4135:2022/
DAM 1
ISO/TC 121/SC 4
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Vocabulary
Voting begins on:
AMENDMENT 1
Matériel d'anesthésie et de réanimation respiratoire — Voting terminates on:
Vocabulaire
AMENDEMENT 1
ICS: 11.040.10; 01.040.11
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 4135:2022/DAM 1:2025(en)
ii
ISO 4135:2022/DAM 1:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Dir
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

Loading comments...