EN ISO 4135:2022/FprA1
(Amendment)Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/FDAM 1:2026)
General Information
- Abstract
- Status
- Not Published
- Publication Date
- 18-Jan-2027
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Current Stage
- 5020 - Submission to Vote - Formal Approval
- Start Date
- 27-Aug-2026
- Completion Date
- 27-Aug-2026
Overview
EN ISO 4135:2022/FprA1 is an important amendment to the international standard that establishes clear and harmonized vocabulary for anaesthetic and respiratory equipment. Developed by CEN in partnership with ISO, this amendment updates and refines key terminology, particularly related to the classification and definition of medical oxygen types. The aim is to improve consistency, safety, and clarity in healthcare technology across global markets.
Precise definitions and terminology are essential for manufacturers, healthcare providers, and regulators involved with anaesthetic, respiratory, and reanimation equipment. This amendment ensures that language used throughout medical device supply chains is consistent and meets current regulatory and clinical needs.
Key Topics
Updated Oxygen Definitions:
The amendment replaces an older term with two new specific terms regarding oxygen mixtures:- Oxygen 90+: Specifies a medical gas mixture with a volume fraction of no less than 90% oxygen, alongside detailed limits for argon, nitrogen, carbon dioxide, carbon monoxide, nitrogen oxides, sulfur dioxide, water, and oils. This definition is comprehensive and independent of production technology.
- Pharmacopeial Oxygen: Refers directly to oxygen products that comply with the requirements of official pharmacopeias, as determined by relevant regulations or healthcare institutions.
Clarification of Composition Requirements:
Clearly outlines the allowed impurities and content in oxygen mixtures used in respiratory and anaesthetic equipment, supporting device compatibility and patient safety.Alignment with International Pharmacopoeias:
The amendment references multiple recognized pharmacopoeias including the European Pharmacopoeia, United States Pharmacopeia, Japanese Pharmacopoeia, and International Pharmacopoeia for standards on medical oxygen.Vocabulary Index Updates:
Updates the vocabulary index to include the new oxygen definitions and removes outdated entries to align with current industry practice.
Applications
EN ISO 4135:2022/FprA1 is widely applicable across the medical device industry and healthcare settings. Its clear terminology and definitions offer numerous practical benefits:
- Medical Device Manufacturing:
Ensures that manufacturers of ventilators, anaesthetic workstations, and other respiratory care equipment use precise and internationally recognized oxygen terminology. - Healthcare Facilities:
Supports clinical and technical staff in specifying and verifying the correct type of medical oxygen for various applications, reducing the risk of misunderstanding or mishandling. - Regulatory Compliance:
Facilitates regulatory approval processes by providing standardized terms that align with current pharmacopoeial and legal requirements. - Supply Chain and Procurement:
Reduces ambiguity in global supply chains by harmonizing oxygen-related specifications, thereby supporting consistent product quality and interoperability. - Education and Training:
Assists in the training of healthcare professionals by embedding a consistent vocabulary within educational materials, guidelines, and protocols.
Related Standards
Several standards intersect with EN ISO 4135:2022/FprA1, providing a broader framework for healthcare technology:
- ISO 4135:2022: The core standard defining vocabulary for anaesthetic and respiratory equipment.
- European Pharmacopoeia and Other National Pharmacopoeias: Official pharmacopeias cited for reference in the definition of pharmacopeial oxygen.
- ISO/TC 121 Standards: A suite of standards relating to various medical gas and device requirements for anaesthetic and respiratory care.
By incorporating precise industry vocabulary and up-to-date definitions, EN ISO 4135:2022/FprA1 supports quality, safety, and interoperability in the global health technology sector.
Relations
- Consolidated By
ISO 4135:2022/FDAmd 1 - Anaesthetic and respiratory equipment — Vocabulary — Amendment 1 - Effective Date
- 12-Feb-2026
- Effective Date
- 16-Jul-2025
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Frequently Asked Questions
EN ISO 4135:2022/FprA1 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/FDAM 1:2026)". This standard covers: Der bestehende Begriff 3.1.1.22 wird gestrichen und durch die beiden neuen Begriffe 3.1.1.22.1 und 3.1.1.22.2 ersetzt:
Der bestehende Begriff 3.1.1.22 wird gestrichen und durch die beiden neuen Begriffe 3.1.1.22.1 und 3.1.1.22.2 ersetzt:
EN ISO 4135:2022/FprA1 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/FprA1 has the following relationships with other standards: It is inter standard links to ISO 4135:2022/FDAmd 1, 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/FprA1 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
SIST EN ISO 4135:2022/oprA1:2026
01-marec-2026
Anestezijska in dihalna oprema - Slovar - Dopolnilo A1 (ISO 4135:2022/DAM
1:2026)
Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO
4135:2022/DAM 1:2026)
Anästhesie- und Beatmungsgeräte - Begriffe - Änderung 1 (ISO 4135:2022/DAM 1:2026)
Matériel d'anesthésie et de réanimation respiratoire - Vocabulaire - Amendement 1 (ISO
4135:2022/DAM 1:2026)
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
SIST EN ISO 4135:2022/oprA1:2026 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 4135:2022/oprA1:2026
SIST EN ISO 4135:2022/oprA1:2026
DRAFT
Amendment
ISO 4135:2022/
DAM 1.2
ISO/TC 121/SC 4
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Vocabulary
Voting begins on:
AMENDMENT 1
2026-02-06
Matériel d'anesthésie et de réanimation respiratoire — Voting terminates on:
Vocabulaire 2026-04-03
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 is circulated as received from the committee 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 4135.2:2022/DAM 1:2026(en)
SIST EN ISO 4135:2022/oprA1:2026
DRAFT
ISO 4135.2:2022/DAM 1:2026(en)
Amendment
ISO 4135:2022/
DAM 1.2
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 is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
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
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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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 4135.2:2022/DAM 1:2026(en)
ii
SIST EN ISO 4135:2022/oprA1:2026
ISO 4135.2:2022/DAM 1:2026(en)
Foreword
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