ISO 4135:2022/Amd 1
(Amendment)Anaesthetic and respiratory equipment — Vocabulary — Amendment 1
- Status
- Not Published
- Technical Committee
- ISO/TC 121/SC 4 - Vocabulary and semantics
- Drafting Committee
- ISO/TC 121/SC 4 - Vocabulary and semantics
- Current Stage
- 6000 - International Standard under publication
- Start Date
- 22-Oct-2026
- Completion Date
- 24-Oct-2026
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ISO 4135:2022/Amd 1 is an ISO amendment to the anaesthetic and respiratory equipment vocabulary. It replaces the existing oxygen entry in ISO 4135:2022 with definitions for oxygen 90+ and pharmacopeial oxygen, so manufacturers, regulators and users can use the same terms when checking compatibility with medical oxygen sources.
What does ISO 4135:2022/Amd 1 specify?
ISO 4135:2022/Amd 1 updates one vocabulary entry in ISO 4135:2022 and aligns the index and bibliography with the new terms. The amendment is focused on oxygen supply compatibility and on how medical device manufacturers can describe that compatibility.
The document is organized around the amended entry 3.1.1.22, the updated index, and bibliography additions that point to the pharmacopeial oxygen monographs used in the definition. It is not a broad rewrite of the vocabulary; it is a targeted update to one topic with supporting references.
What are the key requirements of ISO 4135:2022/Amd 1?
The core change is in Clause 3.1.1.22, where ISO 4135:2022/Amd 1 deletes the existing term and replaces it with two new terms. In practice, readers should use the new vocabulary instead of the former oxygen 93 entry.
3.1.1.22.1 oxygen 90+
ISO 4135:2022/Amd 1 defines oxygen 90+ as a gas mixture intended for medical device manufacturers who need to evaluate compatibility with available pharmacopeial oxygen sources. This matters because the term is meant for compatibility assessment, not for naming a new production technology.
The notes under this term give the technical basis for that assessment. They list worst-case constituent levels for current pharmacopeial oxygen product monographs and indicate that testing may require more than one gas mixture to cover the full range of constituent values.
Compatibility and labelling
ISO 4135:2022/Amd 1 says the definition is not intended to create a new oxygen product monograph tied to a specific production method. It also gives examples of user-facing labels, including “Oxygen 90+ compatible” and “Oxygen 90+ conditionally compatible”. In practice, manufacturers can use those labels to communicate whether a device works with all current pharmacopeial oxygen sources or only with the specific sources listed in accompanying information.
Constituents and contamination control
The note to oxygen 90+ identifies the constituents that matter for compatibility work, including oxygen, argon, nitrogen, carbon dioxide, carbon monoxide, nitrogen oxides, sulfur dioxide, water and oils. This is useful because compatibility testing has to consider trace impurities as well as the oxygen content itself.
The note also says oils can be present as liquid, aerosol or vapour. In practice, that means contamination control and test planning need to cover several physical forms of oil, not just one.
3.1.1.22.2 pharmacopeial oxygen
ISO 4135:2022/Amd 1 defines pharmacopeial oxygen as a gas mixture compliant with the pharmacopeia required by the regulatory authority having jurisdiction or selected by the healthcare facility. This gives users a clear way to link a gas source to the applicable pharmacopeial standard.
What terms does ISO 4135:2022/Amd 1 define?
- oxygen 90+ - a gas mixture used by medical device manufacturers to evaluate compatibility with available pharmacopeial oxygen sources.
- pharmacopeial oxygen - a gas mixture that complies with the pharmacopeia chosen by the regulator or healthcare facility.
- O₂ - oxygen, the main constituent in the oxygen 90+ definition.
- Ar - argon, one of the listed constituents with a maximum level in the note.
- N₂ - nitrogen, another constituent controlled in the oxygen 90+ note.
- CO₂ - carbon dioxide, listed as a trace constituent with a maximum level.
- NOx - nitrogen oxides, included as a trace impurity in the oxygen 90+ note.
- H₂O - water, listed among the controlled constituents for compatibility evaluation.
Who uses ISO 4135:2022/Amd 1?
ISO 4135:2022/Amd 1 is used by manufacturers of medical devices that administer oxygen, especially ventilators and anaesthesia workstations. They use it when evaluating whether a device is compatible with current pharmacopeial oxygen sources and when wording labels such as “Oxygen 90+ compatible”.
It is also relevant to healthcare facilities and regulatory users that select a pharmacopeia for oxygen supply. For those users, the standard provides shared vocabulary for source selection, compatibility review and accompanying information.
What changed in ISO 4135:2022/Amd 1 from the previous edition?
ISO 4135:2022/Amd 1 replaces the old oxygen 93 entry with two new entries: oxygen 90+ and pharmacopeial oxygen. It also updates the index by removing oxygen 93 and adding the two new terms.
The amendment adds bibliography entries for oxygen monographs in the European Pharmacopoeia, USP-NF, the Japanese Pharmacopoeia and The International Pharmacopoeia. These additions support the new definitions and the compatibility context.
Which standards are used with ISO 4135:2022/Amd 1?
- ISO 4135:2022 - the base vocabulary document that this amendment updates.
- European Pharmacopoeia - provides oxygen monographs cited for current pharmacopeial oxygen sources, including Oxygen Ph Eur 0417 and oxygen 93 percent / 98 percent entries.
- USP-NF 2026 - provides the Oxygen and Oxygen 93 Percent monographs used as pharmacopeial sources in the amendment.
- Japanese Pharmacopoeia 18th Edition - provides the Oxygen monograph cited for compatibility reference.
- The International Pharmacopoeia Ed.13 2025-02 - provides medicinal oxygen and oxygen percentage monographs cited in the bibliography.
What does the ISO 4135:2022/Amd 1 document contain?
The document contains the amended vocabulary entry 3.1.1.22, with two replacement terms and detailed notes on compatibility, constituent limits and labelling examples. It also includes the updated index and bibliography entries that point to the relevant pharmacopeial oxygen monographs.
The content is technical but concise: it supports terminology, compatibility evaluation and controlled communication between manufacturers, regulators and users. The bibliography links the vocabulary to the pharmacopoeial sources that define the oxygen products referenced in the new terms.
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 12-Jul-2025
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Frequently Asked Questions
ISO 4135:2022/Amd 1 is a draft published by the International Organization for Standardization (ISO). Its full title is "Anaesthetic and respiratory equipment — Vocabulary — Amendment 1". This standard covers: Anaesthetic and respiratory equipment — Vocabulary — Amendment 1
Anaesthetic and respiratory equipment — Vocabulary — Amendment 1
ISO 4135:2022/Amd 1 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.
ISO 4135:2022/Amd 1 has the following relationships with other standards: It is inter standard links to EN ISO 4135:2022/FprA1, ISO 4135:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 4135:2022/Amd 1 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)
FINAL DRAFT
Amendment
ISO 4135:2022/
FDAM 1
ISO/TC 121/SC 4
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Vocabulary
Voting begins on:
2026-08-24
AMENDMENT 1
Voting terminates on:
Matériel d'anesthésie et de réanimation respiratoire —
2026-10-19
Vocabulaire
AMENDEMENT 1
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO 4135:2022/FDAM 1:2026(en) © ISO 2026
FINAL DRAFT
ISO 4135:2022/FDAM 1:2026(en)
Amendment
ISO 4135:2022/
FDAM 1
ISO/TC 121/SC 4
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Vocabulary
Voting begins on:
AMENDMENT 1
Voting terminates on:
Matériel d'anesthésie et de réanimation respiratoire —
Vocabulaire
AMENDEMENT 1
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 SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
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INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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Published in Switzerland Reference number
ISO 4135:2022/FDAM 1:2026(en) © ISO 2026
ii
ISO 4135:2022/FDAM 1:2026(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 document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical
...
ISO 4135.2:2022/FDAMFDAmd 1:2026(en)
ISO/TC 121/SC 4
Secretariat: ANSI
Date: 2026-05-1308-07
Anaesthetic and respiratory equipment — Vocabulary
Amendment AMENDMENT 1
Matériel d'anesthésie et de réanimation respiratoire — Vocabulaire
AMENDEMENT 1
FDIS stage
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ISO 4135:2022/FDAmd 1(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
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ISO copyright office
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Published in Switzerland
ii
ISO 4135.2:2022/DAMFDAmd 1:2026(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 documentsdocument should be noted. This document was drafted in accordance with the editorial rules
of the ISO/IEC Directives, Part 2 (see www.iso.org/directives 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents.www.iso.org/patents. ISO shall not be held responsible for identifying any or all such
patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.htmlwww.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 4, Vocabulary and semantics., in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
Any feedback or questions on this document should be directed to the user’s natio
...
PROJET FINAL
Amendement
ISO 4135:2022/
FDAM 1
ISO/TC 121/SC 4
Matériel d'anesthésie et de
Secrétariat: ANSI
réanimation respiratoire —
Début de vote:
Vocabulaire
2026-08-24
AMENDEMENT 1
Vote clos le:
2026-10-19
Anaesthetic and respiratory equipment — Vocabulary
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
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INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
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Numéro de référence
ISO 4135:2022/FDAM 1:2026(fr) © ISO 2026
PROJET FINAL
ISO 4135:2022/FDAM 1:2026(fr)
Amendement
ISO 4135:2022/
FDAM 1
ISO/TC 121/SC 4
Matériel d'anesthésie et de
Secrétariat: ANSI
réanimation respiratoire —
Début de vote:
Vocabulaire
2026-08-24
AMENDEMENT 1
Vote clos le:
2026-10-19
Anaesthetic and respiratory equipment — Vocabulary
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2026 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
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Publié en Suisse Numéro de référence
ISO 4135:2022/FDAM 1:2026(fr) © ISO 2026
ii
ISO 4135:2022/FDAM 1:2026(fr)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux
de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général
confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire
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