ISO 4135:2022/FDAmd 1

• Status: Not Published
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: ISO/TC 121/SC 4 - Vocabulary and semantics
• Drafting Committee: ISO/TC 121/SC 4 - Vocabulary and semantics
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 24-Aug-2026
• Completion Date: 24-Aug-2026

• Consolidates: EN ISO 4135:2022/FprA1 - Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/FDAM 1:2026)
• Effective Date: 12-Feb-2026
• Amends: ISO 4135:2022 - Anaesthetic and respiratory equipment — Vocabulary
• Effective Date: 12-Jul-2025

ISO 4135:2022/FDAmd 1 is Amendment 1 to ISO 4135:2022, published by ISO for the vocabulary of anaesthetic and respiratory equipment. It updates the oxygen-related terminology used to assess compatibility with pharmacopeial oxygen sources, and it is written for manufacturers, testers, and users of devices such as ventilators and anaesthesia workstations.

What does ISO 4135:2022/FDAmd 1 specify?

ISO 4135:2022/FDAmd 1 is a terminology amendment focused on one vocabulary entry and the references that support it. It replaces the existing oxygen term in 3.1.1.22 with two new terms, updates the index, and adds bibliography entries for the pharmacopoeial oxygen monographs used in the definitions.

The amendment is organized around:

• a revised vocabulary entry at 3.1.1.22
• updated index entries for the new terms
• added bibliography references [17] through [26]

What are the key requirements of ISO 4135:2022/FDAmd 1?

ISO 4135:2022/FDAmd 1 mainly sets terminology and usage guidance, not product performance limits. Its practical value is in how manufacturers describe oxygen compatibility and how they choose test gases.

• 3.1.1.22.1 oxygen 90+ is defined as a gas mixture intended for manufacturers of medical devices that administer oxygen, so they can check compatibility with available pharmacopeial oxygen sources. In practice, this gives a common compatibility reference for ventilators, anaesthesia workstations, and similar equipment.

• The note to oxygen 90+ gives the constituent gases and impurity types that matter in the compatibility check, including oxygen, argon, nitrogen, carbon dioxide, carbon monoxide, nitrogen oxides, sulfur dioxide, water, and oils. In practice, the manufacturer may need more than one test mixture to cover the full range of source variation.

• The amendment says the oxygen 90+ definition is not a new oxygen product monograph and is not tied to one production technology. In practice, this keeps the term focused on compatibility assessment rather than on how the oxygen is made.

• The notes introduce the labelling concepts “oxygen 90+ compatible” and “oxygen 90+ conditionally compatible.” In practice, the first supports a claim of compatibility with all currently available pharmacopeial oxygen sources, while the second limits the claim to specific sources listed in the accompanying information.

• 3.1.1.22.2 pharmacopeial oxygen is defined as a gas mixture compliant with the pharmacopeia required by the regulatory authority having jurisdiction or selected by the healthcare facility. In practice, this links the oxygen supply definition to the applicable legal or facility choice.

• The index is updated by deleting oxygen 93 and adding oxygen 90+ and pharmacopeial oxygen. In practice, this helps users find the revised vocabulary terms quickly and avoid older terminology.

• The bibliography is expanded with pharmacopoeial oxygen references from Europe, the United States, Japan, and The International Pharmacopoeia. In practice, these references support the worst-case source values mentioned in the note to the oxygen 90+ definition.

What terms does ISO 4135:2022/FDAmd 1 define?

• oxygen 90+ - A gas mixture used by device manufacturers to check compatibility with currently available pharmacopeial oxygen sources.
• pharmacopeial oxygen - Oxygen gas mixture that complies with the pharmacopeia chosen by the regulator or healthcare facility.
• oxygen 90+ compatible - A manufacturer label indicating compatibility with all currently available pharmacopeial oxygen sources.
• oxygen 90+ conditionally compatible - A manufacturer label indicating compatibility only with specific pharmacopeial oxygen sources named in the accompanying information.
• medical devices - The devices, such as ventilators and anaesthesia workstations, that the amendment treats as oxygen-using equipment needing compatibility assessment.
• equipment accompanying information - The device information used to state which specific oxygen sources apply when compatibility is conditional.

Who uses ISO 4135:2022/FDAmd 1?

ISO 4135:2022/FDAmd 1 is used by manufacturers of medical devices that administer oxygen, especially makers of ventilators and anaesthesia workstations. It is also relevant to test and engineering teams that need to choose gas mixtures for compatibility checks.

Healthcare facilities use the vocabulary when selecting or specifying oxygen sources. Regulatory authorities and quality teams can use the terms to align device labels, technical files, and procurement language with the applicable pharmacopeia.

What changed in ISO 4135:2022/FDAmd 1 from the previous edition?

ISO 4135:2022/FDAmd 1 replaces the single oxygen entry at 3.1.1.22 with two entries, oxygen 90+ and pharmacopeial oxygen. It also removes the index entry for oxygen 93 and adds index entries for the new terms.

The amendment adds bibliography references [17] to [26] for the pharmacopoeial oxygen monographs that underpin the new compatibility wording.

Which standards are used with ISO 4135:2022/FDAmd 1?

ISO 4135:2022/FDAmd 1 points users to several pharmacopoeial sources that support the oxygen 90+ note:

• European Pharmacopoeia oxygen monographs, including Oxygen, Ph Eur 0417, Oxygen 93 Percent, Ph Eur 2455, and Oxygen 98 Percent, Ph Eur 3098
• United States Pharmacopeia, USP-NF 2026, including Oxygen, US Ph and Oxygen 93 Percent, US Ph
• Japanese Pharmacopoeia 18th Edition, Oxygen, JP16
• The International Pharmacopoeia Ed.13 2025-02, including Medicinal Oxygen (Oxygenium Medicinalis) and oxygen monographs at 93 %, 98 %, and 99.5 %

These references provide the source specifications behind the compatibility examples in the amendment.

What does the ISO 4135:2022/FDAmd 1 document contain?

ISO 4135:2022/FDAmd 1 contains a short amendment to one vocabulary entry, with explanatory notes that describe how to use the new oxygen compatibility terms. The notes explain the gas constituents to consider, the need for possibly multiple test mixtures, and the intended meaning of compatibility labelling.

It also contains an updated index and added bibliography entries that point to the pharmacopoeial monographs named in the notes. For practical work, the document is mainly used to write specifications, prepare test plans, and state oxygen compatibility in labels and accompanying information.

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
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
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
TTTThhhhiiiis s s s drdrdrdraaaafffftttt i i i is s s s susususubbbbmmmmiiiitttttttteeeed d d d ttttoooo  aaaa  ppppaaaarrrraaaallellellellel l l l vvvvooootttteeee i i i innnn  IIIISSSSOOOO,,,,  CCCCEEEEN.N.N.N.

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,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: [e-mail]
Website: www.iso.orgwww.iso.org
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,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
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,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
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
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir https://www.iso.org/directives).
L'ISO attire l'attention sur le fait que la mise en application du présent document peut entraîner l'utilisation
d'un ou de plusieurs brevets. L'ISO ne prend pas position quant à la preuve, à la validité et à l'applicabilité
de tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l'ISO n'avait
pas reçu notification qu'un ou plusieurs brevets pouvaient être nécessaires à sa mise en application.
Toutefois, il y a lieu d'avertir les responsables de la mise en application du présent document que des
informations plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à
l'adresse www.iso.org/brevets. L'ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou
partie de tels droits de brevet.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l'intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion de
l'ISO aux principes de l'Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir
...