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

Overview

ISO 4135:2022/FDAmd 1: Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 is an update to the ISO 4135:2022 standard, adding critical terminology and definitions for the field of anaesthetic and respiratory equipment. Developed by ISO/TC 121/SC 4 in collaboration with key international bodies, this amendment focuses on enhancing the clarity and consistency of vocabulary concerning oxygen mixtures and standards for medical devices used in respiratory and anaesthetic settings.

A precise and harmonized vocabulary helps manufacturers, healthcare providers, and regulatory agencies improve equipment compatibility, labeling, and safety in medical environments. The content of Amendment 1 introduces new terms, especially around “oxygen 90+” and “pharmacopeial oxygen,” which are central to the specification and compliance of medical gas usage.

Key Topics

• Oxygen 90+:

  • Defined as gas mixtures intended for use by manufacturers of medical devices to assess compatibility with pharmacopeial oxygen sources.
  • Specifies allowable concentrations for oxygen and trace gases, agnostic to production method.
  • Associated with clear labeling for device compatibility: “Oxygen 90+ compatible” and “Oxygen 90+ conditionally compatible.”

• Pharmacopeial Oxygen:

  • Gas mixture compliant with the pharmacopeia as required by relevant regulatory authorities or chosen by healthcare facilities.
  • Aligns device compatibility checks with multiple international pharmacopoeial standards.

• Updated Index and Bibliography:

  • Adds explicit references for “oxygen 90+” and “pharmacopeial oxygen.”
  • Bibliography includes leading pharmacopoeial sources: European Pharmacopoeia, United States Pharmacopeia, Japanese Pharmacopoeia, and The International Pharmacopoeia.

Applications

The adoption of ISO 4135:2022/FDAmd 1 provides multiple practical benefits in the anaesthetic and respiratory equipment sector, such as:

• Medical Device Manufacturing:

  • Ensures a unified understanding when designing, labeling, or testing ventilators, anaesthesia workstations, and related equipment for use with specific oxygen mixtures.
  • Facilitates global market access by aligning device claims with multiple international standards for medical oxygen.

• Regulatory Compliance:

  • Helps manufacturers and healthcare facilities demonstrate and document conformance to safety and purity requirements for oxygen used in therapies.
  • Supports easier communication with regulatory bodies concerning device compatibility and gas purity.

• Healthcare Facility Operations:

  • Assists clinicians and biomedical engineers in identifying the appropriate equipment for use with their available oxygen supply.
  • Enables informed safety assessments and procurement decisions through clear, standardized labeling.

• Quality Assurance and Testing:

  • Guides testing laboratories in preparing relevant gas mixtures for device evaluation and validating manufacturer claims for “oxygen 90+ compatibility.”

Related Standards

ISO 4135:2022/FDAmd 1 integrates with key international standards and regulatory documents in the anaesthetic and respiratory field, including:

• ISO 4135:2022 - Anaesthetic and respiratory equipment - Vocabulary (main standard)
• European Pharmacopoeia (Ph Eur 0417, 2455, 3098)
• United States Pharmacopeia (USP-NF)
• Japanese Pharmacopoeia
• The International Pharmacopoeia
• Additional relevant standards for oxygen mixtures and medical gas quality

By referencing ISO 4135:2022 and key world pharmacopoeias, this amendment provides comprehensive support for global harmonization in respiratory equipment vocabulary and device compatibility labeling.

Keywords: ISO 4135, Anaesthetic equipment standard, respiratory equipment vocabulary, oxygen 90+, pharmacopeial oxygen, medical device compatibility, oxygen standards, pharmacopoeia, device labeling, regulatory compliance, medical gas.

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
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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.
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INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
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SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
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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,
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
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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,
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SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
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ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
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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
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de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général
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