SIST EN ISO 4135:2022/kFprA1:2026

• Status: Not Published
• Public Enquiry End Date: 30-Mar-2026
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 04-Sep-2026
• Due Date: 23-Oct-2026
• Completion Date: 10-Sep-2026
• Ref Project: EN ISO 4135:2022/FprA1 - Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/FDAM 1:2026)

• Amends: SIST EN ISO 4135:2022 - Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)
• Effective Date: 16-Jul-2025

SIST EN ISO 4135:2022/kFprA1:2026 is a draft amendment to ISO 4135:2022 for anaesthetic and respiratory equipment vocabulary, published by SIST and aligned with EN ISO 4135:2022/prA1. It updates oxygen-related terminology used by manufacturers of medical devices, healthcare facilities, and others who specify or assess medical oxygen. The focus is on how oxygen is described for ventilation, respiratory care, and anaesthesia workstations.

What does SIST EN ISO 4135:2022/kFprA1:2026 specify?

SIST EN ISO 4135:2022/kFprA1:2026 specifies an amendment to the vocabulary in ISO 4135:2022. Its main effect is to replace one existing oxygen term with two new terms and to update the index and bibliography so users can apply the revised terminology consistently.

The amendment is organized around one vocabulary entry in Clause 3.1.1.22, plus index and bibliography changes. In practice, that means users need to update controlled vocabularies, product descriptions, and references that still point to the deleted oxygen entry.

What are the key requirements of SIST EN ISO 4135:2022/kFprA1:2026?

The amendment changes the oxygen terminology rather than introducing a testing or performance standard. The key practical point is that it separates a product-style oxygen definition from a pharmacopeia-based oxygen definition.

Clause 3.1.1.22 - new oxygen terms

• Clause 3.1.1.22 is deleted and replaced by 3.1.1.22.1 and 3.1.1.22.2. In practice, any internal documents, labels, databases, or specifications that used the old entry need to be revised.
• 3.1.1.22.1, oxygen 90+, defines a gas mixture with oxygen as the dominant component and sets limits for impurities such as argon, nitrogen, carbon dioxide, carbon monoxide, nitrogen oxides, sulfur dioxide, water, and oils. In practice, this gives manufacturers a clear technical definition to check when they design or assess devices that use oxygen.
• The notes to oxygen 90+ say that the definition is not meant to create a new oxygen product monograph tied to one production technology. In practice, the term is intended to stay neutral about how the gas is made.
• The notes also say the definition is intended for manufacturers of medical devices that use or administer oxygen, including ventilators, respiratory care equipment, and anaesthesia workstations. In practice, this helps users judge compatibility with medical oxygen in devices and systems.
• The notes explain that the technical specification is agnostic to production methods and was developed with current pharmacopeia monographs and current production processes in mind. In practice, this links the vocabulary to real-world supply and procurement conditions.
• 3.1.1.22.2, pharmacopeial oxygen, means oxygen that complies with the pharmacopeia required by the authority having jurisdiction or selected by the healthcare facility. In practice, this supports procurement and compliance decisions where the applicable pharmacopeia matters.

Index and bibliography updates

• The index deletes oxygen 93 and adds oxygen 90+ and pharmacopeial oxygen. In practice, this helps readers find the revised terms quickly.
• The bibliography adds references to several pharmacopeias. In practice, these are the background sources for the oxygen terminology and help readers trace the definitions to established pharmacopeial practice.

What terms does SIST EN ISO 4135:2022/kFprA1:2026 define?

• oxygen 90+ - The new term for a gas mixture with oxygen as the main component and defined impurity limits.
• pharmacopeial oxygen - Oxygen that meets the pharmacopeia selected by the regulator or healthcare facility.
• O2 - The chemical formula for oxygen, used in the composition description of oxygen 90+.
• Ar - The chemical symbol for argon, one of the controlled components in oxygen 90+.
• N2 - The chemical formula for nitrogen, another controlled component in oxygen 90+.
• NOx - A grouped abbreviation for nitrogen oxides, which are limited in oxygen 90+.
• H2O - Water, listed as one of the controlled impurities in oxygen 90+.

Who uses SIST EN ISO 4135:2022/kFprA1:2026?

SIST EN ISO 4135:2022/kFprA1:2026 is used by manufacturers of medical devices that use or administer oxygen, especially ventilators, respiratory care equipment, and anaesthesia workstations. It is also relevant to healthcare facilities that select a pharmacopeia for oxygen supply, and to people who write specifications, evaluate compatibility, or maintain product terminology in procurement and quality systems.

What changed in SIST EN ISO 4135:2022/kFprA1:2026 from the previous edition?

This amendment replaces the existing oxygen entry 3.1.1.22 with two new entries, oxygen 90+ and pharmacopeial oxygen. It also removes oxygen 93 from the index and adds the new terms there. The bibliography is expanded with pharmacopeia references connected to the revised oxygen definitions.

Which standards are used with SIST EN ISO 4135:2022/kFprA1:2026?

The amendment adds bibliography references to pharmacopeias that inform the oxygen terminology:

• European Pharmacopoeia - oxygen monographs for oxygen-related definitions.
• United States Pharmacopeia, USP-NF 2026 - oxygen monograph reference.
• Japanese Pharmacopoeia 18th Edition - oxygen monograph reference.
• The International Pharmacopoeia, Ed. 13 2025-02 - medicinal oxygen and several oxygen strength monographs.

These references matter because they show the pharmacopeial context behind the term pharmacopeial oxygen and the related oxygen definitions.

What does the SIST EN ISO 4135:2022/kFprA1:2026 document contain?

The document contains the draft amendment text for ISO 4135:2022, including the replacement of one vocabulary entry with two new terms. It gives the full wording of the new definitions and notes to entry, so readers can see how oxygen 90+ and pharmacopeial oxygen are meant to be used.

It also updates the index to match the new terminology and adds bibliography entries for the pharmacopeias cited in the amendment. For users, that means the document is mainly a terminology update for drafting, procurement, labeling, and technical evaluation.

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
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: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
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
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
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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 ma
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