EN ISO 4135:2022/FprA1

• Status: Not Published
• Publication Date: 18-Jan-2027
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• 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
• Ref Project: SIST EN ISO 4135:2022/kFprA1:2026 - Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/FDAM 1:2026)

• Consolidated By: ISO 4135:2022/FDAmd 1 - Anaesthetic and respiratory equipment — Vocabulary — Amendment 1
• Effective Date: 12-Feb-2026
• Amends: EN ISO 4135:2022 - Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)
• Effective Date: 16-Jul-2025

EN ISO 4135:2022/FprA1 is Amendment 1 to the vocabulary for anaesthetic and respiratory equipment, issued in the EN ISO system by CEN and aligned with ISO 4135:2022. It adds two oxygen-related terms and updates the indexing and bibliography so manufacturers, healthcare facilities and regulators can use the same wording when describing oxygen products and oxygen-compatible devices.

What does EN ISO 4135:2022/FprA1 specify?

EN ISO 4135:2022/FprA1 is a vocabulary amendment, not a performance test standard. It revises one existing oxygen entry, adds two new terms, and updates the index and bibliography around those terms.

The amendment organizes its content around:

• the replacement of term 3.1.1.22 with two sub-entries
• an index update for the affected vocabulary terms
• bibliography entries that point to the pharmacopoeial sources reviewed when drafting the oxygen definitions

In practice, this means readers are meant to use the amended wording when specifying oxygen supplies, medical gas descriptions and device compatibility language.

What are the key requirements of EN ISO 4135:2022/FprA1?

EN ISO 4135:2022/FprA1 changes the vocabulary used for oxygen in anaesthetic and respiratory equipment. The main technical point is that it separates a composition-based oxygen term from a pharmacopeia-based oxygen term, so users can state exactly what kind of oxygen they mean.

Oxygen 90+

EN ISO 4135:2022/FprA1 deletes the old oxygen entry and replaces it with oxygen 90+ as a defined gas mixture. The definition sets a minimum oxygen content and upper limits for argon, nitrogen, carbon dioxide, carbon monoxide, nitrogen oxides, sulfur dioxide, water and oils.

For readers, this matters because oxygen 90+ is tied to measurable composition limits rather than to a single production route. Manufacturers can use it to write clearer product descriptions, and buyers or testers can check whether a supplied gas matches the stated composition.

The notes under the definition are important in practice:

• the term is not meant to create a new oxygen product monograph tied to one technology
• it is intended for manufacturers of medical devices that use or administer oxygen, such as ventilators, respiratory care equipment and anaesthesia workstations
• its technical specifications are meant to be agnostic to production method
• the definition was developed after reviewing current pharmacopoeial product monographs and production processes

Pharmacopeial oxygen

EN ISO 4135:2022/FprA1 also adds pharmacopeial oxygen. This term means oxygen that complies with the pharmacopeia required by the regulatory authority or chosen by the healthcare facility.

In practice, this gives hospitals, regulators and suppliers a way to point to the governing pharmacopeia instead of to a fixed composition profile. That matters when procurement, local regulation or hospital policy relies on a specific pharmacopeial monograph.

Index and bibliography updates

EN ISO 4135:2022/FprA1 deletes the index entry for oxygen 93 and adds entries for oxygen 90+ and pharmacopeial oxygen. It also adds bibliography items for the pharmacopoeial oxygen monographs that were reviewed.

That helps users find the revised terms quickly and trace the reference basis behind them.

What terms does EN ISO 4135:2022/FprA1 define?

EN ISO 4135:2022/FprA1 defines two oxygen terms and uses several chemical abbreviations in their wording.

• oxygen 90+ - a gas mixture with oxygen at no less than 90% and controlled impurity limits, intended as a composition-based oxygen term.
• pharmacopeial oxygen - oxygen that complies with the pharmacopeia required by the regulator or selected by the healthcare facility.
• O2 - the chemical symbol for oxygen, used to state the oxygen content in the mixture.
• Ar - the chemical symbol for argon, one of the gases limited in the oxygen 90+ definition.
• N2 - the chemical symbol for nitrogen, another controlled component in the oxygen 90+ definition.
• CO2 - the chemical symbol for carbon dioxide, listed as a trace impurity with a tight limit.
• NOx - nitrogen oxides, one of the trace contaminants controlled in the oxygen 90+ definition.

Who uses EN ISO 4135:2022/FprA1?

EN ISO 4135:2022/FprA1 is used by people who need consistent wording for oxygen in medical and respiratory contexts. It is especially relevant to:

• manufacturers of ventilators, respiratory care devices and anaesthesia workstations
• suppliers and buyers of medical oxygen
• healthcare facilities that choose a pharmacopeia for oxygen supply
• regulatory and quality teams that document oxygen compatibility, labeling or procurement language

The practical use is simple: it helps these groups state whether they mean a composition-defined oxygen gas or a pharmacopeia-defined oxygen product.

What changed in EN ISO 4135:2022/FprA1 from the previous edition?

EN ISO 4135:2022/FprA1 replaces the former oxygen entry 3.1.1.22 with two new entries, 3.1.1.22.1 oxygen 90+ and 3.1.1.22.2 pharmacopeial oxygen. It also removes the index entry for oxygen 93, adds index entries for the new terms, and adds bibliography references [17] to [26] for the pharmacopoeial sources reviewed.

Which standards are used with EN ISO 4135:2022/FprA1?

EN ISO 4135:2022/FprA1 points to pharmacopoeial references that support the oxygen terminology. The bibliography includes:

• European Pharmacopoeia oxygen monographs, including Oxygen, Oxygen 93 Percent and Oxygen 98 Percent
• USP-NF 2026, Oxygen
• Japanese Pharmacopoeia 18th Edition, Oxygen
• The International Pharmacopoeia, including Medicinal Oxygen, Oxygen 98 %, Oxygen 99,5 % and Oxygen 93 %

These references provide the monograph basis that the amendment reviewed when defining oxygen 90+ and pharmacopeial oxygen.

What does the EN ISO 4135:2022/FprA1 document contain?

EN ISO 4135:2022/FprA1 contains the revised vocabulary entry for oxygen, explanatory notes on intended use and production-method neutrality, and updates to the index and bibliography. The wording focuses on composition criteria for oxygen 90+ and on pharmacopeia-based compliance for pharmacopeial oxygen.

For engineers and quality teams, the useful part is the exact terminology they can adopt in specifications, labels, procedures and supplier documentation. For procurement and regulatory work, the added bibliography shows which pharmacopoeial monographs were considered when drafting the new terms.

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
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