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

Overview

SIST EN ISO 4135:2022/kFprA1:2026 is an amendment to the international standard ISO 4135:2022, which specifies the approved vocabulary for anaesthetic and respiratory equipment. This update, managed by the Slovenian Institute for Standardization (SIST), aims to enhance clarity and uniformity in terminology for manufacturers, regulators, and healthcare professionals working with medical devices related to anaesthesia and respiratory care.

With the continuous evolution of healthcare technology, clear and precise definitions are vital to ensure safe, effective communication and compliance across industries. This amendment introduces revised and new terms for medical oxygen, reflecting current regulatory and technical requirements in the sector.

Key Topics

• Updated Oxygen Definitions:
  Amendment 1 revises and replaces the existing vocabulary entry for oxygen-related terms, providing two distinct definitions:

  • Oxygen 90+: A gas mixture primarily composed of oxygen (at least 90%), with strict limits on argon, nitrogen, contaminants (CO₂, CO, NOₓ, SO₂), water, and oils, suitable for use in medical devices.
  • Pharmacopeial Oxygen: Oxygen meeting the specifications set by the relevant pharmacopeia as mandated by regulatory authorities or healthcare facility policies.

• Clarity in Medical Gases:
  The new definitions distinguish between types of medical oxygen, ensuring that manufacturers and healthcare providers refer to consistent and regulatory-approved terminology, supporting patient safety and device reliability.

• Index and Bibliography Updates:
  The amendment revises the index to reflect the new nomenclature and incorporates references to leading pharmacopoeias such as the European Pharmacopoeia, United States Pharmacopeia, and others, underlining the global applicability of the terminology.

Applications

The revised vocabulary in SIST EN ISO 4135:2022/kFprA1:2026 is directly relevant to:

• Medical Device Manufacturing:
  Ensures accurate labelling, documentation, and compliance for manufacturers of ventilators, anesthesia workstations, and respiratory support devices using various grades of medical oxygen.

• Healthcare Institutions:
  Facilitates clear communication between procurement, clinical staff, and regulators by distinguishing between different oxygen products and their specifications.

• Regulatory Compliance:
  Provides harmonized language for meeting international regulatory standards for anaesthetic and respiratory equipment, reducing risks of misinterpretation or errors in device application.

• Training and Documentation:
  Supports the development of educational, operational, and maintenance material by establishing standard terminology for medical gases and related equipment.

Related Standards

The amendment to ISO 4135:2022 aligns with the following important standards in the healthcare and medical device sectors:

• European Pharmacopoeia (Ph Eur 0417, 2455, 3098)
• United States Pharmacopeia (USP-NF 2026)
• Japanese Pharmacopoeia (JP16)
• The International Pharmacopoeia (Ed.13, 2025-02)
• SIST EN ISO 7396-1: Medical gas pipeline systems
• SIST EN ISO 13485: Medical device quality management systems
• SIST EN ISO 14971: Application of risk management to medical devices

This vocabulary amendment is crucial in maintaining global consistency in the definition and deployment of anaesthetic and respiratory equipment, contributing to improved patient care, operational clarity, and regulatory harmonization in the medical device industry.

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
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 ma
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