ISO 4135.2:2022/DAM 1:2026(en)

ISO/TC 121/SC 4

Secretariat: ANSI

Date: 2026-01-22

Anaesthetic and respiratory equipment — Vocabulary

Amendment 1

© ISO 2026

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Anaesthetic and respiratory equipment — Vocabulary
AMENDMENT 1: oxygen 90+

Delete existing term 3.1.1.22 and replace with two new terms 3.1.1.22.1 and 3.1.1.22.2:

3.1.1.22.1

oxygen 90+

gas mixture that meets the following criteria for composition:

— oxygen (O₂), volume fraction of no less than 90 %, potentially varying in this range over time;

— argon (Ar), volume fraction of no more than 5 %;

— nitrogen (N₂), volume fraction no more than 10 %;

— carbon dioxide (CO₂), volume fraction of no more than 300 ppm;

— carbon monoxide (CO), volume fraction of no more than 10 ppm;

— nitrogen oxides (NOx), volume fraction of no more than 2 ppm;

— sulfur dioxide (SO₂), volume fraction of no more than 1 ppm;

— water (H₂O), volume fraction of no more than 67 ppm;— oils no more than 0,1 mg/m³

Note 1 to entry: This definition is not intended to establish a new oxygen product monograph associated with a specific production technology.

Note 2 to entry: This definition is intended for use by manufacturers of medical devices that use or administer oxygen, for example, ventilators, respiratory care and anaesthesia workstations.

Note 3 to entry: The technical specifications of oxygen 90+ are agnostic to production methods and provide a clear way for manufacturers and users to implement, evaluate and assess compatibility with ‘medical oxygen’.

Note 4 to entry: Current pharmacopeia product monographs [17] through [26] and current production processes were reviewed when creating this definition.

Note 5 to entry: Oils can be present as liquid, aerosol or vapour.

3.1.1.22.2

pharmacopeial oxygen

oxygen compliant with the pharmacopeia required by the regulatory authority having jurisdiction or the pharmacopeia selected by the healthcare facility.

Index

Delete entry for oxygen 93

Add entries for

Bibliography

Add entries at end for:

[17]   European Pharmacopoeia, https://pheur-online.edqm.eu/home/; Oxygen, Ph Eur 0417

[18]   United States Pharmacopeia, USP-NF 2026, https://online.uspnf.com/uspnf; Oxygen, US Ph

[19]   Japanese Pharmacopoeia 18th Edition; Oxygen, JP16

[20]   The International Pharmacopoeia Ed.13 2025-02; Medicinal Oxygen (Oxygenium Medicinalis)

[21]   The International Pharmacopoeia Ed.13 2025-02; Oxygen 98 %

[22]   The International Pharmacopoeia Ed.13 2025-02; Oxygen 99,5 %

[23]   The International Pharmacopoeia Ed.13 2025-02; Oxygen 93 %

[24]   European Pharmacopoeia, https://pheur-online.edqm.eu/home/; Oxygen 93 Percent, Ph Eur 2455

[25]   European Pharmacopoeia, https://pheur-online.edqm.eu/home/; Oxygen 93 Percent, US Ph

[26]   European Pharmacopoeia, https://pheur-online.edqm.eu/home/; Oxygen 98 Percent, Ph Eur 3098