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FDA-recognized standard · Anesthesiology

ISO 18562-1: Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process

Yes. FDA recognizes ISO 18562-1 Second edition 2024-03 as recognition 1-173, in part, entered 2024-05-29.

Recognized editions of ISO 18562-1

FDA recognitions of ISO 18562-1, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
1-173 ISO 18562-1 Second edition 2024-03 2024-05-29 Partial —

What FDA does not recognize in ISO 18562-1 Second edition 2024-03

Recognition 1-173 is partial. FDA's statement of the extent, verbatim:

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 7.2 b) 1) Parenteral toxicological information may be used in the absence of inhalational toxicological information without modification. Clause 7.3 b) 1) Parenteral toxicological information may be used in the absence of inhalational toxicological information without modification.

Regulations

FDA lists these classification regulations against ISO 18562-1: 21 CFR 868.1400, 21 CFR 868.1840, 21 CFR 868.2885, 21 CFR 868.5160, 21 CFR 868.5260, 21 CFR 868.5270, 21 CFR 868.5330, 21 CFR 868.5340, 21 CFR 868.5440, 21 CFR 868.5450, 21 CFR 868.5454, 21 CFR 868.5580, 21 CFR 868.5620, 21 CFR 868.5630, 21 CFR 868.5690, 21 CFR 868.5730, 21 CFR 868.5800, 21 CFR 868.5895, 21 CFR 868.5905, 21 CFR 868.5915, 21 CFR 868.5925, 21 CFR 868.5975, 21 CFR 868.6250, 21 CFR 880.5400.

Product codes that cite ISO 18562-1

31 FDA product codes cite ISO 18562-1, including BSZ, BTI, BTL, BTM, BTR.

Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.