Standards
ISO 11197:2019 Medical supply units
ISO 11197:2019, Medical supply units, is the ISO standard for the basic safety and essential performance of medical supply units, whether built in a factory or assembled on site; it is the edition in force, and on 22 October 2026 ISO listed its fifth edition as under publication.
What the standard covers
ISO 11197 applies to the basic safety and essential performance of medical supply units, which it refers to as ME (medical electrical) equipment; its scope clause replaces clause 1.1 of IEC 60601-1:2005+A1:2012. It applies to units manufactured in a factory or assembled on site, including cabinetry and other enclosures that incorporate patient care services. A party that assembles components for patient care services into an enclosure on site is considered the manufacturer of the medical supply unit.
Hazards inherent in the intended function of the equipment are not covered by specific requirements in the standard, except for subclauses 7.2.13 and 8.4.1 of IEC 60601-1.
Edition in force and status
- ISO 11197:2019 is the fourth edition, published in November 2019 (36 pages, ISO/TC 121/SC 6). It replaced ISO 11197:2016.
- ISO marked it for revision on 19 May 2023. The final vote on the fifth edition closed on 18 September 2026, and that edition has been under publication (stage 60.00) since then. ISO expects it to replace the 2019 edition within the coming months, so check iso.org before citing the edition.
In medical gas installations
- Under HTM 02-01 (2026), the NHS England guidance, booms, ceiling pendants, wall systems and bedhead trunking systems are typical medical supply units, and terminal units may be incorporated within them.
- HTM 02-01 says flexible connections should not be used within fixed non-adjustable or rotating medical supply units, as set out in BS EN ISO 11197, and that, if modifications are made, the modifier or maintainer of the medical supply unit should assume the responsibility of manufacturer.
- HTM 02-01 also says that flexible connecting assemblies used within the fitting should comply with BS EN ISO 5359 (see ISO 5359).
Related standards
- ISO 9170-1: terminal units for compressed medical gases and vacuum.
- ISO 15001: oxygen compatibility; its scope names medical supply units among the equipment it applies to.
- ISO 7396-1: pipeline systems for compressed medical gases and vacuum.
More questions
Who is the manufacturer of a medical supply unit assembled on site?
Under ISO 11197, a party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.
Is a new edition of ISO 11197 coming?
Yes. ISO lists the fifth edition as under publication since 18 September 2026; until it is published, ISO 11197:2019 is the edition in force.
Sources
- ISO 11197:2019, Medical supply units (iso.org)
- ISO 11197, edition 5, under publication (iso.org)
- NHS England, HTM 02-01 (2026), Part A: Design, installation, validation and verification
- NHS England, HTM 02-01 (2026), Part B: Operational management
- ISO 15001:2010, Compatibility with oxygen (iso.org)
- ISO 9170-1:2017, Terminal units, Part 1 (iso.org)
Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.
Related
- AnswersWhat is a medical gas ceiling pendant?
- StandardsISO 9170-1: terminal units for compressed medical gases and vacuum
- StandardsISO 5359:2014 Low-pressure hose assemblies for medical gases
- StandardsISO 15001:2010 Compatibility with oxygen
- StandardsISO 7396-1: pipelines for compressed medical gases and vacuum