British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of the Standards Policy and Strategy Committee, is responsible for the UK input to ISO/TC 121, ISO/TC 121/SC 4 and CEN/TC 215 for standards relating to anaesthetic and respiratory care equipment and anaesthesiology terminology.

Committee standards activity

In Progress (28)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 23543	Guidance for developing cybersecurity requirements in anaesthetic and respiratory equipment standards Categories: Unclassified documents Drafting begins : 2024-03-01	Drafting
PD ISO/TS 22175	Connectors for respiratory devices Categories: Unclassified documents Drafting begins : 2024-05-31	Drafting
ISO/TC 121 N 1343, ISO/PWI TS 23543	Guidance for developing cybersecurity requirements in anaesthetic and respiratory equipment standards Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Anaesthetic, respiratory and reanimation equipment Proposal begins : 2021-11-26	Proposal
ISO/TC 121 N 1304, ISO/NP TS 22175	Connectors for respiratory devices Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Anaesthetic, respiratory and reanimation equipment Proposal begins : 2021-05-10	Proposal
ISO/TC 121 N 1288, ISO/NP 3273-3	Inhalation Nitric Oxide Systems -- Part 3 Delivery systems Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. Diagnostic \| Medical equipment. Other Proposal begins : 2019-10-24	Proposal
ISO/TC 121 N 1286, ISO/NP 3273-2	Inhalation Nitric Oxide Systems -- Part 2 Supply systems Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. General \| Anaesthetic, respiratory and reanimation equipment \| Medical equipment. Diagnostic \| Medical equipment. Other Proposal begins : 2019-10-24	Proposal
ISO/TC 121 N 1284, ISO/NP TS 3273-1	Inhalation Nitric Oxide Systems -- Part 1 General guidance on the use of inhaled nitric oxide Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. General \| Anaesthetic, respiratory and reanimation equipment \| Medical equipment. Diagnostic \| Medical equipment. Other Proposal begins : 2019-10-24	Proposal
ISO/PWI 19223-3	Lung ventilators and related equipment — Vocabulary and semantics — Part 3: Respiratory care Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Anaesthetic, respiratory and reanimation equipment Proposal begins : 2022-12-14	Proposal
ISO/PWI 19223-2	Lung ventilators and related equipment -- Vocabulary and semantics -- Part 2: High-frequency ventilation Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Anaesthetic, respiratory and reanimation equipment Proposal begins : 2022-12-07	Proposal
CEN/TC 215 N 1723, ISO 80601-2-84	Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Anaesthetic, respiratory and reanimation equipment Proposal begins : 2021-05-11	Proposal

Published (17)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 81060-5:2020	Non-invasive sphygmomanometers. Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2020-02-05	Published standard
PD CR 13903:2001	General guidance on the equipment used for inhaled nitric oxide therapy Categories: Anaesthetic, respiratory and reanimation equipment \| Medical equipment.Therapy Published standard begins : 2000-12-18	Published standard
BS EN ISO 8836:2020	Suction catheters for use in the respiratory tract Categories: Syringes, needles and catheters \| Anaesthetic, respiratory and reanimation equipment Published standard begins : 2020-10-14	Published standard
BS EN ISO 80601-2-70:2020	Medical electrical equipment. Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2020-11-30	Published standard
BS EN ISO 80601-2-69:2020	Medical electrical equipment. Particular requirements for the basic safety and essential performance of oxygen concentrator equipment Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2020-11-23	Published standard
BS EN ISO 80601-2-67:2020	Medical electrical equipment. Particular requirements for basic safety and essential performance of oxygen-conserving equipment Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2020-11-23	Published standard
BS EN ISO 80601-2-56:2017+A1:2020	Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Categories: Medical equipment. Diagnostic Published standard begins : 2020-05-12	Published standard
BS EN ISO 7376:2020	Anaesthetic and respiratory equipment. Laryngoscopesfor tracheal intubation Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2020-09-23	Published standard
BS EN ISO 5367:2023	Anaesthetic and respiratory equipment. Breathing sets and connectors Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2023-07-26	Published standard
BS EN ISO 5360:2016	Anaesthetic vaporizers. Agent-specific filling systems Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2016-03-22	Published standard

Withdrawn (16)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
BS ISO 19223:2019	Lung ventilators and related equipment. Vocabulary and semantics Categories: Health care technology \| Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2021-04-30	Withdrawn
BS EN ISO 80601-2-84:2020	Medical electrical equipment. Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2023-11-16	Withdrawn
BS EN ISO 80601-2-80:2019	Medical electrical equipment. Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2024-09-06	Withdrawn
BS EN ISO 80601-2-79:2019	Medical electrical equipment. Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2019-11-14	Withdrawn
BS EN ISO 80601-2-74:2020	Medical electrical equipment. Particular requirements for basic safety and essential performance of respiratory humidifying equipment Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2021-07-21	Withdrawn
BS EN ISO 80601-2-13:2012+A2:2019	Medical electrical equipment. Particular requirements for basic safety and essential performance of an anaesthetic workstation Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2022-06-17	Withdrawn
BS EN ISO 5360:2007	Anaesthetic vaporizers. Agent-specific filling systems Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2009-05-26	Withdrawn
BS EN ISO 4135:2001	Anaesthetic and respiratory equipment. Vocabulary Categories: Health care technology \| Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2022-03-04	Withdrawn
BS EN ISO 10079-3:2014	Medical suction equipment. Suction equipment powered from a vacuum or positive pressure gas source Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2014-06-17	Withdrawn
BS EN ISO 10079-3:2000	Medical suction equipment. Suction equipment powered from a vacuum or pressure source Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2009-04-27	Withdrawn

Standards Development

CH/121 - Anaesthetic and respiratory equipment

Committee standards activity