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CH/121/9 - Lung Ventilators & Related Equipment

Sector: Governance & Resilience

Categories: Medical equipment. Diagnostic | Medical equipment | Measuring instruments. Temperature | First aid | Medical equipment. General | Medical equipment. Other | Anaesthetic, respiratory and reanimation equipment

Overview: Under the direction of CH/121, is responsible for the UK input to ISO/TC 121/SC 3 and CEN/TC 215

Committee standards activity

In Progress (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.
PD ISO/TS 81060-4	Non-invasive sphygmomanometers. Part 4: Requirements for devices intended for use during patient transport Categories: Unclassified documents Proposal begins :	Proposal
ISO/TC 121/SC 3 N 2547, ISO/NP 80601-xx	Medical electrical equipment -- Part xx: Part 2-XX: Particular requirements for basic safety and essential performance of ventilatory high-flow therapy equipment Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. General \| Medical equipment. Diagnostic \| Medical equipment. Other Proposal begins : 2020-03-17	Proposal
ISO/NP TS 24226	Medical devices — Guidance on the evaluation and acceptance of patient provided medical equipment within the clinical environment Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Anaesthetic, respiratory and reanimation equipment \| Medical equipment. Diagnostic Proposal begins : 2022-11-24	Proposal
ISO/NP 81060-7	Non-invasive sphygmomanometers — Part 7: Part 7: Clinical performance verification of intermittent or repeated intermittent cuffless measurement type Categories: Information management \| Standardization. General rules Proposal begins : 2024-09-25	Proposal
ISO/NP 80601-97	Medical electrical equipment — Part 97: Particular requirements for basic safety and essential performance of respiratory home high-flow therapy equipment Categories: Information management \| Standardization. General rules Proposal begins : 2025-11-02	Proposal
ISO/NP 80601-2-xx	Medical electrical equipment — Part 2-xx: Part 2-XX : Particular requirements for basic safety and essential performance of non-invasive arterial tonometer equipment Categories: Information management \| Standardization. General rules Proposal begins : 2025-02-25	Proposal
ISO/NP 80601-2-93	Medical electrical equipment -- Part 2-93: Part 2-9x: Particular requirements for basic safety and essential performance of inhalational therapy nebulizer equipment Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. General \| Anaesthetic, respiratory and reanimation equipment Proposal begins : 2023-04-20	Proposal
ISO 10651-5:2006,	Adoption without changes as EN ISO "Gas-powered emergency resuscitators" 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 : 2020-06-04	Proposal
BS ISO 81060-7	BS EN ISO 81060-7 Non-invasive sphygmomanometers. Part 7: Clinical performance verification of intermittent or repeated intermittent cuffless measurement type Categories: Anaesthetic, respiratory and reanimation equipment Public comment begins : 2025-09-02	Public comment
BS EN ISO 81060-2	ISO 81060-2 Non-invasive sphygmomanometers. Part 2: Clinical performance verification of intermittent automated measurement type Categories: Medical equipment. Diagnostic Public comment begins : 2026-06-22	Public comment

Show entries

Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TR 21954:2018	Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2018-07-24	Published standard
PD ISO/TR 13154:2017	Medical electrical equipment. Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph Categories: Medical equipment. Diagnostic Published standard begins : 2017-03-29	Published standard
BS EN ISO 8185:2009	Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2009-07-03	Published standard
BS EN ISO 81060-3:2022	Non-invasive sphygmomanometers. Clinical investigation of continuous automated measurement type Categories: Anaesthetic, respiratory and reanimation equipment \| Medical equipment. Diagnostic Published standard begins : 2023-01-20	Published standard
BS EN ISO 81060-2:2019+A2:2024	Non-invasive sphygmomanometers. Clinical investigation of intermittent automated measurement type Categories: Anaesthetic, respiratory and reanimation equipment \| Medical equipment. Diagnostic Published standard begins : 2024-04-04	Published standard
BS EN ISO 80601-2-90:2026	Medical electrical equipment. Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2026-04-22	Published standard
BS EN ISO 80601-2-87:2021	Medical electrical equipment. Particular requirements for basic safety and essential performance of high-frequency ventilators Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2021-05-05	Published standard
BS EN ISO 80601-2-85:2021	Medical electrical equipment. Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2021-04-19	Published standard
BS EN ISO 80601-2-84:2023	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 Published standard begins : 2023-11-16	Published standard
BS EN ISO 80601-2-80:2024	Medical electrical equipment. Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency Categories: Anaesthetic, respiratory and reanimation equipment Published standard begins : 2024-09-06	Published standard

Show entries

Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
BS ISO 80601-2-80:2018	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 : 2019-09-18	Withdrawn
BS ISO 80601-2-79:2018	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 : 2019-09-18	Withdrawn
BS ISO 20789:2018	Anaesthetic and respiratory equipment. Passive humidifiers Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2019-10-23	Withdrawn
BS ISO 18562-4:2017	Biocompatibility evaluation of breathing gas pathways in healthcare applications. Tests for leachables in condensate Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2020-02-19	Withdrawn
BS ISO 18562-3:2017	Biocompatibility evaluation of breathing gas pathways in healthcare applications. Tests for emissions of volatile organic compounds (VOCs) Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2020-02-19	Withdrawn
BS ISO 18562-2:2017	Biocompatibility evaluation of breathing gas pathways in healthcare applications. Tests for emissions of particulate matter Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2020-02-19	Withdrawn
BS ISO 18562-1:2017	Biocompatibility evaluation of breathing gas pathways in healthcare applications. Evaluation and testing within a risk management process Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2020-02-19	Withdrawn
BS ISO 10651-5:2006	Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Gas-powered emergency resuscitators Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2021-08-13	Withdrawn
BS EN ISO 81060-2:2019	Non-invasive sphygmomanometers. Part 2: Clinical investigation of intermittent automated measurement type Categories: Anaesthetic, respiratory and reanimation equipment \| Medical equipment. Diagnostic Withdrawn begins : 2020-09-18	Withdrawn
BS EN ISO 80601-2-90:2021	Medical electrical equipment. Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment Categories: Anaesthetic, respiratory and reanimation equipment Withdrawn begins : 2026-04-22	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

A B H I - Association of British Healthcare Industries
B S I F - Personal Safety Manufacturers Association
BAREMA
Committee Manager
I P E M - Institute of Physics and Engineering in Medicine
Medical Engineering Technologies
National Physical Laboratory
Novosound
Nuralogix

Liaisons with other committees

Individual Capacity - Design & manufacture for mechanical ventilation
Individual capacity - Medical Engineering
Individual capacity - Oximeter Project Expert
Individual Capacity - Patient safety expert
Individual Capacity - Pulse oximetry expert
Individual Capacity - Sphygmomanometer Manufacturer
Individual Capacity – Extractables & Leachables Expert
Liaison - CH/62/1

BSI roles

Committee Chair