British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of CH/150, is responsible for standardization in the fields of cardiovascular implants, neurosurgical implants and active surgical implants and is responsible for the UK input to ISO/TC 150/SC 2, ISO/TC 150/SC 6, and CEN/CENELEC JTC 16 on active implantable medical devices.

Committee standards activity

In Progress (20)

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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/TR 18965	Cardiac valve manufacturing risk management Categories: Implants for surgery, prosthetics and orthotics Approval begins :	Approval
ISO/PWI PAS 7020	Sizing surgically implanted heart valve substitutes Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Implants for surgery, prosthetics and orthotics Proposal begins : 2021-03-04	Proposal
ISO/PWI PAS 7020	Sizing surgically implanted heart valve substitutes Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Implants for surgery, prosthetics and orthotics Proposal begins : 2021-03-04	Proposal
BS ISO 8637-3	Extracorporeal systems for blood purification —. Part 3: Plasmafilters Categories: Implants for surgery, prosthetics and orthotics Drafting begins : 2021-12-21	Drafting
BS ISO 8637-1:2024	Extracorporeal systems for blood purification. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Categories: Implants for surgery, prosthetics and orthotics Approval begins : 2024-06-12	Approval
BS ISO 27185	Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements Categories: Graphical symbols. Specific equipment \| Implants for surgery, prosthetics and orthotics Drafting begins : 2022-05-12	Drafting
BS ISO 23433	Cardiovascular implants and artificial organs - Cannulae for long-term extracorporeal circulation Categories: Unclassified documents Drafting begins : 2019-09-20	Drafting
BS ISO 18193:2021/Amd 1	Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation - Amendment 1: Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation — Amendment 1 Categories: Implants for surgery, prosthetics and orthotics Public comment begins : 2024-11-28	Public comment
BS ISO 18193	Cardiovascular implants and artificial organs - Cannulae for cardiopulmonary bypass and short-term extracorporeal circulation Categories: Unclassified documents Drafting begins : 2019-09-20	Drafting
BS ISO 14708-1	Implants for surgery — Active implantable medical devices —. Part 1: General requirements for safety, marking and for information to be provided by the manufacturer Categories: Unclassified documents Drafting begins : 2024-12-06	Drafting

Published (51)

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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 17137:2021	Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2021-09-17	Published standard
PD ISO/TS 10974:2018	Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2018-04-20	Published standard
PD ISO/TR 21900:2018	Guidance for uncertainty analysis regarding the application of ISO/TS 10974 Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2018-09-19	Published standard
PD ISO/TR 19024:2016	Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2016-08-19	Published standard
PD ISO/TR 12417-2:2022	Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. Local regulatory information Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2022-07-15	Published standard
PD ISO/PAS 7020:2023	Sizing parameters of surgical valve prostheses. Requirements regarding the application of ISO 5840-2 Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2023-05-19	Published standard
BS ISO 8637-3:2024	Extracorporeal systems for blood purification. Plasmafilters Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2024-06-04	Published standard
BS ISO 5910:2024	Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2024-07-17	Published standard
BS ISO 5841-2:2014	Implants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2014-08-05	Published standard
BS ISO 27186:2020	Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2020-12-01	Published standard

Withdrawn (73)

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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 17137:2019	Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2021-09-17	Withdrawn
PD ISO/TS 17137:2014	Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2019-09-10	Withdrawn
PD ISO/TS 10974:2012	Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2018-04-20	Withdrawn
DD ISO/TS 12417:2011	Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2015-10-22	Withdrawn
BS ISO 8637-3:2018	Extracorporeal systems for blood purification. Plasmafilters Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2024-06-04	Withdrawn
BS ISO 7199:2009+A1:2012	Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2014-12-16	Withdrawn
BS ISO 7199:2009	Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2012-04-03	Withdrawn
BS ISO 5910:2018	Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2024-07-17	Withdrawn
BS ISO 5841-2:2000	Implants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2014-08-05	Withdrawn
BS ISO 27186:2010	Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2020-12-01	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

A B H I - Association of British Healthcare Industries
British Heart Valve Society
British Society of Interventional Radiology
BSI Regulatory Services
Committee Manager
Heart Rhythm U K
I E T - Institution of Engineering and Technology
I P E M - Institute of Physics and Engineering in Medicine
Individual capacity - Patient safety, device regulation
LNE-GMED UK
M H R A - Medicines and Healthcare products Regulatory Agency
Medical Devices in Scotland
Pain Society
Renal Association
Royal College of Nursing
University of Leeds

Liaisons with other committees

Chair - CH/150
Individual Capacity - Active Implants
Individual Capacity - Perfusion Expert
Individual Capacity – Artificial Organs & Blood-biomaterial Interaction
Individual capacity – cardiovascular implant devices
Liaison - CH/150/4

BSI roles

Committee Chair

Standards Development

CH/150/2 - Cardiovascular implants

Committee standards activity