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CH/150/2 - Cardiovascular implants

Sector: Governance & Resilience

Categories: Electromagnetic compatibility. General | Syringes, needles and catheters | Medical equipment.Therapy | Graphical symbols. Specific equipment | Medical equipment | Pharmaceutics. Other | Cooking ranges, working tables, ovens and similar appliances | Implants for surgery, prosthetics and orthotics | Electronic components. General | Environmental economics | Microprocessor systems | Medical equipment. General | Water quality. General | Solar energy engineering | Medical equipment. Other | Transfusion, infusion and injection equipment | Anaesthetic, respiratory and reanimation equipment

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 (24)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.

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 ISO 8637-3 Extracorporeal systems for blood purification. Part 3: Plasmafilters

Categories: Transfusion, infusion and injection equipment

Public comment begins : 2025-07-07
Public comment
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 8637-1 ISO 8637-1 Extracorporeal systems for blood purification. Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Categories: Transfusion, infusion and injection equipment

Public comment begins : 2025-07-07
Public comment
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 25735 Cardiovascular implants and artificial organs — Device output-parameter nomenclature and data format used in extracorporeal life support

Categories: Unclassified documents

Proposal begins :
Proposal
BS ISO 24965 EMC for exocardiac implantable cardioverter defibrillators

Categories: Unclassified documents

Proposal begins :
Proposal
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 Cardiovascular implants and artificial organs - Cannulae for cardiopulmonary bypass and short-term extracorporeal circulation

Categories: Unclassified documents

Drafting begins : 2019-09-20
Drafting
Published (52)
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 18965:2025 Medical devices. Examples of the application of the risk management process to cardiac valve replacement and repair systems

Categories: Implants for surgery, prosthetics and orthotics

Published standard begins : 2025-02-13
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
Withdrawn (77)
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