BS EN ISO 14708-5:2022
Implants for surgery. Active implantable medical devices - Circulatory support devices

Standard No.

BS EN ISO 14708-5:2022

Release Date

2022

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 14708-5:2022

Scope

1   Scope This document specifies requirements for safety and performance of active implantable circulatory support devices , including type tests, animal studies and clinical evaluation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products. Included in the scope of this document are: — ventricular assist devices ( VAD ), left or right heart support; — total artificial hearts ( TAH ); — biventricular assist devices ( b...

BS EN ISO 14708-5:2022 Referenced Document

• IEC 60068-1:2013 Environmental testing - Part 1: General and guidance
• IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
• IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
• IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broad-band random and guidance
• IEC 60601-1-10:2007 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers
• IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-6:2010 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability
• IEC 62304:2006 Medical device software - Software life cycle processes
• IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
• ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 14708-1:2014 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
• ISO 14708-5:2020 Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
• ISO 14971:2019 Medical devices — Application of risk management to medical devices

BS EN ISO 14708-5:2022 history

• 2022 BS EN ISO 14708-5:2022 Implants for surgery. Active implantable medical devices - Circulatory support devices