Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

056

Date of Entry 06/07/2021

FR Recognition Number

3-170

Standard

ISO 14708-5 Second edition 2020-05
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices

Scope/Abstract

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 (biVAD);
- percutaneous assist devices;
- paediatric assist devices.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Transition Period

FDA recognition of ISO 14708-5 First edition 2010-02-01 [Rec# 3-92] will be superseded by recognition of ISO 14708-5 Second edition 2020-05 [Rec# 3-170]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-92] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 3-92] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*