Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (Part 1) (First Revision) which is identical with 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’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on recommendation of the Neurosurgery Surgery Instruments , Implants and Accessories Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was originally published in 2013 and was identical with ISO 14708-1 : 2000 ‘Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer’. The first revision of this standard has been undertaken to align it with the latest version of ISO 14708-1 : 2014 to align it with latest international practices.

This Indian Standard is published in seven parts. The other parts in this series are:

Part 2 Cardiac pacemakers

Part 3 Implantable neurostimulators

Part 4 Implantable infusion pumps

Part 5 Circulatory support devices

Part 6 Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

Part 7 Particular requirements for cochlear implant systems

This standard specifies general requirements for active implantable medical devices to provide basic assurance of safety for both patients and users. To minimize the likelihood of a device being misused, this standard also details comprehensive requirements for markings and for other information to be supplied as part of the documentation with any Active Implantable Medical Device. For particular types of Active Implantable Medical Devices, the general requirements can be supplemented or modified by the requirements of other parts of this standard. A requirement of a particular part of this standard takes priority over the corresponding requirements of this general part of the standard. Where particular parts of this standard exist, this standard is not intended to be used alone. Special care is required when applying this standard alone to Active Implantable Medical Devices for which no particular standard has yet been published.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions and terminologies are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker, while in Indian Standards, the current practice is to use a point (.) as the decimal marker.