IS/ISO 14708 : Part 3 : 2017 Implants for Surgery - Active Implantable Medical Devices Part 3 Implantable Neurostimulators

ICS 11.040.40

MHD 07

Reaffirmed 2024

NATIONAL FOREWORD

This Indian Standard (Part 3) (First Revision) which is identical with ISO 14708-3 : 2017 ‘Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators’ 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 Indian Standard is published in seven parts. The other parts in this series are:

Part 1 General requirements for safety, marking and for information to be provided by the manufacturer

Part 2 Cardiac pacemakers

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

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.