IS 17750 : Part 4 : 2025 Implants for Surgery - Active Implantable Medical Devices - Part 4 Implantable Infusion Pump Systems (ISO 14708-4 : 2022, MOD)

ICS 11.040.40

MHD 06

NATIONAL FOREWORD

This Indian Standard (Part 4) which is modified adoption of ISO 14708-4 : 2022 'Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems' issued by the International Organization for Standardization (ISO), was adopted by the Bureau of Indian Standards on the recommendation of the Medical and Surgical Cardiology Equipment Sectional Committee and after approval of the Medical Equipment and Hospital Planning Division Council.

This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1 : 2014. The requirements of this document take priority over those of ISO 14708-1. This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3. The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products.

This standard is published in various 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 3 Implantable neurostimulators

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 and auditory brainstem implant systems

The text of ISO standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions 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'; and

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.