Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, SC 6, Active implants, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/JTC 16, Active implantable medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 14708‑4:2008), which has been technically revised.

The main changes compared to the previous edition are as follows:

— the title of this document has been modified;
— 9.4 additions have been deleted;
— 11.101 has been deleted;
— 14.2 replacement has been deleted;
— 14.101 has been deleted;
— 14.5 has been added;
— Clause 17 has been revised;
— 19.2 replacement has been deleted;
— 19.3 replacement has been deleted;
— 19.101 has been deleted;
— 19.7 has been added;
— 23.2 amendment has been deleted;
— Clause 27 has been revised;
— 28.8 additions have been deleted;
— 28.10 additions have been deleted;
— 28.12 addition has been deleted;
— 28.101 through 28.103 has been deleted;
— 28.31 and 28.32 has been added.

A list of all parts in the ISO 14708 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

BS EN ISO 14708-4:2022

Implants for surgery. Active implantable medical devices. - Implantable infusion pump systems

Current

Published:

31 Aug 2022