ISO 11318:2002 心臓除細動器—植込み型除細動器用のコネクタアセンブリDF-1 —寸法とテスト要件 | ページ 2

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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.

Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

International Standard ISO 11318 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active implants.

This second edition cancels and replaces the first edition (ISO 11318:1993), which has been technically revised.

Annexes A and B form a normative part of this International Standard. Annexes C, D and E are for information only.

Introduction

The purpose of this International Standard is to specify a standard connector assembly, DF-1, to provide interchangeability between implantable defibrillator leads and defibrillator pulse generators from different manufacturers. The safety, reliability and function of a particular connector part are the responsibility of the manufacturer.

Defibrillator connector systems not conforming to this International Standard may be safe and reliable, and may have clinical advantages.

1 Scope

This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrillator generators that do not produce more than 1 kV/50 A peak output. Essential dimensions and performance requirements related to connector fit are specified, along with test methods.

This International Standard does not specify other connector features such as fastening means and material. This International Standard is applicable to the form and fit of the connector assembly, and does not address all aspects of functional compatibility, system performance, or reliability of different implantable defibrillator leads and implantable defibrillator generator assemblies.

3 Terms and definitions

For the purposes of this International Standard, the following terms and definitions apply.