FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

The main task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example "state of the art".

IEC 60601‑4‑4 , which is a technical report, has been prepared by a Joint Working Group of subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice, and ISO subcommittee SC 3: Lung ventilators and related equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.

The text of this technical report is based on the following documents:

Enquiry draft	Report on voting
62A/1186/DTR	62A/1197/RVDTR

Full information on the voting for the approval of this technical report can be found in the report on voting indicated in the above table.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

A list of all parts in the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website.

Terms used throughout this document that have been defined in Clause 3 appear in small capitals.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

The committee has decided that the contents of this document will remain unchanged until the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to the specific document. At this date, the document will be

• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

A bilingual version of this publication may be issued at a later date.

PD IEC/TR 60601-4-4:2017

Medical electrical equipment - Guidance and interpretation. Guidance for writers of particular standards when creating alarm system-related requirements

Current

Published:

30 Sep 2017