Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers

ISO 5841-3:2013 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements related to connector fit are specified, together with appropriate test methods. ISO 5841-3:2013 is applicable only to the form and fit of the connector assembly. ISO 5841-3:2013 supplements ISO 14708‑2 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part.

Implants chirurgicaux — Stimulateurs cardiaques — Partie 3: Connecteurs à bas profil (IS-1) pour stimulateurs implantables

General Information

Status
Published
Publication Date
11-Apr-2013
Current Stage
9060 - Close of review
Start Date
04-Jun-2029
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ISO 5841-3:2013 - Implants for surgery -- Cardiac pacemakers
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 5841-3
Third edition
2013-04-15
Implants for surgery — Cardiac
pacemakers —
Part 3:
Low-profile connectors (IS-1) for
implantable pacemakers
Implants chirurgicaux — Stimulateurs cardiaques —
Partie 3: Connecteurs à bas profil (IS-1) pour stimulateurs implantables
Reference number
ISO 5841-3:2013(E)
©
ISO 2013

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ISO 5841-3:2013(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
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Published in Switzerland
ii © ISO 2013 – All rights reserved

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ISO 5841-3:2013(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Lead connector . 3
4.3 Connector cavity . 4
Annex A (normative) Lead connector electrical impedance test method . 8
Annex B (informative) Rationale .10
© ISO 2013 – All rights reserved iii

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ISO 5841-3:2013(E)

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. 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. www.i
...

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