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ISO 14708-1:2014

(Main)

Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

ISO 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical device to show compliance. ISO 14708-1:2014 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). ISO 14708-1:2014 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.

Implants chirurgicaux — Dispositifs médicaux implantables actifs — Partie 1: Exigences générales pour la sécurité, le marquage et pour les informations à fournir par le fabricant

General Information

Status
Published
Publication Date
10-Aug-2014
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
ISO/TC 150/SC 6 - Active implants
Drafting Committee
ISO/TC 150/SC 6 - Active implants
Current Stage
9092 - International Standard to be revised
Completion Date
12-Dec-2023
Ref Project

Relations

Revises
ISO 14708-1:2000 - Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Effective Date
04-Feb-2009

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Standards Content (Sample)

DRAFT INTERNATIONAL STANDARD ISO/DIS 14708-1
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on Voting terminates on

2013-04-22 2013-07-22
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Implants for surgery — Active implantable medical devices —
Part 1:
General requirements for safety, marking and for information to
be provided by the manufacturer
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 1: Exigences générales pour la sécurité, le marquage et pour les informations à fournir par le fabricant
[Revision of first edition (ISO 14708-1:2000)]
ICS 11.040.40









To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©  International Organization for Standardization, 2013

---------------------- Page: 1 ----------------------
ISO/DIS 14708-1

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 written permission.
Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2013 – All rights reserved

---------------------- Page: 2 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 14708-1
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on Voting terminates on

2013-04-22 2013-07-22
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Implants for surgery — Active implantable medical devicesr —
Part 1:
General requirements for safety, marking and for information to
be provided by the manufacturer
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 1: Exigences générales pour la sécurité, le marquage et pour les informations à fournir par le fabricant
[Revision of first edition (ISO 14708-1:2000)]
ICS 11.040.40









To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©  International Organization for Standardization, 2013

---------------------- Page: 3 ----------------------
ISO/DIS 147-8-1

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 written permission.
Permission can be requested from
...

INTERNATIONAL ISO
STANDARD 14708-1
Second edition
2014-08-15
Implants for surgery — Active
implantable medical devices —
Part 1:
General requirements for safety,
marking and for information to be
provided by the manufacturer
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 1: Exigences générales pour la sécurité, le marquage et pour les
informations à fournir par le fabricant
Reference number
ISO 14708-1:2014(E)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO 14708-1:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
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
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 14708-1:2014(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviations (optional) . 7
5 General requirements for active implantable medical devices .7
5.1 General requirements for non-implantable parts . 7
5.2 General requirements for software . 7
5.3 Usability of non-implantable parts . 7
5.4 Data security and protection from harm caused by unauthorized information tampering 8
5.5 General requirements for risk management . 8
5.6 Misconnection of parts of the active implantable medical device . 9
6 Requirements for particular active implantable medical devices .9
7 General arrangement of the packaging . 9
8 General markings for active implantable medical devices. 9
9 Markings on the sales packaging .10
10 Construction of the sales packaging.11
11 Markings on the sterile pack .12
12 Construction of the non-reusable pack.13
13 Markings on the active implantable medical device .13
14 Protection from unintentional biological effects being caused by t
...

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