AS ISO 14630—20 14630—2003 03 ISO 14630:1997
A S I S O 1 4 6 3 0
Australian Standard ™ . m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
Non-active surgical implants—General implants—General requirements
This Australian Standard was prepared by Committee HE-012, Surgical Implants. It was approved on behalf of the Council of Standards Australia Australia on 21 May 2003 and published on 30 June 2003.
The following are represented on Committee HE-012: Australian Chamber of Commerce and Industry Australian College of Operating Room Nurses Australian Dental Association Australian Industry Group Australian Orthopaedic Association . m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
Australian Society for Biomaterials Commonwealth Department of Health and Ageing Department of Defence (Australia) Medical Industry Association of Australia Inc Neu rologi rol ogi cal Soc iety iet y o f A ustra us tra las ia Royal Australasian College of Surgeons Royal Perth Hospital University of New South Wales University of Sydney
Keeping Standards up-to-date Standards are living documents which reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments which may have been published since the Standard was purchased. Detailed information about Standards can be found by visiting the Standards Australia web site at www.standards.com.au and looking up the relevant Standard in the on-line catalogue. Alternatively, Alternatively, the printed Catalogue provides information information current at 1 January each yea r, and the th e m onthl on thl y mag azi ne, The Global Standard , has a full listing of revisions and amendments published each month. We also welcome suggestions for improvement in our Standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Contact us via email at
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This Standard was issued in draft form for comment as DR 03118.
AS ISO 14630—2003
Australian Standard™ . m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
Non-active surgical implants—General implants—General requirements
First published as AS ISO 14630—2003.
COPYRIGHT © Standards A ustralia Inte rnational All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher. Published by Standards Australia International Ltd GPO Box 5420, Sydney, NSW 2001, Australia ISBN 0 7337 5342 6
ii
PREFACE This Standard was prepared by the Australian members of the Joint Standards Australia/ Standards New Zealand Committee HE-012, Surgical implants. After consultation with stakeholders in both countries, Standards Australia and Standards New Zealand decided to develop this Standard as an Australian, rather than an Australian/New Zealand Standard. This Standard is identical with and has been reproduced from ISO 14630:1997, Non-ac Non -activ tivee surgical implants—General requirements , which was prepared by the European Committee for Standardization (CEN) Technical Committee TC 285, Non-active surgical implants, in collaboration with ISO Technical Committee TC 150, Implants for surgery, in accordance with the Vienna Agreement on technical cooperation between ISO and CEN.
. m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
The objective of this Standard is to specify general requirements for non-active surgical implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests. The terms ‘normative’ and ‘informative’ are used to define the application of the annex to which they apply. A normative annex is an integral part of a standard, whereas an informative annex is only for information and guidance. Whilst Annex A is informative, Clause A.3 includes a list of normative referenced European Standards and their identical and technically related ISO Standards. As this Standard is reproduced from a European Standard, the following applies: (a)
Its number does not appear on each page of text and its identity is shown only on the cover and title page.
(b)
In the source text ‘this European Standard’ should read ‘this Australian Standard’.
(c)
A full point substitutes for a comma when when referring to a decimal marker.
References to International Standards and European Standards should be replaced by references to Australian or Australian/New Zealand Standards as follows: Refere Ref erence nce to Interna Int ernati tional onal Standa Sta ndard rd
Austra Aus tralia lian n Stan S tandar dard d
ISO
AS ISO
10993
Biological evaluation of medical 10993 devices Part 1: Evaluation and testing 10993.1 Part 7: Ethylene oxide 10993.7 sterilization residuals
Biological evaluation of medical devices Part 1: Evaluation and testing Part 7: Ethylene oxide sterilization residuals
11134
Sterilization of health care 11134 products—Requirements for validation and routine control— Industrial moist heat sterilization
Sterilization of health care products—Requirements for validation and routine control— Industrial moist heat sterilization
11135
Medical devices—Validation and routine control of ethylene oxide sterilization
Medical devices—Validation and routine control of ethylene oxide sterilization
10993-1 10993-7
11135
iii ii i
Refere Ref erence nce to Interna Int ernati tional onal Standa Sta ndard rd
Austra Aus tralia lian n Stan S tandar dard d
ISO
AS ISO
11137
Sterilization of health care 11137 products—Requirements for validation and routine control— Radiation sterilization
IEC
Sterilization of health care products—Requirements for validation and routine control— Radiation sterilization
AS
60068 Environmental testing 60068 Environmental testing 60068-2-27 Part 2: Tests—Test Ea and 60068.2.27 60068.2.27 Part 2.27: 2.27: Tests—Test Tests—Test Ea and guidance: Shock guidance: Shock 60068-2-32 60068-2-32 Part 2: Tests—Test Tests—Test Ed: Free fall 60068.2.32 60068.2.32 Part 2.32: Tests—Tes Tests—Testt Ed: Free fall . m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
Refere Ref erence nce to Euro pean pea n St andard and ard
Aust rali an Standar Sta ndar d
EN
AS EN
540
Clinical investigation of medical 540 devices for human subjects
Clinical investigation of medical devices for human subjects
556
Sterilization of medical devices—Requirements for terminally sterilized medical devices to be labelled ‘STERILE’
Sterilization of medical devices—Requirements for medical devices to be designated [STERILE] Part 1: Requirements for terminally sterilized medical devices
556
556.1
iv
CONTENTS
. m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
1 Scope
1
2 Normative references
1
3 Definitions
2
4 Intended performance
2
5 Design attributes
3
6 Materials
3
7 Design evaluation
4
8 Manufacture
5
9 Sterilization
5
10 Packaging
5
11 Information supplied by the manufacturer
6
Annex A (informative) Bibliography
7
v INTRODUCTION
This European Standard provides a method to demonstrate compliance with the relevant essential requirements as outlined in general terms in Annex 1 of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as they apply to non-active surgical implants, hereafter referred to as implants. It also provides a method of addressing the fundamental principles outlined in ISO/TR 14283, as they apply to non active surgical implants. For such products, particular and specific requirements may apply. These additional requirements are specified in the level 2 and 3 standards or their parts.
. m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
NOTE: The structure of this standard and the normative references of this standard are based on the use of the standard in supporting Council Directive 93/42/EEC. For the European Standards listed in the normative references (see clause 2), in some cases International Standards are available (see also clause 2, NOTE 1). Users of International Standards should be aware that they may not necessarily meet the essential requirements of the Council Directive 93/42/EEC or other regulatory requirements for other countries or regions.
vi
NOTES
. m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
AUSTRALIAN STANDARD
1
Non–active surgical implants—General requirements 1 Scope
This European Standard specifies general requirements for non-active surgical implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic transendodontic and transradicular implants and intra-ocular le nses. With regard to safety, this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests. Tests required to be used to demonstrate compliance with this standard are contained in other levels. . m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 540
Clinical investigations of medical devices for human subjects.
EN 550
Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization.
EN 552
Sterilization of medical devices - Validation and routine control of sterilization by irradiation.
EN 554
Sterilization of medical devices - Validation and routine control of steam sterilization by moist heat.
EN 556
Sterilization of medical devices - Requirements for medical devices labelled "Sterile".
EN 868-1
Packaging materials for sterilization of wrapped goods - Part 1: General requirements and requirements for the validation of packaging for terminally sterilized devices.
EN 980
Terminology, symbols and information provided with medical devices - Graphical symbols for use in the labelling of medical devices.
prEN 1041
Terminology, symbols and information provided with medical devices - Information supplied by the manufacturer with medical devices.
prEN 1441
Medical devices - Risk analysis.
prEN ISO 10993-1
Biological evaluation of medical and dental materials and devices Part 1: Guidance on selection of tests.
NOTE 1: For some of the t he European Standards listed in this clause, an identical or technically related International Standards is available. These International Standards are listed in A.3. www.standards.com.au
Standards Australia
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AS ISO 14630-2003, Non-active surgical surgical implants implants General requirements . m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 9 e e r f a s i s i h T
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