ISO 8828:2014
(Main)Implants for surgery — Guidance on care and handling of orthopaedic implants
Implants for surgery — Guidance on care and handling of orthopaedic implants
ISO 8828:2014 specifies the recommended procedures for handling orthopaedic implants, hereafter referred to as implants, from receipt at the hospital until they are implanted or discarded. This guidance applies to implants (such as currently used metal, ceramic, or polymeric implants) and also to acrylic resin and other bone cements. This guidance does not apply to the implant manufacturer. However, it contains references to the stocking of implants that can be useful for manufacturers and especially for third-party suppliers.
Implants chirurgicaux — Principes directeurs pour l'entretien et la manipulation des implants orthopédiques
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INTERNATIONAL ISO
STANDARD 8828
Second edition
2014-11-15
Implants for surgery — Guidance
on care and handling of orthopaedic
implants
Implants chirurgicaux — Principes directeurs pour l’entretien et la
manipulation des implants orthopédiques
Reference number
ISO 8828:2014(E)
©
ISO 2014
---------------------- Page: 1 ----------------------
ISO 8828:2014(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
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ISO 8828:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 General guidance . 1
3.1 Manufacturer’s instructions . 1
3.2 On receipt . 1
3.3 Transport . 2
3.4 Stock records . 2
3.5 Storage . 3
3.6 Stock rotation . 3
3.7 Cleaning and sterilization of non-sterile implants . 3
3.8 Appearance . 4
3.9 Contouring and modifying implants . 4
3.10 Re-use . 4
4 Additional guidance on polymeric implants and materials . 4
4.1 Sterilization . 4
4.2 Acrylic bone cement . 4
4.3 Silicone implants . 4
4.4 Biodegradable implants . 4
5 Additional guidance on ceramic components . 5
5.1 Sterilization and handling . 5
5.2 Dropping of ceramic components . 5
5.3 Manufacturer’s instructions . 5
6 Additional guidance on implants or components of implants with rough surfaces or
surfaces with intrinsic porosity . 5
6.1 Sterile implants. 5
6.2 Subsequent cleaning of implants . 5
6.3 Non-sterile implants . 5
Bibliography . 6
© ISO 2014 – All rights reserved iii
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ISO 8828:2014(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 (see 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 (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery.
This second edition cancels and replaces the first edition (ISO 8828:1988), which has been technically
revised.
iv © ISO 2014 – All rights reserved
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ISO 8828:2014(E)
Introduction
The guidance given in this International Standard on the care and handling of orthopaedic implants
after delivery to the purchaser is intended to help ensure that implants remain free from contamination
or damage prior to insertion into the patient. Guidance is given on the procedures for receiving, storing,
transporting, handling, cleaning, and sterilizing implants. Guidance on procedures for preparing the
implants for use, as well as handling during the surgery, are also outlined. This guidance is aimed at
all personnel involved in receiving and handling implants, including surgeons. It is important that all
personnel be familiar with recommended procedures in order to minimize the risk and occurrence of
damage to implants.
© ISO 2014 – All rights reserved v
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INTERNATIONAL STANDARD ISO 8828:2014(E)
Implants for surgery — Guidance on care and handling of
orthopaedic implants
1 Scope
This International Standard specifies the recommended procedures for handling orthopaedic implants,
hereafter referred to as implants, from receipt at the hospital until they are implanted or discarded.
This guidance applies to implants (such as currently used metal, ceramic, or polymeric implants) and
also to acrylic resin and other bone cements.
This guidance does not apply to the implant manufacturer. However, it contains references to the
stocking of implants that can be useful for manufacturers and especially for third-party suppliers.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
orthopaedic implant
implant
device implanted surgically, wholly or partially, in the body, either temporarily or permanently, and used
either as an aid in the repair of bone or related tissues, or as a temporary or permanent replacement for
these tissues
Note 1 to entry: Acrylic resin cement, used for fixing certain devices, is deemed to be an “implant”.
3 General guidance
3.1 Manufacturer’s instructions
All of the manufacturer’s instructions should be followed and take precedence over the guidance
provided in this International Standard.
3.2 On receipt
3.2.1 General
Packaged implants can arrive either
a) pre-sterilized (see 3.2.2), or
b) non-sterilized (see 3.2.3).
3.2.2 Products supplied sterile
The packaging of products supplied sterile shall be left intact until the time of use. The packaging shall
be inspected for damage. If damage is found, the implant shall be considered non-sterile. The implant
shall then either
a) be returned to the manufacturer for reprocessing, or,
© ISO 2014 – All rights reserved 1
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ISO 8828:2014(E)
b) if appropriate and not proh
...
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8828
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2014-01-19 2014-04-19
Implants for surgery — Guidance on care and handling of
orthopaedic implants
Implants chirurgicaux — Principes directeurs pour l’entretien et la manipulation des implants
orthopédiques
[Revision of first edition (ISO 8828:1988)]
ICS: 11.040.40
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8828:2013(E)
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. ISO 2013
---------------------- Page: 1 ----------------------
ISO/DIS 8828:2013(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2013 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 8828
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Terms and definitions . 1
3 General guidance . 1
3.1 Manufacturer's instructions . 1
3.2 On receipt . 1
3.3 Transport . 2
3.4 Stock records . 2
3.5 Storage . 3
3.6 Stock rotation . 3
3.7 Cleaning and sterilization of non-sterile implants . 3
3.8 Appearance . 4
3.9 Contouring and modifying implants . 4
3.10 Re-use . 4
4 Additional guidance on polymeric implants and materials . 4
4.1 Sterilization . 4
4.2 Acrylic bone cement . 4
4.3 Silicone implants . 4
4.4 Biodegradable implants . 5
5 Additional guidance on ceramic components. 5
5.1 Sterilization and handling . 5
5.2 Dropping of ceramic components . 5
5.3 Manufacturer's instructions . 5
6 Additional guidance on implants or components of implants with rough surfaces or
surfaces with intrinsic porosity . 5
6.1 Sterile implants . 5
6.2 Subsequent cleaning of implants . 5
6.3 Non-sterile implants . 5
Bibliography . 6
© ISO 2013 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/DIS 8828
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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8828 was prepared by Technical Committee ISO/TC 150, Implants for surgery.
This second edition cancels and replaces the first edition (ISO 8828:1988), which has been technically revised.
iv © ISO 2013 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 8828
Introduction
The guidance given in this International Standard on the care and handling of orthopaedic implants after
delivery to the purchaser is intended to help ensure that implants remain free from contamination or damage
prior to insertion into the patient. Guidance is given on the procedures for receiving, storing, transporting,
handling, cleaning and sterilizing implants. Guidance on procedures for preparing the implants for use, as well
as handling during the surgery, are also outlined. This guidance is aimed at all personnel involved in receiving
and handling implants including surgeons. It is important that all personnel should be familiar with
recommended procedures in order to minimize the risk and occurrence of damage to implants.
© ISO 2013 – All rights reserved v
---------------------- Page: 5 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 8828
Implants for surgery — Guidance on care and handling of
orthopaedic implants
1 Scope
This International Standard specifies the recommended procedures for handling orthopaedic implants,
hereafter referred to as implants, from receipt at the hospital until they are implanted or discarded.
This guidance applies to implants (such as currently used metal, ceramic or polymeric implants) and also to
acrylic resin and other bone cements.
This guidance does not apply to the implant manufacturer. However, it contains references to the stocking of
implants that can be useful for manufacturers and especially for third-party suppliers.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
orthopaedic implant
implant
device implanted surgically, wholly or partially, in the body, either temporarily or permanently, and used either
as an aid in the repair of bone or related tissues, or as a temporary or permanent replacement for these
tissues
NOTE Acrylic resin cement, used for fixing certain devices, is deemed to be an "implant".
3 General guidance
3.1 Manufacturer's instructions
All of the manufacturer's instructions should be followed and take precedence over the guidance provided in
this standard.
3.2 On receipt
3.2.1 General
Packaged implants can arrive either:
a) pre-sterilized (see 3.2.2), or
b) non-sterilized (see 3.2.3).
© ISO 2013 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/DIS 8828
3.2.2 Products supplied sterile
The packaging of products supplied sterile shall be left intact until the time of use. The packaging shall be
inspected for damage. If damage is found, the implant shall be considered non-sterile. The implant shall then
either:
a) be returned to the manufacturer for reprocessing; or,
b) if appropriate and not prohibited by the device manufacturer, be taken out of the damaged packaging and
re-sterilized in the user facility following the directions for an applicable method of sterilization provided in
the instructions for use (for guidance see ISO 17664).
3.2.3 Non-sterile implants
Some non-sterile implants can be received in special packaging that is suitable for sterilization using the
method
...
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