ISO 8828:2014

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 2014
© ISO 2014
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ii © ISO 2014 – All rights reserved

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
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).
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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

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.
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,
b) if appropriate and not proh
...