ISO 12891-1:2015

Retrieval and analysis of surgical implants - Part 1: Retrieval and handling

ISO 12891-1:2015 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. It also provides guidance on infection control. NOTE National or other regulations, which can be more stringent, can apply. ISO 12891-1:2015 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.

Retrait et analyse des implants chirurgicaux — Partie 1: Retrait et manipulation

General Information

• Status: Published
• Publication Date: 18-Jun-2015
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150 - Implants for surgery
• Drafting Committee: ISO/TC 150/WG 10 - Use and retrieval of surgical implants
• Current Stage: 9092 - International Standard to be revised
• Start Date: 14-Nov-2024
• Completion Date: 13-Dec-2025

Relations

• Revises: ISO 12891-1:2011 - Implants for surgery - Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
• Effective Date: 05-Nov-2015

Overview

ISO 12891-1:2015, "Retrieval and analysis of surgical implants - Part 1: Retrieval and handling," is an international standard that defines a systematic method for the safe, documented retrieval and handling of surgical implants and associated tissues and fluids. The standard focuses on preventing damage to explanted devices, minimizing infection risks, and ensuring consistent documentation to support subsequent analysis. It applies to retrievals performed during revision surgery or post-mortem and offers guidance even where retrieval is not intended for data collection. National regulations that are more stringent may also apply.

Key Topics and Requirements

ISO 12891-1 specifies essential steps and practical requirements for:

• Clinical history collection: recording patient and implant information (implant history, diagnostics, activity level, dates, and facility).
• Pre-explantation checks: capturing data and non-invasive examinations (e.g., imaging, device functional checks) before removal when feasible.
• Explantation technique: minimizing damage to implants, surrounding tissues, and functional surfaces; recovering fragments and debris.
• Sample collection and labelling: standardized containment, primary/secondary packaging, and clear labelling for traceability.
• Cleaning and decontamination: procedures and guidance to reduce contamination while preserving evidence for analysis.
• Packaging and shipping: requirements for secure packing, use of coolant materials where applicable, and documentation with shipments.
• Infection control: work practices, PPE, workstation maintenance, handling of contaminated materials, and waste disposal.
• Documentation and record-keeping: documentation to accompany retrieved items and records to maintain during analysis and storage.

Annexes provide practical tools: Annex A suggests minimum data to collect; Annex B gives generic decontamination procedures; Annex C lists analyses for tissue and fluid samples.

Applications and Practical Value

ISO 12891-1 is used to:

• Ensure reproducible, safe retrieval of implants for failure investigations.
• Preserve forensic and clinical evidence for root-cause analysis.
• Standardize data and sample handling for research on implant performance and biocompatibility.
• Reduce infection transmission risk during handling, packing, and transport.

Typical use cases include device failure investigations, post-market surveillance, clinical research, device registries, and medico-legal reviews.

Who Should Use This Standard

• Surgeons and operating room staff involved in explantation
• Hospital pathology and clinical laboratories
• Implant manufacturers and service engineers
• Retrieval laboratories, forensic investigators, and research teams
• Shipping and lab logistics personnel handling medical device specimens

Related Standards

• ISO 12891-2: Part 2 covers detailed analysis of retrieved surgical implants and complements the handling methods in Part 1.

Keywords: ISO 12891-1, surgical implant retrieval, implant handling, explantation, implant decontamination, infection control, implant documentation, packaging and shipping.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 12891-1
Third edition
2015-07-01
Retrieval and analysis of surgical
implants —
Part 1:
Retrieval and handling
Retrait et analyse des implants chirurgicaux —
Partie 1: Retrait et manipulation
Reference number
©
ISO 2015
© ISO 2015, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Method . 2
3.1 Obtaining the clinical history of the implant and patient . 2
3.2 Pre-explantation checks and examinations . 2
3.3 Collecting the surgical implant . 2
3.4 Collecting the tissue and fluid samples . 3
3.5 Photographic record of the explantation . 3
3.6 Containing and labelling the retrieved surgical implant, tissues, and fluids for
future identification . 4
3.7 Cleaning the retrieved surgical implant . 4
3.8 Decontaminating the retrieved surgical implant . 6
3.9 Packaging the retrieved surgical implant, tissues, and fluids for shipment. 7
3.10 Use of coolant materials . 8
3.11 Labelling of the packing materials . 8
3.12 Documentation to be supplied with retrieved surgical implants . 8
3.13 Unpacking following shipment . 9
3.14 Cleaning and decontamination following shipment . 9
3.15 Documentation to be maintained during examination, analysis, and storage . 9
4 Analysis of retrieved surrounding tissues and fluids. 9
5 Infection control . 9
5.1 General . 9
5.2 Work practices.10
5.3 Personal protective equipment.10
5.3.1 General.10
5.3.2 Gloves.10
5.3.3 Masks, eye protection, and face shields .10
5.3.4 Gowns, aprons, and other protective body clothing .11
5.4 Maintenance of the worksite.11
5.4.1 Cleaning and disinfection of worksites .11
5.4.2 Protective coverings .11
5.4.3 Equipment and tools .11
5.4.4 Reusable receptacles .12
5.4.5 Contaminated glassware .12
5.4.6 Reusable items .12
5.4.7 Contaminated materials .12
5.5 Human waste disposal . .12
5.6 Special practices .13
Annex A (informative) Suggested minimum information to be obtained for retrieved
surgical implants .14
Annex B (informative) Generic procedures for the decontamination of surgical implants.17
Annex C (informative) Analyses to be performed on retrieved tissue samples and fluids .23
Bibliography .24
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 third edition cancels and replaces the second edition (ISO 12891-1:2011), which has been technically
revised.
ISO 12891 consists of the following parts, under the general title Retrieval and analysis of surgical
implants:
— Part 1: Retrieval and handling
— Part 2: Analysis of retrieved surgical implants
iv © ISO 2015 – All rights reserved

Introduction
The investigation of retrieved surgical implants, adjacent tissues, and associated fluids can be undertaken
to
— determine the cause of a clinical complication or surgical implant failure,
— improve knowledge of surgical implant performance and safety,
— improve knowledge of the interactions of surgical implants and the human body, and
— develop materials with improved biocompatibility and implants with improved functional longevity.
This International Standard specifies methods for the retrieval, handling, and analysis of surgical
implants and associated tissue samples and fluids which are removed from patients during retrieval
surgery or post-mortem. ISO 12891-2 specifies methods for the detailed analysis of surgical implants,
in which protocols are provided for the collection of data and examinations for surgical implants in
relation to their typical applications. For particular investigation programmes, additional, more specific,
protocols can be required. If special analytical techniques are employed, the appropriate handling
procedures need to be specified.
The purpose of this International Standard is to
— specify a method for the retrieval of surgical implants which is intended to prevent damage to
implants, associated tissues, and fluids,
— ensure that retrieved materials are handled safely and decontaminated correctly and that the risk
of transmission of infectious diseases is minimized,
— ensure that the retrieval process is properly documented, and
— allow comparisons between investigation results from different sources.
Many variables are involved when undertaking the retrieval of surgical implants. The retrieval can be
for the routine replacement of a pacemaker battery or it can be for the revision of a defective surgical
implant. The retrieval can be from a living patient or it can be a post-mortem study. The retrieval can
involve the removal of a single surgical implant or multiple components as, for example, in the case of
hip replacements or certain fracture fixation or spinal devices. In addition to the retrieval of the surgical
implant, associated tissues and fluids might also need to be removed. The retrieval can involve a wide
variety of personnel such as surgeons, nurses, other hospital staff, surgical implant manufacturer,
investigator, and shipping service. Finally, the type of analysis to be performed can vary and can include
visual, chemical, histological, and microbiological studies and the eventual analysis can have an impact
on the retrieval process. These variables make it impossible to specify a single method which has to
be followed in all retrieval cases. For this reason, certain requirements listed in this part of ISO 12891
might only be applicable in certain circumstances and for this reason, some of the requirements are
prefaced with statements such as “If applicable” or “Whenever possible”.
This International Standard presents a methodology for the systematic retrieval of surgical implants.
It focuses on the practical requirements in particular. In addition to these requirements, there are legal
and ethical considerations which might need to be taken into account. These considerations include
matters relating to the ownership of the implant, the obtaining of the patient’s consent before the
implant is retrieved, the patient’s right to confidentiality, and the need to protect the patient’s safety,
health, and litigation rights throughout. For a detailed consideration of these issues, appropriate advice
can be sought.
NOTE The methods specified in this International Standard can also be applicable to the retrieval and
analysis of surgical implants in animal studies.
INTERNATIONAL STANDARD ISO 12891-1:2015(E)
Retrieval and analysis of surgical implants —
Part 1:
Retrieval and handling
1 Scope
This part of ISO 12891 specifies the method to be followed for the retrieval and handling of surgical
implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed
for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations,
collection, labelling, cleaning, decontamination, documentation, packing and shipping. This part of
ISO 12891 also provides guidance on infection control.
NOTE National or other regulations, which can be more stringent, can apply.
This part of ISO 12891 does not apply in cases of explantation where there is no intention to collect
retrieval data. However, many clauses give useful information which can apply in these cases also.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
absorbent
material capable of absorbing liquids
Note 1 to entry: Absorbent material can either be particulate or non-particulate.
2.2
contamination
unintentional addition or modification, including exposure to a potentially infectious agent
2.3
infectious waste
waste containing or suspected to contain human pathogenic microbiological agents
2.4
outer shipping container
outermost container in which the package is finally shipped
2.5
primary container
tube, envelope, or other impermeable container which holds the retrieved material to be shipped
2.6
secondary container
container into which the primary container is placed
3 Method
3.1 Obtaining the clinical history of the implant and patient
Whenever possible, the clinical history of the patient and the surgical implant shall be obtained and
recorded. This clinical history shall include at least the following, if available:
— name or identification number of the patient as permitted by the applicable national regulations;
— original diagnosis which resulted in the use of the surgical implant;
— X-ray of the surgical implant in situ taken after the insertion operation;
— patient’s activity level including the ability to perform work, sports, and recreational activities;
— patient’s medical history relevant to the surgical implant, including the hospital or clinic at which
the surgical implant was implanted;
— information on the patient’s experience with the surgical implant just before surgical implant
retrieval;
— date of retrieval;
— hospital or clinic at which the surgical implant was retrieved.
The information obtained should be treated as confidential.
NOTE 1 Annex A gives an example of the information to be obtained. The annex can be modified as necessary,
e.g. for special investigations.
NOTE 2 In any analysis of an explanted surgical implant, it is advantageous to have as much relevant knowledge
of the clinical history as possible.
3.2 Pre-explantation checks and examinations
Whenever possible, data which might be lost post-explantation should be collected prior to explantation.
Whenever possible, a functional check of the implant involving an objective measurement shall be
performed before explantation surgery.
NOTE A functional check assists in the understanding of the post-explantation behaviour.
If applicable, electronic or other data associated with the surgical implant shall be collected before the
implant is explanted. These data should be provided to the evaluator of the surgical implant.
Where appropriate and justifiable, taking into account the need for patient safety, non-invasive
examinations of the implantation site with the implant in situ shall be performed before the implant
is explanted. Such examinations may include X-ray, computed axial tomography scan, or magnetic
resonance imaging.
3.3 Collecting the surgical implant
Taking into account the need for patient safety, the surgical implant shall be retrieved in a manner which
causes as little damage as possible to both the surgical implant and the surrounding tissues. As far
as possible, functional surfaces, e.g. bearing surfaces of joint prostheses, mechanical connections, e.g.
hinges, joints, screws, and fracture surfaces of broken surgical implants, shall be protected during and
after explantation.
Fragments and debris which can provide valuable information shall also be retrieved.
Retrieved surgical implants should be handled with care either by hand or using appropriate instruments.
2 © ISO 2015 – All rights reserved

The following shall be documented:
a) position or orientation or state of the retrieved components, if there is more than one retrieved
component and if the position or orientation or state is abnormal;
b) location and type of damage, if damage occurs during explantation.
NOTE For proper scientific examination, it is advantageous for the surgical implant to be maintained in a
state as close as possible to that in which it existed at the time of retrieval.
3.4 Collecting the tissue and fluid samples
Taking into account the need for patient safety, if tissue and/or fluid samples are to be collected for
analysis, then these shall be retrieved in a manner which causes as little damage as possible to both the
surgical implant and the tissues.
For microbiological investigation, swabs, tissue, and/or fluid samples shall be taken from a location
adjacent to the implant as soon as possible after the surgical implant has been exposed. Where and how
the specimens are taken shall be recorded.
NOTE Special culturing techniques can be required to reveal unusual organisms. Sampling for immunological
investigations requires expert advice and can call for special procedures.
For histological examination, tissue samples shall be taken from a location adjacent to the implant
and/or from other relevant sites (e.g. lymph nodes or any tissue with abnormal appearance).
When possible, tissue samples for histological examination shall include portions extending into the
normal tissue.
The site of the tissue excision and the orientation of the tissue relative to the surgical implant shall
be indicated and recorded. Where possible, the proximal end of the tissue shall be marked (e.g. with a
suture). Where necessary, the original length of the tissue shall be maintained (e.g. with plastic muscle
biopsy clamps or by pinning the tissue to a corkboard or by other means, which avoid contact with metal
which could corrode).
The tissue samples for histological examination shall be transferred as early as possible to an appropriate
fixative or other media. The type of fixative used and the time between excision and placement in the
fixative or media shall be documented. The tissue sample shall be treated in a routine manner as required
for histological examination, unless a special method is needed for special investigations.
If appropriate, the media used to preserve tissue attached to a retrieved surgical implant shall be
selected so as not to affect the surgical implant. When it is not possible to preserve the tissues without
affecting the retrieved surgical implant, the portions of the retrieved surgical implant to be analysed
should be determined and the tissue preserved accordingly.
Fluids obtained by aspiration shall be appropriately preserved for examination unless a special method
is needed for special investigations. The preservation method should be chosen taking into account the
intended analysis.
In post-mortem studies, histological examination of remote tissues, e.g. liver and kidney, should also be
performed if there is a need to assess toxicity in these locations.
3.5 Photographic record of the explantation
Where appropriate, photographic records shall be made of the surgical implant in situ of the surgical site
and of the explanted surgical implant and any associated tissue specimens.
Where appropriate, the orientation of all removed surgical implant components in relation to each other
and their placement in relation to the body and associated excised material shall be recorded. If not
self-explanatory, the proximal end and the orientation in the transverse plane of the implant shall be
marked and documented. Any observed abnormalities in the appearance or condition of the device shall
be recorded.
NOTE As appropriate, either the surgical implant and the tissues themselves or the support upon which they
are placed (e.g. a corkboard) can be marked.
3.6 Containing and labelling the retrieved surgical implant, tissues, and fluids for
future identification
Immediately after collection or photography, all surgical implants, associated tissues, and fluids, which
are retrieved for analysis, shall be placed in appropriate containers that can be sealed in such a way that
any subsequent opening of the containers can be detected. Suitable containers include envelopes, bags,
jars, pots, and boxes.
NOTE Adhesive tape is normally used to seal the containers.
For example, when the container is an envelope, the flap of the envelope shall be taped so that the tape
covers both the flap and the envelope itself. When the container is a bag, the opening of the bag shall
be sealed with tape. Similarly, when the container is a jar, pot, or box, the juncture of the lid and the
container shall be taped. The retriever shall place his initials across the tape. In this way, opening the
container tears the tape and disturbs the initials.
Immediately after containing the surgical implants, tissues, and fluids, all containers shall be labelled
to ensure their precise identification at some later date. The label shall contain at least the following
information:
a) accurate description of the contents of the container (e.g. vascular graft, type XYZ);
b) name or initials of retriever;
c) date, time, and place of retrieval;
d) name or identification number of patient, if available, as permitted by the applicable national
regulations;
e) container number or identifier, if there is more than one container;
f) orientation of each component relative to the others, if there is more than one retrieved component
and if the orientation is abnormal.
The labels used shall be of a non-removable type (labels that tear when someone tries to remove them).
3.7 Cleaning the retrieved surgical implant
All surgical implants which are retrieved for analysis shall be cleaned before decontamination, unless
otherwise specifically instructed. Cleaning can be performed off-site.
Retrieved surgical explants shall be cleaned as follows.
The retrieved surgical implant shall be thoroughly rinsed under running water, but not scrubbed, to
remove all biological contaminants, unless such contaminants are important to the analysis. Adherent
tissues considered important to the analysis shall be treated as a tissue sample (see 3.4). Loosely
adherent material of possible interest should be preserved before the surgical implant is rinsed.
The retrieved surgical implant shall, in addition, be cleaned as recommended by the manufacturer. If the
manufacturer cannot be contacted or is unable to supply a means for cleaning the surgical implant, the
method chosen shall be that given in Table 1 or any other method which has been shown to be effective
while preserving the integrity of the implant, e.g. peracetic acid.
All solutions to be used in the cleaning of retrieved surgical implants shall be prepared at the time
of cleaning and shall not be stored in the laboratory for future use. Proteolytic enzyme solutions and
4 © ISO 2015 – All rights reserved

ultrasonic bath solutions shall be disposed of according to the manufacturer’s instruction or may be
decontaminated using a chemical disinfectant and discarded in the sanitary sewer. Depending on local
sewage company requirements and on the recommendation of the manufacturer, chemical cleaning
agents might need to be neutralized before discarding into the sanitary sewer.
Any biological debris removed from the surgical implants shall be decontaminated by autoclaving, or
disinfected through a chemical disinfectant before disposal (see 5.5).
NOTE Table 1 presents general recommendations and is intended for use only when a manufacturer’s
recommendations cannot be obtained.
When chemical cleaning agents and/or an ultrasonic bath are used, cleaning should be performed
inside a class II, type B (see Reference [2]), biological safety cabinet, which should be exhausted to the
outside. In cases where there is tissue in-growth present, a proteolytic enzyme solution may be used in
conjunction with ultrasonic cleaning, but only when no histological investigation is planned. Retrieved
surgical implants which are too large to be placed in an ultrasonic bath shall be sprayed or surface-wiped
with an appropriate chemical cleaning agent or disinfected according to the ultrasonic bath solutions
manufacturer. Such surgical implants should be cleaned in a biological safety cabinet of the class and
type described above or in an isolated and well-ventilated area in the laboratory. Proper protective
precautions, as specified in Clause 5, should be followed. Disposable swabs, brushes, and wipes may be
used to remove visible debris from such implants, in conjunction with an appropriate chemical agent.
Table 1 — Generic recommendation for cleaning and decontaminating explanted surgical
implants
a b b,c
Device or implant disinfected Cleaning method Decontamination method
Cardiac pacemaker housing Proteolytic enzyme solution or 70 % to Ethylene oxide gas or 70 % to 80 %
80 % isopropanol ethanol or 3 % stabilized hydrogen
peroxide
Leads 70 % to 80 % ethanol or 70 % to 80 % 70 % to 80 % ethanol or 70 % to
isopropanol 80 % isopropanol
Cardiac valve: Mechanical valves Proteolytic enzyme solution at or below Ethylene oxide gas
room temperature with subsequent
ultrasonic treatment
Xenografts Proteolytic enzyme solution Ethylene oxide gas or buffered,
alkaline 2 % solution of
glutaraldehyde
Allografts Broad-spectrum antibiotic solution Ethylene oxide gas or buffered,
alkaline 2 % solution of
glutaraldehyde
Vascular grafts, biologic 2 % buffered alkaline glutaraldehyde Buffered, alkaline 2 % glutaralde-
hyde
Vascular grafts, synthetic Proteolytic enzyme or 3 % stabilized Ethylene oxide gas or buffered,
hydrogen peroxide solution with alkaline 2 % solution of glutaralde-
subsequent ultrasonic treatment hyde or 4 % formaldehyde solution
d
Intra-aortic balloons and other Peracetic acid with subsequent Ethylene oxide gas or 70 % aqueous
temporary cardiac-assist ultrasonic treatment or solution solutions of ethanol or isopropanol
implants sodium hypochlorite (500 mg/l to
600 mg/l)
a
When tissues are to be preserved, methods such as glutaraldehyde fixation may be used.
b
Percentages are volume fractions.
c
For disinfecting, a soaking time of 2 h to 3 h is sufficient. However, a 24 h contact time may be used to provide an extra
margin of safety.
d
WARNING — Peracetic acid is an explosive; it should be used with caution and stored in an explosion-proof
refrigerator.
e
KOH (c = 4 mol/l) shall be used for final disposition of central nervous system explants.
Table 1 (continued)
a b b,c
Device or implant disinfected Cleaning method Decontamination method
Breast implants Intense water rinse, proteolytic enzyme 2 % glutaraldehyde, 4 % formalde-
solution with subsequent ultrasonic hyde or ethylene oxide gas
treatment
Hydrocephalus shunts Proteolytic enzyme solution at or below Buffered, alkaline 2 %
room temperature with subsequent glutaraldehyde, ethylene oxide gas
e
ultrasonic treatment or 4 % formaldehyde
Vascular port and peritoneal Sodium hypochlorite solution (50 mg/l Buffered, alkaline 2 % solution of
access implants to 60 mg/l) or 3% hydrogen peroxide glutaraldehyde or 70 % ethanol or
isopropanol with 0,2 % glutaralde-
hyde
Intraocular lenses (HEMA) Ethylene oxide gas
Silicone elastomeric and 70 % to 80 % aqueous ethanol or Ethylene oxide gas or buffered,
polymeric implant components isopropanol with subsequent ultrasonic alkaline 2% solution of glutaralde-
treatment or sodium hypochlorite hyde
solution (50 mg/l to 60 mg/l) or 3 %
hydrogen peroxide
Polymeric implant components Proteolytic enzyme solution, with Buffered, alkaline 2 % solution of
(PMMA, PE-UHMW) ultrasonic treatment, or sodium glutaraldehyde or ethylene oxide
hypochlorite solution (50 mg/l to gas
60 mg/l) or 3 % hydrogen peroxide
Metallic implant components Intense water rinse, 70 % to 80 % Steam autoclave or ethylene oxide
aqueous ethanol or isopropanol with
subsequent ultrasonic treatment or
proteolytic enzyme or sodium
hypochlorite solution (50 mg/l to
60 mg/l) or 3 % hydrogen peroxide
Ceramic implant components Proteolytic enzyme solution, with Buffered, alkaline 2 % solution of
ultrasonic treatment or sodium glutaraldehyde or ethylene oxide
hypochlorite solution (50 mg/l to gas
60 mg/l) or 3 % hydrogen peroxide
a
When tissues are to be preserved, methods such as glutaraldehyde fixation may be used.
b
Percentages are volume fractions.
c
For disinfecting, a soaking time of 2 h to 3 h is sufficient. However, a 24 h contact time may be used to provide an extra
margin of safety.
d
WARNING — Peracetic acid is an explosive; it should be used with caution and stored in an explosion-proof
refrigerator.
e
KOH (c = 4 mol/l) shall be used for final disposition of central nervous system explants.
3.8 Decontaminating the retrieved surgical implant
After cleaning, all surgical implants which are retrieved for analysis shall be decontaminated, unless
they are to be packaged and sealed without being decontaminated.
Retrieved and cleaned surgical explants shall be decontaminated as follows.
The retrieved surgical implant shall be decontaminated as recommended by the manufacturer. If the
manufacturer cannot be contacted or is unable to supply a means for decontaminating the surgical
implant, the method chosen shall be that given in Table 1 or any other method which has been shown to
be effective while preserving the integrity of the implant.
CAUTION — Unless approved by the manufacturer, do not apply the autoclave method for devices
with batteries. Use alternative methods instead.
6 © ISO 2015 – All rights reserved

Implants destined to be decontaminated at a location outside the biosafety cabinet (described above)
shall be placed into a sealable container for transport. The transport container shall be sprayed or
surface wiped with a sodium hypochlorite solution (50 mg/l to 60 mg/l) or 3 % hydrogen peroxide
before removal from the cabinet.
Generic procedures which have been shown to be effective for the decontamination of retrieved surgical
implants are given in Annex B.
NOTE 1 Table 1 presents general recommendations and is intended for use only when a manufacturer’s
recommendations cannot be obtained.
NOTE 2 Inappropriate decontamination techniques can adversely affect the material properties or function of
the retrieved surgical implant.
3.9 Packaging the retrieved surgical implant, tissues, and fluids for shipment
All retrieved surgical implants which are intended for shipment shall be packed in a manner which
minimizes the potential for breakage, surface damage, contamination of the environment, or exposure
of those handling such packages during transit.
Retrieved surgical implants and, if applicable, associated tissue samples and fluids shall be packed using
the following three layers of packaging:
a) primary container;
b) secondary container;
c) outer shipping container.
Each retrieved surgical implant, tissue sample, or fluid shall be packed separately in its own primary
container, which shall be durable, watertight, and securely closed. Each primary container(s) shall
be placed in a secondary container which shall be durable and securely closed. If there is a potential
for leakage from the primary container, the secondary container shall be watertight and may contain
absorbent material. The secondary container(s) shall be placed in an outer shipping container using
shock-resistant packing material to withstand shocks, pressure changes, and ordinary handling. The
outer shipping container shall make use of absorbent or leakproof material, if there is a potential for
leakage from the secondary container. The net contents of any single package containing liquid shall
comply with local or national transportation shipping regulations.
All retrieved surgical implants should be handled and packaged in accordance with the infection control
requirements specified in Clause 5.
The requirements in this clause apply if the retrieved materials are to be cleaned, decontaminated,
analysed, or processed in an off-site location, e.g. when they are to be returned to the implant
manufacturer for these purposes.
The requirements in this clause apply to the packaging and shipment of retrieved surgical implants and
associated tissue samples and fluids through national postal services or private couriers.
The requirements in this clause apply also to the shipment of retrieved surgical implants or tissue
samples or fluids which are thought to be contaminated by an infectious biological agent.
The requirements in this clause are in addition to, and do not replace, any other packaging or other
requirements for the transportation of biological materials prescribed by governmental bodies.
NOTE 1 References given in the bibliography provide further information.
NOTE 2 Some multi-component surgical implants can be packed in the same container, e.g. implantable pulse
generators and their leads.
NOTE 3 Some surgical implants can be packed moist or wet using an appropriate fluid, e.g. when returning
certain active surgical implants to the implant manufacturer.
3.10 Use of coolant materials
If the contents of the primary container need to be cooled, then coolant materials shall be used. Coolant
materials include ice, dry ice, and gel packs.
Coolant materials shall be packed in such a way that, if they are subject to melting or creation of
condensation, the liquid produced does not escape from the outer shipping container.
If ice or dry ice is used, shock-absorbing material shall be included to immobilize the primary container
as the ice or dry ice melts or sublimates. Packages containing dry ice shall be packed in containers that
permit the venting of the carbon dioxide gas. Usually, the package shall be marked with the words “DRY
ICE” and/or the international symbol for dry ice, UN 1845, shall be used.
NOTE UN 1845 is a symbol developed by the United Nations Committee of Experts on the Transport of
Dangerous Goods.
3.11 Labelling of the packing materials
The primary, secondary, and outer shipping containers shall each bear a label which gives the following
information:
— name, address, and telephone number of the sender;
— biological risks symbol (see ISO 15223-1:2012, symbol 5.4.1);
— the word “Decontaminated” if the surgical implant has been decontaminated.
If the package contains an undecontaminated surgical implant, the outer shipping container shall include
a label which states that upon discovery of damage or leakage, the package should be isolated and the
sender notified.
3.12 Documentation to be supplied with retrieved surgical implants
The following are the documentation to be supplied with retrieved surgical implants and associated
tissue samples and fluids:
— clinical history as specified in 3.1 or Annex A, if available;
— results of the pre-explantation checks and examinations as specified in 3.2, if available;
— position, orientation, or state of the retrieved components and the location and type of any damage
caused during explantation as specified in 3.3, if applicable;
— details of the tissue and/or fluid samples taken for microbiological and/or histological examination
as specified in 3.4, if applicable;
— photographic record of the explantation as specified in 3.5, if available;
— label information for future identification as specified in 3.6;
— details of the cleaning of the retrieved surgical implant as specified in 3.7, if applicable;
— details of the decontamination of the retrieved surgical implant as specified in 3.8, if applicable;
— name and contact details of the retriever.
The above documents and any other correspondence shall be placed inside the outer shipping container
so that the receiving facility is not required to open the secondary container to retrieve any documents
or correspondence. All packing slips and address label(s) shall be affixed to the outer shipping container
so that the receiving facility is not required to open the outer shipping container in order to identify its
contents or the intended receiver.
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3.13 Unpacking following shipment
Unpacking shall proceed in accordance with the general practices outlined in Clause 5.
If the outer shipping container is small, it should be placed within a biological safety cabinet to be
opened. If the outer shipping container is too large to fit into the cabinet, it should be placed on the
floor immediately outside the cabinet and opened. If the secondary container is intact, it should then be
immediately placed within the cabinet for further processing.
First, all paperwork and decontamination documentation and correspondence as specified in 3.12 shall
be removed from the outer shipping container and placed away from direct contact with the potentially
contaminated surgical implant.
Next, the secondary container shall be opened and the primary container removed. The primary
container should be examined for any visible signs of contamination or leakage.
If the primary container is intact, the secondary container, the outer shipping container, and any packing
material may be discarded as non-contaminated waste and should be removed from the cabinet before
opening the primary container. Primary containers which immediately surround the surgical implant
shall be handled as infectious waste in accordance with Clause 5.
3.14 Cleaning and decontamination following shipment
If required, cleaning and decontamination may be performed after shipment in which case, the processes
specified in 3.7 and 3.8 shall be followed, as applicable.
3.15 Documentation to be maintained during examination, analysis, and storage
As explained in 3.12, the documentation shall begin when the surgical implant is retrieved. In addition,
it shall continue until examination and analysis are complete. Everyone who handles, examines, or
stores the implant shall be required to add to the documentation to ensure a complete history and
understanding of the analytical findings.
The following information shall be added to the retrieval documentation:
a) name of the shipping service (postal service, courier, etc.), shipping number, date of shipment, and
time of release;
b) state of the surgical implant following unpacking;
c) details of any post-shipment cleaning or decontamination;
d) location and details of storage, if the surgical implant is to be stored before or after examination;
e) name and contact details of the individual(s) responsible for the handling, analysis, and storage of
the surgical implant.
4 Analysis of retrieved surrounding tissues and fluids
An example of the analyses to be performed on retrieved tissues and fluids is given in Annex C.
NOTE The analysis of retrieved surgical implants and associated interfaces is specified in ISO 12891-2.
5 Infection control
5.1 General
Protect employees who come into contact with explanted implants from exposure. All retrieved implants
and associated tissues should be assumed to be potentially infectious. Due to the risk of infection,
corresponding precautions should be taken, such as handling with gloved hands. The risk of infection
by bacterial, viral, or other agents always exists when contamination with blood or other potentially
infectious material is present.
5.2 Work practices
Employees shall wash their hands as soon as possible after removal of gloves or other personal protective
equipment after hand contact with potentially infectious surgical implants. A commercially available
germicidal soap may be used, but this can become irritating to the skin after frequent use.
Many surgical colleges and institutions recommend that gloves should be checked for punctures after
removal.
If overtly contaminated, all personal protective equipment shall be removed and placed in an
appropriately designated area or container for storage, washing, decontamination, or disposal.
Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in
work areas having a potential for occupational exposure to pathogens.
Food and drink shall not be stored in refrigerators, freezers, or cabinets where implants are stored or in
other are
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