SIST EN ISO 16061:2021

SLOVENSKI STANDARD
oSIST prEN ISO 16061:2020
01-marec-2020
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantatih) -
Splošne zahteve (ISO/DIS 16061:2020)
Instruments for use in association with non-active surgical implants - General
requirements (ISO/DIS 16061:2020)
Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet
werden - Allgemeine Anforderungen (ISO/DIS 16061:2020)
Instruments à utiliser en association avec les implants chirurgicaux non actifs -
Exigences générales (ISO/DIS 16061:2020)
Ta slovenski standard je istoveten z: prEN ISO 16061
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
oSIST prEN ISO 16061:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 16061:2020

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oSIST prEN ISO 16061:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16061
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-01-16 2020-04-09
Instruments for use in association with non-active surgical
implants — General requirements
Instruments à utiliser en association avec les implants chirurgicaux non actifs — Exigences générales
ICS: 11.040.40; 11.040.99
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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 16061:2020(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 2020

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COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 2
5 Design attributes . 3
6 Selection of materials . 4
7 Design evaluation . 4
7.1 General . 4
7.2 Pre-clinical evaluation . 4
7.3 Clinical evaluation . 5
7.4 Post-market surveillance . 5
8 Manufacture . 5
9 Sterilization . 6
9.1 Instruments supplied sterile . 6
9.2 Instruments supplied non-sterile . 6
9.3 Instruments that are resterilizable . 6
10 Packaging . 6
10.1 Protection from damage in storage and transport. 6
10.2 Maintenance of sterility in transit . 6
11 Information supplied by the manufacturer . 7
11.1 General . 7
11.2 Marking on instruments . 7
11.3 Label . 8
11.4 Instructions for use . 9
11.5 Additional information for instruments with a measuring function .10
Annex A (informative) Examples of typical applications of instruments to be used in
association with non-active surgical implants and materials found acceptable for
instrument manufacture .11
Bibliography .13
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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 fourth edition cancels and replaces the third edition (ISO 16061:2015), which has been technically
revised.
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Introduction
This document provides a method of addressing the fundamental principles outlined in
[16] 1)
ISO/TR 14283  as they apply to instruments to be used in association with non-active surgical
implants. It also provides a method that can be used to demonstrate compliance with applicable
regulatory requirements relevant to the general safety and performance of medical devices as they
apply to instruments to be used in association with non-active surgical implants.
There are three levels of standards dealing with instruments to be used in association with non-active
surgical implants. They are as follows, with level 1 being the highest.
— Level 1: General requirements for instruments to be used in association with non-active surgical
implants.
— Level 2: Particular requirements for families of instruments to be used in association with non-
active surgical implants.
— Level 3: Specific requirements for types of instruments to be used in association with non-active
surgical implants.
Level 1 standards include this document which contains requirements that apply to all instruments to
[17]
be used in association with non-active surgical implants, ISO 14630, which contains requirement
[18]
for non-active surgical implants and ISO 14708-1 which contains requirements for active implants.
They also anticipate that there are additional requirements in the level 2 and level 3 standards.
Level 2 standards apply to a more restricted set or family of instruments, such as those designed for use
with non-active surgical implants used in neurosurgery, cardiovascular surgery, or joint replacement.
Level 3 standards apply to specific types of instruments within a family of instruments used in
association with non-active surgical implants, such as hip joints or arterial stents.
To address all requirements for a specific instrument, it is advisable that the standard of the lowest
available level be consulted first.
Compliance with a level 3 standard is intended to imply compliance with the applicable level 2
standards, if available, and with the applicable level 1 standard.
NOTE The requirements in this document correspond to international consensus. Individual or national
standards or regulatory bodies can prescribe other requirements.
1) Numbers in square brackets refer to the Bibliography.
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oSIST prEN ISO 16061:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 16061:2020(E)
Instruments for use in association with non-active surgical
implants — General requirements
1 Scope
This document specifies general requirements for instruments to be used in association with non-
active surgical implants. These requirements apply to instruments when they are manufactured and
when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term “instrument” refers to an instrument for use in
association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but does
not apply to the power-driven systems themselves.
With regard to safety, this document gives requirements for intended performance, design attributes,
materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the
instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and
transradicular implants and ophthalmic implants.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of
development, validation and routine control
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2019, Medical devices — Application of risk management to medical devices
ISO/TS 13004, Sterilization of health care products — Radiation — Substantiation of selected sterilization
dose: Method VDmaxSD
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ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 17664:2017, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 25424, Sterilization of health care products — Low temperature steam and formaldehyde —
Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 80000-1, Quantities and units — Part 1: General
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971:2019 and the following
terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
associated implant
specific non-active surgical implant in association with which a specific instrument is intended to be
used during a surgical procedure
3.2
instrument
non-active medical device intended for use during surgical procedures related to specific non-active
surgical implants
Note 1 to entry: Examples of typical applications of instruments to be used in association with non-active surgical
implants are presented in the A.1.
3.3
non-active surgical implant
surgical implant, the operation of which does not depend on a source of electrical energy or any source
of power other than that directly generated by the human body or gravity
[SOURCE: ISO 14630:2013, 3.6]
4 Intended performance
The intended performance of an instrument shall be described and documented by addressing the
following, with particular regard to safety:
a) intended purpose;
b) functional characteristics; and
c) intended conditions of use.
Instruments shall be evaluated to demonstrate that the intended performance is achieved (see
Clause 7).
NOTE Information to support the description of the intended performance can be found in sources such as:
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— published standards;
— published clinical and scientific literature;
— validated test results.
5 Design attributes
The development of the design attributes of an instrument to meet the performance intended by the
manufacturer shall take into account at least the following:
a) role of the instrument in conjunction with the associated the non-active surgical implant (e.g.
implantation, positioning, alignment, removal, etc.);
b) biocompatibility of materials for their intended use, including the influence of material by-products
from manufacturing and chemical residuals;
c) physical, mechanical, biological and chemical properties of the instrument materials;
d) potential deterioration of the material characteristics;
e) usability;
f) for instruments requiring user processing (e.g. sterilization) or intended to be reused, compatibility
with intended processing agent (e.g. cleaning agent, disinfectant, and sterilizing agent) and
intended processing conditions (e.g. temperature, pressure, vacuum, humidity, time, etc.);
g) stability of instrument materials under intended manufacturing conditions (e.g. chemicals,
temperature, pressure, vacuum, humidity, time, etc.);
h) ease of cleaning, disinfection (if intended by the manufacturer) and sterilization both by the
manufacturer and the user;
i) ease of maintenance;
j) effects of contact between the instrument and the body;
k) effects of contact between the instrument and the non-active surgical implant, and other
instruments;
l) shape and dimensions of the instrument, including their possible effects on the body;
m) wear characteristics of materials and the effect of wear and wear products on the instrument and
the body;
n) insertion, removal, and interconnection of parts;
o) extent of fluid leakage and/or diffusion of substances into or out of instruments;
p) accuracy and stability of instruments with a measuring function;
q) reciprocal interference with other devices in the specified use environment;
EXAMPLE Compatibility with diagnostic imaging systems such magnetic resonance imaging (MRI)
equipment. See the Bibliography for standards related to the hazards associated with the MR environment.
r) ability of the instrument or fragment of instrument to be located by means of an external imaging
device (see 11.4 o)); and
s) compatibility with medicinal substances incorporated into or intended to be used with the
instrument.
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6 Selection of materials
The selection of materials to be used for the manufacture of instruments shall be based on a risk
analysis, which shall take into account at least the following:
a) the properties required for the intended purpose considering factors such as mechanical/
functional requirements, anatomical location, size, geometry, and conditions for use; and, duration
and frequency of use over the lifetime of the instrument;
b) any intended treatment to the material or to the surface of the instrument (e.g. chemical, electro-
chemical, thermal, mechanical, coating, etc.);
c) the effects of instrument manufacturing, handling, cleaning, packaging, sterilization, storage, and
processing (if applicable); and
NOTE For information on processing of health care products, see ISO 17664.
d) possible adverse reactions by the human body and body fluids to the instrument materials.
EXAMPLE Adverse reaction to leachable chemicals, degradation products, additives (e.g., plasticisers and
fillers) and impurities.
NOTE Annex A lists some of the materials that have been found acceptable in certain applications. Reference
to Annex A does not eliminate the need to conduct a risk analysis taking into account the factors outlined above.
A biological evaluation of the final, finished instrument shall be performed and shall form part of the
pre-clinical evaluation (see 7.2).
7 Design evaluation
7.1 General
Instruments shall be evaluated in association with the non-active surgical implant they are designed
for, in order to demonstrate that the safety and the intended performance is achieved (see Clause 4).
Safety and intended performance shall be demonstrated by pre-clinical evaluation, clinical evaluation
and, if available, post-market surveillance, including appropriate risk management at all stages of the
life cycle of the instrument.
NOTE Further information on risk management can be found in ISO 14971.
7.2 Pre-clinical evaluation
Instruments shall undergo pre-clinical evaluation based on a critical review of:
a) data obtained from testing of the instrument or demonstrably similar instruments and,
when available, data from validated techniques for evaluating instrument safety and intended
performance; and
b) all available field data, safety reports, relevant complaint information, and adverse event data for
the instrument or demonstrably similar instruments.
The pre-clinical evaluation can be supported by a critical review of:
c) applicable standards; and
d) the relevant scientific literature relating to the safety, performance, design characteristics, and
intended use of the instrument or of demonstrably similar instruments.
Testing of the instrument is required unless the critical review above is sufficient to demonstrate the
safety and intended performance of the instrument. If testing of the instrument is required, the testing
shall simulate conditions of intended use and, if applicable, re-use.
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Testing to demonstrate the usability of the instruments is required unless the use of the instrument
can be evaluated by direct comparison with existing devices.
NOTE 1 Testing to demonstrate usability can include cadaveric evaluation or simulated cadaveric evaluation.
NOTE 2 Further information on a process for demonstrating the usability of an instrument can be found in
[24]
IEC 62366-1 .
The biological evaluation of the final, finished instrument shall be performed in accordance with
ISO 10993-1. When determining the biocompatibility of the final, finished instrument, residuals from
the manufacturing processes (e.g., lubricants, cleaning agents, mold release agents) shall also be
considered.
If the manufacturer specifies the instrument may be processed by the user, consideration of the specified
processing on the degradation that might limit the service life of the instrument, e.g. functionality and
biocompatibility, shall be taken.
NOTE See also ISO 17664:2017, 6.3.
7.3 Clinical evaluation
A clinical evaluation of the instrument is required. If the pre-clinical evaluation is adequate to
demonstrate the safety and intended performance of the instrument in the conditions of intended
use, the results of the pre-clinical evaluation satisfy the requirement for the clinical evaluation and no
further evaluation is required.
If the pre-clinical evaluation is not adequate to demonstrate the safety and intended performance of
the instrument in the conditions of intended use, a critical review of the results of all available clinical
investigations conducted using the instrument or demonstrably similar instruments under the intended
conditions of use is required. If the results demonstrate the safety and intended performance of the
instrument in the conditions of intended use, the results of the critical review satisfy the requirement
for the clinical evaluation and no further evaluation is required. Otherwise, a clinical investigation is
required.
If a clinical investigation is required, it shall be performed in accordance with ISO 14155.
7.4 Post-market surveillance
A systematic procedure to collect and review post-market data gained from use of the instrument shall
be in place.
The design of the procedure to collect and review post-market data should be based on the risk that the
instrument failure presents to the patient or end user.
Suitable methods for collection of post-market data on the instrument can include, but are not limited
to, complaints analysis and user feedback.
[20]
NOTE Guidance on post-market surveillance for manufacturers can be found in ISO/TR 20416 .
8 Manufacture
Instruments shall be manufactured to specifications in accordance with the required design attributes
(see Clause 5).
Instruments can be delivered sterile or non-sterile. In both cases, the manufacturer shall provide
instruments that have been cleaned to remove manufacturing contaminants.
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9 Sterilization
9.1 Instruments supplied sterile
For terminally sterilized instruments to be designated “STERILE”, the theoretical probability of there
−6
being a viable microorganism present on or in the instrument shall be equal to or less than 1 × 10 .
If instruments are to be sterilized by ethylene oxide, it shall be done according to ISO 11135.
If instruments are to be sterilized by irradiation, it shall be done according to ISO 11137-1, ISO 11137-2,
and ISO 11137-3. If applicable, ISO/TS 13004 may be used to meet the requirements of ISO 11137-2.
If instruments are to be sterilized by moist heat, it shall be done according to ISO 17665-1.
If instruments are to be sterilized using low-temperature steam and formaldehyde, it shall be done
according to ISO 25424.
NOTE In some regulatory jurisdictions, low-temperature steam and formaldehyde sterilization is not an
accepted sterilization method.
If non-active surgical implants are to be sterilized by any other terminal sterilization method, ISO 14937
shall apply.
9.2 Instruments supplied non-sterile
For instruments that are supplied non-sterile, the manufacturer shall provide information on the
processing of these instruments in accordance with ISO 17664.
9.3 Instruments that are resterilizable
For instruments that are claimed to be resterilizable, the manufacturer shall provide information on
the processing of these instruments in accordance with ISO 17664.
10 Packaging
10.1 Protection from damage in storage and transport
For each instrument, the packaging shall be designed so that, under conditions specified by the
manufacturer for storage, transport, and handling (in
...