Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

This document specifies the general requirements for instruments to be used in association with nonactive
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 it
does not apply to the power-driven systems themselves.
With regard to safety, this document gives the 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.

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2021)

Dieses Dokument legt die allgemeinen Anforderungen für Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden, fest. Diese Anforderungen gelten für Instrumente während ihrer Herstellung und wenn sie nach Aufarbeitung geliefert werden.
ANMERKUNG   Sofern nicht anders angegeben bezeichnet der Begriff „Instrument“ in diesem Dokument ein Instrument, das in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet wird.
Dieses Dokument ist auch für Instrumente anzuwenden, die mit Antriebseinheiten verbunden werden können, aber es gilt nicht für die Antriebseinheiten selbst.
In Bezug auf die Sicherheit legt dieses Dokument die Anforderungen für die vorgesehene Funktion, Konstruktionsmerkmale, Werkstoffe, Designbewertung, Herstellung, Sterilisation, Verpackung und durch den Instrumentenhersteller bereitgestellte Informationen, im Weiteren Hersteller genannt, fest.
Dieses Dokument ist nicht für Instrumente anzuwenden, die in Verbindung mit Dentalimplantaten, transendodontischen und transradikulären Implantaten sowie ophthalmologischen Implantaten verwendet werden.

Instruments à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales (ISO 16061:2021)

Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantatih) - Splošne zahteve (ISO 16061:2021)

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
31-Mar-2021
Completion Date
31-Mar-2021

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SLOVENSKI STANDARD
SIST EN ISO 16061:2021
01-julij-2021
Nadomešča:
SIST EN ISO 16061:2015
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantatih) -
Splošne zahteve (ISO 16061:2021)
Instruments for use in association with non-active surgical implants - General
requirements (ISO 16061:2021)

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet

werden - Allgemeine Anforderungen (ISO 16061:2021)

Instruments à utiliser en association avec les implants chirurgicaux non actifs -

Exigences générales (ISO 16061:2021)
Ta slovenski standard je istoveten z: EN ISO 16061:2021
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN ISO 16061:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16061:2021
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SIST EN ISO 16061:2021
EN ISO 16061
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2021
EUROPÄISCHE NORM
ICS 11.040.40; 11.040.99 Supersedes EN ISO 16061:2015
English Version
Instruments for use in association with non-active surgical
implants - General requirements (ISO 16061:2021)

Instruments à utiliser en association avec les implants Instrumente, die in Verbindung mit nichtaktiven

chirurgicaux non actifs - Exigences générales (ISO chirurgischen Implantaten verwendet werden -

16061:2021) Allgemeine Anforderungen (ISO 16061:2021)
This European Standard was approved by CEN on 5 January 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16061:2021 E

worldwide for CEN national Members.
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SIST EN ISO 16061:2021
EN ISO 16061:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 16061:2021
EN ISO 16061:2021 (E)
European foreword

This document (EN ISO 16061:2021) has been prepared by Technical Committee ISO/TC 150 "Implants

for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the

secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by September 2021, and conflicting national standards

shall be withdrawn at the latest by September 2021.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 16061:2015.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 16061:2021 has been approved by CEN as EN ISO 16061:2021 without any modification.

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SIST EN ISO 16061:2021
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SIST EN ISO 16061:2021
INTERNATIONAL ISO
STANDARD 16061
Fourth edition
2021-03
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
Reference number
ISO 16061:2021(E)
ISO 2021
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SIST EN ISO 16061:2021
ISO 16061:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 16061:2021
ISO 16061:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ................................................................................................................................................................................................................................vi

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 .............................................................................................................................................................................................................. 6

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 transport, storage and handling.......................................................................... 6

10.2 Maintenance of sterility in transport, storage and handling ........................................................................... 7

11 Information supplied by the manufacturer ............................................................................................................................. 7

11.1 General ........................................................................................................................................................................................................... 7

11.2 Marking on instruments ................................................................................................................................................................. 8

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

© ISO 2021 – All rights reserved iii
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SIST EN ISO 16061:2021
ISO 16061:2021(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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to

the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see

www .iso .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active

surgical implants, in accordance with the Agreement on technical cooperation between ISO and CEN

(Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 16061:2015), which has been technically

revised. The main changes compared to the previous edition are as follows:

— A requirement to include intended purpose has been added in the list of items to be included when

establishing the intended performance of the instrument.

— The list of design attributes in Clause 5 has been reorganized and several new attributes have added

to the list.

— The selection of materials to be used in the instrument has been based on a risk analysis and the

clause now includes a list of the minimum factors to be considered in the risk analysis.

— The requirement for pre-clinical evaluation has been expanded and includes the requirement for

testing and biological evaluation of the final instrument.

— A clinical evaluation of the instrument has been added as a requirement in all cases. However, if the

pre-clinical evaluation demonstrates the safety and intended performance of the instrument in the

conditions of intended use, the results of the pre-clinical evaluation will satisfy the requirement for

the clinical evaluation.
— A new requirement for post-market surveillance has been added to Clause 7.

— The requirements in Clause 11 have been reorganized and clarified to reflect current practice and

to reference ISO 17664:2017, Clause 6 for instructions for applicable processing step (i.e. cleaning,

disinfection, drying, packaging, and sterilization) that need to be carried out by someone other than

the manufacturer.
iv © ISO 2021 – All rights reserved
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SIST EN ISO 16061:2021
ISO 16061:2021(E)

— Annex A has been simplified to provide more consistent guidance on selection of material using a

risk-based approach. The stainless-steel grade material characteristic tables have been removed.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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SIST EN ISO 16061:2021
ISO 16061:2021(E)
Introduction

This document provides a method of addressing the fundamental principles outlined in 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 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

be used in association with non-active surgical implants, ISO 14630, which contains the requirement

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.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 16061:2021
INTERNATIONAL STANDARD ISO 16061:2021(E)
Instruments for use in association with non-active surgical
implants — General requirements
1 Scope

This document specifies the 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 it

does not apply to the power-driven systems themselves.

With regard to safety, this document gives the 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 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 14971, Medical devices — Application of risk management to medical devices
© ISO 2021 – All rights reserved 1
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SIST EN ISO 16061:2021
ISO 16061:2021(E)

ISO 17664, 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 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 https:// www .iso .org/ obp
3.1
associated implant

specific non-active surgical implant (3.4) associated with a specific instrument (3.3) intended to be used

during a surgical procedure
3.2
final instrument

instrument (3.3) that has been subjected to all manufacturing processes for the “to be marketed”

instrument including packaging and if applicable, sterilization

Note 1 to entry: Derived from the definition of “final product” in ISO 10993-1:2018, 3.8 to reinforce that the

instrument to be evaluated is the final product referred to in ISO 10993-1.
3.3
instrument

non-active medical device intended for use during surgical procedures related to specific non-active

surgical implants (3.4)

Note 1 to entry: Examples of typical applications of instruments to be used in association with non-active surgical

implants are presented in A.1.
3.4
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 14630:2012, 3.6, modified — the second term "implant" has been deleted.]

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;
c) intended conditions of use.
2 © ISO 2021 – All rights reserved
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SIST EN ISO 16061:2021
ISO 16061:2021(E)

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:

— 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 non-active surgical implant (e.g.

implantation, positioning, alignment, removal);

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) compatibility with intended processing agent (e.g. cleaning agent, disinfectant, and sterilizing

agent) and intended processing conditions (e.g. temperature, pressure, vacuum, humidity, time) for

instruments requiring user processing (e.g. sterilization) or intended to be reused;

g) stability of instrument materials under intended manufacturing conditions (e.g. chemicals,

temperature, pressure, vacuum, humidity, time);

h) potential deterioration of the form and/or function of the instrument due to repeated use and

reprocessing;

i) ease of cleaning, disinfection (if intended by the manufacturer) and sterilization both by the

manufacturer and the user;
j) ease of maintenance;
k) effects of contact between the instrument and the body;

l) effects of contact between the instrument and the non-active surgical implant, and other

instruments;

m) shape and dimensions of the instrument, including their possible effects on the body or the non-

active surgical implant;

n) wear characteristics of materials and the effect of wear and wear products on the instrument, the

body or the non-active surgical implant;
o) insertion, removal, and interconnection of parts;

p) extent of fluid leakage and/or diffusion of substances into or out of instruments;

q) accuracy and stability of the measurement for instruments with a measuring function;

r) reciprocal interference with other devices in the specified use environment;
© ISO 2021 – All rights reserved 3
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SIST EN ISO 16061:2021
ISO 16061:2021(E)

EXAMPLE Compatibility with diagnostic imaging systems such magnetic resonance imaging (MRI)

equipment. See References [35], [37] and [38] for standards related to the hazards associated with the

magnetic resonance environment.

s) ability of the instrument or fragment of instrument to be located by means of an external imaging

device [see 11.4, q)];

t) compatibility with medicinal substances incorporated into or intended to be used with the

instrument.
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, dimensions, geometry, and conditions for use; and,

duration and frequency of use over the intended 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);

c) the effects of instrument manufacturing, handling, cleaning, packaging, sterilization, storage, and

processing (if applicable);
NOTE 1 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 1 Adverse reaction to leachable chemicals, degradation products, additives (e.g. plasticisers

and fillers) and impurities.

e) possible adverse reactions between the non-active surgical implant materials and instrument

materials in the presence of body fluids.
EXAMPLE 2 Electrochemical corrosion.

NOTE 2 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 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 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:
4 © ISO 2021 – All rights reserved
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SIST
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