SIST EN ISO 14971:2020

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

This document specifies terminology, principles and a process for risk management of medical devices,
including software as a medical device and in vitro diagnostic medical devices. The process described in
this document intends to assist manufacturers of medical devices to identify the hazards associated with
the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor
the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The
process described in this document applies to risks associated with a medical device, such as risks related
to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical
devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not
specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does
not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2019)

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2019)

Le présent document spécifie la terminologie, les principes et un processus de gestion des risques relatifs aux dispositifs médicaux, y compris les logiciels utilisés en tant que dispositifs médicaux et les dispositifs médicaux de diagnostic in vitro. Le processus décrit dans le présent document vise à aider les fabricants de dispositifs médicaux à identifier les dangers associés au dispositif médical, à estimer et évaluer les risques correspondants, à maîtriser ces risques et à surveiller l'efficacité des moyens de maîtrise.
Les exigences du présent document s'appliquent à tous les stades du cycle de vie d'un dispositif médical. Le processus décrit dans le présent document s'applique aux risques associés à un dispositif médical, tels que les risques concernant la biocompatibilité, la sécurité des données et des systèmes, l'électricité, les parties en mouvement, le rayonnement et l'aptitude à l'utilisation.
Le processus décrit dans le présent document peut aussi s'appliquer aux produits qui ne sont pas nécessairement des dispositifs médicaux dans certaines juridictions et peut être utilisé par d'autres personnes impliquées dans le cycle de vie de dispositifs médicaux.
Le présent document ne s'applique pas à ce qui suit:
—          les décisions relatives à l'utilisation d'un dispositif médical au cours d'une procédure clinique particulière; ou
—          la gestion des risques commerciaux.
Le présent document impose aux fabricants d'établir des critères objectifs d'acceptabilité des risques, mais ne spécifie pas de niveaux de risque acceptables.
La gestion des risques peut faire partie intégrante d'un système de management de la qualité. Cependant, le présent document n'exige pas du fabricant qu'il mette en place un système de management de la qualité.
NOTE       Des recommandations relatives à l'application du présent document sont données dans l'ISO/TR 24971[9].

Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2019)

General Information

• Status: Published
• Public Enquiry End Date: 04-Oct-2018
• Publication Date: 23-Apr-2020
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 6100 - Translation of adopted SIST standards (Adopted Project)
• Start Date: 29-Apr-2021
• Due Date: 28-Apr-2022
• Completion Date: 27-Oct-2021
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 14971:2019 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Relations

• Replaces: SIST EN ISO 14971:2012 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
• Effective Date: 01-May-2020
• Amended By: SIST EN ISO 14971:2020/A11:2022 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)
• Effective Date: 10-Nov-2021
• Replaces: SIST EN ISO 14971:2012 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14971:2020
01-maj-2020
Nadomešča:
SIST EN ISO 14971:2012
Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih
pripomočkih (ISO 14971:2019)

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO
14971:2019)

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux

(ISO 14971:2019)
Ta slovenski standard je istoveten z: EN ISO 14971:2019
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14971:2020 en

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

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SIST EN ISO 14971:2020
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SIST EN ISO 14971:2020
EUROPEAN STANDARD
EN ISO 14971
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2019
ICS 11.040.01
Supersedes EN ISO 14971:2012
English version
Medical devices - Application of risk management to
medical devices (ISO 14971:2019)

Dispositifs médicaux - Application de la gestion des Medizinprodukte - Anwendung des

risques aux dispositifs médicaux (ISO 14971:2019) Risikomanagements auf Medizinprodukte (ISO

14971:2019)
This European Standard was approved by CEN on 5 August 2019.

CEN and CENELEC 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 and CENELEC 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 and CENELEC member into its own language and notified to the CEN-CENELEC

Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees 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.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels

© 2019 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 14971:2019 E

reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 14971:2020
EN ISO 14971:2019 (E)
Contents Page

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

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SIST EN ISO 14971:2020
EN ISO 14971:2019 (E)
European foreword

This document (EN ISO 14971:2019) has been prepared by Technical Committee ISO/TC 210 "Quality

management and corresponding general aspects for medical devices" in collaboration with Technical

Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical

devices” the secretariat of which is held by NEN.

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 June 2020, and conflicting national standards shall be

withdrawn at the latest by June 2020.

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 14971:2012.

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 14971:2019 has been approved by CEN as EN ISO 14971:2019 without any modification.

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SIST EN ISO 14971:2020
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SIST EN ISO 14971:2020
INTERNATIONAL ISO
STANDARD 14971
Third edition
2019-12
Medical devices — Application of risk
management to medical devices
Dispositifs médicaux — Application de la gestion des risques aux
dispositifs médicaux
Reference number
ISO 14971:2019(E)
ISO 2019
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SIST EN ISO 14971:2020
ISO 14971:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 14971:2020
ISO 14971:2019(E)
Contents Page

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

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

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 General requirements for risk management system ...................................................................................................... 7

4.1 Risk management process ........................................................................................................................................................ 7

4.2 Management responsibilities ..................................................................................................................................................... 8

4.3 Competence of personnel .............................................................................................................................................................. 9

4.4 Risk management plan .................................................................................................................................................................. 9

4.5 Risk management file ................................................................................................................................................................10

5 Risk analysis ..........................................................................................................................................................................................................10

5.1 Risk analysis process ..................................................................................................................................................................10

5.2 Intended use and reasonably foreseeable misuse ..........................................................................................10

5.3 Identification of characteristics related to safety ................................................................................................11

5.4 Identification of hazards and hazardous situations ......................................................................................11

5.5 Risk estimation .................................................................................................................................................................................11

6 Risk evaluation ....................................................................................................................................................................................................12

7 Risk control .............................................................................................................................................................................................................12

7.1 Risk control option analysis ....................................................................................................................................................12

7.2 Implementation of risk control measures ..................................................................................................................13

7.3 Residual risk evaluation .............................................................................................................................................................13

7.4 Benefit-risk analysis .......................................................................................................................................................................14

7.5 Risks arising from risk control measures ...................................................................................................................14

7.6 Completeness of risk control ................................................................................................................................................14

8 Evaluation of overall residual risk ..................................................................................................................................................14

9 Risk management review ..........................................................................................................................................................................15

10 Production and post-production activities..............................................................................................................................15

10.1 General ........................................................................................................................................................................................................15

10.2 Information collection ...................................................................................................................................................................15

10.3 Information review ..........................................................................................................................................................................16

10.4 Actions .........................................................................................................................................................................................................16

Annex A (informative) Rationale for requirements ...........................................................................................................................17

Annex B (informative) Risk management process for medical devices ...........................................................................26

Annex C (informative) Fundamental risk concepts ............................................................................................................................30

Bibliography .............................................................................................................................................................................................................................36

© ISO 2019 – All rights reserved iii
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SIST EN ISO 14971:2020
ISO 14971:2019(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 210, Quality management and

corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical

equipment used in medical practice.

This third edition cancels and replaces the second edition (ISO 14971:2007), which has been technically

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

— A clause on normative references has been included, in order to respect the requirements for fixed

in Clause 15 of ISO/IEC Directives, Part 2:2018.

— The defined terms are updated and many are derived from ISO/IEC Guide 63:2019. Defined terms

are printed in italic to assist the reader in identifying them in the body of the document.

— Definitions of benefit, reasonably foreseeable misuse and state of the art have been introduced.

— More attention is given to the benefits that are expected from the use of the medical device. The term

benefit-risk analysis has been aligned with terminology used in some regulations.

— It is explained that the process described in ISO 14971 can be used for managing risks associated

with medical devices, including those related to data and systems security.

— The method for the evaluation of the overall residual risk and the criteria for its acceptability are

required to be defined in the risk management plan. The method can include gathering and reviewing

data and literature for the medical device and for similar medical devices and similar other products

on the market. The criteria for the acceptability of the overall residual risk can be different from the

criteria for acceptability of individual risks.

— The requirements to disclose residual risks have been moved and merged into one requirement,

after the overall residual risk has been evaluated and judged acceptable.

— The review before commercial distribution of the medical device concerns the execution of the risk

management plan. The results of the review are documented as the risk management report.

iv © ISO 2019 – All rights reserved
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SIST EN ISO 14971:2020
ISO 14971:2019(E)

— The requirements for production and post-production activities have been clarified and restructured.

More detail is given on the information to be collected and the actions to be taken when the collected

information has been reviewed and determined to be relevant to safety.

— Several informative annexes are moved to the guidance in ISO/TR 24971, which has been revised

in parallel. More information and a rationale for the requirements in this third edition of ISO 14971

have been provided in Annex A. The correspondence between the clauses of the second edition and

those of this third edition is given in Annex B.

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 2019 – All rights reserved v
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SIST EN ISO 14971:2020
ISO 14971:2019(E)
Introduction

The requirements contained in this document provide manufacturers with a framework within which

experience, insight and judgment are applied systematically to manage the risks associated with the

use of medical devices.

This document was developed specifically for manufacturers of medical devices on the basis of

established principles of risk management that have evolved over many years. This document could be

used as guidance in developing and maintaining a risk management process for other products that are

not necessarily medical devices in some jurisdictions and for suppliers and other parties involved in the

medical device life cycle.

This document deals with processes for managing risks associated with medical devices. Risks can be

related to injury, not only to the patient, but also to the user and other persons. Risks can also be related

to damage to property (for example objects, data, other equipment) or the environment.

Risk management is a complex subject because each stakeholder can place a different value on the

acceptability of risks in relation to the anticipated benefits. The concepts of risk management are

particularly important in relation to medical devices because of the variety of stakeholders including

medical practitioners, the organizations providing health care, governments, industry, patients and

members of the public.
It is generally accepted that the concept of risk has two key components:
— the probability of occurrence of harm; and
— the consequences of that harm, that is, how severe it might be.

All stakeholders need to understand that the use of a medical device involves an inherent degree of risk,

even after the risks have been reduced to an acceptable level. It is well known that in the context of a

clinical procedure some residual risks remain. The acceptability of a risk to a stakeholder is influenced

by the key components listed above and by the stakeholder’s perception of the risk and the benefit. Each

stakeholder’s perception can vary depending upon their cultural background, the socio-economic and

educational background of the society concerned and the actual and perceived state of health of the

patient. The way a risk is perceived also takes into account other factors, for example, whether exposure

to the hazard or hazardous situation seems to be involuntary, avoidable, from a man-made source, due

to negligence, arising from a poorly understood cause, or directed at a vulnerable group within society.

As one of the stakeholders, the manufacturer reduces risks and makes judgments relating to the safety

of a medical device, including the acceptability of residual risks. The manufacturer takes into account

the generally acknowledged state of the art, in order to determine the suitability of a medical device

to be placed on the market for its intended use. This document specifies a process through which the

manufacturer of a medical device can identify hazards associated with the medical device, estimate and

evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of

the controls throughout the life cycle of the medical device.

The decision to use a medical device in the context of a particular clinical procedure requires the residual

risks to be balanced against the anticipated benefits of the procedure. Such decisions are beyond the

scope of this document and take into account the intended use, the circumstances of use, the performance

and risks associated with the medical device, as well as the risks and benefits associated with the clinical

procedure. Some of these decisions can be made only by a qualified medical practitioner with knowledge

of the state of health of an individual patient or the patient’s own opinion.

For any particular medical device, other standards or regulations could require the application of

specific methods for managing risk. In those cases, it is necessary to also follow the requirements

outlined in those documents.
vi © ISO 2019 – All rights reserved
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SIST EN ISO 14971:2020
ISO 14971:2019(E)

The verbal forms used in this document conform to the usage described in Clause 7 of the ISO/

IEC Directives, Part 2:2018. For the purposes of this document, the auxiliary verb:

— “shall” means that compliance with a requirement or a test is mandatory for compliance with this

document;

— “should” means that compliance with a requirement or a test is recommended but is not mandatory

for compliance with this document;

— “may” is used to describe permission (e.g. a permissible way to achieve compliance with a

requirement or test);
— “can” is used to express possibility and capability; and

— “must” is used to express an external constraint that is not a requirement of the document.

© ISO 2019 – All rights reserved vii
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SIST EN ISO 14971:2020
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SIST EN ISO 14971:2020
INTERNATIONAL STANDARD ISO 14971:2019(E)
Medical devices — Application of risk management to
medical devices
1 Scope

This document specifies terminology, principles and a process for risk management of medical devices,

including software as a medical device and in vitro diagnostic medical devices. The process described in

this document intends to assist manufacturers of medical devices to identify the hazards associated with

the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor

the effectiveness of the controls.

The requirements of this document are applicable to all phases of the life cycle of a medical device. The

process described in this document applies to risks associated with a medical device, such as risks related

to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

The process described in this document can also be applied to products that are not necessarily medical

devices in some jurisdictions and can also be used by others involved in the medical device life cycle.

This document does not apply to:

— decisions on the use of a medical device in the context of any particular clinical procedure; or

— business risk management.

This document requires manufacturers to establish objective criteria for risk acceptability but does not

specify acceptable risk levels.

Risk management can be an integral part of a quality management system. However, this document does

not require the manufacturer to have a quality management system in place.
[9]
NOTE Guidance on the application of this document can be found in ISO/TR 24971 .
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
accompanying documentation

materials accompanying a medical device (3.10) and containing information for the user or those

accountable for the installation, use, maintenance, decommissioning and disposal of the medical device

(3.10), particularly regarding safe use

Note 1 to entry: The accompanying documentation can consist of the instructions for use, technical description,

installation manual, quick reference guide, etc.
© ISO 2019 – All rights reserved 1
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SIST EN ISO 14971:2020
ISO 14971:2019(E)

Note 2 to entry: Accompanying documentation is not necessarily a written or printed document but could involve

auditory, visual, or tactile materials and multiple media types.
3.2
benefit

positive impact or desirable outcome of the use of a medical device (3.10) on the health of an individual,

or a positive impact on patient management or public health

Note 1 to entry: Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes

related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on

public health.
3.3
harm

injury or damage to the health of people, or damage to property or the environment

[SOURCE: ISO/IEC Guide 63:2019, 3.1]
3.4
hazard
potential source of harm (3.3)
[SOURCE: ISO/IEC Guide 63:2019, 3.2]
3.5
hazardous situation

circumstance in which people, property or the environment is/are exposed to one or more hazards (3.4)

Note 1 to entry: See Annex C for an explanation of the relationship between hazard and hazardous situation.

[SOURCE: ISO/IEC Guide 63:2019, 3.3, modified — Note 1 to entry added.]
3.6
intended use
intended purpose

use for which a product, process (3.14) or service is intended according to the specifications, instructions

and information provided by the manufacturer (3.9)

Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted

with, user profile, use environment, and operating principle are typical elements of the intended use.

[SOURCE: ISO/IEC Guide 63:2019, 3.4]
3.7
in vitro diagnostic medical device
IVD medical device

device, whether used alone or in combination, intended by the manufacturer (3.9) for the in vitro

examination of specimens derived from the human body solely or principally to provide information for

diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials,

specimen receptacles, software, and related instruments or apparatus or other articles

[SOURCE: ISO 18113-1:2009, 3.27, modified — NOTE deleted.]
3.8
life cycle

series of all phases in the life of a medical device (3.10), from the initial conception to final

decommissioning and disposal
[SOURCE: ISO/IEC Guide 63:2019, 3.5]
2 © ISO 2019 – All rights reserved
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SIST EN ISO 14971:2020
ISO 14971:2019(E)
3.9
manufacturer

natural or legal person with responsibility for the design and/or manufacture of a medical device (3.10)

with the intention of making the medical device (3.10) available for use, under his name, whether or not

such a medical device (3.10) is designed and/or manufactured by that person himself or on his behalf by

another person(s)

Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all

applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to

be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory

Authority (RA) within that jurisdiction.

Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These

responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse

event reporting and notification of corrective actions.

Note 3 to entry: “Design and/or manufacture” may include specification development, production,

fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or

remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for

a medical purpose.

Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another

person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided

the assembly or adaptation does not change the intended use of the medical device.

Note 5 to entry: Any person who changes the intended use of, or modi
...

SLOVENSKI SIST EN ISO 14971
STANDARD
maj 2020
Medicinski pripomočki – Uporaba obvladovanja tveganja pri medicinskih
pripomočkih (ISO 14971:2019)
Medical devices – Application of risk management to medical devices
(ISO 14971:2019)
Medizinprodukte – Anwendung des Risikomanagements auf Medizinprodukte
(ISO 14971:2019)
Dispositifs médicaux – Application de la gestion des risques aux dispositifs
médicaux (ISO 14971:2019)
Referenčna oznaka
ICS 11.040.01 SIST EN ISO 14971:2020 (sl)
Nadaljevanje na straneh II in od 1 do 43

2021-11. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14971 : 2020
NACIONALNI UVOD

Standard SIST EN ISO 14971 (sl), Medicinski pripomočki – Uporaba obvladovanja tveganja pri

medicinskih pripomočkih (ISO 14971:2019), 2020, ima status slovenskega standarda in je istoveten

evropskemu standardu EN ISO 14971 (en, de, fr), Medical devices – Application of risk management to

medical devices (ISO 14971:2019), 2019.
Ta standard nadomešča SIST EN ISO 14971:2012.
NACIONALNI PREDGOVOR

Evropski standard EN ISO 14971:2019 je pripravil tehnični odbor Evropskega komiteja za

standardizacijo CEN/CLC/TC 3 Vodenje kakovosti in ustrezni splošni vidiki medicinskih pripomočkov

(Quality management and corresponding general aspects for medical devices). Slovenski standard

SIST EN ISO 14971:2020 je prevod evropskega standarda EN ISO 14971:2019. V primeru spora glede

besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v enem od treh

uradnih jezikov CEN. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC VAZ Varovanje

zdravja.

Odločitev za privzem tega standarda je dne 24. aprila 2020 sprejel SIST/TC VAZ Varovanje zdravja.

ZVEZA Z NACIONALNIMI STANDARDI
Ta dokument se ne sklicuje na druge standarde.
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 14971:2019
PREDHODNA IZDAJA
– standard SIST EN ISO 14971:2012
OPOMBE

– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN ISO 14971:2020

to pomeni “slovenski standard”.
– Uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO 14971:2019 in je objavljen z dovoljenjem

Upravni center
CEN-CENELEC
Rue de la Science 23
B-1040 Bruselj

This national document is identical with EN ISO 14971:2019 and is published with the permission of

CEN-CENELEC
Management Centre
Rue de la Science 23
B-1040 Brussels
---------------------- Page: 2 ----------------------
EVROPSKI STANDARD EN ISO 14971
EUROPEAN STANDARD
NORME EUROPÉENNE
december 2019
EUROPÄISCHE NORM
ICS 11.940.01 Nadomešča EN ISO 14971:2012
Slovenska izdaja
Medicinski pripomočki – Uporaba obvladovanja tveganja pri
medicinskih pripomočkih (ISO 14971:2019)

Medical devices – Application of Dispositifs médicaux – Application Medizinprodukte – Anwendung

risk management to medical de la gestion des risques aux des Risikomanagements auf

devices (ISO 14971:2019) dispositifs médicaux Medizinprodukte (ISO 14971:2019)
(ISO 14971:2019)
Ta evropski standard je CEN odobril 5. avgusta 2019.

Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi

je predpisano, da mora biti ta evropski standard brez kakršnih koli sprememb sprejet kot nacionalni

standard. Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so

na voljo pri Upravnem centru CEN-CENELEC ali članih CEN in CENELEC.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih

jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri

Upravnem centru CEN-CENELEC, veljajo kot uradne izdaje.

Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški odbori

Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije,

Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije,

Nizozemske, Norveške, Poljske, Portugalske, Republike Severna Makedonija, Romunije,

Slovaške, Slovenije, Srbije, Španije, Švedske, Švice, Turčije in Združenega kraljestva.

CEN-CENELEC
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
Upravni center CEN-CENELEC
Rue de la Science 23, B-1040 Bruselj

© 2019 CEN/CENELEC Lastnice avtorskih pravic so vse države članice CEN in Ref. št. EN ISO 14971:2019 E

CENELEC.
---------------------- Page: 3 ----------------------
SIST EN ISO 14971 : 2020
VSEBINA Stran

Evropski predgovor ................................................................................................................................... 3

Predgovor ................................................................................................................................................ 4

Uvod ........................................................................................................................................................ 6

1 Področje uporabe ................................................................................................................................ 8

2 Zveze s standardi ................................................................................................................................ 8

3 Izrazi in definicije ................................................................................................................................. 8

4 Splošne zahteve za sistem obvladovanja tveganja ........................................................................... 14

4.1 Proces obvladovanja tveganja ....................................................................................................... 14

4.2 Odgovornost vodstva ...................................................................................................................... 15

4.3 Kompetentnost osebja .................................................................................................................... 16

4.4 Načrt obvladovanja tveganja .......................................................................................................... 16

4.5 Dokumentacija o obvladovanju tveganja ........................................................................................ 17

5 Analiza tveganja ................................................................................................................................ 17

5.1 Proces analize tveganja ................................................................................................................. 17

5.2 Predvidena uporaba in razumno predvidljiva napačna uporaba .................................................... 18

5.3 Identifikacija karakteristik v zvezi z varnostjo ................................................................................. 18

5.4 Identifikacija nevarnosti in nevarnih stanj ........................................................................................ 18

5.5 Ocena tveganja .............................................................................................................................. 19

6 Vrednotenje tveganja ......................................................................................................................... 19

7 Nadzor tveganja ................................................................................................................................ 19

7.1 Analiza možnosti nadzora tveganja ................................................................................................ 19

7.2 Izvajanje ukrepov nadzora tveganja ............................................................................................... 20

7.3 Vrednotenje preostalega tveganja .................................................................................................. 21

7.4 Analiza razmerja med koristmi in tveganji ...................................................................................... 21

7.5 Tveganja, ki izhajajo iz ukrepov nadzora tveganja ......................................................................... 21

7.6 Popolnost nadzora tveganja ........................................................................................................... 21

8 Vrednotenje celotnega preostalega tveganja .................................................................................... 21

9 Pregled obvladovanja tveganja ......................................................................................................... 22

10 Aktivnosti med proizvodnjo in po proizvodnji .................................................................................. 22

10.1 Splošno ......................................................................................................................................... 22

10.2 Zbiranje informacij ........................................................................................................................ 22

10.3 Pregled informacij ......................................................................................................................... 23

10.4 Ukrepi ........................................................................................................................................... 23

Dodatek A (informativni): Utemeljitev zahtev ........................................................................................ 24

Dodatek B (informativni): Proces obvladovanja tveganja za medicinske pripomočke .......................... 33

Dodatek C (informativni): Temeljni pojmi tveganja ................................................................................ 37

Literatura ................................................................................................................................................ 43

---------------------- Page: 4 ----------------------
SIST EN ISO 14971 : 2020
Evropski predgovor

Ta dokument (EN ISO 14971:2019) je pripravil tehnični odbor ISO/TC 210 "Vodenje kakovosti in ustrezni

splošni vidiki za medicinske pripomočke" v sodelovanju s tehničnim odborom CEN/CLC/TC 3 "Vodenje

kakovosti in ustrezni splošni vidiki za medicinske pripomočke", katerega sekretariat vodi NEN.

Ta evropski standard mora dobiti status nacionalnega standarda bodisi z objavo istovetnega besedila

ali z razglasitvijo najpozneje do junija 2020, nacionalne standarde, ki so v nasprotju s tem standardom,

pa je treba razveljaviti najpozneje do junija 2020.

Opozoriti je treba na možnost, da so nekateri elementi tega dokumenta lahko predmet patentnih pravic.

CEN ne prevzema odgovornosti za identifikacijo posameznih ali vseh takih patentnih pravic.

Ta dokument nadomešča EN ISO 14971:2012.

V skladu z notranjimi predpisi CEN-CENELEC morajo ta evropski standard obvezno uvesti nacionalne

organizacije za standardizacijo naslednjih držav: Avstrije, Belgije, Bolgarije, Cipra, Češke republike,

Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,

Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Republike Severna

Makedonija, Romunije, Srbije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega

kraljestva.
Razglasitvena objava

Besedilo standarda ISO 14971:2019 je CEN odobril kot EN ISO 14971:2019 brez kakršnihkoli

sprememb.
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SIST EN ISO 14971 : 2020
Predgovor

ISO (Mednarodna organizacija za standardizacijo) je svetovna zveza nacionalnih organov za standarde

(članov ISO). Mednarodne standarde navadno pripravljajo tehnični odbori ISO. Vsak član, ki želi delovati

na določenem področju, za katero je bil ustanovljen tehnični odbor, ima pravico biti zastopan v tem

odboru. Pri delu sodelujejo tudi mednarodne vladne in nevladne organizacije, povezane z ISO. V vseh

zadevah, ki so povezane s standardizacijo na področju elektrotehnike, ISO tesno sodeluje z

Mednarodno elektrotehniško komisijo (IEC).

Postopki, uporabljeni pri pripravi tega dokumenta, in predvideni postopki za njegovo vzdrževanje so

opisani v Direktivah ISO/IEC, 1. del. Posebna pozornost naj se nameni različnim kriterijem odobritve,

potrebnim za različne vrste dokumentov ISO. Ta dokument je bil pripravljen v skladu z uredniškimi pravili

Direktiv ISO/IEC, 2. del (glej www.iso.org/directives).

Opozoriti je treba, da so nekateri elementi tega dokumenta lahko predmet patentnih pravic. ISO ne

prevzema odgovornosti za identifikacijo posameznih ali vseh takih patentnih pravic. Podrobnosti o

morebitnih patentnih pravicah, opredeljenih med pripravo tega dokumenta, bodo navedene v uvodu

in/ali na seznamu ISO s prejetimi patentnimi izjavami (glej www.iso.org/patents).

Morebitna trgovska imena, uporabljena v tem dokumentu, so informacije za uporabnike in ne pomenijo

podpore blagovni znamki.

Za razlago prostovoljne narave standardov, pomena specifičnih pojmov in izrazov ISO, povezanih z

ugotavljanjem skladnosti, ter informacij o tem, kako ISO spoštuje načela Svetovne trgovinske

organizacije (WTO) v tehničnih ovirah pri trgovanju (TBT), glej spletno mesto
www.iso.org/iso/foreword.html.

Ta dokument sta pripravila tehnični odbor ISO/TC 210, Vodenje kakovosti in ustrezni splošni vidiki za

medicinske pripomočke, in IEC/SC 62A, Skupni vidiki električne opreme, ki se uporablja v medicinski

praksi.

Ta tretja izdaja razveljavlja in nadomešča drugo izdajo (ISO 14971:2007), ki je strokovno revidirana.

Glavne spremembe glede na predhodno različico so naslednje:

‒ vključena je točka glede zvez s standardi za upoštevanje zahtev, določenih v 15. točki 2. dela

Direktiv ISO/IEC:2018;

‒ definirani izrazi so posodobljeni in številni izhajajo iz ISO/IEC Vodila 63:2019. Definirani izrazi so

natisnjeni v ležeči pisavi za pomoč bralcem pri prepoznavanju izrazov v glavnem delu besedila;

‒ vključene so definicije za korist, razumno predvidljivo napačno uporabo in stanje tehnike;

‒ več pozornosti je namenjeno koristim, ki se pričakujejo od uporabe medicinskega pripomočka. Izraz

analize razmerja med koristmi in tveganji je usklajen s terminologijo, ki se uporablja v nekaterih

predpisih;

‒ pojasnjeno je, da se lahko proces, opisan v standardu ISO 14971, uporablja za obvladovanje

tveganja, povezanega z medicinskimi pripomočki, vključno s tistimi, ki so povezani z varnostjo

podatkov in sistemov;

‒ metodo za vrednotenje celotnega preostalega tveganja in kriterije za njegovo sprejemljivost je treba

določiti v načrtu obvladovanja tveganja. Ta metoda lahko vključuje zbiranje in pregledovanje

podatkov oziroma literature za medicinske pripomočke in podobne medicinske pripomočke ter

podobne druge izdelke na trgu. Kriteriji za sprejemljivost celotnega preostalega tveganja se lahko

razlikujejo od kriterijev za sprejemljivost posameznih tveganj;

‒ zahteve za razkrivanje preostalih tveganj so premaknjene in združene v eno zahtevo, po tem ko je

bilo celotno preostalo tveganje ovrednoteno in ocenjeno kot sprejemljivo;

‒ pregled pred dajanjem medicinskega pripomočka v promet je povezan z izvedbo načrta

obvladovanja tveganja. Rezultati tega pregleda so navedeni v poročilu o obvladovanju tveganja;

---------------------- Page: 6 ----------------------
SIST EN ISO 14971 : 2020

‒ zahteve za aktivnosti med proizvodnjo in po proizvodnji so bile pojasnjene in prestrukturirane. Več

podrobnosti je podanih za informacije, ki jih je treba zbrati, in za ukrepe, ki jih je treba izvesti, ko so

zbrane informacije pregledane in opredeljene kot pomembne za varnost;

‒ več informativnih dodatkov je premaknjenih v napotke tehničnega poročila ISO/TR 24971, ki je bilo

vzporedno pregledano. Več informacij in utemeljitev zahtev v tej tretji izdaji standarda ISO 14971

je navedenih v dodatku A. Primerjava med točkami druge izdaje in te tretje izdaje je podana v

dodatku B.

Uporabnik naj vse povratne informacije ali vprašanja o tem dokumentu posreduje nacionalnemu organu

za standarde v svoji državi. Celoten seznam teh organov je na voljo na spletnem mestu

www.iso.org/members.html.
---------------------- Page: 7 ----------------------
SIST EN ISO 14971 : 2020
Uvod

Zahteve, ki jih vsebuje ta dokument, proizvajalcem zagotavljajo okvir, znotraj katerega so sistematično

uporabljene izkušnje, vpogled in presoja za obvladovanje tveganj, povezanih z uporabo medicinskih

pripomočkov.

Ta dokument je bil pripravljen posebej za proizvajalce medicinskih pripomočkov na podlagi uveljavljenih

načel obvladovanja tveganja, ki so se razvijala več let. Ta dokument se lahko uporablja kot napotek pri

razvijanju in vzdrževanju procesa obvladovanja tveganja za druge izdelke, ki v nekaterih zakonodajah

niso nujno medicinski pripomočki, ter za dobavitelje in druge stranke, ki so vključeni v življenjski cikel

medicinskega pripomočka.

Ta dokument obravnava procese za obvladovanje tveganj, povezanih z medicinskimi pripomočki.

Tveganja so lahko povezana s poškodbo, ne le pacienta, ampak tudi uporabnika in drugih oseb.

Tveganja so lahko povezana s poškodovanjem lastnine (na primer predmetov, podatkov, druge opreme)

ali okolja.

Obvladovanje tveganja je kompleksna zadeva, saj lahko vsak udeleženec pripisuje drugačno vrednost

sprejemljivosti tveganj glede na predvidene koristi. Pojmi obvladovanja tveganja so še posebno

pomembni v zvezi z medicinskimi pripomočki zaradi različnih udeležencev, vključno z zdravniki,

zdravstvenimi organizacijami, vladami, industrijo, pacienti in posamezniki.
Splošno sprejeto je, da ima pojem tveganje dva ključna sestavna dela:
‒ verjetnost nastanka škode in
‒ posledice te škode, tj. kako resna bi lahko bila.

Vsi udeleženci morajo razumeti, da uporaba medicinskega pripomočka vključuje določeno stopnjo

tveganja, tudi če so bila tveganja zmanjšana na sprejemljivo raven. Dobro znano je, da v okviru

kliničnega postopka ostanejo nekatera preostala tveganja. Na sprejemljivost tveganja s strani

udeleženca vplivata zgoraj navedena ključna sestavna dela ter udeleženčevo dojemanje tveganja in

koristi. Dojemanje posameznega udeleženca se lahko zelo razlikuje, odvisno od njegovega kulturnega

ozadja, družbeno-ekonomskih razmer in izobrazbe zadevne družbe ter dejanskega in zaznanega

zdravstvenega stanja pacienta. V načinu dojemanja tveganja se upoštevajo tudi drugi dejavniki, na

primer, ali je videti, kot da je izpostavljenost nevarnosti ali nevarnemu stanju neprostovoljna, ali se ji je

mogoče izogniti, ali jo povzroča človek, ali jo povzroča malomarnost, ki izvira iz slabo razumljivega

vzroka, ali je usmerjena v ranljivo skupino znotraj družbe.

Proizvajalec, kot eden od udeležencev, zmanjša tveganja in sprejema odločitve v zvezi z varnostjo

medicinskega pripomočka, vključno s sprejemljivostjo preostalih tveganj. Proizvajalec upošteva splošno

sprejeto stanje tehnike, da ugotovi primernost medicinskega pripomočka za dajanje na trg za predvideno

uporabo. Ta dokument določa postopek, s katerim lahko proizvajalec medicinskega pripomočka

identificira nevarnosti, povezane z medicinskim pripomočkom, oceni in ovrednoti tveganja, povezana s

temi nevarnostmi, nadzoruje ta tveganja in spremlja uspešnost tega nadzorovanja v življenjskem ciklu

medicinskega pripomočka.

Za odločitev, da se nek medicinski pripomoček uporabi v določenem kliničnem postopku, morajo biti

preostala tveganja uravnotežena s pričakovanimi koristmi tega postopka. Takšne odločitve niso

obravnavane v tem dokumentu in upoštevajo predvideno uporabo, okoliščine uporabe, izvedbo in

tveganja, ki so povezana z medicinskim pripomočkom, kot tudi tveganja in koristi, povezana s kliničnim

postopkom. Nekatere od teh odločitev lahko sprejme samo usposobljen zdravnik, ki je seznanjen z

zdravstvenim stanjem posameznega pacienta oziroma z mnenjem samega pacienta.

Za kateri koli poseben medicinski pripomoček lahko drugi standardi ali predpisi zahtevajo uporabo

specifičnih metod obvladovanja tveganja. V takih primerih je treba upoštevati zahteve, navedene v teh

dokumentih.
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SIST EN ISO 14971 : 2020

Glagolske oblike, uporabljene v tem dokumentu, so skladne z uporabo, opisano v 7. točki Direktiv

ISO/IEC, 2. del: 2018. V tem dokumentu pomožni glagol:

‒ "je treba" pomeni, da je upoštevanje zahteve ali preskusa obvezno v skladu s tem dokumentom;

‒ "naj" pomeni, da je upoštevanje zahteve ali preskusa priporočeno, vendar ni obvezno v skladu s

tem dokumentom;

‒ "lahko" se uporablja za opis dovoljenja (npr. dovoljeni način za doseganje skladnosti z zahtevo ali

preskusom);
‒ "je mogoče" se uporablja za izražanje možnosti in sposobnosti ter

‒ "morati" se uporablja za izražanje zunanje omejitve, ki ni zahteva tega dokumenta.

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SIST EN ISO 14971 : 2020
Medicinski pripomočki – Uporaba obvladovanja tveganja pri
medicinskih pripomočkih
1 Področje uporabe

Ta dokument določa terminologijo, načela in proces za obvladovanje tveganja medicinskih

pripomočkov, vključno s programsko opremo kot medicinskim pripomočkom ter in vitro diagnostičnimi

medicinskimi pripomočki. Postopek, opisan v tem dokumentu, je namenjen podpori proizvajalcem

medicinskih pripomočkov pri identificiranju nevarnosti, povezanih z medicinskim pripomočkom, pri

ocenjevanju in vrednotenju s tem povezanih tveganj, pri nadzorovanju teh tveganj in spremljanju

uspešnosti ukrepov nadzora.

Zahteve tega dokumenta veljajo za vse faze življenjskega cikla medicinskega pripomočka. Postopek,

opisan v tem dokumentu, se uporablja za tveganja, povezana z medicinskimi pripomočki, kot so

tveganja v zvezi z biološko združljivostjo, varnostjo podatkov in sistemov, elektriko, premikajočimi se

deli, sevanjem in uporabljivostjo.

Postopek, opisan v tem dokumentu, je mogoče uporabiti tudi za izdelke, ki niso nujno medicinski

pripomočki v nekaterih zakonodajah in ki jih mogoče uporabljajo tudi drugi, vključeni v življenjski cikel

medicinskega pripomočka.
Ta dokument se ne uporablja za:

‒ odločitve glede uporabe medicinskega pripomočka v okviru določenega kliničnega postopka ali

‒ poslovno obvladovanje tveganja.

Ta dokument od proizvajalcev zahteva, da vzpostavijo objektivne kriterije za sprejemljivost tveganja,

vendar ne določa sprejemljivih stopenj tveganja.

Obvladovanje tveganja je lahko sestavni del sistema vodenja kakovosti. Vendar ta dokument od

proizvajalca ne zahteva, da ima uveden sistem vodenja kakovosti.
[9].
OPOMBA: Navodila za uporabo tega dokumenta je mogoče najti v ISO/TR 24971
2 Zveze s standardi
Ta dokument se ne sklicuje na druge standarde.
3 Izrazi in definicije
V tem dokumentu se uporabljajo naslednji izrazi in definicije.

ISO in IEC hranita terminološke zbirke podatkov za uporabo pri standardizaciji na naslednjih naslovih:

‒ brskanje po spletni strani ISO: na voljo na spletnem mestu https://www.iso.org/obp

‒ IEC Electropedia: na voljo na spletnem mestu http://www.electropedia.org/
3.1
spremna dokumentacija

materiali, ki spremljajo medicinski pripomoček (3.10) in vsebujejo informacije za uporabnika ali tiste, ki

so odgovorni za namestitev, uporabo, vzdrževanje, izločitev iz uporabe in odstranitev medicinskega

pripomočka (3.10), zlasti glede varne uporabe

Opomba 1: Spremno dokumentacijo lahko sestavljajo navodila za uporabo, tehnični opis, navodila za namestitev, hitri

referenčni vodnik itd.
---------------------- Page: 10 ----------------------
SIST EN ISO 14971 : 2020

Opomba 2: Spremna dokumentacija ni nujno pisni ali natisnjeni dokument, ampak lahko vključuje zvočne, vizualne ali taktilne

materiale in materiale večpredstavnostnih vrst.
3.2
korist

pozitiven vpliv ali želeni rezultat uporabe medicinskega pripomočka (3.10) za zdravje posameznika ali

pozitiven vpliv na obravnavo pacienta ali javno zdravje

Opomba 1: Koristi lahko vključujejo pozitivne vplive na klinične rezultate, pacientovo kakovost življenja, rezultate, povezane

z diagnozo, pozitiven vpliv diagnostičnih naprav na klinične rezultate ali pozitiven vpliv na javno zdravje.

3.3
škoda
poškodba ali ogrozitev zdravja ljudi ali poškodovanje lastnine ali okolja
[VIR: ISO/IEC Vodilo 63:2019, 3.1]
3.4
nevarnost
možen izvor škode (3.3)
[VIR: ISO/IEC Vodilo 63:2019, 3.2]
3.5
nevarno stanje

okoliščine, v katerih so ljudje, lastnina ali okolje izpostavljeni eni ali več nevarnostim (3.4)

Opomba 1: Za razlago povezave med nevarnostjo in nevarnim stanjem glej dodatek C.

[VIR: ISO/IEC Vodilo 63:2019, 3.3, spremenjeno – Dodana je opomba 1.]
3.6
predvidena uporaba
predviden namen

uporaba, za katero so izdelek, proces (3.14) ali storitev predvideni, v skladu s specifikacijami, navodili

in informacijami, ki jih zagotovi proizvajalec (3.9)

Opomba 1: Tipični elementi predvidene uporabe so predvidena medicinska indikacija, populacija pacientov, del telesa ali

vrsta tkiva, na katerega vplivajo, profil uporabnika, okolje uporabe in načelo delovanja.

[VIR: ISO/IEC Vodilo 63:2019, 3.4]
3.7
in vitro diagnostični medicinski pripomoček
medicinski pripomoček IVD

pripomoček, ki ga je proizvajalec (3.9) predvidel za uporabo samostojno ali v kombinaciji za preiskave

vzorcev in vitro iz človeškega telesa izključno ali zlasti za pridobivanje podatkov za namene diagnostike,

spremljanja ali združljivosti, vključno z reagenti, kalibratorji, kontrolnimi materiali, vsebniki za vzorce,

programsko opremo in s tem povezanimi instrumenti ali aparaturami ali drugimi predmeti

[VIR: ISO 18113-1:2009, 3.27, spremenjen – OPOMBA je izbrisana.]
3.8
življenjski cikel

vse faze v življenjski dobi medicinskega pripomočka (3.10), od začetne zasnove do končne izločitve iz

uporabe in odstranitve
[VIR: ISO/IEC Vodilo 63:2019, 3.5]
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SIST EN ISO 14971 : 2020
3.9
proizvajalec

fizična ali pravna oseba, ki je odgovorna za zasnovo in/ali proizvodnjo medicinskega pripomočka (3.10)

z namenom, da je medicinski pripomoček (3.10) na voljo za uporabo pod njenim imenom, ne glede na

to, ali je takšen medicinski pripomoček (3.10) zasnovala in/ali proizvedla ta oseba sama ali druge osebe

v njenem imenu

Opomba 1: Fizična ali pravna oseba je pravno odgovorna za zagotavljanje skladnosti z vsemi veljavnimi zakonodajnimi

zahtevami za medicinski pripomoček v državah ali zakonodajah, kjer je pripomoček na voljo ali se prodaja, razen

če to odgovornost zakonodajni organ v zakonodaji prenese na drugo osebo.

Opomba 2: Odgovornosti proizvajalca so opisane v drugih navodilih GHTF. Te odgovornosti vključujejo izpolnjevanje zahtev

pred in po dajanju na trg, kot sta poročanje o stranskih učinkih in obvestilo o korektivnih ukrepih.

Opomba 3: "Zasnova in/ali proizvodnja" lahko vključuje razvoj specifikacij, proizvodnjo, izdelavo, sestavo, obdelavo,

pakiranje, prepakiranje, označevanje, ponovno označevanje, sterilizacijo, namestitev ali ponovno izdelavo

medicinskega pripomočka ali združevanje več pripomočkov in po možnosti drugih izdelkov za medicinske

namene.

Opomba 4: Vsaka oseba, ki v skladu z navodili za uporabo sestavi ali prilagodi medicinski pripomoček, ki ga je dobavila druga

oseba za posameznega pacienta, ni proizvajalec, če sestava ali prilagoditev ne spremeni predvidene uporabe

medicinskega pripomočka.

Opomba 5: Vsaka oseba, ki spremeni njegovo predvideno uporabo ali spremeni medicinski pripomoček in ne deluje v imenu

prvotnega proizvajalca ter da ta pripomoček na voljo za uporabo pod lastnim imenom, naj se šteje za proizvajalca

spremenjenega medicinskega pripomočka.

Opomba 6: Pooblaščeni predstavnik, distributer ali uvoznik, ki zgolj doda svoj naslov in kontaktne podatke na medicinski

pripomoček ali embalažo, pri tem pa ne prekrije ali spremeni obstoječih označb, se ne šteje za proizvajalca.

Opomba 7: V obsegu, v katerem za dodatno opremo veljajo zakonodajne zahteve za medicinski pripomoček, se oseba,

odgovorna za zasnovo in/ali proizvodnjo te dodatne opreme, šteje za proizvajalca.

[VIR: ISO/IEC Vodilo 63:2019, 3.6]
3.10
medicinski pripomoček

instrument, aparatura, orodje, stroj, naprava, vsadek, reagent za uporabo in vitro, programska oprema,

material ali drug oziroma podoben predmet, ki ga je proizvajalec (3.9) predvidel za uporabo, samostojno

ali v kombinaciji, pri ljudeh za enega ali več določenih zdravstvenih namenov:

‒ diagnosticiranje, preprečevanje, spremljanje, zdravljenje ali lajšanje bolezni;

‒ diagnosticiranje, spremljanje, zdravljenje ali lajšanje poškodb;

‒ preiskovanje, nadomeščanje, spreminjanje ali podpora anatomskih funkcij ali fizioloških procesov;

‒ podpora ali ohranjanje življenja;
‒ nadzor spočetja;
‒ razkuževanje medicinskih pripomočkov (3.10);
‒ zagotavljanje informacij s preiskavo vzorcev in vitro iz človeškega telesa

in ki svojega glavnega predvidenega učinka na človeško telo ne dosega na farmakološki, imunološki

ali metabolični način, vendar pa so mu lahko ti procesi pri njegovem delovanju v pomoč.

Opomba 1: Izdelki, ki se lahko v nekaterih zakonodajah štejejo za medicinske pripomočke, v drugih pa ne, vključujejo:

‒ snovi za dezinfekcijo,
‒ pripomočke za invalidne osebe,
‒ pripomočke s tkivi živalskega in/ali človeškega izvora,
‒ p
...