EN ISO 14971:2000/A1:2003
(Amendment)Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)
Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)
65.62 is synchronized with the special DOW of EN ISO 14971:2000 = 2004-03-31.
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte - Änderung 1: Begründung der Anforderungen (ISO 14971:2000/Amd.1:2003)
Wie bereits in der Einleitung erläutert, ist eine Norm zum Risikomanagement erforderlich, die auf sämtliche Medizinprodukte anzuwenden ist. Risiken treten während des gesamten Lebenszyklus eines Produktes auf, und Risiken, die an einem bestimmten Punkt des Lebenszyklus offensichtlich werden, dürfen gegebenenfalls durch eine Maßnahme zu einem ganz anderen Zeitpunkt während des Lebenszyklus behandelt werden. Aus diesem Grunde ist diese Internationale Norm dazu vorgesehen, für den gesamten Lebenszyklus zu gelten. Das bedeutet, dass die Norm Anweisungen für die Hersteller enthält, die Prinzipien des Risikomanagements auf ein Medizinprodukt von dessen anfänglicher Konzipierung bis zur letztendlichen Entnahme aus dem Verkehr und Entsorgung anzuwenden.
Diese Internationale Norm ist nicht dazu bestimmt, auf die klinische Entscheidungsfindung angewendet zu werden. Die Entscheidung über die Einleitung eines klinischen Verfahrens unter Verwendung eines Medizinproduktes macht es erforderlich, die Restrisiken gegen den zu erwartenden Nutzen des Verfahrens abzuwägen. Bei derartigen Beurteilungen sollten der bestimmungsgemäße Gebrauch/die Zweckbestimmung, die Leistung und die mit dem Medizinprodukt verbundenen Risiken sowie die mit dem klinischen Verfahren oder den Anwendungsbedingungen verbundenen Risiken und der entsprechende Nutzen berücksichtigt werden. Einige dieser Beurteilungen dürfen nur von einem qualifizierten medizinischen Praktiker vorgenommen werden, der den Gesundheitszustand des einzelnen Patienten und die eigene Meinung des Patienten kennt.
Obgleich es erhebliche Diskussionen darüber gegeben hat, bis zu welchem Wert ein Risiko noch als vertretbar gilt, legt diese Internationale Norm keine Werte für die Vertretbarkeit von Risiken fest. Die Festlegung eines einzigen Wertes für die Vertretbarkeit eines Risikos wäre nicht angemessen, weil
die große Vielzahl der von dieser Norm betroffenen Produkten und Situationen einen einzigen Wert bedeutungslos machen würde, un
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux - Amendement 1: Justification des exigences (ISO 14971:2000/AM1:2003)
Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih – Dopolnilo 1: Osnovna načela za zahteve (ISO 14971:2000/AM1:2003)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14971:2001/A1:2003
01-september-2003
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
SULSRPRþNLK±'RSROQLOR 2VQRYQDQDþHOD]D]DKWHYH ,62 $0
Medical devices - Application of risk management to medical devices - Amendment 1:
Rationale for requirements (ISO 14971:2000/AM1:2003)
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte - Änderung
1: Begründung der Anforderungen (ISO 14971:2000/Amd.1:2003)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux -
Amendement 1: Justification des exigences (ISO 14971:2000/AM1:2003)
Ta slovenski standard je istoveten z: EN ISO 14971:2000/A1:2003
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14971:2001/A1:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14971:2001/A1:2003
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SIST EN ISO 14971:2001/A1:2003
EUROPEAN STANDARD
EN ISO 14971:2000/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2003
ICS 11.040.01
English version
Medical devices - Application of risk management to medical
devices - Amendment 1: Rationale for requirements (ISO
14971:2000/AM1:2003)
Dispositifs médicaux - Application de la gestion des risques Medizinprodukte - Anwendung des Risikomanagements
aux dispositifs médicaux - Amendement 1: Justification des auf Medizinprodukte - Änderung 1: Begründung der
exigences (ISO 14971:2000/AM1:2003) Anforderungen (ISO 14971:2000/AM1:2003)
This amendment A1 modifies the European Standard EN ISO 14971:2000; it was approved by CEN on 28 February 2003 and by
CENELEC on 18 March 2003.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN or CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CEN or CENELEC member into its own language and notified to the CEN Management Centre has the same status as
the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria,
Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,
Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:
rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Brussels
© 2003 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14971:2000/A1:2003 E
worldwide for CEN national Members and for CENELEC
Members.
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SIST EN ISO 14971:2001/A1:2003
EN ISO 14971:2000/A1:2003 (E)
CORRECTED 2003-07-23
Foreword
This document (EN ISO 14971:2000/A1:2003) has been prepared by Technical Committee
ISO/TC 210 "Quality management and corresponding general aspects for medical devices" in
collaboration with CMC and CENELEC.
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 2003, and conflicting national
standards shall be withdrawn at the latest by September 2003.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 14971:2000/A1:2003 has been approved by CEN and CENELEC as
EN ISO 14971:2000/A1:2003 without any modifications.
2
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SIST EN ISO 14971:2001/A1:2003
INTERNATIONAL ISO
STANDARD 14971
First edition
2000-12-15
AMENDMENT 1
2003-03-01
Medical devices — Application of risk
management to medical devices
AMENDMENT 1: Rationale for requirements
Dispositifs médicaux — Application de la gestion des risques aux
dispositifs médicaux
AMENDEMENT 1: Justification des exigences
Reference number
ISO 14971:2000/Amd.1:2003(E)
©
ISO 2003
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SIST EN ISO 14971:2001/A1:2003
ISO 14971:2000/Amd.1:2003(E)
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ii © ISO 2003 — All rights reserved
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SIST EN ISO 14971:2001/A1:2003
ISO 14971:2000/Amd.1:2003(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
Amendment 1 to ISO 14971:2000 was prepared by Technical Committee ISO/TC 210, Quality management
and corresponding general aspects for medical devices, and Subcommittee IEC/SC 62A, Common aspects of
electrical equipment used in medical practice.
At the time of publication of ISO 14971:2000, it was anticipated that maintenance of the standard would be
required within a few years. IEC/SC 62A has already anticipated that a revision may be needed in about 2005.
In anticipation of the maintenance process, ISO/TC 210-IEC/SC 62A Joint Working Group 1, Application of
risk management to medical devices, developed this Amendment to document its reasoning for establishing
the various requirements contained in ISO 14971. Those who make future revisions to the standard can use
this Amendment, along with experience gained in the use of the standard, to make the standard more useful
to manufacturers, regulatory bodies, and health care providers.
The material in this Amendment is purely informative. It does not alter in any way the requirements of
ISO 14971 or modify any of the other informative material.
© ISO 2003 — All rights reserved iii
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SIST EN ISO 14971:2001/A1:2003
ISO 14971:2000/Amd.1:2003(E)
Introduction
A standard for the application of risk management to medical devices became important largely because of
the increasing recognition by regulators that the manufacturer should apply risk management to medical
devices. No medical device risk management standard existed, and ISO 14971 was written to fill that gap.
ISO/TC 210 Working Group 4 was formed to develop the new standard. Almost simultaneously, drafters of the
third edition of IEC 60601-1 planned to have risk management included in the standard then under
development. They saw the need for a separate risk management activity and formed Working Group 15 of
IEC/SC 62A. Recognizing that the efforts of these two working groups overlapped, IEC and ISO formed the
Joint Working Group 1 (JWG 1) on Risk Management combining the membership of both working groups.
This collaboration resulted in the publication of ISO 14971 with both an ISO and an IEC logo. The dual logo
signifies that both ISO and IEC recognize ISO 14971 as the International Standard covering the application of
risk management to medical devices.
When JWG 1 started its discussions on the international risk management standard, there was no satisfactory
standard in place to address risk management for medical devices. Crucial features of risk management
needed to be addressed such as the process of risk evaluation, as well as the balancing of risks and benefits
for medical devices. Manufacturers, regulatory bodies, and health care providers had recognized that
“absolute safety” in medical devices was not achievable. In addition, the risks that derive from the increasing
diversity of medical devices and their applications cannot be completely addressed through product safety
standards. The recognition of these facts and the consequent need to manage risks from medical devices
throughout their life cycle led to the decision to develop ISO 14971.
The JWG 1’s original plan was to write ISO 14971 in several parts, each dealing with a specific aspect of risk
management. ISO 14971-1:1998, covering risk analysis, was intended as the first part of an overall risk
management standard. Later, the JWG 1 decided that it was better to develop a single document that would
include all aspects of risk management. The main reason for this was that it was apparent that risk
management would be mandated by several regulatory regimes in the world, including Europe. It was
therefore no longer useful or necessary to have a separate standard on risk analysis available. Also, making
one risk management standard instead of having several parts would much better show the coherence
between the several aspects of risk management.
In this Amendment, the numbering parallels the numbering of the clauses and subclauses of ISO 14971:2000.
iv © ISO 2003 — All rights reserved
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SIST EN ISO 14971:2001/A1:2003
ISO 14971:2000/Amd.1:2003(E)
Medical devices — Application of risk management to medical
devices
AMENDMENT 1: Rationale for requirements
Page 31
Add the following annex before the Bibliography.
Annex H
(informative)
Rationale for requirements
H.1 Rationale for Clause 1, Scope
As explained in the Introduction, a risk management standard applying to all medical devices is required.
Risks exist throughout the product life cycle, and risks that become apparent at one point in the life cycle may
be managed by action taken at a completely different point in the life cycle. For this reason, this International
Standard is intended to be a complete life cycle standard. This means that it instructs manufacturers to apply
risk management principles to a medical device from its initial conception until its ultimate decommissioning
and disposal.
This International Standard is not intended to be applicable to clinical decision making. The decision to
embark upon a clinical procedure utilizing a medical device requires the residual risks to be balanced against
the anticipated benefits of the procedure. Such judgements should take into account the intended
use/intended purpose, performance, and risks associated with the medical device as well as the risks and
benefits associated with the clinical procedure or the circumstances of use. Some of these judgements may
be made only by a qualified health care professional with knowledge of the state of health of an individual
patient and the patient's own opinion.
Although there has been significant debate over what constitutes an acceptable level of risk, this International
Standard does not specify acceptability levels. Specifying a single level for acceptable risk would be
inappropriate because
the wide variety of devices and situations covered by this International Standard would make a single
level meaningless, and
local laws, customs, and values are more appropriate for defining risk acceptability for a particular culture
or region of the world.
Because not all countries require a quality system for medical device manufacturers, a quality system is not
required in this International Standard. However, a quality system is extremely helpful in managing risks
properly. Because of this and because most medical device manufacturers do employ a quality system, this
International Standard is constructed so that it can easily be incorporated into the quality system that they use.
The relationship with ISO 13485:1996 is shown in Table G.2 in Annex G.
© ISO 2003 — All rights reserved 1
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SIST EN ISO 14971:2001/A1:2003
ISO 14971:2000/Amd.1:2003(E)
H.2 Rationale for Clause 2, Terms and definitions
It was not intended to invent a host of new and possibly unfamiliar terms and so this International Standard is
intentionally built upon the wealth of risk management information both in standards and in the literature.
Existing definitions were used wherever possible. The primary sources for the definitions were ISO/IEC
1)
Guide 51:1999 and ISO 8402:1994 .
It was known that risk management would be made mandatory, either explicitly or implicitly, by the European
Union (EU), the United States, and other countries and regions of the world. Therefore definitions were used
that would be widely acceptable in a regulatory sense. For example, the term “manufacturer” (2.6) while based
on the medical device directive in the EU, is consistent with the definition used in the United States. The term
“medical device” (2.7) was taken from ISO 13485 where a similar consideration for local regulations had also
been applied. The combined term “intended use/intended purpose” (2.5) was used because there was no
consensus on which term to use. The Medical Device Directive uses “intended purpose,” whereas the United
States regulations use “intended use.” Both terms have essentially the same definition. It was decided to use
the combined term along with a definition that is similar to that used in both the EU and the United States.
Only three terms in this International Standard are not based on definitions in other standards. These are “risk
control” (2.16), “risk management” (2.18), and “risk management file” (2.19). The definition for “risk control”
was provided to be consistent with the definitions of “risk analysis” and “risk evaluation” given by
ISO/IEC Guide 51. The definition for “risk management” emphasizes the use of a systematic approach and
the need for management overview. The concept of a “risk management file” was originally expressed in
IEC 60601-1-4, but the definition was changed because the definition in IEC 60601-1-4 refers to quality
records, which need not exist for compliance with ISO 14971.
H.3 Rationale for Clause 3, General requirements for risk management
Although risk management activities are highly individual to the device being evaluated, there are basic
elements that need to be included in the risk management process. This clause satisfies that need. This
clause also allows for some differences in the requirements for meeting this standard, based on local
differences in regulatory approaches.
H.3.1 National or regional regulatory requirements
Worldwide applicability of this International Standard is important despite differing regional regulatory
requirements. This subclause was needed so that both Europe and the United States (as well as other
countries and regions) could use this International Standard in their regulatory programmes. In Europe,
manufacturers do not need to have a certified quality system in place to meet the essential requirements
necessary for applying a CE mark to their product. In the United States, a quality system is always required to
market a device (unless the device is specifically exempted). Subclauses 3.3 and 3.4 closely follow quality
system requirements. This subclause enables manufacturers to apply 3.3 and 3.4 in conjunction with a quality
system, when required by their local regulatory authorities.
H.3.2 Risk management process
This subclause requires each manufacturer to establish a risk management process as part of the design of a
medical device. This is required so that the manuf
...
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