SIST EN ISO 14971:2012
(Main)Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2007, korrigierte Fassung 2007-10-01)
Diese Internationale Norm legt einen Prozess für einen Medizinproduktehersteller fest zur Identifizierung der mit
Medizinprodukten verbundenen Gefährdungen, einschließlich Produkte für die In-vitro-Diagnostik (IVD). Er
dient der Einschätzung und der Bewertung zugehöriger Risiken, zur Beherrschung dieser Risiken und der
Überwachung der Wirksamkeit von Maßnahmen zur Risikobeherrschung.
Die Anforderungen dieser Internationalen Norm gelten für alle Phasen des Lebenszyklus eines
Medizinprodukts.
Diese Internationale Norm gilt nicht für die klinische Entscheidungsfindung.
In dieser Norm werden keine vertretbaren Risikobereiche festgelegt.
Diese Norm fordert nicht, dass der Hersteller über ein Qualitätsmanagementsystem verfügt. Das Risikomanagement
kann jedoch ein Bestandteil eines Qualitätsmanagementsystems sein.
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007, Version corrigée de 2007-10-01)
L'ISO 14971:2007 spécifie un processus pour permettre au fabricant d'identifier les phénomènes dangereux et les situations dangereuses associés aux dispositifs médicaux, y compris les dispositifs médicaux de diagnostic in vitro (DIV), d'estimer et d'évaluer les risques, de maîtriser ces risques et de surveiller l'efficacité de cette maîtrise.
Les exigences de l'ISO 14971:2007 s'appliquent à tous les stades du cycle de vie d'un dispositif médical.
Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2007, popravljena verzija 2007-10-01)
Standard ISO 14971 določa postopek proizvajalca za opredelitev nevarnosti v zvezi z medicinskimi pripomočki, vključno z in vitro diagnostičnimi (IVD) medicinskimi pripomočki, za oceno z njimi povezanih tveganj, izvajanje nadzora nad tveganji in spremljanje učinkovitosti nadzora. Zahteve standarda ISO 14971:2007 veljajo za vse faze življenjskega cikla medicinskega pripomočka.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14971:2012
01-september-2012
1DGRPHãþD
SIST EN ISO 14971:2009
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
SULSRPRþNLK ,62 SRSUDYOMHQDYHU]LMD
Medical devices - Application of risk management to medical devices (ISO 14971:2007,
Corrected version 2007-10-01)
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO
14971:2007, korrigierte Fassung 2007-10-01)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
(ISO 14971:2007, Version corrigée de 2007-10-01)
Ta slovenski standard je istoveten z: EN ISO 14971:2012
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14971:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14971:2012
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SIST EN ISO 14971:2012
EUROPEAN STANDARD
EN ISO 14971
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2012
ICS 11.040.01 Supersedes EN ISO 14971:2009
English version
Medical devices - Application of risk management to medical
devices (ISO 14971:2007, Corrected version 2007-10-01)
Dispositifs médicaux - Application de la gestion des risques Medizinprodukte - Anwendung des Risikomanagements auf
aux dispositifs médicaux (ISO 14971:2007, Version Medizinprodukte (ISO 14971:2007, korrigierte Fassung
corrigée de 2007-10-01) 2007-10-01)
This European Standard was approved by CEN on 16 May 2012.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2012 CEN/CENELEC Ref. No. EN ISO 14971:2012 E
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
Foreword
The text of ISO 14971:2007, Corrected version 2007-10-01, has been prepared by Technical
Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices”
of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 14971:2012 by Technical Committee CEN-CLC/TC 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 January 2013, and conflicting national standards shall
be withdrawn at the latest by January 2013.
This document supersedes EN ISO 14971:2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and
the European Free Trade Association, and supports essential requirements of EU Directives
93/42/EEC on Medical Devices, 90/385/EEC on Active Implantable Medical Devices and 98/79/EC on
In Vitro Diagnostic Devices.
For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are an integral
part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of
Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14971:2007, Corrected version 2007-10-01, has been approved by CEN as an
EN ISO 14971:2012 without any modification.
3
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
Annex ZA
(informative)
Relationship between this European Standard and Requirements of
EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Requirements of the New Approach Directive 93/42/EEC on Medical Devices.
Within the limits of the scope of this standard (Clause 1 of EN ISO 14971:2012), compliance with the
clauses of this standard confers a presumption of conformity with requirements of that Directive and
associated EFTA regulations, once this standard is cited in the Official Journal of the European Union
under that Directive and has been implemented as a national standard in at least one Member State.
This Annex ZA explains to which requirements, under which conditions and to what extent
presumption of conformity can be claimed.
Whilst only a limited number of requirements is covered just by the application of this standard,
authorities in charge of medical devices strongly recommend using this standard. The standard leads,
according to experience of the authorities, to a higher degree of compliance with legal obligations.
EN ISO 14971:2012 provides a process for managing risks associated with medical devices. Because
this standard describes an ongoing, lifecycle process applicable in part or in all to the Essential
Requirements of Directive 93/42/EEC on Medical Devices, it is – very exceptionally – not meaningful
to link individual clauses of the standard to specific corresponding Essential Requirements.
Compliance with all the normative clauses in EN ISO 14971 will ensure that a process is in place to
address general risk management aspects related to medical devices, which are included in the
Essential Requirements. However, because this is an international standard, intended to be applicable
in jurisdictions all over the world, it is not the primary goal of the standard to cover exactly any of the
European Essential Requirements. Therefore, for all of the Essential Requirements, conformity is not
entirely achieved by complying only with the requirements specified in this standard. Manufacturers
and conformity assessment bodies will need to feed the Essential Requirements into the risk
management process provided by the standard. Explanation on the correspondence of the standard
and the Essential Requirements is included in Table ZA.1. Further explanation on content deviations
between the standard and the ERs is provided below the table.
4
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/subclause(s) of Essential Requirements Qualifying
this EN (ERs) of Directive 93/42/EEC remarks/Notes
ER 1 is not directly covered by EN
ISO 14971, since the standard does
not provide requirements on design
and manufacture. However, the
standard provides a tool to generate
the information that is a necessary
1-9 1
preliminary step for a manufacturer
to demonstrate that the device is in
conformity with ER 1.
For content deviations, see points 1,
2, 3, 4 below.
- The second sentence of ER 2 is
partly covered by 6.2. For content
deviations, see points 1, 2, 3, 5, 6, 7
below.
- The other parts of ER 2 are not
directly covered by EN ISO 14971,
since the standard does not provide
requirements on design and
1-9 2
construction, nor does it apply the
concept of ‘safety principles’ as
intended in the MDD. However, the
standard provides a tool to generate
the information that is a necessary
preliminary step for a manufacturer
to demonstrate that the device is in
conformity with ER 2.
ER 4 is not directly covered by EN
ISO 14971, since the standard does
not apply the concept of ‘safety
principles’ as intended in the MDD.
1-9 4 However, the standard provides a
tool to generate the information that
is a necessary preliminary step for a
manufacturer to demonstrate that the
device is in conformity with ER 4.
ER 5 is not directly covered by EN
ISO 14971, since the standard does
not provide requirements on design,
manufacture or packaging. However,
1-9 5 the standard provides a tool to
generate the information that is a
necessary preliminary step for a
manufacturer to demonstrate that the
device is in conformity with ER 5.
5
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
ER 6 is covered. However, for
6.4, 6.5 and 7 6 content deviations, see points 1, 2, 3,
4 below.
ER 7.1 is only partly covered by EN
ISO 14971, since the standard does
not provide requirements on design
and manufacture and does not cover
performances and characteristics
related thereto. Furthermore, it does
not provide specific requirements on
the items that must be paid particular
1-9 7.1
attention. However, the standard
provides a tool to generate the
information that is a necessary
preliminary step for a manufacturer
to demonstrate that the device is in
conformity with ER 7.1.
For content deviations, see points 1
to 7 below.
Content deviations
The following aspects have been identified where the standard deviates or might be understood as
deviating from the Essential Requirements:
1. Treatment of negligible risks:
1
a) According to standard ISO 14971, the manufacturer may discard negligible risks .
b) However, Sections 1 and 2 of Annex I to Directive 93/42/EEC require that all risks, regardless of
their dimension, need to be reduced as much as possible and need to be balanced, together with all
other risks, against the benefit of the device.
c) Accordingly, the manufacturer must take all risks into account when assessing Sections 1 and 2 of
Annex I to Directive 93/42/EEC.
2. Discretionary power of manufacturers as to the acceptability of risks:
a) ISO 14971 seems to imply that manufacturers have the freedom to decide upon the threshold for
2
risk acceptability and that only non-acceptable risks have to be integrated into the overall risk-benefit
3
analysis .
b) However, Sections 1 and 2 of Annex I to Directive 93/42/EEC require that all risks have to be
reduced as far as possible and that all risks combined, regardless of any "acceptability" assessment,
need to be balanced, together with all other risks, against the benefit of the device.
c) Accordingly, the manufacturer may not apply any criteria of risk acceptability prior to applying
Sections 1 and 2 of Annex I to Directive 93/42/EEC.
1
This is explicitly stated in D.8.2.
2
Sections 5, 6.4, 6.5, 7: reference to the criteria set-up in the management plan which is under the discretion of the
manufacturer (see Sections 3.2, 3.4d)). See also D.4: "This International Standard does not specify acceptable risk. That
decision is left to the manufacturer."
3
See D.6.1.
6
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
3. Risk reduction "as far as possible" versus "as low as reasonably practicable":
a) Annex D.8 to ISO 14971, referred to in 3.4, contains the concept of reducing risks "as low as
reasonably practicable" (ALARP concept). The ALARP concept contains an element of economic
consideration.
b) However, the first indent of Section 2 of Annex I to Directive 93/42/EEC and various particular
Essential Requirements require risks to be reduced "as far as possible" without there being room for
economic considerations.
c) Accordingly, manufacturers and Notified Bodies may not apply the ALARP concept with regard to
economic considerations.
4. Discretion as to whether a risk-benefit analysis needs to take place:
a) 6.5 of ISO 14971 says: "If the residual risk is not judged acceptable using the criteria established in
the risk management plan and further risk control is not practicable, the manufacturer may gather and
review data and literature to determine if the medical benefits of the intended use outweigh the
residual risk." Clause 7 of ISO 14971 says: "If the overall residual risk is not judged acceptable using
the criteria established in the risk management plan, the manufacturer may gather and review data
and literature to determine if the medical benefits of the intended use outweigh the overall residual
risk." Both quotes imply that an overall risk-benefit analysis does not need to take place if the overall
residual risk is judged acceptable when using the criteria established in the risk management plan.
Equally, D.6.1 says: "A risk/benefit analysis is not required by this International Standard for every
risk."
b) According to Section 1 of Annex I to Directive 93/42/EEC, an overall risk-benefit analysis must take
place in any case, regardless of the application of criteria established in the management plan of the
manufacturer. Furthermore, Section 6 of Annex I to Directive 93/42/EEC requires undesirable side-
effects to "constitute an acceptable risk when weighed against the performance intended".
c) Accordingly, the manufacturer must undertake the risk-benefit analysis for the individual risk and the
overall risk-benefit analysis (weighing all risks combined against the benefit) in all cases.
5. Discretion as to the risk control options/measures:
a) 6.2 of ISO 14971 obliges the manufacturer to "use one or more of the following risk control options
in the priority order listed: (a) inherent safety by design; (b) protective measures in the medical device
itself or in the manufacturing process; (c) information for safety" and leaves a discretion as to the
application of these three options: shall the second or third control option still be used when the first
was used? 6.4 indicates that further risk control measures do not need to be taken if, after applying
one of the control options, the risk is judged acceptable according to the criteria of the risk
management plan.
b) However, the second sentence of Section 2 of Annex I to Directive 93/42/EEC requests "to conform
to safety principles, taking account of the generally acknowledged state of the art" and "to select the
most appropriate solutions" by applying cumulatively what has been called "control options" or "control
mechanisms" in the standard.
c) Accordingly, the manufacturer must apply all the "control options" and may not stop his endeavours
if the first or the second control option has reduced the risk to an "acceptable level" (unless the
additional control option(s) do(es) not improve the safety).
6. Deviation as to the first risk control option:
a) 6.2 of ISO 14971 obliges the manufacturer to "use one or more of the following risk control options
in the priority order listed: (a) inherent safety by design …" without determining what is meant by this
term.
b) However, the first indent of the second sentence of Section 2 of Annex I to Directive 93/42/EEC
requires to "eliminate or reduce risks as far as possible (inherently safe design and construction)".
c) Accordingly, as the Directive is more precise than the standard, manufacturers must apply the
former and cannot rely purely on the application of the standard.
7. Information of the users influencing the residual risk:
a) The residual risk is in 2.15 and in 6.4 of ISO 14971 defined as the risk remaining after application of
the risk control measures. 6.2 of ISO 14971 regards "information for safety" to be a control option.
7
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
b) However, the last indent of Section 2 of Annex I to Directive 93/42/EEC says that users shall be
informed about the residual risks. This indicates that, according to Annex I to Directive 93/42/EEC and
contrary to the concept of the standard, the information given to the users does not reduce the
(residual) risk any further.
c) Accordingly, manufacturers shall not attribute any additional risk reduction to the information given
to the users.
Conformity assessment procedures
EN ISO 14971 can also be used to support the following parts of conformity assessment procedures in
the European Medical Devices Directives:
− an adequate description of results of the risk analysis (included in the risk management file, see
3.5 of EN ISO 14971:2012);
− an undertaking by the manufacturer to institute and keep up to date a systematic procedure to
review experience gained from devices in the post-production phase and to implement appropriate
means to apply any necessary corrective action (see Clause 9 of EN ISO 14971:2012).
NOTE Other and more detailed requirements are applicable to this aspect.
WARNING — Other requirements and other EU Directives may be applicable to a product
falling within the scope of this standard.
8
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
Annex ZB
(informative)
Relationship between this European Standard and Requirements of
EU Directive 90/385/EEC on Active Implantable Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Requirements of the New Approach Directive 90/385/EEC on Active Implantable Medical Devices.
Within the limits of the scope of this standard (Clause 1 of EN ISO 14971:2012), compliance with the
clauses of this standard confers a presumption of conformity with requirements of that Directive and
associated EFTA regulations, once this standard is cited in the Official Journal of the European Union
under that Directive and has been implemented as a national standard in at least one Member State.
This Annex ZB explains to which requirements, under which conditions and to what extent
presumption of conformity can be claimed.
Whilst only a limited number of requirements is covered just by the application of this standard,
authorities in charge of medical devices strongly recommend using this standard. The standard leads,
according to experience of the authorities, to a higher degree of compliance with legal obligations.
EN ISO 14971:2012 provides a process for managing risks associated with medical devices. Because
this standard describes an ongoing, lifecycle process applicable in part or in all to the Essential
Requirements of Directive 90/385/EEC on Active Implantable Medical Devices, it is – very
exceptionally – not meaningful to link individual clauses of the standard to specific corresponding
Essential Requirements.
Compliance with all the normative clauses in EN ISO 14971 will ensure that a process is in place to
address general risk management aspects related to medical devices, which are included in the
Essential Requirements. However, because this is an International Standard, intended to be
applicable in jurisdictions all over the world, it is not the primary goal of the standard to cover exactly
any of the European Essential Requirements. Therefore, for all of the Essential Requirements,
conformity is not entirely achieved by complying only with the requirements specified in this standard.
Manufacturers and conformity assessment bodies will need to feed the Essential Requirements into
the risk management process provided by the standard. Explanation on the correspondence of the
standard and the Essential Requirements is included in Table ZB.1. Further explanation on content
deviations between the standard and the ERs is provided below the table.
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC
Clause(s)/subclause(s) of Essential Requirements Qualifying
this EN (ERs) of Directive 90/385/EEC remarks/Notes
ER 1 is not directly covered by EN
ISO 14971, since the standard does
not provide requirements on design
and manufacture. However, the
standard provides a tool to generate
the information that is a necessary
1-9 1
preliminary step for a manufacturer
to demonstrate that the device is in
conformity with ER 1.
For content deviations, see points 1,
2, 3 below.
9
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
ER 3 is not directly covered by EN
ISO 14971, since the standard does
not apply the concept of ‘safety
principles’ as intended in the AIMDD.
1-9 3 However, the standard provides a
tool to generate the information that
is a necessary preliminary step for a
manufacturer to demonstrate that the
device is in conformity with ER 3.
ER 4 is not directly covered by EN
ISO 14971, since the standard does
not provide requirements on design,
manufacture or packaging. However,
1-9 4 the standard provides a tool to
generate the information that is a
necessary preliminary step for a
manufacturer to demonstrate that the
device is in conformity with ER 4.
ER 5 is covered. However, for
6.4, 6.5 and 7 5 content deviations, see points 1, 2, 3,
4 below.
ER 6 is not directly covered by EN
ISO 14971, since the standard does
not provide requirements on design
and construction, nor does it apply
the concept of ‘safety principles’ as
intended in the AIMDD. However, the
standard provides a tool to generate
1-9 6
the information that is a necessary
preliminary step for a manufacturer
to demonstrate that the device is in
conformity with ER 6.
For content deviations, see point 3
below.
ER 9 is only partly covered by EN
ISO 14971, since the standard does
not provide requirements on design
and manufacture and does not cover
performances and characteristics
related thereto. Furthermore, it does
not provide specific requirements on
the items that must be paid particular
1-9 9
attention. However, the standard
provides a tool to generate the
information that is a necessary
preliminary step for a manufacturer
to demonstrate that the device is in
conformity with ER 9.
For content deviations, see points 1
to 4 below.
10
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
Content deviations
The following aspects have been identified where the standard deviates or might be understood as
deviating from the Essential Requirements:
1. Treatment of negligible risks:
4
a) According to ISO 14971, the manufacturer may discard negligible risks .
b) However, Sections 1 and 6 of Annex I to Directive 90/385/EEC require that all risks, regardless of
their dimension, need to be reduced as much as possible.
c) Accordingly, the manufacturer must take all risks into account when assessing Sections 1 and 6 of
Annex I to Directive 90/385/EEC.
2. Discretionary power of manufacturers as to the acceptability of risks:
a) ISO 14971 seems to imply that manufacturers have the freedom to decide upon the threshold for
5
risk acceptability and that only non-acceptable risks have to be integrated into the overall risk-benefit
6
analysis .
b) However, Sections 1 and 6 of Annex I to Directive 90/385/EEC require that all risks have to be
reduced as far as possible.
c) Accordingly, the manufacturer may not apply any criteria of risk acceptability prior to applying
Sections 1 and 6 of Annex I to Directive 90/385/EEC.
3. Risk reduction "as far as possible" versus "as low as reasonably practicable":
a) D.8 of ISO 14971, referred to in 3.4, contains the concept of reducing risks "as low as reasonably
practicable" (ALARP concept). The ALARP concept contains an element of economic consideration.
b) However, various Essential Requirements require risks to be reduced "as far as possible" without
there being room for economic considerations.
c) Accordingly, manufacturers and Notified Bodies may not apply the ALARP concept with regard to
economic considerations.
4. Discretion as to whether a risk-benefit analysis needs to take place:
a) 6.5 of ISO 14971 says: "If the residual risk is not judged acceptable using the criteria established in
the risk management plan and further risk control is not practicable, the manufacturer may gather and
review data and literature to determine if the medical benefits of the intended use outweigh the
residual risk." Clause 7 of ISO 14971 says: "If the overall residual risk is not judged acceptable using
the criteria established in the risk management plan, the manufacturer may gather and review data
and literature to determine if the medical benefits of the intended use outweigh the overall residual
risk." Both quotes imply that an overall risk-benefit analysis does not need to take place if the overall
residual risk is judged acceptable when using the criteria established in the risk management plan.
Equally, D.6.1 says: "A risk-benefit analysis is not required by this International Standard for every
risk."
b) Section 5 of Annex I to Directive 90/385/EEC requires any side effects or undesirable conditions to
"constitute acceptable risks when weighed against the performances intended", implying that an
overall risk-benefit analysis must take place in any case, regardless of the application of criteria
established in the management plan of the manufacturer.
c) Accordingly, the manufacturer must undertake the risk-benefit analysis for the individual risk and the
overall risk-benefit analysis (weighing all risks combined against the benefit) in all cases.
4
This is explicitly stated in D.8.2.
5
Sections 5, 6.4, 6.5, 7: reference to the criteria set-up in the management plan which is under the discretion of the
manufacturer (see Sections 3.2, 3.4d)). See also D.4: "This International Standard does not specify acceptable risk. That
decision is left to the manufacturer."
6
See D.6.1.
11
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
Conformity assessment procedures
EN ISO 14971 can also be used to support the following parts of conformity assessment procedures in
the European Medical Devices Directives:
− an adequate description of results of the risk analysis (included in the risk management file, see
3.5 of EN ISO 14971:2012);
− an undertaking by the manufacturer to institute and keep up to date a systematic procedure to
review experience gained from devices in the post-production phase and to implement appropriate
means to apply any necessary corrective action (see Clause 9 of EN ISO 14971:2012).
NOTE Other and more detailed requirements are applicable to this aspect.
WARNING — Other requirements and other EU Directives may be applicable to a product
falling within the scope of this standard.
12
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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
Annex ZC
(informative)
Relationship between this European Standard and Requirements of
EU Directive 98/79/EC on In Vitro Diagnostic Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Requirements of the New Approach Directive 98/79/EC on In Vitro Diagnostic Medical Devices.
Within the limits of the scope of this standard (Clause 1 of EN ISO 14971:2012), compliance with the
clauses of this standard confers a presumption of conformity with requirements of that Directive and
associated EFTA regulations, once this standard is cited in the Official Journal of the European Union
under that Directive and has been implemented as a national standard in at least one Member State.
This Annex ZC explains to which requirements, under which conditions and to what extent
presumption of conformity can be claimed.
Whilst only a limited number of requirements is covered just by the application of this standard,
authorities in charge of medical devices strongly recommend using this standard. The standard leads,
according to experience of the authorities, to a higher degree of compliance with legal obligations.
EN ISO 14971:2012 provides a process for managing risks associated with medical devices. Because
this standard describes an ongoing, lifecycle process applicable in part or in all to the Essential
Requirements of Directive 98/79/EC on In Vitro Diagnostic Medical Devices, it is – very exceptionally –
not meaningful to link individual clauses of the standard to specific c
...
SLOVENSKI SIST EN ISO 14971
STANDARD
september 2012
Medicinski pripomočki – Uporaba obvladovanja tveganja pri medicinskih
pripomočkih (ISO 14971:2007, popravljena verzija 2007-10-01)
Medical devices – Application of risk management to medical devices (ISO
14971:2007, Corrected version 2007-10-01)
Dispositifs médicaux – Application de la gestion des risques aux dispositifs
médicaux (ISO 14971:2007, Version corrigée de 2007-10-01)
Medizinprodukte – Anwendung des Risikomanagements auf Medizinprodukte
(ISO 14971:2007, korrigierte Fassung 2007-10-01)
Referenčna oznaka
ICS 11.040.01 SIST EN ISO 14971:2012 (sl)
Nadaljevanje na strani II in od 1 do 94
© 2016-09. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14971 : 2012
NACIONALNI UVOD
Standard SIST EN ISO 14971 (sl), Medicinski pripomočki – Uporaba obvladovanja tveganja pri
medicinskih pripomočkih (ISO 14971:2007, popravljena verzija 2007-10-01), 2012, 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 14971:2007, Corrected version
2007-10-01), 2012.
Ta standard nadomešča SIST EN ISO 14971:2009.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 14971:2012 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 14971:2012 je prevod evropskega standarda EN ISO 14971:2012. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v enem izmed treh
uradnih jezikov CEN. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC VAZ Varovanje
zdravja.
Odločitev za izdajo tega standarda je dne 21. maja 2012 sprejel SIST/TC VAZ Varovanje zdravja.
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 14971:2012
PREDHODNA IZDAJA
– standard SIST EN ISO 14971:2004
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN ISO
14971:2012 to pomeni “slovenski standard”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO 14971:2012 in je objavljen z dovoljenjem
Upravni Center
CEN-CENELEC
Avenue Marnix 17
B-1000 Bruselj
This national document is identical with EN ISO 14971:2012 and is published with the permission of
CEN-CENELEC
Management Centre
Avenue Marnix 17
B-1000 Brussels
II
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EVROPSKI STANDARD EN ISO 14971
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM julij 2012
ICS 11.040.01 Nadomešča EN ISO 14971:2009
Slovenska izdaja
Medicinski pripomočki – Uporaba obvladovanja tveganja pri medicinskih
pripomočkih (ISO 14971:2007, popravljena verzija 2007-10-01)
Medical devices – Application of Dispositifs médicaux – Application de Medizinprodukte – Anwendung des
risk management to medical la gestion des risques aux dispositifs Risikomanagements auf
devices (ISO 14971:2007, médicaux (ISO 14971:2007, Version Medizinprodukte (ISO 14971:2007,
Corrected version 2007-10-01) corrigée de 2007-10-01) korrigierte Fassung 2007-10-01)
Ta evropski standard je CEN sprejel dne 16. maja 2012.
Člani CEN in CENELEC morajo izpolnjevati notranje predpise CEN/CENELEC, ki predpisujejo pogoje,
pod katerimi mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Seznami
najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki se na zahtevo lahko dobijo
pri Upravnem centru CEN-CENELEC ali kateremkoli članu 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, Nekdanje jugoslovanske
republike Makedonije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije,
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: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN/CENELEC. Lastnice avtorskih pravic so vse države članice CEN/CENELEC Ref. oznaka: EN ISO 14971:2012 E
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SIST EN ISO 14971 : 2012
Predgovor k evropskemu standardu
Besedilo standarda ISO 14971:2007, popravljena verzija 2007-10-01, je pripravil tehnični odbor ISO/TC
210 "Vodenje kakovosti in ustrezni splošni vidiki za medicinske pripomočke" mednarodne organizacije
za standardizacijo (ISO) in ga je kot EN ISO 14971:2012 privzel tehnični odbor 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 januarja 2013, nacionalne standarde, ki so v nasprotju s tem
standardom, pa je treba razveljaviti najpozneje do januarja 2013.
Ta dokument nadomešča EN ISO 14971:2009.
Opozoriti je treba na možnost, da je lahko nekaj elementov tega dokumenta predmet patentnih pravic.
CEN [in/ali CENELEC] ne prevzema odgovornosti za identifikacijo katerihkoli ali vseh takih patentnih
pravic.
Ta dokument je CEN pripravil v okviru pooblastila, ki sta mu ga dala Evropska komisija in Evropsko
združenje za prosto trgovino, in podpira bistvene zahteve direktiv EU 93/42/EGS o medicinskih
pripomočkih, 90/385/EGS o aktivnih medicinskih pripomočkih za vsaditev in 98/79/ES o diagnostičnih
medicinskih pripomočkih in vitro.
Glede povezave z direktivami EU glej informativne dodatke ZA, ZB in ZC, ki so sestavni del tega
dokumenta.
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, Nekdanje jugoslovanske republike Makedonije, Nemčije, Nizozemske, Norveške,
Poljske, Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega
kraljestva.
Razglasitvena objava
Besedilo ISO 14971:2007, popravljena verzija 2007-10-01, je CEN odobril brez sprememb kot
EN ISO 14971:2012.
2
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SIST EN ISO 14971 : 2012
Dodatek ZA
(informativni)
Povezava med tem evropskim standardom in zahtevami direktive EU 93/42/EGS
o medicinskih pripomočkih
Ta evropski standard je CEN pripravil v okviru pooblastila, ki sta mu ga dala Evropska komisija in
Evropsko združenje za prosto trgovino, da bi se zagotovila skladnost z zahtevami direktive novega
pristopa 93/42/EGS o medicinskih pripomočkih.
Ko je ta standard objavljen v Uradnem listu Evropske unije v okviru navedene direktive in je privzet kot
nacionalni standard v vsaj eni državi članici, skladnost s točkami tega standarda, v okviru področja
uporabe tega standarda (EN ISO 14971:2012, točka 1), ustvarja domnevo o skladnosti z zahtevami te
direktive ter s tem povezanimi predpisi EFTA. V tem dodatku ZA je razloženo, za katere zahteve, pod
kakšnimi pogoji in v kolikšnem obsegu je mogoče uveljavljati domnevo o skladnosti.
Čeprav je z uporabo samo tega standarda izpolnjeno le omejeno število zahtev, pa organi, odgovorni
za medicinske pripomočke, zelo priporočajo njegovo uporabo. Glede na izkušnje teh organov ta
standard vodi k višji stopnji skladnosti z zakonskimi obveznostmi.
EN ISO 14971:2012 določa postopek za obvladovanje tveganja v zvezi z medicinskimi pripomočki. Ker
ta standard opisuje stalen proces v življenjskem ciklu in se delno ali v celoti nanaša na bistvene zahteve
direktive 93/42/EGS o medicinskih pripomočkih, izjemoma ni smiselno povezovati posameznih točk
standarda z ustreznimi specifičnimi bistvenimi zahtevami.
Z upoštevanjem vseh normativnih točk v EN ISO 14971 bo zagotovljen proces za obravnavanje splošnih
vidikov obvladovanja tveganja v zvezi z medicinskimi pripomočki, ki so vključeni v bistvene zahteve. Ker
pa je to mednarodni standard, namenjen uporabi v jurisdikcijah po vsem svetu, ni njegov osnovni namen
zajeti prav vsako od evropskih bistvenih zahtev. Zato skladnost z vsemi bistvenimi zahtevami ni v celoti
dosežena, če se upoštevajo samo zahteve, navedene v tem standardu. Proizvajalci in organi
ugotavljanja skladnosti bodo morali bistvene zahteve vključiti v postopek obvladovanja tveganja, ki ga
zagotavlja ta standard. Razlaga primerjave tega standarda z bistvenimi zahtevami je vključena v
preglednico ZA.1. Pod preglednico je podana nadaljnja razlaga vsebinskih odstopanj med standardom
in bistvenimi zahtevami.
3
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SIST EN ISO 14971 : 2012
Preglednica ZA.1: Primerjava med tem evropskim standardom in direktivo 93/42/EGS
Točka(-e)/podtočka(-e) tega Bistvene zahteve (BZ) Ustrezne pripombe/
evropskega standarda direktive 93/42/EGS Opombe
BZ 1 ni neposredno zajeta v EN ISO
14971, saj standard ne vsebuje zahtev
glede zasnove in izdelave. Vendar pa
standard zagotavlja orodje za
1-9 1 pridobivanje informacij, ki je potreben
predhodni korak za proizvajalca, da
dokaže, da je naprava v skladu z BZ 1.
Za vsebinska odstopanja glej točke 1, 2,
3, 4 spodaj.
– Drugi stavek BZ 2 je delno zajet v točki
6.2. Za vsebinska odstopanja glej točke
1, 2, 3, 5, 6, 7 spodaj.
– Drugi deli BZ 2 niso neposredno zajeti
v EN ISO 14971, saj standard ne
vsebuje zahtev glede zasnove in
1-9 2 konstrukcije, niti ne uporablja pojma
"varnostna načela", kot je predvideno v
direktivi o medicinskih pripomočkih.
Vendar pa standard zagotavlja orodje
za pridobivanje informacij, ki je potreben
predhodni korak za proizvajalca, da
dokaže, da je naprava v skladu z BZ 2.
BZ 4 ni neposredno zajeta v EN ISO
14971, saj standard ne uporablja pojma
"varnostna načela", kot je predvideno v
direktivi o medicinskih pripomočkih.
1-9 4
Vendar pa standard zagotavlja orodje za
pridobivanje informacij, ki je potreben
predhodni korak za proizvajalca, da
dokaže, da je naprava v skladu z BZ 4.
BZ 5 ni neposredno zajeta v EN ISO
14971, saj standard ne vsebuje zahtev
glede zasnove, izdelave ali embalaže.
1-9 5 Vendar pa standard zagotavlja orodje za
pridobivanje informacij, ki je potreben
predhodni korak za proizvajalca, da
dokaže, da je naprava v skladu z BZ 5.
BZ 6 je zajeta. Za vsebinska odstopanja
6.4, 6.5 in 7 6
glej točke 1, 2, 3, 4 spodaj.
BZ 7.1 je samo delno zajeta v EN ISO
14971, saj standard ne vsebuje zahtev
glede zasnove in izdelave ter ne zajema
lastnosti in karakteristik v zvezi s tem.
Nadalje standard ne vsebuje specifičnih
zahtev glede postavk, ki jim je treba
1-9 7.1 nameniti posebno pozornost. Vendar pa
standard zagotavlja orodje za
pridobivanje informacij, ki je potreben
predhodni korak za proizvajalca, da
dokaže, da je naprava v skladu z BZ 7.1.
Za vsebinska odstopanja glej točke od 1
do 7 spodaj.
4
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SIST EN ISO 14971 : 2012
Vsebinska odstopanja
Identificirani so naslednji vidiki, kjer standard odstopa od bistvenih zahtev oziroma bi se lahko razumelo,
kot da odstopa od njih:
1. Obravnava zanemarljivega tveganja
1
a) V skladu s standardom ISO 14971 lahko proizvajalec izloči zanemarljivo tveganje .
b) Vendar pa se v poglavjih 1 in 2 dodatka I k direktivi 93/42/EGS zahteva, da je treba tveganje ne
glede na njegovo velikost čim bolj zmanjšati in skupaj z vsemi drugimi tveganji uravnotežiti s
koristnostjo naprave.
c) Skladno s tem mora proizvajalec pri ocenjevanju poglavij 1 in 2 dodatka I k direktivi 93/42/EGS
upoštevati vsa tveganja.
2. Diskrecijska pravica proizvajalcev glede sprejemljivosti tveganja
a) Zdi se, kot da ISO 14971 nakazuje, da se lahko proizvajalci svobodno odločajo glede praga
2 3
sprejemljivosti tveganja in da je treba v analizo razmerja med vsemi tveganji in koristmi vključiti
samo nesprejemljiva tveganja.
b) Toda v poglavjih 1 in 2 dodatka I k direktivi 93/42/EGS se zahteva, da je treba tveganje ne glede na
njegovo velikost zmanjšati, kolikor je mogoče, in da morajo biti vsa združena tveganja, ne glede na
oceno "sprejemljivosti", skupaj z vsemi drugimi tveganji uravnotežena s koristnostjo naprave.
c) Skladno s tem proizvajalec ne sme uporabiti nobenih kriterijev sprejemljivosti tveganja pred
uporabo poglavij 1 in 2 dodatka I k direktivi 93/42/EGS.
3. Zmanjšanje tveganja "kolikor je mogoče" proti "kolikor je razumno izvedljivo"
a) Točka D.8 v dodatku k ISO 14971, navedena v točki 3.4, vsebuje pojem zmanjšanja tveganja
"kolikor je razumno izvedljivo" (pojem ALARP). Pojem ALARP vsebuje element ekonomskega
vidika.
b) Vendar pa se v prvi alineji 2. poglavja dodatka I k direktivi 93/42/EGS ter v različnih posebnih
bistvenih zahtevah zahteva, da mora biti tveganje "kolikor je mogoče" zmanjšano brez
upoštevanja ekonomskega vidika.
c) Skladno s tem proizvajalci in priglašeni organi ne smejo uporabljati pojma ALARP v zvezi z
ekonomskimi vidiki.
4. Diskrecijska pravica glede odločanja o potrebnosti analize razmerja med tveganji in koristmi
a) Točka 6.5 v ISO 14971 se glasi: "Če je z uporabo kriterijev, vzpostavljenih v načrtu obvladovanja
tveganja, ocenjeno, da preostalo tveganje ni sprejemljivo in da nadaljnji nadzor tveganja ni izvedljiv,
lahko proizvajalec zbere in pregleda podatke in literaturo, da ugotovi, ali medicinske koristi predvidene
uporabe odtehtajo preostalo tveganje". Točka 7 v ISO 14971 se glasi: "Če je z uporabo kriterijev,
vzpostavljenih v načrtu obvladovanja tveganja, ocenjeno, da celotno preostalo tveganje ni
sprejemljivo, lahko proizvajalec zbere in pregleda podatke in literaturo, da ugotovi, ali medicinske
koristi predvidene uporabe odtehtajo celotno preostalo tveganje". Oba citata pomenita, da analiza
razmerja med vsemi tveganji in koristmi ni potrebna, če je z uporabo kriterijev, vzpostavljenih v načrtu
obvladovanja tveganja, ocenjeno, da je celotno preostalo tveganje sprejemljivo. Enako se glasi D.6.1:
"Ta mednarodni standard ne zahteva analize razmerja med tveganji in koristmi za vsako tveganje."
b) V skladu s 1. poglavjem dodatka I k direktivi 93/42/EGS mora biti v vsakem primeru opravljena analiza
razmerja med vsemi tveganji in koristmi, ne glede na uporabo kriterijev, ki jih vzpostavi proizvajalec v
načrtu obvladovanja. 6. poglavje dodatka I k direktivi 93/42/EGS nadalje zahteva, da morajo neželeni
stranski učinki "predstavljati sprejemljivo tveganje glede na predvideno izvedbo".
1
To je izrecno navedeno v D.8.2.
2
Poglavja 5, 6.4, 6.5, 7: sklic na kriterije, vzpostavljene v načrtu obvladovanja, ki je po lastni presoji proizvajalca (glej poglavja
3.2, 3.4d)). Glej tudi D.4: "Ta mednarodni standard ne določa sprejemljivega tveganja. To je prepuščeno v odločanje
proizvajalcu."
3
Glej D.6.1.
5
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SIST EN ISO 14971 : 2012
c) Skladno s tem mora proizvajalec v vseh primerih izvesti analizo razmerja med tveganji in koristmi
za posamezno tveganje ter analizo razmerja med vsemi tveganji in koristmi (tehtanje vseh tveganj
skupaj glede na korist).
5. Diskrecijska pravica glede različnih možnosti/ukrepov za nadzor tveganja
a) ISO 14971 v točki 6.2 zavezuje proizvajalca, da "po naslednjem prednostnem vrstnem redu
uporabi eno ali več možnosti nadzora tveganja: (a) inherentna varnost zasnove; (b) zaščitni ukrepi
v samem medicinskem pripomočku ali v proizvodnem procesu; (c) varnostne informacije" in
prepušča diskrecijsko pravico glede uporabe teh treh možnosti: ali je treba drugo in tretjo možnost
nadzora še vedno uporabiti, če je bila uporabljena prva? Točka 6.4 navaja, da nadaljnjih ukrepov
nadzora tveganja ni treba sprejemati, če se oceni, da je tveganje po uporabi ene od možnosti
nadzora sprejemljivo v skladu s kriteriji načrta obvladovanja tveganja.
b) Vendar pa drugi stavek 2. poglavja dodatka I k direktivi 93/42/EGS zahteva "skladnost z načeli
varnosti ob upoštevanju splošno priznanega stanja tehnike" in "izbiro najprimernejših rešitev" s
skupno uporabo t.i. "možnosti nadzora" ali "mehanizmov nadzora" v standardu.
c) Skladno s tem mora proizvajalec uporabiti vse "možnosti nadzora" in svojih prizadevanj ne sme
ustaviti, če je prva ali druga možnost nadzora zmanjšala tveganje na "sprejemljivo stopnjo" (razen
če dodatna(-e) možnost(-i) nadzora ne izboljša(-jo) varnosti).
6. Odstopanje glede na prvo možnost nadzora tveganja
a) ISO 14971 v točki 6.2 zavezuje proizvajalca, da "uporabi eno ali več od naslednjih možnosti
nadzora tveganja na seznamu po prednostnem vrstnem redu: (a) inherentna varnost zasnove…"
brez opredeljevanja, kaj ta izraz pomeni.
b) Vendar pa prva alineja drugega stavka 2. poglavja dodatka I k direktivi 93/42/EGS zahteva, da
"se mora tveganje odpraviti oziroma zmanjšati, kolikor je mogoče (inherentno varna zasnova in
konstrukcija)".
c) Glede na to, da je direktiva natančnejša od standarda, morajo proizvajalci skladno s tem
uporabljati prvo in se ne morejo zanašati zgolj na standard.
7. Obveščanje uporabnikov, ki vplivajo na preostalo tveganje
a) V točkah 2.15 in 6.4 standarda ISO 14971 je preostalo tveganje opredeljeno kot tveganje, ki
ostane po uporabi ukrepov za nadzor tveganja. V standardu ISO 14971, točka 6.2, se "varnostne
informacije" štejejo za možnost nadzora.
b) Vendar pa zadnja alineja 2. poglavja dodatka I k direktivi 93/42/EGS pravi, da morajo biti
uporabniki obveščeni o preostalem tveganju. To pomeni, da v skladu z dodatkom I k direktivi
93/42/EGS in v nasprotju s konceptom standarda, informacije, ki so dane uporabnikom, nadalje
ne zmanjšujejo (preostalega) tveganja.
c) Skladno s tem proizvajalci ne smejo pripisovati informacijam, ki jih dajejo uporabnikom,
nikakršnega dodatnega zmanjševanja tveganja.
Postopki ugotavljanja skladnosti
EN ISO 14971 se lahko uporablja tudi kot podpora pri naslednjih delih postopkov ugotavljanja skladnosti
v evropskih direktivah o medicinskih pripomočkih:
− pri ustreznem opisu rezultatov analize tveganja (vključen v dokumentacijo o obvladovanju tveganja,
glej EN ISO 14971:2012, točka 3.5);
− pri izpolnjevanju zaveze proizvajalca, da bo uvedel in posodabljal sistematičen postopek za
pregledovanje izkušenj, ki jih je pridobil z napravami, v fazi po proizvodnji in da bo uvajal ustrezne
načine za uporabo morebitnih potrebnih korektivnih ukrepov (glej EN ISO 14971:2012, točka 9).
OPOMBA: Za ta vidik veljajo tudi druge, podrobnejše zahteve.
OPOZORILO: Za izdelke, ki sodijo v področje uporabe tega standarda, lahko veljajo tudi druge
zahteve in druge direktive EU.
6
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SIST EN ISO 14971 : 2012
Dodatek ZB
(informativni)
Povezava med tem evropskim standardom in zahtevami direktive EU 90/385/EGS
o aktivnih medicinskih pripomočkih za vsaditev
Ta evropski standard je CEN pripravil v okviru pooblastila, ki sta mu ga dala Evropska komisija in
Evropsko združenje za prosto trgovino, da bi se zagotovila skladnost z zahtevami direktive novega
pristopa 90/385/EGS o aktivnih medicinskih pripomočkih za vsaditev.
Ko je ta standard objavljen v Uradnem listu Evropske unije v okviru navedene direktive in je privzet kot
nacionalni standard v vsaj eni državi članici, skladnost s točkami tega standarda, v okviru področja
uporabe tega standarda (EN ISO 14971:2012, točka 1), ustvarja domnevo o skladnosti z zahtevami te
direktive ter s tem povezanimi predpisi EFTA. V tem dodatku ZB je razloženo, za katere zahteve, pod
kakšnimi pogoji in v kolikšnem obsegu je mogoče uveljavljati domnevo o skladnosti.
Čeprav je z uporabo samo tega standarda izpolnjeno le omejeno število zahtev, pa organi, odgovorni
za medicinske pripomočke, zelo priporočajo njegovo uporabo. Glede na izkušnje teh organov ta
standard vodi k višji stopnji skladnosti z zakonskimi obveznostmi.
EN ISO 14971:2012 določa postopek za obvladovanje tveganja v zvezi z medicinskimi pripomočki. Ker
ta standard opisuje stalen proces v življenjskem ciklu, ki se delno ali v celoti nanaša na bistvene zahteve
direktive 90/385/EGS o aktivnih medicinskih pripomočkih za vsaditev, izjemoma ni smiselno povezovati
posameznih točk standarda z ustreznimi specifičnimi bistvenimi zahtevami.
Z upoštevanjem vseh normativnih točk v EN ISO 14971 bo zagotovljen proces za obravnavanje splošnih
vidikov obvladovanja tveganja v zvezi z medicinskimi pripomočki, ki so vključeni v bistvene zahteve. Ker
pa je to mednarodni standard, namenjen uporabi v jurisdikcijah po vsem svetu, ni njegov osnovni namen
zajeti prav vsako od evropskih bistvenih zahtev. Zato skladnost z vsemi bistvenimi zahtevami ni v celoti
dosežena, če se upoštevajo samo zahteve, navedene v tem standardu. Proizvajalci in organi
ugotavljanja skladnosti bodo morali bistvene zahteve vključiti v postopek obvladovanja tveganja, ki ga
zagotavlja standard. Razlaga primerjave tega standarda z bistvenimi zahtevami je vključena v
preglednico ZB.1. Pod preglednico je podana nadaljnja razlaga vsebinskih odstopanj med standardom
in bistvenimi zahtevami.
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SIST EN ISO 14971 : 2012
Preglednica ZB.1: Primerjava med tem evropskim standardom in direktivo 90/385/EGS
Točka(-e)/podtočka(-e) tega Bistvene zahteve (BZ) Ustrezne pripombe/
evropskega standarda direktive 90/385/EGS Opombe
BZ 1 ni neposredno zajeta v EN ISO 14971,
saj standard ne vsebuje zahtev glede zasnove
in izdelave. Vendar pa standard zagotavlja
orodje za pridobivanje informacij, ki je
1-9 1
potreben predhodni korak za proizvajalca, da
dokaže, da je naprava v skladu z BZ 1.
Za vsebinska odstopanja glej točke 1, 2, 3
spodaj.
BZ 3 ni neposredno zajeta v
EN ISO 14971, saj standard ne uporablja
pojma "varnostna načela", kot je predvideno v
direktivi o aktivnih medicinskih pripomočkih za
1-9 3 vsaditev (AIMDD).
Vendar pa standard zagotavlja orodje za
pridobivanje informacij, ki je potreben
predhodni korak za proizvajalca, da dokaže,
da je naprava v skladu z BZ 3.
BZ 4 ni neposredno zajeta v EN ISO 14971,
saj standard ne vsebuje zahtev glede
zasnove, izdelave ali embalaže. Vendar pa
1-9 4 standard zagotavlja orodje za pridobivanje
informacij, ki je potreben predhodni korak za
proizvajalca, da dokaže, da je naprava v
skladu z BZ 4.
BZ 5 je zajeta. Glede vsebinskih odstopanj pa
6.4, 6.5 in 7 5
glej točke 1, 2, 3, 4 spodaj.
BZ 6 ni neposredno zajeta v EN ISO 14971,
saj standard ne vsebuje zahtev glede zasnove
in konstrukcije, niti ne uporablja pojma
"varnostna načela", kot je predvideno v
direktivi o aktivnih medicinskih pripomočkih za
1-9 6
vsaditev. Vendar pa standard zagotavlja
orodje za pridobivanje informacij, ki je
potreben predhodni korak za proizvajalca, da
dokaže, da je naprava v skladu z BZ 6.
Za vsebinska odstopanja glej točko 3 spodaj.
BZ 9 je samo delno zajeta v EN ISO 14971,
saj standard ne vsebuje zahtev glede zasnove
in izdelave ter ne zajema lastnosti in
karakteristik v zvezi s tem. Nadalje standard
ne vsebuje specifičnih zahtev glede postavk,
ki jim je treba nameniti posebno pozornost.
1-9 9
Vendar pa standard zagotavlja orodje za
pridobivanje informacij, ki je potreben
predhodni korak za proizvajalca, da dokaže,
da je naprava v skladu z BZ 9.
Za vsebinska odstopanja glej točke od 1 do
4 spodaj.
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SIST EN ISO 14971 : 2012
Vsebinska odstopanja
Identificirani so naslednji vidiki, kjer standard odstopa od bistvenih zahtev oziroma bi se lahko razumelo,
kot da odstopa od njih:
1. Obravnava zanemarljivega tveganja
4
a) V skladu s standardom ISO 14971 lahko proizvajalec izloči zanemarljivo tveganje
b) Vendar pa se v poglavjih 1 in 6 dodatka I k direktivi 90/385/EGS zahteva, da je treba tveganje ne
glede na njegovo velikost čim bolj zmanjšati.
c) Skladno s tem mora proizvajalec pri ocenjevanju poglavij 1 in 6 dodatka I k direktivi 90/385/EGS
upoštevati vsa tveganja.
2. Diskrecijska pravica proizvajalcev glede sprejemljivosti tveganja
a) Zdi se, kot da ISO 14971 nakazuje, da se lahko proizvajalci svobodno odločajo glede praga
5 6
sprejemljivosti tveganja in da je treba v analizo razmerja med vsemi tveganji in koristmi vključiti
samo nesprejemljiva tveganja.
b) Vendar pa se v poglavjih 1 in 6 dodatka I k direktivi 90/385/EGS zahteva, da je treba vsa tveganja
zmanjšati, kolikor je mogoče.
c) Skladno s tem proizvajalec ne sme uporabiti nobenih kriterijev sprejemljivosti tveganja pred
uporabo poglavij 1 in 6 dodatka I k direktivi 90/385/EGS.
3. Zmanjšanje tveganja "kolikor je mogoče" proti "kolikor je razumno izvedljivo"
a) Točka D.8 v dodatku k ISO 14971, navedena v točki 3.4, vsebuje pojem zmanjšanja tveganja
"kolikor je razumno izvedljivo" (pojem ALARP). Pojem ALARP vsebuje element ekonomskega
vidika.
b) Vendar pa se v različnih bistvenih zahtevah zahteva, da mora biti tveganje "kolikor je mogoče"
zmanjšano brez upoštevanja ekonomskega vidika.
c) Skladno s tem proizvajalci in priglašeni organi ne smejo uporabljati pojma ALARP v zvezi z
ekonomskimi vidiki.
4. Diskrecijska pravica glede odločanja o potrebnosti analize razmerja med tveganji in koristmi
a) Točka 6.5 v ISO 14971 se glasi: "Če je z uporabo kriterijev, vzpostavljenih v načrtu obvladovanja
tveganja, ocenjeno, da preostalo tveganje ni sprejemljivo in da nadaljnje obvladovanje tveganja ni
izvedljivo, lahko proizvajalec zbere in pregleda podatke in literaturo, da ugotovi, ali medicinske koristi
predvidene uporabe odtehtajo preostalo tveganje". Točka 7 v ISO 14971 se glasi: "Če je z uporabo
kriterijev, vzpostavljenih v načrtu obvladovanja tveganja, ocenjeno, da celotno preostalo tveganje ni
sprejemljivo, lahko proizvajalec zbere in pregleda podatke in literaturo, da ugotovi, ali medicinske
koristi predvidene uporabe odtehtajo celotno preostalo tveganje". Oba citata pomenita, da analiza
razmerja med vsemi tveganji in koristmi ni potrebna, če je z uporabo kriterijev, vzpostavljenih v načrtu
obvladovanja tveganja, ocenjeno, da je celotno preostalo tveganje sprejemljivo. Enako se glasi D.6.1:
"Ta mednarodni standard ne zahteva analize razmerja med tveganji in koristmi za vsako tveganje."
b) V 5. poglavju dodatka I k direktivi 90/385/EGS se zahteva, da morajo morebitni stranski učinki ali
neželene razmere "predstavljati sprejemljivo tveganje glede na predvidene lastnosti", kar pomeni,
da je treba analizo razmerja med vsemi tveganji in koristmi v vsakem primeru opraviti, ne glede
na uporabo kriterijev, ki jih je vzpostavil proizvajalec v načrtu za obvladovanje tveganja.
4
To je izrecno navedeno v D.8.2.
5
Poglavja 5, 6.4, 6.5, 7: sklic na kriterije, vzpostavljene v načrtu obvladovanja, ki je po lastni presoji proizvajalca (glej poglavja
3.2, 3.4d)). Glej tudi D.4: "Ta mednarodni standard ne določa sprejemljivega tveganja. To je prepuščeno v odločanje
proizvajalcu."
6
Glej D.6.1.
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SIST EN ISO 14971 : 2012
c) Skladno s tem mora proizvajalec v vseh primerih izvesti analizo razmerja med tveganji in koristmi
za posamezno tveganje ter analizo razmerja med vsemi tveganji in koristmi (pretehtati vsa
tveganja skupaj glede na korist).
Postopki ugotavljanja skladnosti
EN ISO 14971 se lahko uporablja tudi kot podpora pri naslednjih delih postopkov ugotavljanja skladnosti
v evropskih direktivah o medicinskih pripomočkih:
− pri ustreznem opisu rezultatov analize tveganja (vključen v dokumentacijo o obvladovanju tveganja,
glej EN ISO 14971:2012, točka 3.5);
− pri izpolnjevanju zaveze proizvajalca, da bo uvedel in posodabljal sistematičen postopek za
pregledovanje izkušenj, ki jih je pridobil z napravami, v fazi po proizvodnji in da bo uvajal ustrezne
načine za uporabo morebitnih potrebnih korektivnih ukrepov (glej EN ISO 14971:2012, točka 9).
OPOMBA: Za ta vidik veljajo tudi druge, podrobnejše zahteve.
OPOZORILO: Za izdelke, ki sodijo v področje uporabe tega standarda, lahko veljajo tudi druge
zahteve in druge direktive EU.
10
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SIST EN ISO 14971 : 2012
Dodatek ZC
(informativni)
Povezava med tem evropskim standardom in zahtevami direktive EU 98/79/ES o
diagnostičnih medicinskih pripomočkih in vitro
Ta evropski standard je CEN pripravil v okviru pooblastila, ki sta mu ga dala Evropska komisija in
Evropsko združenje za prosto trgovino, da bi se zagotovila skladnost z zahtevami direktive novega
pristopa 98/79/ES o diagnostičnih medicinskih pripomočkih in vitro.
Ko je ta standard objavljen v Uradnem listu Evropske unije v okv
...
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