EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

ISO 14971:2007 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 Risiko-management 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

• Status: Withdrawn
• Publication Date: 03-Jul-2012
• Withdrawal Date: 17-Dec-2019
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 18-Dec-2019
• 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: 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: SIST EN ISO 14971:2012 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Relations

• Replaces: EN ISO 14971:2009 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
• Effective Date: 23-May-2012
• Replaced By: EN ISO 14971:2019 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)
• Effective Date: 30-Nov-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2012
1DGRPHãþD
SIST EN ISO 14971:2009
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
SULSRPRþNLK,62SRSUDYOMHQDYHU]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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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
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
3
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.

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.
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
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:

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
risk acceptability and that only non-acceptable risks have to be integrated into the overall risk-benefit
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.


This is explicitly stated in D.8.2.
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."
See D.6.1.
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 pr
...

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.

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
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
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

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
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.

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.
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.
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
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, vzpostavl
...