EN ISO 25539-1:2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)

ISO 25539-1:2017 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
ISO 25539-1:2017 is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of transjugular intrahepatic portosystemic shunting (TIPS)]. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts) are within the scope of this document, the specific requirements and testing are not described. Similarly, specific prosthesis configurations (e.g. fenestrated, branched) are within the scope, but specific requirements and testing are not described for these devices.
ISO 25539-1:2017 is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.
Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. This document provides requirements beyond the requirements of ISO 10555‑4, specific to the use of balloons with endovascular prostheses.
ISO 25539-1:2017 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.
The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.
NOTE 1       Cardiac valved conduits are within the scope of ISO 5840‑1.
Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.
NOTE 2       Vascular device-drug combination products are within the scope of ISO 12417.
ISO 25539-1:2017 does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of endovascular prostheses.
The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.
NOTE 3       Absorbable materials are within the scope of ISO/TS 17137 and ISO/TR 37137.

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2017)

Dieses Dokument legt auf der Grundlage des derzeitigen medizinischen Wissenstandes Anforde¬rungen an die Bewertung von endovaskulären Systemen (Prothesen und Einführsystemen) und Anforderun¬gen an die Nomenklatur, die Konstruktionsmerkmale und die vom Hersteller bereitzustellenden Informationen fest. Ein Leitfaden zur Entwicklung von In vitro-Prüfverfahren wird in einem informativen Anhang dieses Dokuments gegeben. Dieses Dokument sollte als Ergänzung zu ISO 14630 angesehen werden, die allgemeine Anforderungen an die Funktion nichtaktiver chirurgischer Implantate festlegt.
Dieses Dokument gilt für endovaskuläre Systeme zur Behandlung von Aneurysmen, Stenosen oder sonstigen vaskulären Anomalien oder Pathologien (z. B. Dissektionen, Durchtrennungen) oder zur Herstellung von Shunts zwischen Gefäßen [z. B. Herstellung von transjugularen intrahepatischen portosystemischen Shunts (TIPS)]. Einige der Anforde¬rungen gelten ausschließlich für die endovaskuläre Behandlung von arteriellen Aneurysmen oder Stenosen. Obgleich andere Anwendungen endovaskulärer Systeme als die Behandlung von arteriellen Aneurysmen oder Stenosen (z. B. Dissektionen, Durchtrennungen, Shunts) ebenfalls in den Anwendungsbereich des vor¬liegenden Dokuments fallen, werden die speziellen Anforderungen und Prüfungen nicht beschrieben. Analog fallen auch bestimmte Prothesenkonstruktionen (z. B. solche mit Fensterung oder Verzweigung) in den Anwen¬dungsbereich, ohne dass spezielle Anforderungen oder Prüfungen dafür beschrieben werden.
Dieses Dokument gilt nicht für Gefäß-Okkluder, mit Ausnahme von kontralateralen iliakalen Ok¬kludern, sofern diese als integraler Bestandteil einer aorto-uni-iliakalen endovaskulären Prothese verwendet werden. Obgleich kontralaterale iliakale Arterien-Okkluder im Falle ihres Einsatzes als integraler Bestandteil einer aorto-uni-iliakalen endovaskulären Prothese in den Anwendungsbereich dieses Dokuments fallen, werden keine speziellen Anforderungen oder Prüfungen dafür beschrieben.
Ballons, die dazu dienen, die Prothese an der richtigen Stelle im Verhältnis zur Gefäßwand oder zu überlappenden Komponenten zu positionieren, fallen in den Anwendungsbereich dieses Dokuments, selbst wenn sie kein integraler Bestandteil des endovaskulären System sind. In diesem Dokument sind Anforde-rungen festgelegt, die über die Anforderungen von ISO 10555 4 hinausgehen und speziell für den Einsatz von Ballons mit endovaskulären Prothesen gelten.
Dieses Dokument gilt nicht für Verfahren und Produkte, die vor der Einführung des endo¬vaskulären Systems verwendet wurden, wie z. B. Ballonangioplastieprodukte.
Die Klappenkomponente von mit einer endovaskulären Prothesenkomponente versehenen Klappen-leitungen und die Kombination aus Klappenkomponente und endovaskulärer Prothesenkomponente fallen nicht in den Anwendungsbereich dieses Dokuments. Dieses Dokument kann bei der Ermittlung der für die endovaskuläre Prothesenkomponente einer Klappenleitung geeigneten Bewertung von Nutzen sein, es werden aber keine speziellen Anforderungen oder Prüfungen für diese Implantate beschrieben.
ANMERKUNG 1   Herzklappenleitungen fallen in den Anwendungsbereich von ISO 5840 3.
Pharmakologische Aspekte von Arzneimittel abgebenden oder mit Arzneimitteln umhüllten endovasku-lären Prothesen werden in der vorliegenden Norm nicht behandelt.
ANMERKUNG 2   Vaskuläre Kombinationsprodukte aus Implantat und Arzneimittel fallen in den Anwendungsbereich von ISO/TS 12417.
Dieses Dokument enthält weder Anforderungen an lebensfähiges Gewebe und nicht-lebensfähige biologische Materialien, die bei der Erstellung von endovaskulären Prothesen zum Einsatz kommen, noch deren Bewertung.
Die Anforderungen an die Qualitätsminderung und andere zeitabhängige Aspekte von bei der Erstel¬lung von endovaskulären Prothesen verwendeten resorbierbaren Materialien und deren Bewertung sind nicht Gegenstand dem vorliegenden Dokument.

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses endovasculaires (ISO 25539-1:2017)

ISO 25539-1:2017 spécifie les exigences relatives à l'évaluation des systèmes endovasculaires (prothèses et systèmes de pose) et les exigences relatives à la nomenclature, aux caractéristiques de conception et aux informations fournies par le fabricant, sur la base des connaissances médicales actuelles. Les préconisations relatives à l'élaboration des méthodes d'essai in vitro figurent dans une annexe informative du présent document. Le présent document peut être considéré comme un complément à l'ISO 14630, qui spécifie les exigences générales relatives aux performances des implants chirurgicaux non actifs.
ISO 25539-1:2017 est applicable aux systèmes endovasculaires utilisés pour le traitement des anévrismes, sténoses et autres troubles ou pathologies vasculaires (par exemple dissections, sections transversales) ou pour créer des shunts entre les vaisseaux (par exemple création d'un shunt intra-hépatique par voie transjugulaire [TIPS]). Certaines des exigences sont spécifiques au traitement endovasculaire des anévrismes ou sténoses artériels. Bien que les utilisations de systèmes endovasculaires autres que pour le traitement des sténoses et anévrismes artériels (par exemple dissections, sections transversales, shunts) entrent dans le domaine d'application du présent document, les exigences et essais spécifiques ne sont pas décrits. De la même manière, les configurations spécifiques de prothèse (par exemple fenêtrée, branchée) entrent dans le domaine d'application du présent document, mais les exigences et essais spécifiques ne sont pas décrits pour ces dispositifs.
Les dispositifs d'occlusion vasculaire ne sont pas abordés dans le présent document, sauf lorsqu'il s'agit de dispositifs d'occlusion de l'artère iliaque controlatérale utilisés comme partie intégrante d'une prothèse endovasculaire aorto-uni-iliaque. Bien que les dispositifs d'occlusion de l'artère iliaque controlatérale, utilisés comme partie intégrante d'une prothèse endovasculaire aorto-uni-iliaque, entrent dans le domaine d'application du présent document, les exigences et essais spécifiques ne sont pas décrits pour ces dispositifs.
Les ballonnets utilisés pour obtenir une apposition appropriée de la prothèse sur la paroi du vaisseau ou des composants chevauchants entrent dans le domaine d'application du présent document, bien qu'ils ne font pas partie intégrante des systèmes endovasculaires. Le présent document fournit des exigences allant au-delà de celles de l'ISO 10555‑4, spécifiques à l'utilisation de ballonnets avec des prothèses endovasculaires.
Les techniques et les dispositifs utilisés avant l'introduction du système endovasculaire, tels que les dispositifs d'angioplastie par ballonnet, sont exclus du domaine d'application du présent document.
La valve des conduits à valve constitués d'un composant de prothèse endovasculaire ainsi que la combinaison du composant à valve et du composant de prothèse endovasculaire sont exclues du domaine d'application du présent document. Le présent document peut être utile pour identifier l'évaluation appropriée du composant de prothèse endovasculaire d'un conduit à valve; néanmoins, les exigences et essais spécifiques relatifs à ces dispositifs n'y sont pas décrits.
NOTE 1       Les conduits à valve cardiaques entrent dans le domaine d'application de l'ISO 5840‑1.
Les aspects pharmacologiques relatifs aux prothèses endovasculaires à élution médicamenteuse ou à enrobage médicamenteux ne sont pas traités dans le présent document.

Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 1. del: Znotrajžilne proteze (ISO 25539-1:2017)

Ta dokument določa zahteve za ocenjevanje znotrajžilnih sistemov (proteze in sistemi za dovajanje) ter zahteve glede nomenklature, oblike in informacij, ki jih proizvajalec priskrbi na podlagi trenutnega medicinskega znanja. Smernice za razvoj preskusnih metod in vitro je vključen v informativni dodatek tega dokumenta. Ta dokument se lahko šteje za dodatek k standardu ISO 14630, ki določa splošne zahteve za lastnosti neaktivnih kirurških vsadkov.
Ta dokument se uporablja za znotrajžilne sisteme, ki se uporabljajo za zdravljenje anevrizem, stenoz ali drugih
žilnih nepravilnosti ali patologij (npr. disekcije, transekcije) oziroma ustvarjanje obvodov med žilami [npr. ustvarjanje transjugularnih znotrajjetrnih sistemsko-portalnih obvodov (TIPS)]. Nekatere od teh zahtev veljajo posebej za znotrajžilno zdravljenje arterijskih anevrizem ali stenoz. Čeprav uporabe znotrajžilnih sistemov poleg zdravljenja arterijskih anevrizm ali stenoz (npr. disekcija, transekcija, obvodi) spadajo na področje uporabe tega dokumenta, posebne zahteve in preskušanja niso opisani.
Na področje uporabe spadajo tudi konfiguracije protez (npr. fenestrirana, razvejana), vendar posebne zahteve in preskušanja za te naprave niso opisani.
Ta dokument se ne uporablja za žilna mašila, razen mašila za kontralateralne iliakalne arterije, ko se uporabljajo kot sestavni del aorto-uni-iliakalnih znotrajžilnih protez. Čeprav mašila za kontralateralne iliakalne arterije, ko se uporabljajo kot sestavni del aorto-uni-iliakalnih znotrajžilnih protez, spadajo na področje uporabe tega dokumenta, posebne zahteve in preskušanja za te naprave niso opisani.
Baloni, ki se uporabljajo za doseganje ustreznega položaja proteze v primerjavi z žilno steno ali prekrivajočimi elementi, spadajo na področje uporabe tega dokumenta, čeprav niso sestavni deli znotrajžilnega sistema. Ta dokument podaja zahteve, ki presegajo zahteve standarda ISO 10555-4 in se uporabljajo za balone z znotrajžilnimi protezami.
Ta dokument se ne uporablja za postopke in naprave, ki se uporabljajo pred vstavljanjem
znotrajžilnega sistema, kot so balon ali naprave za angioplastiko.
Zaklopna komponenta kanalne zaklopke, spojena s komponento znotrajžilne proteze, in kombinacija zaklopne komponente in komponente znotrajžilne proteze ne spadata na področje uporabe tega dokumenta. Ta dokument je lahko v pomoč pri ustreznem ocenjevanju komponente znotrajžilne proteze kanalne zaklopke, vendar posebne zahteve in preskušanje za te naprave niso opisani.
OPOMBA 1: Srčne kanalne zaklopke spadajo na področje uporabe standarda ISO 5840-1.
Farmakološki vidiki elucije zdravil ali znotrajžilnih protez, premazanih z zdravili, niso obravnavani v tem dokumentu.
OPOMBA 2: Izdelki s kombinacijami žilne naprave in zdravila spadajo na področje uporabe standarda ISO 12417.
Ta dokument ne obravnava ocenjevanja in zahtev za živa tkiva in nežive biološke materiale, ki se uporabljajo pri izdelavi znotrajžilnih protez.
Ocenjevanje in zahteve za razgradnjo in druge časovno odvisne vidike
vpojnih materialov, ki se uporabljajo pri izdelavi znotrajžilnih protez, niso obravnavani v tem dokumentu.
OPOMBA 3: Vpojni materiali spadajo na področje uporabe standardov ISO/TS 17137 in ISO/TR 37137.

General Information

• Status: Published
• Publication Date: 14-Mar-2017
• Withdrawal Date: 14-Mar-2020
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Mar-2017
• Completion Date: 15-Mar-2017
• 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: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 25539-1:2017 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)

Relations

• Replaces: EN ISO 25539-1:2009/AC:2011 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
• Effective Date: 22-Mar-2017
• Replaces: EN ISO 25539-1:2009 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
• Effective Date: 09-Jul-2014

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2017
1DGRPHãþD
SIST EN ISO 25539-1:2009
SIST EN ISO 25539-1:2009/AC:2011
9VDGNLLPSODQWDWL]DVUFHLQRåLOMH=QRWUDMåLOQLSULSRPRþNLGHO=QRWUDMåLOQH
SURWH]H,62
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO
25539-1:2017)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 1: Endovaskuläre
Prothesen (ISO 25539-1:2017)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses
endovasculaires (ISO 25539-1:2017)
Ta slovenski standard je istoveten z: EN ISO 25539-1:2017
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 25539-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 25539-1:2009
English Version
Cardiovascular implants - Endovascular devices - Part 1:
Endovascular prostheses (ISO 25539-1:2017)
Implants cardiovasculaires - Dispositifs Kardiovaskuläre Implantate - Endovaskuläre
endovasculaires - Partie 1: Prothèses endovasculaires Implantate - Teil 1: Endovaskuläre Prothesen (ISO
(ISO 25539-1:2017) 25539-1:2017)
This European Standard was approved by CEN on 23 December 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25539-1:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

European foreword
This document (EN ISO 25539-1:2017) has been prepared by Technical Committee ISO/TC 150
“Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical
implants” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2017 and conflicting national standards
shall be withdrawn at the latest by September 2017.
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 supersedes EN ISO 25539-1:2009.
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 Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 25539-1:2017 has been approved by CEN as EN ISO 25539-1:2017 without any
modification.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between undated normative references and dated EN and ISO standards
Normative references as Equivalent dated standard
listed in Clause 2
EN ISO
ISO 10993 (all parts) EN ISO 10993-1:2009 ISO 10993-1:2009
EN ISO 10993-2:2006 ISO 10993-2:2006
EN ISO 10993-3:2014 ISO 10993-3:2014
EN ISO 10993-4:2009 ISO 10993-4:2002 and
Amd 1:2006
EN ISO 10993-5:2009
ISO 10993-5:2009
EN ISO 10993-6:2009
ISO 10993-6:2007
EN ISO 10993-7:2008 and
EN ISO 10993-7:2008/AC:2009 ISO 10993-7:2008 and
ISO 10993-7:1/Cor 1:2009
EN ISO 10993-9:2009
ISO 10993-9:2009
EN ISO 10993-10:2013
ISO 10993-10:2010
EN ISO 10993-11:2009
ISO 10993-11:2006
EN ISO 10993-12:2012
ISO 10993-12:2012
EN ISO 10993-13:2010
ISO 10993-13:2010
EN ISO 10993-14:2009
ISO 10993-14:2001
EN ISO 10993-15:2009
ISO 10993-15:2000
EN ISO 10993-16:2010
ISO 10993-16:2010
EN ISO 10993-17:2009
ISO 10993-17:2002
EN ISO 10993-18:2009
ISO 10993-18:2005
-
ISO/TS 10993-19:2006
-
ISO/TS 10993-20:2006
ISO 11135 EN ISO 11135:2014 ISO 11135:2014
ISO 11137 (all parts) EN ISO 11137-1:2015 ISO 11137-1:2006 and
Amd 1:2013
EN ISO 11137-2:2015
ISO 11137-2:2013
EN ISO 11137-3:2006
ISO 11137-3:2006
ISO 11607-1 EN ISO 11607-1:2009 and ISO 11607-1:2006 and
EN ISO 11607-1:2009/A1:2014 Amd 1:2014
ISO 14155 EN ISO 14155:2011 ISO 14155:2011 and
Cor. 1:2011
ISO 14160 EN ISO 14160:2011 ISO 14160:2011
ISO 14630:2012 EN ISO 14630:2012 ISO 14630:2012
ISO 14937 EN ISO 14937:2009 ISO 14937:2009
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
ISO 17665 (all parts) EN ISO 17665-1:2006 ISO 17665-1:2006
CEN ISO/TS 17665-2:2009 ISO/TS 17665-2:2009
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardisation request M/023
concerning the development of European standards related to medical devices to provide a voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope
of this standard, a presumption of conformity with the corresponding Essential Requirements of that
Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ’as far as possible’, ’to a minimum’, ’to the lowest possible level’, ’minimized’
or ’removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1— Correspondence between this European Standard and
Annex I of Directive 93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 93/42/EEC this EN
7.2 11.2 Partially covered by the sub-
clause: There is a requirement
for devices to be designed to
protect patients from
sterilization residuals when the
device is used.
Other contaminants and
residues are not covered.
Manufacturing and packing to
minimize these risks are not
covered.
8.1 11.1, 12.1.5 Partially covered by the sub-
clauses: Requirements for
ensuring sterility are included
for devices that are supplied
sterile (11.1) which would
eliminate or reduce as far as
possible the risk of infection to
the patient.
Maintenance of sterility in
transit is covered in 12.1.5.
Risk of infection to the user and
third party are not covered.
Minimizing contamination
during use is not covered.
8.3 11.1, 12.1, 10 with 6.4(c) Sterility assurance (11.1),
manufacturing (10), packaging
design and maintenance of
sterility (12.1) are covered.
6.4(c) includes the requirement
for the design attributes to take
the need for sterility into
account.
8.4 11.1, 10 with 6.4(c) Manufacturing (10),
sterilization validation and
routine control (11.1) are
covered, with the requirement
for the design attributes to take
the need for sterility into
account (6.4(c)).
9.1 8.5.1.5, 12.3.2(i) Endovascular systems may be
designed to be used with
accessory devices (e.g., guide
wires, introducer sheaths).
Accessory devices are
evaluated for compatibility
with the endovascular system
in simulated use testing
(8.5.1.5).
Requirements regarding
instructions for use include
preparation and implantation
techniques including the use of
ancillary devices (12.3.2(i)).
9.2, first indent 4.3, 6.2, 6.3, 8.5.1.2, 8.5.2.7, Partially covered by the sub-
8.5.1.5 clauses: Device design is
covered through the
requirement to specify
dimensions (4.3), design
attribute requirements (6.2
and 6.3) and the requirements
for dimensional verification
(8.5.1.2, 8.5.2.7).
The risk of injury to the patient
is also covered through
simulated use testing (8.5.1.5).
Manufacturing to minimize
risks associated with physical
features is not covered.
9.2, second indent 6.3 (g), 8.5.2.9 Only risks associated with
magnetic fields is covered
through design attribute
(6.3(g)) and MRI safety
(8.5.2.9) requirements.
The other environmental
conditions are not applicable.
13.1 12.2, 12.3 The labelling (12.2) and
instructions for use (12.3) sub-
clauses cover this directive.
13.3(a) 12.2.1(a) Partially covered by the sub-
clause: This directive is
covered with the exception of
the requirement regarding the
name and address of the
authorised representative
where the manufacturer does
not have a registered place of
business in the Community.
13.3(b) 12.2.1(b), (c), (d), (e), (f) Identification of the device and
the contents of the packaging is
covered:
12.2.1
b) product name;
c) the material of
construction and type of
construction;
d) the configuration (see
4.3). A symbol may be
substituted for a written
description of the
prosthesis;
e) the nominal length(s);
f) the nominal diameter(s);
13.3(c) 12.2.1(g) The inclusion of the word
‘STERILE’ on the product label
is covered by the requirement
to include the words
“STERILE—DO NOT
RESTERILIZE—SINGLE USE
ONLY”, or equivalent phrase or
symbols, in prominent form
per the sub-clause.
13.3(d) 12.2.1(k) This directive is covered by the
requirement to include the
manufacturer’s batch or lot
number per the sub-clause, but
only if the batch code is
preceded by the word ‘LOT.’
13.3(e) 12.2.1(j) This directive is covered by the
requirement to include the
date of sterilization and/or
expiration date per the sub-
clause.
13.3(f) 12.2.1(g) Partially covered by the sub-
clause: This directive is
covered by the requirement to
include the words ‘SINGLE USE
ONLY’ per the sub-clause.
Consistency of marking across
the community is not covered.
13.3(i) 12.2.1(m) Partially covered by the sub-
clause: This directive is
covered by the requirement to
include the manufacturers
recommendations for storage
(when applicable) per the sub-
clause.
Handling is not covered.
13.3(k) 12.2.1(l) Partially covered by the sub-
clause: The only warning that is
included indicates not to use if
the package is opened or
damaged.
13.3(m) 12.2.1(h) This directive is covered by the
requirement to include the
method of sterilization per the
sub-clause.
13.4 12.3.2(d) This directive is covered. The
intended purpose is obvious,
but the intended use is
required to be specified in the
instructions for use per the
sub-clause.
13.6(a) [13.3(a),(b), (c), (f), (i), 12.3.2(a), (b), (c)
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