EN 45502-1:2015
(Main)Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance. This Part 1 of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). This Part 1 of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.
Aktive implantierbare medizinische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu stellende Informationen
Dieser Teil 1 von EN 45502 legt Anforderungen fest, die allgemein für AKTIVE IMPLANTIERBARE MEDIZINISCHE GERÄTE gelten. ANMERKUNG 1 Für besondere Arten von AKTIVEN IMPLANTIERBAREN MEDIZINISCHEN GERÄTEN werden diese allgemeinen Anforderungen durch die Anforderungen Besonderer Festlegungen ergänzt oder modifiziert, die die zusätzlichen Teile dieser Norm bilden. Die Prüfungen, die in dieser EN 45502 festgelegt sind, sind Typprüfungen und an Prüflingen eines AKTIVEN IMPLANTIERBAREN MEDIZINISCHEN GERÄTES durchzuführen, um die Einhaltung der Anforderung festzustellen. Dieser Teil der EN 45502 ist nicht nur anwendbar für AKTIVE IMPLANTIERBARE MEDIZINISCHE GERÄTE, die elektrisch betrieben werden, sondern auch für solche, die von anderen Energiequellen (zum Beispiel durch Gasdruck oder Federkraft) angetrieben werden. Dieser Teil der EN 45502 ist auch für einige nicht-implantierbare Teile und Zubehör anwendbar. ANMERKUNG 2 Die in dieser Europäischen Norm verwendete Terminologie soll der Terminologie der Richtlinie 90/385/EWG entsprechen. ANMERKUNG 3 In dieser europäischen Norm, werden Begriffe, die in Abschnitt 3 definiert werden, in KAPITÄLCHEN gedruckt. Wo definierte Begriffe als Merkmal eines anderen Begriffes dienen, wird dieser nicht in Kapitälchen gedruckt, es sei denn der fraglichen Begriff ist auch definiert.
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 1: Exigences générales de sécurité, marquage et informations fournies par le fabricant
La présente Partie 1 de la EN 45502 spécifie les exigences généralement applicables aux DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS. NOTE 1 Les exigences générales relatives à des types spéciaux de DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS sont complétées ou modifiées par les exigences des normes particulières, qui sont regroupées dans les parties additionnelles de cette Norme Européenne. Les essais spécifiés dans la EN 45502 sont des essais de type et doivent être réalisés sur des échantillons d’un DISPOSITIF MEDICAL IMPLANTABLE ACTIF afin d’en démontrer la conformité. La présente Partie 1 de la EN 45502 est applicable non seulement aux DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS qui sont alimentés électriquement, mais également à ceux qui fonctionnent à partir d'autres sources d'énergie (par exemple, un gaz pressurisé ou des ressorts). La présente Partie 1 de la EN 45502 est également applicable à certaines parties non implantables et aux accessoires des DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS. NOTE 2 La terminologie utilisée dans la présente Norme Européenne est prévue pour être cohérente avec celle de la Directive 90/385/CEE. NOTE 3 Dans la présente Norme Européenne, les termes imprimés en petites majuscules sont utilisés tels qu’ils sont définis à l’Article 3. Lorsqu’un terme défini est utilisé comme qualificatif d’un autre terme, il n’est pas imprimé en petites majuscules, sauf si la notion ainsi qualifiée est elle-même également définie.
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 1. del: Splošne zahteve za varnost, označevanje in informacije, ki jih priskrbi proizvajalec
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aktive implantierbare medizinische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu tellende InformationenDispositifs médicaux implantables actifs - Partie 1: Règles générales de sécurité, marquage et informations fournies par le fabricantImplants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 45502-1:2015SIST EN 45502-1:2015en01-oktober-2015SIST EN 45502-1:2015SLOVENSKI
STANDARDSIST EN 45502-1:20001DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 45502-1
May 2015 ICS 11.040.01
Supersedes
EN 45502-1:1997
English Version
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Dispositifs médicaux implantables actifs - Partie 1: Règles générales de sécurité, marquage et informations fournies par le fabricant
Aktive implantierbare medizinische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu tellende Informationen This European Standard was approved by CENELEC on 20 April 2015. 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 European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17,
B-1000 Brussels © 2015 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members.
Ref. No. EN 45502-1:2015 E SIST EN 45502-1:2015
Contents Page Foreword .4 Introduction .5 1 Scope .6 2 Normative references .6 3 Terms and definitions .7 4 Symbols and abbreviations (optional). 12 5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES . 12 6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES . 14 7 General arrangement of the packaging . 14 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES . 14 9 MARKINGS on the SALES PACKAGING . 15 10 Construction of the SALES PACKAGING. 16 11 MARKINGS on the STERILE PACK . 17 12 Construction of the NON-REUSABLE PACK . 18 13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE . 18 14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE . 19 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE IMPLANTABLE MEDICAL DEVICE . 21 16 Protection from HARM to the patient caused by electricity . 21 17 Protection from HARM to the patient caused by heat. 22 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL DEVICE . 22 19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE . 23 20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external defibrillators . 24 21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by electrical fields applied directly to the patient . 27 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous medical treatments . 28 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces . 29 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic discharge . 30 25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric pressure changes . 31 26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature changes . 31 27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing radiation . 31 28 Accompanying documentation . 32 SIST EN 45502-1:2015
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Annex A (informative)
General guidance and rationale . 37 Annex ZA
(normative) . 47 Annex ZZ (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices . 48 Bibliography . 59
Figures Figure 1 – Damped sinus defibrillation waveform . 25 Figure 2 – Defibrillation test voltage generator. 25 Figure 3 – Timing sequence used for Test 1 and Test 2 . 26 Figure 4 – Test setup for truncated exponential DEFIBRILLATION waveform . 26 Figure 5 – Biphasic DEFIBRILLATION waveform for Test 2 . 27 Figure A.1 – RLC implementation for generating a damped sinus defibrillation waveform . 42 Figure A.2 – Positioning and scanning the ultrasound field exposure upon the implantable part . 44 Tables Table 1 – Timing parameters of test signal for Test 2 . 26 SIST EN 45502-1:2015
Foreword This document (EN 45502-1:2015) has been prepared by CEN/CLC/JWG AIMD "CEN/CENELEC Joint Working Group on Active Implantable Medical Devices".
The following dates are fixed:
• latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-04-20 • latest date by which the national standards conflicting with this document have to be withdrawn (dow) 2018-04-20
This document supersedes EN 45502-1:1997.
a) update according to the modified AIMD; b) update of normative references to the “state of the art”; c) implementation of usability issues; d) implementation of links to information security; e) implementation of elements according to EN 14971:2012; f) improvement of Clause 14 “Protection from unintentional biological effects being caused by the active implantable medical device”; g) improvement of Clause 20 “Protection of the active implantable medical device from damage caused by external defibrillators”; h) improvement of Clause 22 “Protection of the active implantable medical device from changes caused by miscellaneous medical treatments” especially for ultrasonic diagnostic devices.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this document.
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Introduction This European Standard specifies general requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES to provide basic assurance of safety for both patients and users. To minimize the likelihood of a device being misused, this European Standard also details comprehensive requirements for MARKINGS and for other information to be supplied as part of the documentation with any ACTIVE IMPLANTABLE MEDICAL DEVICE. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICE, the general requirements can be supplemented or modified by the requirements of other parts of EN 45502. A requirement of a particular part of EN 45502 takes priority over the corresponding requirement of this general part of EN 45502. Where particular parts of EN 45502 exist, this general standard of EN 45502 is not intended to be used alone. Special care is required when applying this general standard part of EN 45502 alone to ACTIVE IMPLANTABLE MEDICAL DEVICES for which no particular part of EN 45502 has yet been published. SIST EN 45502-1:2015
1 Scope This part of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance. This part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). This part of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 2 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 3 In this part of EN 45502, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 60068-2-14:2009, Environmental testing – Part 2 14: Tests – Test N: Change of temperature (IEC 60068-2-14:2009) EN 60068-2-27:2009, En
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