SIST 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 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.
Aktive implantierbare medizinische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu tellende 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.
Dispositifs médicaux implantables actifs - Partie 1: Règles 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
SIST EN 45502-1:2015
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
EN 45502-1:2015 - 2 -
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
EN 45502-1:2015 - 4 -
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.
EN 45502-1:2015 includes the following significant technical changes with respect to 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.
SIST EN 45502-1:2015
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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
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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, Environmental testing – Part 2 27: Tests – Test Ea and guidance: Shock (IEC 60068-2-27:2008) EN 60068-2-47:2005, Environmental testing – Part 2 47: Tests – Mounting of specimens for vibration, impact and similar dynamic tests (IEC 60068-2-47:2005) EN 60068-2-64:2008, Environmental testing – Part 2 64: Tests – Test Fh: Vibration, broadband random and guidance (IEC 60068-2-64:2008) EN 60601-1:2006, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005) EN 60601-1:2006/A1:2013, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A1:2012) EN 62304:2006, Medical devices software – Software life-cycle processes (IEC 62304:2006) EN 62366:2008, Medical devices – Application of usability engineering to medical devices (IEC 62366:2007) EN ISO 10993-1:2009, Biological testing of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2003) EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) SIST EN 45502-1:2015
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EN ISO 14155:2011-10, Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2011) EN ISO 14971:2012, Medical devices – Application of risk management to medical devices (ISO 14971:2007) ISO 8601:2004, Data elements and interchange formats – Information interchange – Representation of dates and times 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 ACTIVE MEDICAL DEVICE MEDICAL DEVICE relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity 3.2 ACTIVE IMPLANTABLE MEDICAL DEVICE ACTIVE MEDICAL DEVICE which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure Note 1 to entry: For purposes of this part of EN 45502, an ACTIVE IMPLANTABLE MEDICAL DEVICE can be a single ACTIVE MEDICAL DEVICE, or a system consisting of a set of components and accessories, including software, which interact to achieve the performance intended by the MANUFACTURER. Not all of these components or accessories may be required to be partially or totally implanted. 3.3 AUTHORIZED REPRESENTATIVE any natural or legal person established in the European Community who, explicitly designated by the MANUFACTURER, acts and can be addressed by authorities and bodies in the Community instead of the MANUFACTURER with regard to the latter's obligations 3.4 BEGINNING OF SERVICE BOS when an individual ACTIVE IMPLANTABLE MEDICAL DEVICE is first released by the MANUFACTURER as fit for placing on the market 3.5 CATHETER flexible tube allowing access to a point within the body at its distal end through a lumen, often for delivering a substance Note 1 to entry: A CATHETER CAN be combined with a LEAD. 3.6 CORRECT USE NORMAL USE without USE ERROR [SOURCE: EN 62366:2008, 3.7] 3.7 END OF SERVICE EOS point at which an individual PROLONGED SERVICE PERIOD has elapsed and performance to design specification cannot be assured SIST EN 45502-1:2015
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3.8 HAND HELD part of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to be supported by the hand during NORMAL USE [SOURCE: EN 60601-1:2006 + A1:2013, 3.37, modified — 'Electrical equipment' replaced by 'part of an ACTIVE IMPLANTABLE MEDICAL DEVICE'.] 3.9 HARM physical injury or damage to health of people, or damage to property or the environment [SOURCE: EN ISO 14971:2012, 2.2] 3.10 HAZARD potential source of HARM [SOURCE: EN ISO 14971:2012, 2.3] 3.11 INFORMATION SECURITY protection of information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to provide confidentiality, integrity, and availability [SOURCE: FIPS PUB 199] 3.12 LABEL area bearing a MARKING, affixed to an ACTIVE IMPLANTABLE MEDICAL DEVICE or package but not an integral part of the ACTIVE IMPLANTABLE MEDICAL DEVICE or package 3.13 LEAD flexible tube enclosing one or more insulated electrical conductors, intended to transfer electrical energy along its length Note 1 to entry: A LEAD can be combined with a CATHETER. 3.14 MANUFACTURER natural or legal person with responsibility for the design, manufacture, packaging and labelling of an ACTIVE IMPLANTABLE MEDICAL DEVICE before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party Note 1 to entry: This definition also applies to the natural or legal person who assembles, packages, PROCESSES, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as an ACTIVE IMPLANTABLE MEDICAL DEVICE with a view to their being placed on the market under his own name. This definition also applies to the MANUFACTURER of non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICE. 3.15 MARKING inscription on a device, package, or LABEL SIST EN 45502-1:2015
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3.16 MEDICAL DEVICE instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its MANUFACTURER to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the MANUFACTURER to be used for human beings for the purpose of – diagnosis, prevention, monitoring, treatment or alleviation of disease, – diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, – investigation, replacement or modification of the anatomy or of a physiological process, – control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means 3.17 MEDICINAL SUBSTANCE substance or combination of substances presented as having properties for treating or preventing disease in human beings; or any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis Note 1 to entry: Based on Article 1 of European Union Directive 2001/83/EC. 3.18 MEDICINAL SUBSTANCE DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA MEDICINAL SUBSTANCE based on blood constituents which are prepared industrially by public or private establishments, such MEDICINAL SUBSTANCE including, in particular, albumin, coagulating factors and immunoglobulins of human origin 3.19 NON-REUSABLE PACK single use pack designed to allow the contents to be sterilized and to maintain that sterility 3.20 NORMAL USE operation, including routine inspection and adjustments by any user, and stand-by, according to the instructions for use or in accordance with generally accepted practice for those MEDICAL DEVICES provided without instructions for use Note 1 to entry: USE ERROR can occur in NORMAL USE. Note 2 to entry: MEDICAL DEVICES that can be used safely without instructions for use are exempted from having instructions for use by some authorities with jurisdiction. [SOURCE: EN 60601-1:2006 + A1:2013, 3.71, modified — 'Operator' replaced by 'user' and 'or in accordance with generally accepted practice for those MEDICAL DEVICES provided without instructions for use' added to the end of the definition.] 3.21 PORTABLE part of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to be moved from one location to another while being carried by one or more persons [SOURCE: EN 60601-1:2006 + A1:2013, 3.85, modified — 'Transportable equipment' replaced by 'part of an ACTIVE IMPLANTABLE MEDICAL DEVICE'.] SIST EN 45502-1:2015
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3.22 PROCESS set of inter-related or interacting resources and activities which transform inputs into outputs [SOURCE: EN ISO 14971:2012, 2.130] 3.23 PROLONGED SERVICE PERIOD PSP period during which the ACTIVE IMPLANTABLE MEDICAL DEVICE continues to function as defined by the MANUFACTURER beyond the RECOMMENDED REPLACEMENT TIME 3.24 RADIOACTIVE SUBSTANCE substance that contains one or more radionuclides the activity or concentration of which cannot be disregarded as far as radiation protection is concerned Note 1 to entry: Based on European Council Directive 96/29/Euratom. 3.25 RECOMMENDED REPLACEMENT TIME RRT point at which the power source indicator reaches the value set by the MANUFACTURER of the ACTIVE IMPLANTABLE MEDICAL
DEVICE for its recommended replacement Note 1 to entry: This indicates entry into the PROLONGED SERVICE PERIOD. 3.26 RESIDUAL RISK RISK remaining after RISK CONTROL measures have been taken [SOURCE: EN ISO 14971:2012, 2.15] 3.27 RISK combination of the probability of occurrence of HARM and the severity of that HARM [SOURCE: EN ISO 14971:2012, 2.16] 3.28 RISK ANALYSIS systematic use of available information to identify HAZARDS and to estimate the RISK Note 1 to entry: RISK ANALYSIS includes examination of different sequences of events that can produce hazardous situations and HARM. See Annex E of EN ISO 14971:2012. [SOURCE: EN ISO 14971:2012, 2.17] 3.29 RISK ASSESSMENT overall PROCESS comprising a RISK ANALYSIS and a RISK EVALUATION [SOURCE: EN ISO 14971:2012, 2.18] 3.30 RISK CONTROL PROCESS in which decisions are made and measures implemented by which RISKS are reduced to, or maintained within, specified levels [SOURCE: EN ISO 14971:2012, 2.19] SIST EN 45502-1:2015
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3.31 RISK EVALUATION PROCESS of comparing the estimated RISK against given RISK criteria to determine the acceptability of the RISK [SOURCE: EN ISO 14971:2012, 2.21] 3.32 RISK MANAGEMENT systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring RISK [SOURCE: EN ISO 14971:2012, 2.22] 3.33 RISK MANAGEMENT FILE set of records and other documents that are produced by RISK MANAGEMENT [SOURCE: EN ISO 14971:2012, 2.23] 3.34 SALES PACKAGING packaging that protects and identifies the ACTIVE IMPLANTABLE MEDICAL DEVICE during storage and handling by the purchaser Note 1 to entry: The SALES PACKAGING may be enclosed in further packaging, for example, a 'shipping package', for delivery. 3.35 SEALED SOURCE source containing RADIOACTIVE SUBSTANCES whose structure is such as to prevent, under normal conditions of use, any dispersion of the RADIOACTIVE SUBSTANCES into the environment Note 1 to entry: Based on European Council Directive 96/29/Euratom. 3.36 STERILE PACK NON-REUSABLE PACK in which the contents have been sterilized 3.37 USABILITY characteristic of the user interface that establishes effectiveness, efficiency, ease of user learning and user satisfaction [SOURCE: EN 62366:2008, 3.17] 3.38 USABILITY ENGINEERING application of knowledge about human behaviour, abilities, limitations, and other characteristics related to the design of tools, devices, systems, tasks, jobs, and environments to achieve adequate USABILITY [SOURCE: EN 62366:2008, 3.18] SIST EN 45502-1:2015
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3.39 USE ERROR act or omission of an act that results in a different ACTIVE IMPLANTABLE MEDICAL DEVICE response than intended by the MANUFACTURER or expected by the user Note 1 to entry: USE ERROR includes slips, lapses, and mistakes. Note 2 to entry: An unexpected physiological response of the patient is not in itself considered USE ERROR. [SOURCE: EN 62366:2008, 3.21, modified — 'MEDICAL DEVICE' replaced by 'ACTIVE IMPLANTABLE MEDICAL DEVICE'.] 3.40 VALIDATION confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled [SOURCE: EN 62366:2008, 3.26] 4 Symbols and abbreviations (optional) When appropriate, symbols, abbreviated terms and identification colour may be used in the MARKINGS and accompanying documentation of an ACTIVE IMPLANTABLE MEDICAL DEVICE. Symbols, abbreviated terms and identification colour shall conform to harmonized standards (e.g. EN ISO 15223-1). Where no harmonized standard exists, the symbols, abbreviated terms and identification colour shall be described in the accompanying documentation. Compliance is checked by inspection. NOTE Symbols for use with particular ACTIVE IMPLANTABLE MEDICAL DEVICES can be specified in subsequent parts of EN 45502. 5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES 5.1 General requirements for non-implantable parts The non-implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE which is connected to or equipped with an electrical power source shall comply with the appropriate requirements of EN 60601-1:2006 and its A1:2013, as determined in the RISK ANALYSIS, unless a requirement in that standard is superseded by a requirement in this or other parts of EN 45502. NOTE
Other subclauses in this standard require compliance with some subclauses of EN 60601-1:2006 and its A1:2013 even for non-implantable parts that are not electrically powered. Compliance is checked by assessment of the test report and the RISK ANALYSIS provided by the MANUFACTURER. 5.2 General requirements for software Software of an ACTIVE IMPLANTABLE MEDICAL DEVICE or software that falls within the definition of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be designed according to software life cycle process activities compliant with EN 62304:2006 and shall be validated. Compliance is checked by assessment of the software life cycle PROCESS in accordance with EN 62304:2006, 1.4 and assessment of the VALIDATION report provided by the MANUFACTURER. SIST EN 45502-1:2015
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5.3 USABILITY of non-implantable parts 5.3.1 USABILITY of non-implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE connected to or equipped with an electrical power source The MANUFACTURER shall address in a USABILITY ENGINEERING PROCESS the RISK of poor USABILITY, including those associated with identification, MARKING and documents Compliance is checked by assessment of the MANUFACTURER’S documentations that the acceptance criteria of the USABILITY VALIDATION plan have been met (see EN 62366:2008, 5.9). 5.3.2 USABILITY of non-implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE not connected to or equipped with an electrical power source The non-implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall provide adequate USABILITY such that the RISKS resulting from CORRECT USE and USE ERRORS are acceptable. Compliance is checked by assessment of the MANUFACTURER’S documentations that
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Active implantable medical devices - Part 1: General requirements for safety, marking
and information to be provided by the manufacturer
Aktive implantierbare medizinische Geräte - Teil 1: Allgemeine Festlegungen für die
Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu stellende Informationen
Dispositifs médicaux implantables actifs - Partie 1: Règles générales de sécurité,
marquage et informations fournies par le fabricant
Ta slovenski standard je istoveten z: prEN 45502-1:2010
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN 45502-1:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 45502-1:2010
DRAFT
EUROPEAN STANDARD
prEN 45502-1
NORME EUROPÉENNE
July 2010
EUROPÄISCHE NORM
ICS 11.040.40 Will supersede EN 45502-1:1997
English version
Active implantable medical devices -
Part 1: General requirements for safety, marking and information to be
provided by the manufacturer
Dispositifs médicaux implantables actifs - Aktive implantierbare medizinische Geräte -
Partie 1: Règles générales de sécurité, Teil 1: Allgemeine Festlegungen für die
marquage et informations fournies par le Sicherheit, Aufschriften und vom Hersteller
fabricant zur Verfügung zu stellende Informationen
This draft European Standard is submitted to CENELEC members for CENELEC enquiry.
Deadline for CENELEC: 2010-12-17.
It has been drawn up by CEN/CLC/JWG AIMD.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CENELEC in three official versions (English, French, German).
A version in any other language made by translation under the responsibility of a CENELEC member into its own
language and notified to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia,
Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to
change without notice and shall not be referred to as a European Standard.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Project: 22891 Ref. No. prEN 45502-1:2010 E
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1 Foreword
2 This draft European Standard was prepared by the CEN/CENELEC Joint Working Group on Active
3 Implantable Medical Devices (CEN/CLC/JWG AIMD). Members of the Joint Working Group were
4 nominated by one of the members of either CEN or CENELEC. It is submitted to CENELEC enquiry.
5 This document will supersede EN 45502-1:1997.
6 This draft European Standard has been prepared under Mandate M/432 given to CEN and CENELEC
7 by the European Commission and the European Free Trade Association and covers essential
8 requirements of EC Directive 90/385/EEC.
9 Although both this European Standard and the Directive deal with the same range of products, the
10 structure and purpose of the two documents are different. Annex A of this European Standard
11 correlates the requirements of the Directive with the subclauses of this Standard.
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12 Contents
13 Introduction . 5
14 1 Scope . 6
15 2 Normative references . 6
16 3 Terms and definitions . 7
17 4 Symbols and abbreviations (optional).11
18 5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES .11
19 6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES .13
20 7 General arrangement of the packaging .13
21 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES .14
22 9 MARKINGS on the SALES PACKAGING .14
23 10 Construction of the SALES PACKAGING.15
24 11 Markings on the STERILE PACK .16
25 12 Construction of the non-reusable pack .17
26 13 Markings on the active implantable medical device .17
27 14 Protection from unintentional biological effects being caused by the active
28 implantable medical device .18
29 15 Protection from HARM to the patient or user caused by external physical features of the
30 ACTIVE IMPLANTABLE MEDICAL DEVICE .19
31 16 Protection from harm to the patient caused by electricity .19
32 17 Protection from harm to the patient caused by heat .20
33 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE
34 MEDICAL DEVICE .20
35 19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE .21
36 20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external
37 defibrillators .22
38 21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by high
39 power electrical fields applied directly to the patient .25
40 22 Protection of the active implantable medical device from changes caused by
41 miscellaneous medical treatments .25
42 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces .26
43 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by
44 electrostatic discharge .28
45 25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by
46 atmospheric pressure changes .28
47 26 Protection of the active implantable medical device from damage caused by
48 temperature changes .29
49 27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing
50 radiation .29
51 28 Accompanying documentation .30
52 Annex A (informative) General guidance and rationale .34
53 Bibliography .43
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54
55 Figures
56 Figure 1 – Damped sinus defibrillation waveform . 22
57 Figure 2 – RCL circuit for generating a damped sinus defibrillation waveform . 23
58 Figure 3 – Timing sequence used for DEFIBRILLATION test . 23
59 Figure 4 – Test setup for truncated exponential DEFIBRILLATION waveform . 24
60 Figure 5 – Biphasic DEFIBRILLATION waveform for Test 2 . 24
61
62 Tables
63 Table 1 – Timing parameters of test signal for Test 2 . 24
64
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65 Introduction
66 This European Standard specifies general requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES, to
67 provide basic assurance of safety for both patients and users.
68 To minimize the likelihood of a device being misused, this standard also details comprehensive
69 requirements for MARKINGS and for other information to be supplied as part of the documentation with
70 any ACTIVE IMPLANTABLE MEDICAL DEVICE.
71 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICE, the general requirements are
72 supplemented or modified by the requirements of particular standards as separate parts of EN 45502.
73 A requirement of such a particular standard takes priority over the corresponding requirement of this
74 general standard. Where particular standards exist, this general standard should not be used alone.
75 Special care is required when applying this general standard alone to ACTIVE IMPLANTABLE MEDICAL
76 DEVICES for which no particular standard has yet been published.
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77 1 Scope
78 This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE
79 MEDICAL DEVICES.
80 NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or
81 modified by the requirements of particular standards which form additional parts of this European Standard.
82 The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an
83 ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance.
84 This Part 1 of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are
85 electrically powered but also to those powered by other energy sources (for example by gas pressure
86 or by springs).
87 This Part 1 of EN 45502 is also applicable to some non-implantable parts and accessories of the
88 ACTIVE IMPLANTABLE MEDICAL DEVICES.
89 NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive
90 90/385/EEC.
91 NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined
92 term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also
93 defined.
94 2 Normative references
95 The following referenced documents are indispensable for the application of this document. For dated
96 references, only the edition cited applies. For undated references, the latest edition of the referenced
97 document (including any amendments) applies.
98 EN 556-1:2001, Sterilization of medical devices – Requirements for medical devices to be labelled
99 'STERILE' – Part 1: Requirements for terminally sterilized devices
100 EN 60068-2-14:2009, Environmental testing – Part 2-14: Tests – Test N: Change of temperature
101 (IEC 60068-2-14:2009)
102 EN 60068-2-27:2009, Environmental testing – Part 2-27: Tests – Test Ea and guidance: Shock
103 (IEC 60068-2-27:2008)
104 EN 60068-2-47:2005, Environmental testing – Part 2-47: Tests – Mounting of specimens for vibration,
105 impact and similar dynamic tests (IEC 60068-2-47:2005)
106 EN 60068-2-64:2008, Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband
107 random and guidance (IEC 60068-2-64:2008)
108 EN 60601-1:2006 + corr. Mar. 2010, Medical electrical equipment – Part 1: General requirements for
109 basic safety and essential performance (IEC 60601-1:2005)
110 EN 60601-1-2:2007 + corr. Mar. 2010, Medical electrical equipment – Part 1: General requirements for
111 basic safety and essential performance – Collateral standard: Electromagnetic compatibility –
112 Requirements and tests (IEC 60601-1-2:2007, mod.)
113 EN 62304:2006 + corr. Nov. 2008, Medical devices software – Software life-cycle processes
114 (IEC 62304:2006)
115 EN 62366:2008, Medical devices – Application of usability engineering to medical devices
116 (IEC 62366:2007)
117 EN ISO 10993-1:2009, Biological testing of medical devices – Part 1: Evaluation and testing within a
118 risk management process (ISO 10993-1:2009)
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1)
119 EN ISO 11607-1:2006 , Packaging for terminally sterilized medical devices – Part 1: Requirements
120 for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
121 EN ISO 14155-1:2009, Clinical investigation of medical devices for human subjects – Part 1: General
122 requirements (ISO 14155-1:2003)
123 EN ISO 14155-2:2009, Clinical investigation of medical devices for human subjects – Part 2: Clinical
124 investigation plans (ISO 14155-2:2003)
125 EN ISO 14971:2009, Medical devices – Application of risk management to medical devices
126 (ISO 14971:2007, Corrected version 2007-10-01)
127 ISO 8601:2004, Data elements and interchange formats – Information interchange – Representation
128 of dates and times
129 3 Terms and definitions
130 For the purposes of this document the following terms and definitions apply.
131 3.1
132 MEDICAL DEVICE
133 any instrument, apparatus, appliance, software, material or other article, whether used alone or in
134 combination, together with any accessories, including the software intended by its MANUFACTURER to
135 be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper
136 application, intended by the MANUFACTURER to be used for human beings for the purpose of
137 – diagnosis, prevention, monitoring, treatment or alleviation of disease,
138 – diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
139 – investigation, replacement or modification of the anatomy or of a physiological process,
140 – control of conception,
141 and which does not achieve its principal intended action in or on the human body by pharmacological,
142 immunological or metabolic means, but which may be assisted in its function by such means
143 3.2
144 ACTIVE MEDICAL DEVICE
145 MEDICAL DEVICE relying for its functioning on a source of electrical energy or any source of power other
146 than that directly generated by the human body or gravity
147 3.3
148 ACTIVE IMPLANTABLE MEDICAL DEVICE
149 ACTIVE MEDICAL DEVICE which is intended to be totally or partially introduced, surgically or medically,
150 into the human body or by medical intervention into a natural orifice, and which is intended to remain
151 after the procedure
152 NOTE For purposes of this Part 1 of EN 45502, an ACTIVE IMPLANTABLE MEDICAL DEVICE can be a single ACTIVE
153 MEDICAL DEVICE, or a system consisting of a set of components and accessories, including software, which interact to
154 achieve the performance intended by the MANUFACTURER. Not all of these components or accessories may be required to be
155 partially or totally implanted.
156 3.4
157 CATHETER
158 flexible tube allowing access to a point within the body at its distal end through a lumen, often for
159 delivering a substance
160 NOTE A CATHETER may be combined with a LEAD.
———————
1)
Superseded by EN ISO 11607-1:2009, Packaging for terminally sterilized medical devices – Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2006).
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161 3.5
162 LEAD
163 flexible tube enclosing one or more insulated electrical conductors, intended to transfer electrical
164 energy along its length
165 NOTE A LEAD may be combined with a CATHETER.
166 3.6
167 NON-REUSABLE PACK
168 single use pack designed to allow the contents to be sterilized and to maintain that sterility
169 3.7
170 STERILE PACK
171 NON-REUSABLE PACK in which the contents have been sterilized
172 3.8
173 SALES PACKAGING
174 packaging that protects and identifies the ACTIVE IMPLANTABLE MEDICAL DEVICE during storage and
175 handling by the purchaser
176 NOTE The SALES PACKAGING may be enclosed in further packaging, for example, a 'shipping package', for delivery.
177 3.9
178 MARKING
179 inscription on a device, package, or LABEL
180 3.10
181 LABEL
182 area bearing a MARKING, affixed to an ACTIVE IMPLANTABLE MEDICAL DEVICE or package but not an
183 integral part of the ACTIVE IMPLANTABLE MEDICAL DEVICE or package
184 3.11
185 RADIOACTIVE SUBSTANCE
186 any substance that contains one or more radionuclides the activity or concentration of which cannot be
187 disregarded as far as radiation protection is concerned
188 [Based on 96/29/Euratom]
189 3.12
190 SEALED SOURCE
191 source containing RADIOACTIVE SUBSTANCES whose structure is such as to prevent, under normal
192 conditions of use, any dispersion of the radioactive substances into the environment
193 [Based on 96/29/Euratom]
194 3.13
195 MANUFACTURER
196 natural or legal person with responsibility for the design, manufacture, packaging and labelling of an
197 ACTIVE IMPLANTABLE MEDICAL DEVICE before it is placed on the market under his own name, regardless
198 of whether these operations are carried out by that person himself or on his behalf by a third party
199 NOTE This definition also applies to the natural or legal person who assembles, packages, processes, fully refurbishes
200 and/or labels one or more ready-made products and/or assigns to them their intended purpose as an ACTIVE IMPLANTABLE
201 MEDICAL DEVICE with a view to their being placed on the market under his own name. This definition also applies to the
202 manufacturer of non implantable parts and accessories of the ACTICE IMPLANABLE MEDICAL DEVICE.
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203 3.14
204 MEDICINAL SUBSTANCE
205 any substance or combination of substances presented as having properties for treating or preventing
206 disease in human beings; or any substance or combination of substances which may be used in or
207 administered to human beings either with a view to restoring, correcting or modifying physiological
208 functions by exerting a pharmacological, immunological or metabolic action, or to making a medical
209 diagnosis
210 [Based on Article 1 of Directive 2001/83/EC]
211 3.15
212 MEDICINAL SUBSTANCE DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA
213 MEDICINAL SUBSTANCES based on blood constituents which are prepared industrially by public or private
214 establishments, such MEDICINAL SUBSTANCES including, in particular, albumin, coagulating factors and
215 immunoglobulins of human origin
216 3.16
217 HARM
218 physical injury or damage to health of people, or damage to property or the environment
219 [EN ISO 14971:2009, definition 2.2]
220 3.17
221 HAZARD
222 potential source of HARM
223 [EN ISO 14971:2009, definition 2.3]
224 3.18
225 RESIDUAL RISK
226 RISK remaining after RISK CONTROL measures have been taken
227 [EN ISO 14971:2009, definition 2.15]
228 3.19
229 RISK
230 combination of the probability of occurrence of HARM and the severity of that HARM
231 [EN ISO 14971:2009, definition 2.16]
232 3.20
233 RISK ANALYSIS
234 systematic use of available information to identify HAZARDS and to estimate the RISK
235 NOTE RISK ANALYSIS includes examination of different sequences of events that can produce hazardous situations and HARM.
236 See Annex E [of EN ISO 14971:2009].
237 [EN ISO 14971:2009, definition 2.17]
238 3.21
239 RISK ASSESSMENT
240 overall process comprising a RISK ANALYSIS and a RISK EVALUATION
241 [EN ISO 14971:2009, definition 2.18]
242 3.22
243 RISK CONTROL
244 process in which decisions are made and measures implemented by which RISKS are reduced to, or
245 maintained within, specified levels
246 [EN ISO 14971:2009, definition 2.19]
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247 3.23
248 RISK EVALUATION
249 process of comparing the estimated RISK against given RISK criteria to determine the acceptability of
250 the RISK
251 [EN ISO 14971:2009, definition 2.21]
252 3.24
253 RISK MANAGEMENT
254 systematic application of management policies, procedures and practices to the tasks of analysing,
255 evaluating, controlling and monitoring RISK
256 [EN ISO 14971:2009, definition 2.22]
257 3.25
258 RISK MANAGEMENT FILE
259 set of RECORDS and other documents that are produced by RISK MANAGEMENT
260 [EN ISO 14971:2009, definition 2.23]
261 3.26
262 PORTABLE
263 term referring to part of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to be moved from one location
264 to another while being carried by one or more persons
265 [EN 60601-1:2006, definition 3.85 modified]
266 3.27
267 HAND HELD
268 term referring to part of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to be supported by the hand
269 during NORMAL USE
270 [EN 60601-1:2006, definition 3.37 modified]
271 3.28
272 CORRECT USE
273 normal use without use error
274 [EN 62366:2008, definition 3.7]
275 3.29
276 NORMAL USE
277 operation, including routine inspection and adjustments by any USER, and stand-by, according to the
278 instructions for use or in accordance with generally accepted practice for those MEDICAL DEVICES
279 provided without instructions for use
280 [EN 60601-1:2006, definition 3.71, modified]
281 NOTE 1 USE ERROR can occur in NORMAL USE.
282 NOTE 2 MEDICAL DEVICES that can be used safely without instructions for use are exempted from having instructions for use by
283 some authorities with jurisdiction.
284 3.30
285 USE ERROR
286 act or omission of an act that results in a different ACTIVE IMPLANTABLE MEDICAL DEVICE response than
287 intended by the MANUFACTURER or expected by the USER
288 NOTE 1 USE ERROR includes slips, lapses, and mistakes.
289 NOTE 2 An unexpected physiological response of the patient is not in itself considered USE ERROR.
290 [EN 62366:2008, definition 3.21, modified]
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291 3.31
292 BEGINNING OF SERVICE
293 BOS
294 when an individual ACTIVE IMPLANTABLE MEDICAL DEVICE is first released by the manufacturer as fit for
295 placing on the market
296 3.32
297 END OF SERVICE
298 EOS
299 when the PROLONGED SERVICE PERIOD has elapsed and performance to design specification cannot be
300 assured
301 3.33
302 PROLONGED SERVICE PERIOD
303 PSP
304 period during which the ACTIVE IMPLANTABLE MEDICAL DEVICE continues to function as defined by the
305 MANUFACTURER to prolong basic bradyarrhythmia pacing beyond the RECOMMENDED REPLACEMENT TIME
306 3.34
307 RECOMMENDED REPLACEMENT TIME
308 RRT
309 when the POWER SOURCE INDICATOR reaches the value set by the MANUFACTURER of the ACTIVE IMPLANTABLE
310 MEDICAL DEVICE for its recommended replacement
311 NOTE This indicates entry into the PROLONGED SERVICE PERIOD
312 3.35
313 AUTHORIZED REPRESENTATIVE
314 means any natural or legal person established in the European Community who, explicitly designated
315 by the MANUFACTURER, acts and may be addressed by authorities and bodies in the Community
316 instead of the MANUFACTURER with regard to the latter's obligations
317 4 Symbols and abbreviations (optional)
318 When appropriate, symbols, abbreviated terms and identification colour may be used in the MARKINGS
319 and accompanying documentation of an ACTIVE IMPLANTABLE MEDICAL DEVICE. Symbols, abbreviated
320 terms and identification colour shall conform to harmonized standards (e.g. EN 980). Where no
321 harmonized standard exists, the symbols, abbreviated terms and identification colour shall be
322 described in the accompanying documentation.
323 Compliance shall be checked by inspection.
324 NOTE Symbols for use with particular ACTIVE IMPLANTABLE MEDICAL DEVICES can be specified in subsequent parts of
325 EN 45502.
326 5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES
327 5.1 General requirements for software
328 Software of an ACTIVE IMPLANTABLE MEDICAL DEVICE or software that falls within the definition of an
329 ACTIVE IMPLANTABLE MEDICAL DEVICE shall be designed and validated according to software life cycle
330 process activities compliant with EN 62304.
331 Compliance is determined by inspection and assessment as required by EN 62304:2006, 1.4.
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332 5.2 General requirements for non-implantable parts
333 The non-implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE which is connected to or equipped
334 with a electrical power source shall comply with the requirements of EN 60601-1:2006, unless a
335 requirement in that standard is superseded by a requirement in this or other parts of EN 45502.
336 Compliance shall be checked by review of the test results and the RISK ANALYSIS provided by the
337 MANUFACTURER.
338 5.3 Usability of non implantable parts
339 5.3.1 Usability of non implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE connected to
340 or equipped with a electrical power source
341 The MANUFACTURER shall address in a USABILITY ENGINEERING PROCESS the RISK of poor USABILITY,
342 including those associated with identification, MARKING and documents (see EN 60601-1:2006, 12.2).
343 Compliance is determined by inspection and assessment as required by EN 60601-1:2006, 12.2.
344 5.3.2 Usability of non implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE not
345 connected to or equipped with a electrical power source
346 The non-implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall provide adequately USABILITY
347 such that the RISKS resulting from CORRECT USE and USE ERRORS are acceptable.
348 Compliance is considered to exist when a usability engineering process complying with EN 62366 has
349 been followed and the acceptance criteria in the usability validation plan have been met (see
350 EN 62366:2008, 5.9).
351 Compliance is checked by review of the test results and the RISK ANALYSIS provided by the
352 MANUFACTURER.
353 5.4 Data security and protection from harm caused by unauthorized information tampering
354 When communication with the implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE through
355 wireless communication channels is provided, the MANUFACTURER shall provide application-appropriate
356 mechanisms, interlocks and protocols for protection against unauthorized information tampering
357 causing damage to the implantable parts of the ACTIVE IMPLANTABLE MEDICAL DEVICE, and/or resulting in
358 an unacceptable level of RISK to the patient.
359 Compliance is checked by the inspection of the RISK MANAGEMENT FILE.
360 5.5 General requirements for RISK MANAGEMENT
361 5.5.1 RISK MANAGEMENT policy
362 The MANUFACTURER shall define and document a policy for determining acceptable RISK and the
363 acceptability of the RESIDU
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