1、BSI Standards PublicationBS EN 45502-1:2015Implants for surgery Activeimplantable medical devicesPart 1: General requirements for safety,marking and for information to be providedby the manufacturerBS EN 45502-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of
2、EN 45502-1:2015. It supersedes BS EN 45502-1:1998 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/2, Cardiovascular implants.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does
3、not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 72639 2 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from lega
4、l obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 45502-1 May 2015 ICS 11.040.01 Supersedes E
5、N 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 mdicaux implantables actifs - Partie 1: Rglesgnrales de scurit, marquage et informations four
6、nies par le fabricant Aktive implantierbare medizinische Gerte - Teil 1:Allgemeine Festlegungen fr die Sicherheit, Aufschriften und vom Hersteller zur Verfgung zu tellende Informationen This European Standard was approved by CENELEC on 20 April 2015. CEN and CENELEC members are bound to comply with
7、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 Manageme
8、nt 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 Ce
9、ntre 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, Gree
10、ce,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 Comit Europen de Normalisation ElectrotechniqueE
11、uropisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015CEN/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 BS EN 45502-1:2015E
12、N 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
13、 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 IMPLANTA
14、BLE 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 patien
15、t 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 t
16、he 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 mis
17、cellaneous 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
18、 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 BS EN 45502-1:2015- 3 -
19、EN 45502-1:2015 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 D
20、amped 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 impleme
21、ntation 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 BS EN 45502-1:2015EN 45502-1:2015 - 4 - Foreword This document (EN 45502-1
22、: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) 201
23、6-04-20 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
24、 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
25、 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 me
26、dical 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
27、 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. BS EN 45502-1:2015- 5
28、 - EN 45502-1:2015 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 requi
29、rements 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
30、 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
31、 part of EN 45502 alone to ACTIVE IMPLANTABLE MEDICAL DEVICES for which no particular part of EN 45502 has yet been published. BS EN 45502-1:2015EN 45502-1:2015 - 6 - 1 Scope This part of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For
32、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 samp
33、les 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 als
34、o 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 acces
35、sories. 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 printe
36、d 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
37、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: Ch
38、ange 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
39、) 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, Medic
40、al 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 (IE
41、C 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 packagi
42、ng systems (ISO 11607-1:2006) BS EN 45502-1:2015- 7 - EN 45502-1:2015 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
43、 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 electr
44、ical 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 natur
45、al 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 ach
46、ieve 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
47、 can be addressed by authorities and bodies in the Community instead of the MANUFACTURER with regard to the latters 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 flexib
48、le 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
49、PROLONGED SERVICE PERIOD has elapsed and performance to design specification cannot be assured BS EN 45502-1:2015EN 45502-1:2015 - 8 - 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
