BS EN ISO 25539-1-2017 Cardiovascular implants Endovascular devices Endovascular prostheses《心血管植入物 血管内设备 血管内假体》.pdf

1、BS EN ISO 25539-1:2017Cardiovascular implants Endovascular devicesPart 1: Endovascular prosthesesBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 25539-1:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 25539-1:2

2、017. It supersedes BS EN ISO 25539-1:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/2, Cardiovascular implants.A list of organizations represented on this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 not purp

3、ort to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 88279 1 ICS 11.040.40Compliance with a British Standard cannot confer immunity from legal obligat

4、ions.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 25539-1 March 2017 ICS 11.040.40 Supersedes

5、EN ISO 25539-1:2009English Version Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017) Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothses endovasculaires (ISO 25539-1:2017) Kardiovaskulre Implantate - Endovaskulre Implantate

6、- Teil 1: Endovaskulre Prothesen (ISO 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

7、 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 languag

8、e 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,

9、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 COMMIT

10、TEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 worldwide for CEN national Members. Ref. No. EN ISO 25539-1:2017 EBS EN ISO

11、 25539-1:2017EN ISO 25539-1:2017 (E) 3 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 Eu

12、ropean 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 th

13、e 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 t

14、he 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 foll

15、owing 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,

16、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

17、 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 a

18、ny 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 a

19、vailable, 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. BS EN ISO 25539-1:2017EN ISO 25539-1:2017 (E) 4 Table Correl

20、ations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 Equivalent dated standard EN ISO ISO 10993 (all parts) EN ISO 10993-1:2009 EN ISO 10993-2:2006 EN ISO 10993-3:2014 EN ISO 10993-4:2009 EN ISO 10993-5:2009 EN ISO 10993-6:2009 EN ISO

21、10993-7:2008 and EN ISO 10993-7:2008/AC:2009 EN ISO 10993-9:2009 EN ISO 10993-10:2013 EN ISO 10993-11:2009 EN ISO 10993-12:2012 EN ISO 10993-13:2010 EN ISO 10993-14:2009 EN ISO 10993-15:2009 EN ISO 10993-16:2010 EN ISO 10993-17:2009 EN ISO 10993-18:2009 - - ISO 10993-1:2009 ISO 10993-2:2006 ISO 1099

22、3-3:2014 ISO 10993-4:2002 and Amd 1:2006 ISO 10993-5:2009 ISO 10993-6:2007 ISO 10993-7:2008 and ISO 10993-7:1/Cor 1:2009 ISO 10993-9:2009 ISO 10993-10:2010 ISO 10993-11:2006 ISO 10993-12:2012 ISO 10993-13:2010 ISO 10993-14:2001 ISO 10993-15:2000 ISO 10993-16:2010 ISO 10993-17:2002 ISO 10993-18:2005

23、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 EN ISO 11137-2:2015 EN ISO 11137-3:2006 ISO 11137-1:2006 and Amd 1:2013 ISO 11137-2:2013 ISO 11137-3:2006 ISO 11607-1 EN ISO 11607-1:2009 and EN ISO 11607-1:2009/A1:2014 ISO

24、 11607-1:2006 and 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-

25、1:2006 CEN ISO/TS 17665-2:2009 ISO 17665-1:2006 ISO/TS 17665-2:2009 BS EN ISO 25539-1:2017EN ISO 25539-1:2017 (E) 5 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

26、 prepared under a Commissions 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 s

27、tandard 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

28、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

29、minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers 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

30、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 Corresp

31、ondence between this European Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.2 11.2 Partially covered by the sub-clause: There is a requirement for devices to be designed to protect patients from s

32、terilization 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 BS

33、 EN ISO 25539-1:2017EN ISO 25539-1:2017 (E) 6 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 duri

34、ng 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) Manu

35、facturing (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, intro

36、ducer 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

37、, 6.3, 8.5.1.2, 8.5.2.7, 8.5.1.5 Partially covered by the sub-clauses: Device design is covered through the requirement to specify dimensions (4.3), design attribute requirements (6.2 and 6.3) and the requirements BS EN ISO 25539-1:2017EN ISO 25539-1:2017 (E) 7 for dimensional verification (8.5.1.2,

38、 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 (

39、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 except

40、ion 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) prod

41、uct name;c) the material of construction and type ofconstruction;d) the configuration (see4.3). A symbol may besubstituted for a writtendescription of theprosthesis;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

42、 by the requirement to include the words “STERILEDO NOT RESTERILIZESINGLE USE BS EN ISO 25539-1:2017EN ISO 25539-1:2017 (E) 8 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 manufacturers batc

43、h 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 direc

44、tive 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

45、 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 met

46、hod 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), (j), (k) 12.3.2(a), (b), (c), (i), (j), (l), (e) Pa

47、rtially covered by the sub-clauses: This directive is covered as follows: 13.3 (a) is covered byBS EN ISO 25539-1:2017EN ISO 25539-1:2017 (E) 9 12.3.2 (a) with the exception of the name and address of the authorised representative where the manufacturer does not have a registered place of business i

48、n the Community, nor the method of sterilization. 13.3(b) is covered by12.3.2(b), (c) 13.3(c) is covered by12.3.2(j) 13.3(f) is covered by12.3.2(j) 13.3(i) is covered by12.3.2(l) with theexception of handling 13.3(j) is covered by12.3.2(i) 13.3(k) is covered by12.3.2(e)13.6(b) 12.3.2(f), (g) This di

49、rective is covered with respect to the inclusion of any undesirable side effects by the requirement to include the potential adverse events (12.3.2(f) and performance information by the requirement to include data from clinical studies (if applicable) (12.3.2(g). 13.6(c) 12.3.2(i) Use of endovascular systems involves the use of additional medical devices (e.g., syringes, wire guides). This directive is covered by the requirement to include recommended methods for the preparation of the endovascular system and implantation techni