EN ISO 10555-6-2017 en Intravascular catheters - Sterile and single-use catheters - Part 6 Subcutaneous implanted ports.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Intravascular catheters - Sterile and single-use cathetersPart 6: Subcutaneous implanted ports (ISO 10555-6:2015)BS EN ISO 10555-6:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-6 August 2017 ICS 11.

2、040.25 English Version Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)Cathters intravasculaires - Cathters striles et non rutilisables - Partie 6: Chambres cathter implantables (ISO 10555-6:2015) Intravaskulre Katheter - Sterile Ka

3、theter zur einmaligen Verwendung - Teil 6: Subkutan implantierte Ports (ISO 10555-6:2015) This European Standard was approved by CEN on 30 July 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status

4、of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, Germa

5、n). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia,

6、 Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey a

7、nd United Kingdom. EUROPEAN COMMITTEE 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.

8、No. EN ISO 10555-6:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 105556:2017. It is identical to ISO 105556:2015. It supersedes BS ISO 105556:2015, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/205, Nonactive medi

9、cal devices.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published b

10、y BSI Standards Limited 2017ISBN 978 0 580 95653 9ICS 11.040.25Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2015.Amendments/corrigenda issued since p

11、ublicationDate Text affected31 December 2017 This corrigendum renumbers BS ISO 105556:2015 as BS EN ISO 105556:2017BRITISH STANDARDBS EN ISO 105556:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-6 August 2017 ICS 11.040.25 English Version Intravascular catheters - Sterile and sin

12、gle-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)Cathters intravasculaires - Cathters striles et non rutilisables - Partie 6: Chambres cathter implantables (ISO 10555-6:2015) Intravaskulre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 6: Subkutan implantierte

13、 Ports (ISO 10555-6:2015) This European Standard was approved by CEN on 30 July 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists

14、and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under th

15、e responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugos

16、lav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT

17、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 10555-6:2017 EBS EN ISO 105556:2017EN ISO 10555-6:201

18、7 (E) 3 European foreword The text of ISO 10555-6:2015 has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and catheters” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 10555-6:2017 by Technical Committee

19、 CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2018, and conflicting national standards shall be withdra

20、wn at the latest by February 2018. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by th

21、e European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this document. The following referenced documents are indispensable for the application

22、of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced doc

23、ument has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and oth

24、erwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO standards

25、 Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 10555-1:2013 EN ISO 10555-1:2013 ISO 10555-1:2013 ISO 10555-3:2013 EN ISO 10555-3:2013 ISO 10555-3:2013 BS EN ISO 105556:2017EN ISO 10555-6:2017 (E) 4 According to the CEN-CENELEC Internal Reg

26、ulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland,

27、Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10555-6:2015 has been approved by CEN as EN ISO 10555-6:2017 without any modification

28、. BS EN ISO 105556:2017EN ISO 10555-6:2017 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European standard has been prepared under a Commissions standardisation request M/295 concerning

29、 the development of European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under

30、 that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference

31、 from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or remov

32、ed, 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 This Annex ZA is based on normative references according

33、to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex I of Dir

34、ective 93/42/EEC OJ L 169 Essential Requirements (ER) of Directive 93/42/EEC Clause(s) / sub-clause(s) of this EN Remarks / Notes 7.5 4.2 ER 7.5 is covered only in respect of biocompatibility. Covers lubricants limited size drops on surfaces in design and manufacturing. 9.1 4.5.3, 4.5.6.1, 6.4 g) ER

35、 9.1 is covered by Standard Clause 4.5.3 in respect of leakage only. ER 9.1 is covered by Standard Clause 4.5.6.1 only in respect of peak tensile force between the port and the catheter. ER 9.1 is covered by Standard Clause 6.4g only in respect of specifications of the devices required to connect th

36、e port to the power injector. The connection must be standardized. The maximum for the connected injector. The intended purpose should be stated on the label BS EN ISO 105556:2017EN ISO 10555-6:2017 (E) 6 Essential Requirements (ER) of Directive 93/42/EEC Clause(s) / sub-clause(s) of this EN Remarks

37、 / Notes or in the instruction for use, if not obvious. A pressure limit and maximum flowrate is required in the instruction for use, if the catheter is indicated for power injection. Covers restrictions on use indicated on labelling. 9.2 4.5.3, 4.5.4, 4.6, 4.7, 5 ER 9.2 first dash is covered by Sta

38、ndard Clause 4.5.3 in respect of leakage only. ER 9.2 first dash is covered by Standard Clause 4.5.4 in respect of the flushing volume only. ER 9.2 first dash is covered by Standard Clause 4.6 in respect of the flow rate only. ER 9.2 first dash is covered by Standard Clause 4.7 in respect of the bur

39、st pressure. ER 9.2 second dash is covered by Standard Clause 5 in respect of MRI compatibility only. The risk of injury, in connection with physical features including the volume/pressure ratio and dimensional features in the design process. 12.7.1 4.5.3, 4.6.2, 4.7.2 ER 12.7.1 is covered by Standa

40、rd Clause 4.5.3 in respect of leakage only. ER 12.7.1 is covered by Standard Clause 4.6.2 in respect of flow rate only. ER 12.7.1 is covered by Standard Clause 4.7.2 in respect of burst pressure only. The catheter and port must be designed to protect the patient. 12.9 4.3 ER 12.9 is covered in respe

41、ct of distance marking on the catheter only. Indicators for length adjustment. 13.3 a) 6.3 Standard Clause 6.3 first dash covers ER 13.3 a) but only in respect of the name of the manufacturer and only provided the labels are located as required by the Directive. 13.3 b) 6.1, 6.3 Standard Clause 6.1

42、covers ER 13.3 b) only in respect of the marking on the actual product. Standard Clause 6.3 second and third dash covers ER 13.3 b) but only in respect of the designation and item number and Batch/Lot/serial number. 13.3 d) 6.3 ER 13.3 d) is covered by Standard Clause 6.3 third dash but only when th

43、e any batch code is preceded by the word LOT. Label and traceability label 13.4 6.2, 6.4 ER 13.4 is covered by Standard Clause 6.2 but only in respect of identification of power injection. BS EN ISO 105556:2017EN ISO 10555-6:2017 (E) 7 Essential Requirements (ER) of Directive 93/42/EEC Clause(s) / s

44、ub-clause(s) of this EN Remarks / Notes ER 13.4 is covered by Standard Clause 6.2 but only in respect of the information given in Standard Clause 6.4 a-g. 13.6 a) 6.4 13.6 b) 6.4 Only covers devices for power injection. 13.6 c) 6.4 g) 13.6 d) 6.4 c), d) 13.6 e) 6.4 a) 13.6 f) 6.4 e) 13.6 i) 6.4 g) 1

45、3.6 l) 6.4 e) Precautions to be taken as regards exposure in reasonably foreseeable environmental conditions to magnetic fields. 13.6 n) 6.4 Does not specify unusual risk. 13.6 q) 6.4 WARNING 1: Presumption of conformity stays valid only as long as a reference to this European standard is maintained

46、 in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this stan

47、dard. BS EN ISO 105556:2017ISO 10555-6:2015(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements of the implantable subcutaneous implanted port and catheter . 34.1 General . 34.2 Biocompatibility 44.3 Distance markings 44.4 Nominal dimensions of the subcutaneous

48、implanted port 44.5 Physical requirements 44.5.1 Radio-detectability . 44.5.2 Surface finish . 44.5.3 Freedom from leakage 44.5.4 Flushing volume . 44.5.5 Characteristics of the septum . 54.5.6 Characteristics of the connection or the catheter . 54.6 Flow rate . 54.6.1 Subcutaneous implanted ports n

49、ot indicated for power injection . 54.6.2 Subcutaneous implanted ports indicated for power injection . 54.7 Burst pressure of the subcutaneous implanted port and catheter 64.7.1 Subcutaneous implanted ports not indicated for power injection . 64.7.2 Subcutaneous implanted ports indicated for power injection . 65 Magnetic Resonance Imaging (MRI) compatibility . 66 Information to be supplied by the manufacturer . 66.1 Marking on the device 66.2 Primary packaging . 66.3 Labels for traceability . 76.4 Instruction fo