EN ISO 1135-4-2015 en Transfusion equipment for medical use - Part 4 Transfusion sets for single use gravity feed《医用输液设备 第4部分 一次性使用输血器 重力饲料 (ISO 1135-4 2015)》.pdf

1、BSI Standards PublicationBS EN ISO 1135-4:2015Incorporating corrigendum February 2016BS EN ISO 1135-4:2015Transfusion equipment formedical usePart 4: Transfusion sets for single use,gravity feedBS EN ISO 1135-4:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of E

2、N ISO 1135-4:2015. Together with BS EN ISO 1135-5:2015, it supersedes BS EN ISO 1135-4:2012 which is withdrawn.This standard has been technically revised with the following changes:- the scope has been restricted to gravity feed applications and the whole document aligned accordingly;- transfusion s

3、ets for single use used in conjunction with pressure infusion apparatus are now covered by BS EN ISO 1135-5:2015;- clause 3.3 “Designation examples” has been deleted;- clause 7.6 “Assessment of blood component depletion” and clause 7.7 “Assessment of damage to blood components” have been added;- the

4、 Normative references and the Bibliography have been updated;- some minor editorial changes were introduced in the whole document.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request

5、 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 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 93545 9ICS 11.040.20Compliance with a British St

6、andard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2016.Amendments/corrigenda issued since publicationDate Text affected29 February 2016 Implementation of CEN Correction Notice 27 J

7、anuary 2016: Table ZA.1 replacedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1135-4 December 2015 ICS 11.040.20 Supersedes EN ISO 1135-4:2012English Version Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015) Matriel de transfus

8、ion usage mdical - Partie 4: Appareils de transfusion non rutilisables alimentation par gravit (ISO 1135-4:2015) Transfusionsgerte zur medizinischen Verwendung - Teil 4: Transfusionsgerte fr Schwerkrafttransfusionen zur einmaligen Verwendung (ISO 1135-4:2015) This European Standard was approved by C

9、EN on 24 July 2015. 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 and bibliographical references concerning such national standards

10、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 the responsibility of a CEN member into its own language and notifie

11、d 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 Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icela

12、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Managem

13、ent Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 1135-4:2015 EBS EN ISO 1135-4:2015EN ISO 1135-4:2015 (E) 3 European foreword This document (EN ISO 1135-4:2015) has been prepare

14、d by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given

15、 the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2016, and conflicting national standards shall be withdrawn at the latest by June 2016. Attention is drawn to the possibility that some of the elements of this document may be the

16、subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. Together with EN ISO 1135-5:2015 this document supersedes EN ISO 1135-4:2012. This document has been prepared under a mandate given to CEN by the European Commission and the Euro

17、pean 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 following c

18、ountries 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, Norway,

19、 Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 1135-4:2015 has been approved by CEN as EN ISO 1135-4:2015 without any modification. The following referenced documents are indispensable for the application

20、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

21、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

22、erwise to the dated ISO or IEC standard, as listed in Table 1. NOTE The way in which these references documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 1135-4:2015EN ISO 1135-4:2015 (E) 4 Table 1 Correlations between undated norm

23、ative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 594-1 - ISO 594-1:1986 ISO 594-2 - ISO 594-2:1998 ISO 3696 EN ISO 3696:1995 ISO 3696:1987 ISO 3826-1:2013 EN ISO 3826-1:2013 ISO 3826-1:2013 ISO

24、3826-2 EN ISO 3826-2:2008 ISO 3826-2:2008 ISO 7864 EN ISO 7864:1995 ISO 7864:1993 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus ISO 10993-4 AMD 1:2006 ISO 14644-1 EN ISO 14644-1:1999 ISO 14644-1:1999 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1

25、:2012 EN ISO 1135-4:2015 (E) 4 Table 1 Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 594-1 - ISO 594-1:1986 ISO 594-2 - ISO 594-2:1998 ISO 3696 EN ISO 3696:19

26、95 ISO 3696:1987 ISO 3826-1:2013 EN ISO 3826-1:2013 ISO 3826-1:2013 ISO 3826-2 EN ISO 3826-2:2008 ISO 3826-2:2008 ISO 7864 EN ISO 7864:1995 ISO 7864:1993 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus ISO 10993-4 AMD 1:2006 ISO 14644-1 EN ISO 1

27、4644-1:1999 ISO 14644-1:1999 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 BS EN ISO 1135-4:2015EN ISO 1135-4:2015 (E) 3 European foreword This document (EN ISO 1135-4:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for

28、 medical and pharmaceutical use” in collaboration with Technical Committee 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 la

29、test by June 2016, and conflicting national standards shall be withdrawn at the latest by June 2016. Attention is drawn to the possibility that some of the 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

30、patent rights. Together with EN ISO 1135-5:2015 this document supersedes EN ISO 1135-4:2012. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with

31、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 following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech

32、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 the United Kingdom.

33、Endorsement notice The text of ISO 1135-4:2015 has been approved by CEN as EN ISO 1135-4:2015 without any modification. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amen

34、dments) 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 document has not been superseded and that its relevant contents can still be considered the generally acknowle

35、dged 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 otherwise to the dated ISO or IEC standard, as listed in Table 1. NOTE The way in which these references docum

36、ents are cited in normative requirements determines the extent (in whole or in part) to which they apply. EN ISO 1135-4:2015 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices This European Standard has

37、 been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices Once this standard is cited in the Official Journal of the European Union

38、 under that Directive and has been implemented as a national standard in at least one Member State, 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

39、that Directive 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 / Directive 90/385/EEC, as amended by 2007/47/EC. This means that risks have

40、to be reduced as far as possible, to a 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,

41、 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on Normative References according to Table of References, 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

42、.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 3.2, 5.1, 5.2, 5.3, Clause 6, Clause 7 7.2 The part of ER 7.2 relating to packaging is not addres

43、sed (for packaging see Clause 9 of this standard). Clause 4, 5.1, 5.2, 5.3, Clause 6, Clause 7 7.3 ER covered by biological evaluation 5.2, 5.3, 5.10, 8.2, 8.3, A.2, A.4 7.5 Only the first paragraph is covered. 5.1, 5.3 7.6 3.2, Clause 5 8.1 5.12, Clause 8, Clause 9 8.3 Maintenance of sterility in s

44、torage is covered. 7.2 8.4 Sterilization process is covered. 5.1, A.1 8.5 BS EN ISO 1135-4:2015EN ISO 1135-4:2015 (E) 4 Table 1 Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN

45、 ISO or IEC ISO 594-1 - ISO 594-1:1986 ISO 594-2 - ISO 594-2:1998 ISO 3696 EN ISO 3696:1995 ISO 3696:1987 ISO 3826-1:2013 EN ISO 3826-1:2013 ISO 3826-1:2013 ISO 3826-2 EN ISO 3826-2:2008 ISO 3826-2:2008 ISO 7864 EN ISO 7864:1995 ISO 7864:1993 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 1099

46、3-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus ISO 10993-4 AMD 1:2006 ISO 14644-1 EN ISO 14644-1:1999 ISO 14644-1:1999 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 EN ISO 1135-4:2015 (E) 6 Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Not

47、es 8.2, 8.3 8.7 5.4, 5.11 9.1 The second sentence of ER 9.1 is not addressed. 5.4 refers to ISO 3826-1. 5.11 refers to ISO 594-1 and ISO 594-2. Clauses 3, 4, 5, 6, 7 9.2 5.2, 5.3, A.2 12.7 Only 12.7.1 is addressed. Only tensile strength is addressed. Clause 8 13.1 8.2, 8.3 13.2 ISO 15223-1 and ISO 3

48、826-2 are addressed when using symbols. 8.2 a), b), c), d), e), f), g), i), j), k), 8.3 a), b), c), d), e), f), g) 13.3 The part of 13.3a) relating to the authorized representative is not addressed. Presumption of conformity to the rest of 13.3a) is only provided if the name and address of the manuf

49、acturer are given. 13.3b) is addressed in Clause 3.1 and 4.3. 13.3d) is only covered if the batch number is preceded by the word LOT. 13.3f) Requirement “indication of single use must be consistent across the Community” is not addressed in the standard. 13.3g) and h) are not addressed in the standard. 8.2, 8.3 13.4 13.4 is addressed regarding to the label. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 1135-4:2015EN ISO 1135-4:2015 (E) 3 Eu