EN ISO 20696-2018 Sterile urethral catheters for single use.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Sterile urethral catheters for single use (ISO 20696:2018)BS EN ISO 20696:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 20696 July 2018 ICS 11.040.25 Supersedes EN 1616:1997English Version Sterile urethra

2、l catheters for single use (ISO 20696:2018)Sondes urinaires striles non rutilisables (ISO 20696:2018) Sterile Harnblasenkatheter zur einmaligen Verwendung (ISO 20696:2018) This European Standard was approved by CEN on 5 May 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulati

3、ons 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 member.

4、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 notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN m

5、embers 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Por

6、tugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploita

7、tion in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 20696:2018 ENational forewordThis British Standard is the UK implementation of EN ISO 20696:2018. It supersedes BS EN 1616:1997, which is withdrawn.The UK participation in its preparation was entrusted to

8、Technical Committee CH/84, Catheters and syringes.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

9、Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 93138 3ICS 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 31 July 2018

10、.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 20696:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 20696 July 2018 ICS 11.040.25 Supersedes EN 1616:1997English Version Sterile urethral catheters for single use (ISO 20696:2018)Sondes urinaire

11、s striles non rutilisables (ISO 20696:2018) Sterile Harnblasenkatheter zur einmaligen Verwendung (ISO 20696:2018) This European Standard was approved by CEN on 5 May 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europea

12、n 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 member. This European Standard exists in three official versions (

13、English, French, German). 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, Belgi

14、um, 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, Serbia, Slovakia, Slovenia, Spain, Sweden,

15、 Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for C

16、EN national Members. Ref. No. EN ISO 20696:2018 EBS EN ISO 20696:2018EN ISO 20696:2018 (E) 3 European foreword This document (EN ISO 20696:2018) has been prepared by Technical Committee ISO/TC 84 “ Devices for administration of medicinal products and catheters “ in collaboration with Technical Commi

17、ttee 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 January 2019, and conflicting national standards shall be with

18、drawn at the latest by January 2019. 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 supersedes EN 1616:1997. According to the CEN-CENE

19、LEC Internal Regulations, 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, Ic

20、eland, Ireland, 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 20696:2018 has been approved by CEN as EN ISO 20696:2018 without any

21、modification. BS EN ISO 20696:2018ISO 20696:2018(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Intended performance . 35 General requirements . 35.1 Risk management . 35.2 Biocompatibility 35.3 Detectability 35.4 Surface finish 35.5 Size designation . 35.

22、5.1 General 35.5.2 Outer diameter 35.5.3 Effective shaft lengths .45.6 MRI compatibility . 55.7 Connector 55.8 Sterilization 56 Specific requirements . 56.1 Strength . 56.2 Connector security . 56.3 Balloon safety . 56.4 Catheter inflation lumen integrity and volume maintenance 56.4.1 General 56.4.2

23、 Compliant balloon. 66.4.3 Non-compliant balloon . 66.5 Flow rate . 66.6 Corrosion resistance 76.7 Kink stability . 76.8 Peak tensile force 76.9 Inflated balloon resistance to traction 77 Information to be supplied by the manufacturer . 87.1 General . 87.2 Marking on the device and/or packaging 87.3

24、 Instructions for use . 8Annex A (normative) Test method for determining the strength of the catheter 10Annex B (normative) Test method for determining the security of fit of the drainage funnel .14Annex C (normative) Test method for determining balloon safety .16Annex D (normative) Test method for

25、determining inflation lumen leakage and/or function and/or balloon deflation (catheter with compliant balloon) .19Annex E (normative) Test method for determination of flow rate through catheter .21Annex F (normative) Test method for corrosion resistance .23Annex G (informative) Test method for deter

26、mining kink stability .24Annex H (normative) Test method for determining peak tensile force of urethral catheter .26Annex I (normative) Test method for determining balloon size deflation reliability (catheter with non-compliant balloon) .28Annex J (normative) Test method for determining inflated bal

27、loon resistance to traction 30 ISO 2018 All rights reserved iiiContents PageBS EN ISO 20696:2018ISO 20696:2018(E)Bibliography .34iv ISO 2018 All rights reservedBS EN ISO 20696:2018ISO 20696:2018(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national

28、standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International

29、 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for

30、 its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .o

31、rg/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be

32、 in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning o

33、f ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/iso/foreword .html.This document was prepared by Technical

34、 Committee ISO/TC 84, Devices for administration of medicinal products and catheters.This document is based on EN 1616, Sterile urethral catheters for single use. ISO 2018 All rights reserved vBS EN ISO 20696:2018ISO 20696:2018(E)IntroductionGuidance on transition periods for implementing the requir

35、ements of this document is given in ISO/TR 19244.vi ISO 2018 All rights reservedBS EN ISO 20696:2018Sterile urethral catheters for single use1 ScopeThis document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.This document does not in

36、clude drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.NOTE Ureteral stents are covered in ASTM F1828-97.2 Normative referencesThe following documents are referred to in the text in such a w

37、ay that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 14971, Medical devices Application of risk management to

38、medical devicesISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 80369-1, Small bore connectors for liquids and gases in healthcare applications Part 1: General requirements3 Terms and definitionsFor the purposes of this document

39、, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at https: /www .iso .org/obp IEC Electropedia: available at https: /www .electropedia .org/3.1balloon capacityvolum

40、e of liquid to be introduced into the catheter in order to fill the inflation channel and inflate the balloon3.2coatingsubstance applied to the surface of the catheter3.3compliant balloonballoon that continues to expand in size as internal pressure increases3.4effective lengthL1length of the cathete

41、r that can be inserted into the bodyINTERNATIONAL STANDARD ISO 20696:2018(E) ISO 2018 All rights reserved 1BS EN ISO 20696:2018ISO 20696:2018(E)3.5effective shaft lengthL3length of non-perforated portion of the catheter excluding the tip, balloon(s), funnel(s) (3.6), protective sleeves and/or access

42、 port(s)3.6funnelproximal portion of the catheter, which may be connected to a drainage systemNote 1 to entry: See Figures J.1 and J.2.3.7intermittentintended to be removed immediately after emptying the bladder3.8non-compliant balloonballoon that expands to one specific size or size range, even as

43、internal pressure increases3.9outer diametermaximum dimension measured across the cylindrical portion of the shaft3.10overall lengthL2total length from the tip of the catheter to the end of the funnel (3.6)3.11riskcombination of the probability of occurrence of harm and the severity of that harmSOUR

44、CE: ISO 14971:2007, 2.163.12risk analysissystematic use of available information to identify hazards and to estimate the risk (3.11)Note 1 to entry: Risk analysis includes examination of different sequences of events that can produce hazardous situations and harm (see ISO 14971:2007, Annex E).SOURCE

45、: ISO 14971:2007, 2.173.13risk assessmentoverall process comprising a risk analysis (3.12) and a risk evaluationSOURCE: ISO 14971:2007, 2.183.14risk management fileset of records and other documents that are produced by risk managementSOURCE: ISO 14971:2007, 2.233.15urethral cathetertubular device i

46、ntended for being introduced into the urinary bladder through the urethra in order to provide drainage, drug delivery and/or flushing of the bladder2 ISO 2018 All rights reservedBS EN ISO 20696:2018ISO 20696:2018(E)4 Intended performanceThe urethral catheter shall demonstrate the ability to accurate

47、ly and safely access the intended location. The urethral catheter shall demonstrate the ability to drain urine.5 General requirements5.1 Risk managementAn established risk management process shall be applied to the design of the device.Compliance shall be checked by inspection of the risk management

48、 file verifying compliance to ISO 14971.5.2 BiocompatibilityThe device shall be free from biological hazard in accordance with appropriate testing under ISO 10993-1.5.3 DetectabilityThe catheter or at least its effective length shall be detectable by X-ray or by other means (ultra-sound, MRI, etc.),

49、 if required by the risk assessment.NOTE Such as ASTM F640 or DIN 13273-7.5.4 Surface finishWhen examined by normal or corrected to normal vision, the external surface of the effective length of the catheter shall appear free from: extraneous matter; process and surface defects that may present an unacceptable risk of patient harm.If deemed necessary based on risk assessment, inspection shall be conducted under a minimum 2,5 magnification.5.5 Size designation5.5.1 GeneralThe nominal size of the catheter shall be designated as sp