EN 20697-2018 Sterile drainage catheters and accessory devices for single use.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Sterile drainage catheters and accessory devices for single useBS EN ISO 20697:2018National forewordThis British Standard is the UK implementation of EN ISO 20697:2018. It is identical to ISO 20697:2018. It supersedes B

2、S EN 1617:1997, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes.A list of organizations represented on this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 necessa

3、ry provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 93139 0ICS 11.040.25Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was

4、published under the authority of the Standards Policy and Strategy Committee on 31 July 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 20697:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 20697July 2018ICS 11.040.25 Supersedes EN 1617:1997EUROPE

5、AN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN 20697:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersSterile dr

6、ainage catheters and accessory devices for single use (ISO 20697:2018)Sondes et dispositifs auxiliaires striles de drainage non rutilisables (ISO 20697:2018)Sterile Drainagekatheter und Zubehr zur einmaligen Verwendung (ISO 20697:2018)This European Standard was approved by CEN on 3 May 2018.CEN memb

7、ers 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 may be obtained on applicati

8、on 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 notified to the CEN-CENELEC Manageme

9、nt 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, Iceland, Ireland, Italy, Latvia, Li

10、thuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN 20697:2018 (E)European forewordThis document (EN ISO 20697:2018) has been prepared by Technical Committee ISO/TC 84 “ Device

11、s for administration of medicinal products and catheters “ 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

12、by endorsement, at the latest by January 2019, and conflicting national standards shall be withdrawn 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 a

13、ny or all such patent rights.This document supersedes EN 1617:1997.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 Republic, Denmark, E

14、stonia, 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 the United Kingdom.Endorsement n

15、oticeThe text of ISO 20697:2018 has been approved by CEN as EN ISO 20697:2018 without any modification.iiBS EN ISO 20697:2018ISO 20697:2018Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Intended performance . 35 General requirements . 35.1 Risk management .

16、35.2 Biocompatibility 45.3 Detectability 45.4 Surface finish 45.5 Size designation . 45.5.1 General 45.5.2 Outer diameter 45.5.3 Effective length 45.5.4 Nominal balloon inflation volume 55.6 Connector 55.7 MRI compatibility . 65.8 Sterilization 66 Specific requirements . 66.1 Kink stability . 66.2 C

17、orrosion resistance 66.3 Resistance to deformation 66.4 Peak tensile force 66.4.1 Connections 66.4.2 Drainage catheters and other accessory devices . 76.5 Impact resistance 76.6 Flow rate . 76.7 Retention strength . 76.8 Balloon safety . 76.9 Catheter inflation lumen integrity and volume maintenance

18、 86.9.1 General 86.9.2 Compliant balloon. 86.9.3 Non-compliant balloon . 86.10 Inflated balloon resistance to traction 86.11 Freedom from leakage during aspiration or vacuum 87 Information supplied by the manufacturer . 97.1 General . 97.2 Marking on the device and/or packaging 97.3 Instructions for

19、 use . 9Annex A (informative) Test method for determining kink stability .11Annex B (normative) Test method for corrosion resistance 13Annex C (normative) Test method for resistance to deformation by suction .14Annex D (normative) Test method for determining peak tensile force of connections .15Anne

20、x E (normative) Test method for determining peak tensile force of drainage catheter 16Annex F (normative) Test method for impact resistance of collection device .18Annex G (normative) Test method for determination of flow rate through catheter .20Annex H (informative) Test method for retention stren

21、gth 22 ISO 2018 All rights reserved iiiContents PageBS EN ISO 20697:2018ISO 20697:2018Annex I (normative) Test method for determining balloon safety 24Annex J (normative) Test method for determining inflation lumen leakage and/or function and/or balloon deflation (catheter with compliant balloon) .2

22、7Annex K (normative) Test method for determining balloon size and deflation reliability (catheter with non-compliant balloon) .29Annex L (normative) Test method for determining inflated balloon resistance to traction .31Annex M (normative) Test method for resistance to leakage during aspiration or v

23、acuum 35Bibliography .37iv ISO 2018 All rights reservedBS EN ISO 20697:2018ISO 20697:2018ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out

24、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 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO coll

25、aborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approv

26、al 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.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the sub

27、ject 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 in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trad

28、e 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 of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adheren

29、ce 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 Committee ISO/TC 84, Devices for administration of medicinal products and catheters.This document is based on EN 1

30、617, Sterile drainage catheters for single use. ISO 2018 All rights reserved vBS EN ISO 20697:2018ISO 20697:2018IntroductionGuidance on transition periods for implementing the requirements of this document is given in ISO/TR 19244.vi ISO 2018 All rights reservedBS EN ISO 20697:2018Sterile drainage c

31、atheters and accessory devices for single use1 ScopeThis document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or

32、percutaneously, for drainage of fluid or air to the exterior.The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation.This document is not applicable to:a) suction catheters;b) tracheal catheters;c) urethral catheters;NOTE See ISO 20696.d) urete

33、ral stents, biliary stents, and other stents;NOTE See ISO 14630 and ASTM F1828-97 for stents requirements.e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;f) neuraxial catheters used for removal of cerebrospinal fluid;NOTE See ISO 20698.g) enteral catheters

34、used for removal of solutions or substances from the gastrointestinal tract;NOTE See ISO 20695.h) coatings.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only t

35、he edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 14155, Clinical investigation of medical devices

36、 for human subjects Good clinical practiceISO 80369-1, Small bore connectors for liquids and gases in healthcare applications Part 1: General requirements3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.INTERNATIONAL STANDARD ISO 20697:2018 ISO 2018

37、 All rights reserved 1BS EN ISO 20697:2018ISO 20697:2018ISO 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/3.1accessory devic

38、edevice that is used with the drainage system (3.6) for access and/or drainage e.g. collection device(s) (3.3) and, where applicable, other accessories such as suction source(s) (3.16), connecting tube(s) (3.4), connector(s), trocar(s), split needle(s)/cannula(s), or introducer(s)3.2catheter compone

39、ntpart which is integral with the drainage catheterEXAMPLE Catheter connectors, securement devices, Heimlich valve.3.3collection devicebag, bellows or other portable container designed for collecting liquid3.4connecting tubetube designed for connecting the drainage catheter and collection device (3.

40、3), or collection device (3.3) and suction source (3.15)3.5drainage cathetertube designed for draining fluid or air from a body cavity or a surgical wound3.6drainage systemfunctional assembly of drainage catheter (3.5) and collection device(s) (3.3) and, where applicable, other accessories such as s

41、uction source(s) (3.16), connecting tube(s) (3.4), connector(s) or trocar(s)Note 1 to entry: A drainage system may be supplied either in the ready-for-use state or in a state requiring the assembly of some components by the user. Drainage may be achieved either by gravity, by negative pressure gener

42、ated by an external power source, by manipulation by the user, or by the pre-evacuation of the collection device (3.3).3.7effective lengthL 1length of the catheter, or pre- and post-hydration lengths of hydratable catheters, that can be inserted into the body3.8overall lengthL 2total length from the

43、 tip of the catheter to the end of the funnel (3.10)3.9effective shaft lengthL 3length of non-perforated portion of the catheter excluding the tip, balloon(s), funnel(s) (3.10), protective sleeves and/or access port(s)3.10funnelproximal portion of the catheter, which may be connected to a drainage s

44、ystem (3.7)2 ISO 2018 All rights reservedBS EN ISO 20697:2018ISO 20697:20183.11retention meansphysical feature of the catheter within the body that prevents movement of the catheter out of the bodyEXAMPLE Pigtail, suture with pigtail, malecot, balloon.3.12riskcombination of the probability of occurr

45、ence of harm and the severity of that harmSOURCE: ISO 14971:2007, 2.163.13risk analysissystematic use of available information to identify hazards and to estimate the risk (3.12)SOURCE: ISO 14971:2007, 2.17Note 1 to entry: Risk analysis includes examination of different sequences of events that can

46、produce hazardous situations and harm (see Annex E of ISO 14971:2007).3.14risk assessmentoverall process comprising a risk analysis (3.12) and a risk evaluationSOURCE: ISO 14971:2007, 2.183.15risk management fileset of records and other documents that are produced by risk managementSOURCE: ISO 14971

47、:2007, 2.233.16suction sourceself-contained device capable of exerting a negative pressure on a drainage catheter (3.5) or systemNote 1 to entry: The suction source may be the collection device (3.3).3.17trocarneedle, pointed rod sleeve or any combination thereof which assists in passing the drainag

48、e catheter (3.5) through the body wall4 Intended performanceThe drainage catheter shall demonstrate the ability to accurately and safely access the intended location. The drainage system shall demonstrate the ability to maintain drainage.If the drainage catheter has retention means, it shall demonst

49、rate the ability to prevent undesired dislodgement. The method of release of retention shall be described in the instructions for use.5 General requirements5.1 Risk managementAn established risk management process shall be applied to the design of the device and a risk analysis shall be performed.EXAMPLE ISO 14971. ISO 2018 All rights reserved 3BS EN ISO 20697:2018ISO 20697:2018Compliance shall be checked by inspection of the risk management file. If clinical studies are performed, these studies shall document measurements taken under c