BS EN ISO 8836-2014 Suction catheters for use in the respiratory tract《用于呼吸道的抽吸导管》.pdf

1、BSI Standards PublicationBS EN ISO 8836:2014Suction catheters for usein the respiratory tract (ISO8836:2014)BS EN ISO 8836:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 8836:2014.It supersedes BS EN ISO 8836:2009 which is withdrawn.The UK participatio

2、n in its preparation was entrusted to TechnicalCommittee CH/121/5, Airways and related equipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsi

3、ble for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 74655 0ICS 11.040.10; 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theSt

4、andards Policy and Strategy Committee on 30 November 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8836 October 2014 ICS 11.040.25; 11.040.10 Supersedes EN ISO 8836:2009English Version Suction catheters for use in the respiratory t

5、ract (ISO 8836:2014) Sondes daspiration pour les voies respiratoires (ISO 8836:2014) Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2014) This European Standard was approved by CEN on 25 July 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the co

6、nditions 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. This European Standard exi

7、sts 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 members are the national st

8、andards 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, Portugal, Romania, Slovakia,

9、Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means rese

10、rved worldwide for CEN national Members. Ref. No. EN ISO 8836:2014 EBS EN ISO 8836:2014EN ISO 8836:2014 (E) 3 Foreword This document (EN ISO 8836:2014) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215 “Re

11、spiratory and anaesthetic equipment” the secretariat of which is held by BSI. 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 April 2015, and conflicting national standards shall be withdrawn at t

12、he latest by April 2015. 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 patent rights. This document supersedes EN ISO 8836:2009. This document has

13、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 EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CEN

14、ELEC 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, I

15、celand, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8836:2014 has been approved by CEN as EN ISO 8836:2014 without any modificat

16、ion. BS EN ISO 8836:2014EN ISO 8836:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Asso

17、ciation to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with t

18、he 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 When an Essential Requirement does not appear in Table

19、 ZA.1, it means that it is not addressed by this standard. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC amended by 2007/47/EC Qualifying remarks/notes 4, 6 7.1 (second, and third

20、 indents) In the EU, competent authorities always require applicable ERs 6.1, 9.1, 9.2 7.2 6.1 mandates that these devices shall satisfy the biological safety testing indicated in ISO 10993-1. 9.1 and 9.2 covers the integrity of the packaging only for devices supplied sterile 4.1.1, 4.1.2, 6 7.3 fir

21、st sentence 4.1.1, 4.1.2, and 6 mandates a risk assessment be carried out which does not exclude risks associated with materials and the substances with which they may come into contact. 6.8, 10.3.2 i) 7.5 Partly addressed by 6.8 and 10.3.2 i) calls specifically for a warning if phthalates are incor

22、porated 9.1, 9.2, 10.3.2 f) 10.4.2 g) 8.1 9.1 and 10.3.2 f) and 10.4.2 g) mandate that sterile devices are clearly marked according to EN 5561 mandates the requirements of ISO 11607-1 to ensure that the packaging is suitable to prevent contamination during transportation and use. 9.2 8.3 Partly addr

23、essed by 9.2 which mandates the requirements of ISO 11607-1 that the packaging is suitable to prevent contamination during transportation and use. 9.1 8.4 9.1 mandates that sterile devices satisfy 4.1 of EN 5561 BS EN ISO 8836:2014EN ISO 8836:2014 (E) 5 9.1 8.5 9.1 mandates that sterile devices sati

24、sfy 4.1 of EN 5561 10.3.2 f) 10.4.2 g) 8.7 Partly covered. Marked sterile if appropriate 7.3 7.4.1 7.4.2 7.4.6 8.1 8.4 8.5 9.1 Generally covered by mandating construction and testing of interface connectors, and leakage and resistance when attached to breathing systems. 5.1 5.2 7.1 7.2 7.4.1 7.4.3 7

25、.4.4 7.4.5 8.1 8.2 8.3 8.6 9.2 (first three requirements) Partly covered to address only the risk of injury in connection with their physical features by specifying sizing and marking conventions for the ID/OD and length of the catheter, design and construction of the tip, additional protections if

26、provided by components of a closed suction catheter, security of construction, performance of the catheter shaft and vacuum control device, and radiopacity. 10.1.3 10.1.4 10.1.5 10.1.6 10.1 (first sentence) Partly covered to address indication of tip angle, length measurement and marking in cm and c

27、olour codes for length marks, if provided. Limits of accuracy are specified in the standard and not disclosed by the manufacturer. 10.1.3 10.1.4 10.1.5 10.1.6 10.2 Tip direction and length mark positions are mandated to provide ergonomic visibility during intubation. 10.1.4 10.1.5 10.3 Length markin

28、g is mandated using SI units (mm). Additional use of (cm) is permitted. 7.4.2.1 7.4.2.2 7.4.5 12.7.4 Suction catheter gas connectors are mandated to comply with ISO 5356-1 for 15 mm and 22 mm connectors. Suction catheter flushing system connectors are mandated to comply with ISO 594-1 or ISO 594-2 f

29、or Luers. BS EN ISO 8836:2014EN ISO 8836:2014 (E) 6 10 Annex A, Clause 4 13.1 Covered by mandating marking and labelling and instructions on the suction catheter, connector, unit label, shelf/multi-unit label and instructions for use. Annex A, Clause 4 draws attention to consideration of disclosure

30、of specific labelling and instructions for intended use that may deviate from the currently accepted medical practice. 10.2 13.2 Symbols are mandated in 10.2 to conform to EN 1041, ISO 7000 or ISO 15223-1 and ISO 15223-2 10.3.2 c) 10.4.2 c) 13.3 a) Manufacturer identification mandated on the device

31、and on individual pack or any insert. Authorized representative mandated on the individual pack or any insert. 10.3.2 10.4.2 13.3 b) 10.3.2 f) 10.4.2 g) 13.3 c) 10.4.2 d) 13.3 d) Batch code preceded by the word “LOT” mandated for EU countries. 10.4.2 e) 13.3 e) Use by date is partly addressed where

32、appropriate as an indication of the date by which the catheter should be used. The EU regulation makes it mandatory. 10.4.2 g) 10.4.2 i) 13.3 f) Annex A, Clause 4 13.3 j) Annex A, Clause 4 draws attention to consideration of disclosure of specific labelling and instructions for intended use that may

33、 deviate from the currently accepted medical practice. 10.3.2 f) 10.4.2 g) 13.3 m) 10.3 10.4 f) 13.6, a), b), c) Instructions are limited to the mandated information on labelling of individual packs, and preparation for use instructions on the shelf/multi-pack label only. 10.4.2 h) 13.6 h) Limited t

34、o mandated instructions for cleaning, disinfection, and resterilization on the shelf/multi-pack label only. Risks associated with the reuse of devices marked for single use are covered partly by the risk management file and use of the informative Annex F Hazard identification for risk assessment 10.

35、4.2 f) 13.6 i) Limited to mandated instructions for preparation for use on the shelf/multi-pack label only. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard BS EN ISO 8836:2014ISO 8836:2014(E)Contents PageForeword vIntro

36、duction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 *General requirements for open and closed suction catheters . 54.1 Risk management . 54.2 Safety . 65 Specific requirements for open and closed suction catheters 65.1 Size and length designations. 65.2 *Dimensions 66 Materials

37、 . 77 *Design 87.1 Lumen of the suction catheter . 87.2 Suction catheter tip . 87.3 *Suction catheter connector 87.4 Additional requirements for closed suction catheters 108 Performance requirements 128.1 Security of construction . 128.2 Shaft performance . 128.3 *Vacuum control device performance .

38、 138.4 *Leakage 138.5 *Resistance to flow . 138.6 *Radiopacity . 139 Requirements for suction catheters supplied sterile139.1 Sterility assurance . 139.2 Packaging of suction catheters supplied sterile 1410 Marking .1410.1 Marking on suction catheters 1410.2 Use of symbols 1510.3 Labelling of indivi

39、dual packs . 1610.4 Labelling of shelf/multi-unit packs 16Annex A (informative) Rationale .18Annex B (normative) Test method for security of attachment .21Annex C (normative) Measurement of residual vacuum 22Annex D (normative) Method of testing leakage 24Annex E (informative) Hazard identification

40、for risk assessment .25Bibliography .27 ISO 2014 All rights reserved iiiBS EN ISO 8836:2014ISO 8836:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is nor

41、mally 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 organizations, governmental and non-governmental, in liaison with ISO, also take part in

42、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 its further maintenance are described in the ISO/IEC Directives, Part 1. In particular th

43、e 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. www.iso.org/directivesAttention is drawn to the possibility that some of the elements of this document ma

44、y 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 in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patentsAn

45、y 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 meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in t

46、he Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related equipment.This fourth edition of ISO 8836 cancels and replaces the

47、third edition (ISO 8836:2007), of which it constitutes a technical revision.iv ISO 2014 All rights reservedBS EN ISO 8836:2014ISO 8836:2014(E)IntroductionThis International Standard specifies dimensions and requirements for suction catheters for use in the respiratory tract. It is concerned with the

48、 basic requirements and method of size designation of both open and closed suction catheters made of flexible materials.The method of describing tube dimensions and configuration has been devised in order to assist clinicians in the selection of the most suitable suction catheter for a particular pa

49、tient. Size is designated by outside diameter which is important when selecting a catheter because of its relationship to the ease with which the catheter can be passed through a tracheal or tracheostomy tube.234Revisions in this fourth edition are intended to harmonize this International Standard with recent amendments in the European Medical Device Directive.Major technical revisions in this edition include requirements for closed suction catheters, new requirements to harmonize this International Standard with requirements for critical care ventila