BS EN ISO 10079-2-2014 Medical suction equipment Manually powered suction equipment《医用抽吸设备 第2部分 手动抽吸设备》.pdf

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1、BSI Standards PublicationBS EN ISO 10079-2:2014Medical suction equipmentPart 2: Manually powered suctionequipment (ISO 10079-2:2014)BS EN ISO 10079-2:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10079-2:2014. It supersedes BS EN ISO 10079-2:2009 which

2、 iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121, Anaesthetic and respiratory 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 necessaryprovis

3、ions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 77703 5ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published u

4、nder the authority of theStandards Policy and Strategy Committee on 31 May 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10079-2 May 2014 ICS 11.040.10 Supersedes EN ISO 10079-2:2009English Version Medical suction equipment - Part

5、2: Manually powered suction equipment (ISO 10079-2:2014) Appareils daspiration mdicale - Partie 2: Appareils daspiration manuelle (ISO 10079-2:2014) Medizinische Absauggerte - Teil 2: Handbetriebene Absauggerte (ISO 10079-2:2014) This European Standard was approved by CEN on 15 February 2014. CEN me

6、mbers 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 applica

7、tion 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 Manag

8、ement 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

9、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix

10、 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10079-2:2014 EBS EN ISO 10079-2:2014EN ISO 10079-2:2014 (E) 3 Foreword This document (EN ISO 10079-2:2014) has been prepared by Technical Committee ISO/T

11、C 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” 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 b

12、y endorsement, at the latest by November 2014, and conflicting national standards shall be withdrawn at the latest by May 2017. 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 i

13、dentifying any or all such patent rights. This document supersedes EN ISO 10079-2:2009. 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. For relationship with EU Direc

14、tive, 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 Republic, D

15、enmark, 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. Endorsement

16、 notice The text of ISO 10079-2:2014 has been approved by CEN as EN ISO 10079-2:2014 without any modification. BS EN ISO 10079-2:2014EN ISO 10079-2:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Sta

17、ndard has 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 Directive 93/42/EEC. Once this standard is cited in the Official Journal of the European Union under that Directive an

18、d has been implemented as a national standard in at least one Member State, 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 relevant Essential Requirements of that Directive. NOT

19、E 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 Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifyi

20、ng remarks/notes 4.1, 4.4, 12 s) 7.1 Partly covered There are no requirements for materials apart from a requirement to perform a risk assessment and to disclose the presence of Latex. As these devices are only for extracting body fluids toxicity and biological compatibility is not considered a risk

21、. 4.1, 5, 6.1.3, 7.5.2 7.2 4.1, 4.2, 5, 6.1.3, 7.6, 10 7.3 Only the first part of this ER is covered 4.1, 5, 6.1.3, 7.5.2 8.1 4.1, 6.2, 6.3, 12 c), 9.1 10 9.2 Only covered as far as temperature is concerned 7.4 12.7.1 Only covered as far as stability is concerned 11, 12 13.1 11.1 13.2 11.2 a) 13.3a)

22、 11.2 b) 13.3 b) 11.2 c) 13.3 c) 11.2 d) 13.3 d) 11.2 e) 13.3 e) 11.2 f) 13.3 f) BS EN ISO 10079-2:2014EN ISO 10079-2:2014 (E) 5 11.2 k) 13.3 k) 12 b) 13.4 Partly covered: disclosure of the intended purpose is included in the Instructions for use but not the labelling. 12 13.6 a) Covered for the ite

23、ms in 13.3 a), b), c), f), i) and k) 12 d), e), f), g), j), k), l), o), t) 13.6 b) 12 k) 13.6 c) 12 d), f), g), j), u), v), x) 13.6 d) 12 i) 13.6 h) First two paragraphs only 12 f), g) 13.6 i) 12 y) 13.6 q) WARNING Other requirements and other EU Directives may be applicable to the product(s) fallin

24、g within the scope of this standard. BS EN ISO 10079-2:2014ISO 10079-2:2014(E) ISO 2014 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 General requirements . 34.1 Risk management . 34.2 Usability 44.3 Clinical investigation 44.4 Biophys

25、ical or modelling research 45 Cleaning, disinfection and sterilization 46 Design requirements 46.1 Collection container 46.2 Connections . 56.3 Suction tubing 56.4 Vacuum level indicators 67 Operational requirements . 67.1 Ease of operation 67.2 Dismantling and reassembly . 67.3 Mechanical shock 67.

26、4 Stability 67.5 Protection devices 77.6 Immersion in water 78 Physical requirements for field and transport use suction equipment 78.1 (*)Dimensions 78.2 Mass 79 Performance requirements for vacuum level and flowrate 89.1 Vacuum level . 89.2 Free air flowrate 89.3 Pharyngeal suction 810 (*)Resistan

27、ce to environment of suction equipment for field and/or transport use . 810.1 Operating conditions . 810.2 Storage . 811 Marking 811.1 Use of symbols . 811.2 Equipment . 811.3 Equipment or carrying case . 912 Information to be supplied by the manufacturer . 9Annex A (normative) Test methods .11Annex

28、 B (informative) Rationale statement 17Annex C (informative) Lumen size and its effect on flowrate 18Annex D (informative) Schematic of suction equipment 19Bibliography .20BS EN ISO 10079-2:2014ISO 10079-2:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federat

29、ion of national 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 committe

30、e. International 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 th

31、ose intended for 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

32、(see www.iso.org/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 do

33、cument will be 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 meaning of ISO specific terms an

34、d expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory

35、 equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use.This third edition cancels and replaces the second edition (ISO 10079-2:1999), which has been technically revised.ISO 10079 consists of the following parts, under the general title Medical suction equipment: Part 1: E

36、lectrically powered suction equipment Part 2: Manually powered suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas sourceAnnex A forms a normative part of this part of ISO 10079 while Annexes B, C and D are for information only.Annex B contains rationale statem

37、ents for some of the requirements of this part of ISO 10079. The clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale contained in Annex B, included to provide additional insight into the reasoning that led to the requirements and recommendations that ha

38、ve been incorporated in this part of ISO 10079. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this part of ISO 10079, but will expedite any subsequent revisions.iv ISO 2014 All rights reservedBS EN ISO 10079-2:2014INTERNATIONAL

39、 STANDARD ISO 10079-2:2014(E)Medical suction equipment Part 2: Manually powered suction equipment1 ScopeThis part of ISO 10079 specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand

40、 or both. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.The commonest use of manually powered suction is in situations outside of health care settings often described as field use or transport use. Use in these situations may involve extreme conditions

41、 of weather or terrain. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079.This part of ISO 10079 does not apply to the following:a) end pieces such as suction catheters, Yankauer sucker and suction tips;b) dental suction equi

42、pment;c) mucus extractors, including neonatal mucus extractors.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the

43、latest edition of the referenced document (including any amendments) applies.ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and socketsISO 70001), Graphical symbols for use on equipment Registered symbolsISO 14155, Clinical investigation of medical devices for hum

44、an subjects Good clinical practiceISO 14971, Medical devices Application of risk management to medical devicesISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 80369 (all parts), Small-bore connectors

45、for liquids and gases in healthcare applicationsIEC 62366, Medical devices Application of usability engineering to medical devicesEN 1041, Information supplied by the manufacturer of medical devices3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.1)

46、 The graphical symbol collections of ISO 7000, ISO 7001 and ISO 7010 are also available on the Online Browsing Platform http:/www.iso.org/obp. ISO 2014 All rights reserved 1BS EN ISO 10079-2:2014ISO 10079-2:2014(E)3.1collection containercontainer in which liquids and solid particles are collected3.2

47、end-piecethat part of the suction equipment applied to the patient which begins at the site where material is drawn in and ends at the first detachable connectionNote 1 to entry: Examples of commonly used end-pieces are a Yankauer sucker and a suction catheter.3.3exhaust portopening through which ex

48、haust gas is discharged3.4field useuse of suction equipment in situations outside of the health care facility at the site of accidents or other emergencies3.5filterdevice for retention of particulate matter3.6free air flowraterate of unrestricted flow of air through a designated inlet3.7inlet portop

49、ening through which liquid, solid particles or gas enter3.8intermediate tubingtubing between the collection container and the vacuum source3.9manually powered suctiongeneration of vacuum by direct human effort3.10overfill protection devicedevice intended to prevent liquid or solid particles from entering the intermediate tubing3.11single fault conditioncondition in which a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is presentNote 1 to entry: Maintenan