1、BSI Standards PublicationBS EN ISO 10079-3:2014Medical suction equipmentPart 3: Suction equipment powered from avacuum or positive pressure gas source (ISO10079-3:2014)BS EN ISO 10079-3:2014Incorporating corrigendum June 2014BS EN ISO 10079-3:2014 BRITISH STANDARDNational forewordThis British Standa
2、rd is the UK implementation of EN ISO10079-3:2014. It supersedes BS EN ISO 10079-3:2009 which 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
3、request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 77704 2ICS 11.040.10Compliance with a Britis
4、h Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 May 2014.Amendments issued since publicationDate Text affectedBS EN ISO 10079-3:2014 BRITISH STANDARDAmendments/corrigenda issued since
5、publicationDate Text affected30 June 2014 Implementation of CEN correction notice May 2014: Supersession information updated on CEN title page and forewordISBN 978 0 580 86983 9EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10079-3 May 2014 ICS 11.040.10 Supersedes EN ISO 10079-3:2009Engli
6、sh Version Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) Appareils daspiration mdicale - Partie 3: Appareils daspiration aliments par une source de vide ou de pression (ISO 10079-3:2014) Medizinische Absauggerte - Teil
7、3: Vakuum- oder druckquellenbetriebene Absauggerte (ISO 10079-3:2014)This European Standard was approved by CEN on 15 February 2014. 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 sta
8、ndard 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 (English, French, German). A version in
9、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, Belgium, Bulgaria, Croatia, Cyprus, Czech Re
10、public, 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 United Kingdom. EUROPE
11、AN 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 reserved worldwide for CEN national Members. Ref. No. EN ISO 10079-3:2014 E
12、EN ISO 10079-3:2014 (E) 3 Foreword This document (EN ISO 10079-3:2014) has been prepared by Technical Committee ISO/TC 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. Thi
13、s 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 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
14、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 10079-3:2009. This document has been prepared under a mandate given to CEN by the European Commission and the
15、 European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, 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 co
16、untries 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,
17、Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10079-3:2014 has been approved by CEN as EN ISO 10079-3:2014 without any modification. BS EN ISO 10079-3:2014EN ISO 10079-3:2014 (E)EN ISO 10079-3:2014 (E) 4 A
18、nnex 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 Association to provide a means of conforming to Esse
19、ntial Requirements of 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 the normative clauses of this standard given in Table ZA.1 confers,
20、within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive. NOTE 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 th
21、is European Standard and Directive 93/42/EEC Clause(s) / sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 4.1, 4.4, 12 t) 7.1 Partly covered There are no requirements for materials apart from a requirement to perform a risk assessment and to discl
22、ose the presence of latex. As these devices are only for extracting body fluids toxicity and biological compatibility is not considered a risk. 4.1, 5, 7.5, 7.5.2, 7.7 7.2 4.1, 4.2, 5 7.3 Only the first part of this ER is covered 7.5.1, 7.5.2 8.1 4.1, 6.3, 6.5 9.1 4.1, 10 9.2 Only covered as far as
23、temperature is concerned 7.4 12.7.1 Only covered as far as stability is concerned 7.6 12.7.3 6.5 12.7.4 11, 12 13.1 11.2 a) 13.3 a) 11.2 b) 13.3 b) 11.2 c) 13.3 c) 11.2 d) 13.3 d) 11.2 e) 13.3 e) BS EN ISO 10079-3:2014EN ISO 10079-3:2014 (E)EN ISO 10079-3:2014 (E) 5 11.2 f) 13.3 f) 12 b) 13.4 Partly
24、 covered: disclosure of the intended purpose is included in the Instructions for use but not the labelling. 12 13.6a) Covered for the items in 13.3 a), b), c), f), i) and k) 12 b), c), d), f),g), h), j), k), o), t), u) 13.6 b) 12 k) 13.6 c) 12 b), c), d), h), j), v) 13.6 d) 12 i) 13.6 h) First two p
25、aragraphs only 12 d) 13.6 i) 12 z) 13.6 q) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 10079-3:2014EN ISO 10079-3:2014 (E)BS EN ISO 10079-3:2014ISO 10079-3:2014(E) ISO 2014 All rights reserved iiiContents
26、 PageForeword v1 Scope . 12 Normative references 13 Terms and definitions . 24 General requirements . 44.1 Risk management . 44.2 Usability 54.3 Clinical investigation 54.4 Biophysical or modelling research 65 Cleaning, disinfection and sterilization 66 Design requirements 66.1 Collection container
27、66.2 Connections . 76.3 Suction tubing 76.4 Vacuum level indicators 76.5 Supply connections . 87 Operational requirements . 87.1 Ease of operation 87.2 Dismantling and reassembly . 87.3 Mechanical shock 87.4 Stability 97.5 Protective devices . 97.6 Noise 97.7 Air leakage . 108 Physical requirements
28、for field and transport use suction equipment .108.1 (*)Dimensions . 108.2 Mass . 109 Performance requirements for vacuum level and flowrate .119.1 High vacuum/high flowrate equipment . 119.2 Medium vacuum equipment. 119.3 Low vacuum/low flowrate equipment 119.4 Low vacuum/high flowrate equipment 11
29、9.5 Thoracic drainage equipment for adults . 119.6 Intermittent vacuum equipment 129.7 Vacuum regulators with fixed setting 129.8 Vacuum regulators with variable setting 129.9 Equipment intended for pharyngeal suction .1210 (*)Resistance to environment of suction equipment for field and/or transport
30、 use .1210.1 Operating conditions 1210.2 Storage 1211 Marking .1211.1 Use of symbols 1211.2 Equipment 1311.3 Equipment or carrying case 1412 Information to be supplied by the manufacturer 14Annex A (normative) Test methods 16Annex B (informative) Rationale statement 27Annex C (informative) Lumen siz
31、e and its effect on flowrate 28BS EN ISO 10079-3:2014ISO 10079-3:2014(E)iv ISO 2014 All rights reservedAnnex D (informative) Schematic of suction equipment 29Bibliography .30BS EN ISO 10079-3:2014ISO 10079-3:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide feder
32、ation 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 commit
33、tee. 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
34、those 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
35、2 (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
36、 document 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 term
37、s and 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 respira
38、tory equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use.This third edition cancels and replaces the second edition (ISO 10079-3:1999), which has been technically revised.ISO 10079 consists of the following parts, under the general title Medical suction equipment: Part
39、1: Electrically 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 st
40、atements 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 tha
41、t have 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. ISO 2014 All rights reserved vBS EN ISO 10079-3:2014BS EN ISO
42、 10079-3:2014Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source1 ScopeThis part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suc
43、tion. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.The equipment can be stand-alone or part of an integrated system.Additional requirements for suc
44、tion 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) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;b) end-piece such as sucti
45、on catheters, Yankauer sucker and suction tips;c) syringes;d) dental suction equipment;e) anaesthetic gas scavenging systems;f) laboratory suction;g) autotransfusion systems;h) closed systems for wound drainage;i) mucus extractors, including neonatal mucus extractors;j) ventouse (obstetric) equipmen
46、t;k) breast pumps;l) liposuction;m) uterine aspiration;n) plume evacuation systems.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 unda
47、ted references, the latest edition of the referenced document (including any amendments) applies.INTERNATIONAL STANDARD ISO 10079-3:2014(E) ISO 2014 All rights reserved 1BS EN ISO 10079-3:2014ISO 10079-3:2014(E)ISO 3744, Acoustics Determination of sound power levels and sound energy levels of noise
48、sources using sound pressure Engineering methods for an essentially free field over a reflecting planeISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and socketsISO 5359, Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gase
49、sISO 70001), Graphical symbols for use on equipment Registered symbolsISO 14155, Clinical investigation of medical devices for human 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 for liquids and gases in healthcare applicationsIEC 60601-1:2005+A1:2012, Medical electrical equ
