BS EN ISO 10079-1-2015 Medical suction equipment Electrically powered suction equipment《医疗吸引设备 电动吸引设备》.pdf

1、BSI Standards PublicationBS EN ISO 10079-1:2015Medical suction equipmentPart 1: Electrically powered suctionequipmentBS EN ISO 10079-1:2015Incorporating corrigendum February 2016BS EN ISO 10079-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 10079-1:2

2、015. It supersedes BS EN ISO 10079-1:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121, Anaesthetic and respiratory equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication d

3、oes not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 93408 7ICS 11.040.10Compliance with a British Standard cannot confer immunity from l

4、egal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate Text affected29 February 2016 Implementation of CEN Correction Notice 2 December 2015: EN Foreword and Annex

5、ZA updatedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10079-1 November 2015 ICS 11.040.10 Supersedes EN ISO 10079-1:2009English Version Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015) Appareils daspiration mdicale - Partie 1: Appareils lectr

6、iques daspiration (ISO 10079-1:2015) Medizinische Absauggerte - Teil 1: Elektrisch betriebene Absauggerte (ISO 10079-1:2015) This European Standard was approved by CEN on 13 May 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving

7、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 exists in three officia

8、l 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 standards bodies of Au

9、stria, 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, Slovenia, Spain, Swe

10、den, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CE

11、N national Members. Ref. No. EN ISO 10079-1:2015 EEN ISO 10079-1:2015 (E) 3 European foreword This document (EN ISO 10079-1:2015) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthe

12、tic 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 May 2016, and conflicting national standards shall be withdrawn at the latest by November 20

13、18. 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 10079-1:2009. This document has been prepared unde

14、r 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-CENELEC Internal Regu

15、lations, 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, Iceland, Ireland, I

16、taly, 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 10079-1:2015 has been approved by CEN as EN ISO 10079-1:2015 without any modification. iiBS EN

17、 ISO 10079-1:2015EN ISO 10079-1:2015 (E)EN ISO 10079-1:2015 (E) 4 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request

18、 M/023 concerning the development of European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the Eur

19、opean Union under that Directive, 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 corresponding essential requirements of that Directive and associated EFTA regulations. NOTE 1 W

20、here a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, mi

21、nimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 When an Essential Requirement does not ap

22、pear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.1 Third indent only 4

23、.4 7.2 5; 7.5 Partly covered There are no requirements for packaging. 7.3 First part only 6.1.3 7.6 6.2.3; 6.5; 7.5.1; 7.5.2 8.1 4.2; 5; 7.5.1 8.7 11.3 c) 9.1 First sentence only 6.2; 6.3 9.2 4; 6.1.3 Partly covered Electrical safety is by ref to IEC 606011 and risk management by ref to ISO 14971. i

24、iiBS EN ISO 10079-1:2015EN ISO 10079-1:2015(E)EN ISO 10079-1:2015 (E) 5 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 10.1 6.4.6 Partly covered. There are no requirements for the manufacturer to disclose the accuracy of the vacuum level indicator. 10.

25、2 6.4 10.3 11.3 i) Covered for volume measurements only 12.1 4 Covered by ref to IEC 606011 12.1a) 4 Covered by ref to IEC 606011 12.2 4 Covered by ref to IEC 606011 although suction equipment is not considered life-support equipment. 12.5 4 Covered by ref to IEC 606011 and thereby to IEC 6060112 12

26、.6 4; 6.5 Covered by ref to IEC 606011 12.7.1 6.1.3; 7.4 12.7.2 4 Covered by ref to IEC 606011 12.7.3 7.6 12.7.4 4 Covered by ref to IEC 606011 12.7.5 4 Covered by ref to IEC 606011 12.8.2 Second sentence only 7.5.3.2 12.9 11.3 i); j); k); l); m); n); o); p); q); r) 13.1 11 13.2 11.2 13.3a) 11.3 a)

27、13.3b) 11.3 b) 13.3c) 11.3 c) 13.3d) 11.3 d) 13.3e) 11.3 e) 13.3 f) 11.3 f) 13.3 k) 11.4 c); q); y) 13.3 l) 11.3 d) 13.3 m) 11.4 i) 13.4 11.4 b) 13.6 a) 11.4 Not covered for the requirement of ER 13.3b) 13.6 b) 11.4 d); e) ivBS EN ISO 10079-1:2015EN ISO 10079-1:2015(E)EN ISO 10079-1:2015 (E) 6 Essen

28、tial Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 13.6 c) 11.4 d) ;k) 13.6 d) 11.4 d); j); v) Calibration is not covered 13.6 f) 11.4 x) 13.6 h) First two paragraphs only 11.4 i) 13.6 i) 11.4 j) 13.6 q) 11.4 z) WARNING 1 Presumption of conformity stays valid o

29、nly as long as a reference to this European Standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2 Other Union legislation may be a

30、pplicable to the products falling within the scope of this standard. vBS EN ISO 10079-1:2015EN ISO 10079-1:2015(E)BS EN ISO 10079-1:2015ISO 10079-1:2015(E)Foreword v1 Scope . 12 Normative references 13 Terms and definitions . 24 General requirements . 44.1 Risk management . 44.2 Usability 54.3 Clini

31、cal investigation 54.4 Biophysical or modelling research 54.5 Test methods . 55 Cleaning, disinfection and sterilization 56 Design requirements 66.1 Collection container 66.1.1 General 66.1.2 Container capacity 66.1.3 Container strength . 66.2 Connections . 66.2.1 Tubing connectors for collection co

32、ntainers . 66.2.2 Inlet port . 76.2.3 Exhaust port. 76.3 Suction tubing 76.4 Vacuum level indicators 76.5 Spillage on electrical suction equipment . 87 Operational requirements . 87.1 Ease of operation 87.2 Dismantling and reassembly . 87.3 Mechanical shock 87.4 Stability 87.5 Protective devices . 9

33、7.5.1 Contamination protection 97.5.2 Overfill protection devices 97.5.3 Pressure protection . 97.6 Noise 97.6.1 Low vacuum/low flowrate equipment . 97.6.2 Suction equipment other than that specified in 7.6.1 97.7 Air leakage . 107.7.1 Collection containers for general use .107.7.2 Collection contai

34、ners for thoracic drainage 108 Physical requirements for suction equipment for field use .108.1 (*) Dimensions . 108.2 Mass . 109 Performance requirements for vacuum level and flowrate .109.1 High vacuum/high flowrate equipment . 109.2 Medium vacuum equipment. 119.3 Low vacuum/low flowrate equipment

35、 119.4 Low vacuum/high flowrate equipment 119.5 Thoracic drainage equipment for adults . 119.6 Intermittent vacuum equipment 119.7 Vacuum regulators with fixed setting 119.8 Vacuum regulators with variable setting 129.9 Equipment intended for pharyngeal suction . 12 ISO 2015 All rights reserved iiiC

36、ontents PageBS EN ISO 10079-1:2015ISO 10079-1:2015(E)vi ISO 2015 All rights reservedviiiBS EN ISO 10079-1:2015ISO 10079-1:2015(E)9.10 Battery powered transportable suction equipment 129.11 Interruption of the power supply 1210 (*) Resistance to environment of suction equipment for field and/or trans

37、port use .1210.1 Operating conditions 1210.2 Storage 1211 Information to be supplied by the manufacturer (labelling and instructions for use) .1311.1 Information supplied by the manufacturer shall comply with EN 1041. 1311.3 Labelling of equipment . 1311.4 Instructions for use 14Annex A (normative)

38、Test methods 16Annex B (informative) Rationale statement 27Annex C (informative) Lumen size and its effect on flowrate 28Annex D (informative) Schematic of suction equipment 29Bibliography .30iv ISO 2015 All rights reservedBS EN ISO 10079-1:2015ISO 10079-1:2015(E)vii ISO 2015 All rights reserved BS

39、EN ISO 10079-1:2015ISO 10079-1:2015(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 normally carried out through ISO technical committees. Each member body

40、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 collaborates closely with the International Electrotech

41、nical 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 approval criteria needed for the different types of ISO d

42、ocuments 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 subject of patent rights. ISO shall not be held respon

43、sible 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 trade name used in this document is information given f

44、or 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 the Technical Barriers to Trade (TBT) see the following UR

45、L: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use.This third edition cancels and replaces the second edition (ISO 10079-1:1999), which has bee

46、n technically revised.ISO 10079 consists of the following parts, under the general title Medical suction equipment: Part 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

47、 normative part of this part of ISO 10079 while Annex B, Annex C, and Annex D are for information only.Annex B contains rationale statements for some of the requirements of this part of ISO 10079. The clauses and subclauses marked with an asterisk (*) at the beginning of the paragraph have correspon

48、ding rationale contained in Annex B included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated into this part of ISO 10079. It is considered that knowledge of the reasons for the requirements will not only facilitate the pro

49、per application of this part of ISO 10079, but will expedite any subsequent revisions.Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems. ISO 2015 All rights reserved vBS EN ISO 10079-1:2015ISO 10079-1:2015(E)viii ISO 2015 All rights reserved BS EN ISO 10079-1:2015Medical suction equipment P