1、September 2014 Translation by DIN-Sprachendienst.English price group 14No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).
2、ICS 11.040.10!%:J“2235839www.din.deDDIN EN ISO 10079-2Medical suction equipment Part 2: Manually powered suction equipment (ISO 10079-2:2014);English version EN ISO 10079-2:2014,English translation of DIN EN ISO 10079-2:2014-09Medizinische Absauggerte Teil 2: Handbetriebene Absauggerte (ISO 10079-2:
3、2014);Englische Fassung EN ISO 10079-2:2014,Englische bersetzung von DIN EN ISO 10079-2:2014-09Appareils daspiration mdicale Partie 2: Appareils daspiration manuelle (ISO 10079-2:2014);Version anglaise EN ISO 10079-2:2014,Traduction anglaise de DIN EN ISO 10079-2:2014-09SupersedesDIN EN ISO 10079-2:
4、2009-07www.beuth.deDocument comprises 29 pagesIn case of doubt, the German-language original shall be considered authoritative.08.14 DIN EN ISO 10079-2:2014-09 2 A comma is used as the decimal marker. National foreword This document (EN ISO 10079-2:2014) has been prepared by Technical Committee CEN/
5、TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom) in collaboration with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: ANSI, USA). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und
6、Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-01 AA Ansthesie und Beatmung. Annex B “Rationale statement” includes remarks to some clauses and subclauses in the main body of this standard. The relevant clauses and subclauses have been marked with an
7、asterisk (*) after their number. DIN EN ISO 10079 consists of the following parts, under the general title Medical suction equipment: Part 1: Electrically powered suction equipment (under revision) Part 2: Manually powered suction equipment Part 3: Suction equipment powered from a vacuum or positive
8、 pressure gas source The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 5356-1 DIN EN ISO 5356-1 ISO 7000 DIN ISO 7000 ISO 8836 DIN EN ISO 8836 ISO 10079-1 DIN EN ISO 10079-1 ISO 10079-3 DIN EN ISO 10079-3 ISO 10651-4 DIN EN ISO 10651-4 IS
9、O 14155 DIN EN ISO 14155 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 80369-1 DIN EN ISO 80369-1 IEC 62366 DIN EN 62366 (VDE 0750-241) Amendments This standard differs from DIN EN ISO 10079-2:2009-07 as follows: a) general requirements for the risk management, usability, clinical in
10、vestigation and biophysical or modelling research have been supplemented; b) requirements for the cleaning, disinfection and sterilization of parts intended for re-use have been revised; c) requirements for connections have been revised; d) requirements for vacuum level indicators have been suppleme
11、nted; e) requirements for suction equipment with interrupted suction have been supplemented; f) requirements for marking and information to be supplied by the manufacturer have been revised; g) test methods have been revised; h) the former Annex B “Table of typical ranges of volume for collection co
12、ntainers for specific uses” has been deleted; i) the standard has been editorially revised. Previous editions DIN EN ISO 10079-2: 1996-11, 2000-03, 2009-07 DIN EN ISO 10079-2:2014-09 3 National Annex NA (informative) Bibliography DIN EN 62366 (VDE 0750-241), Medical devices Application of usability
13、engineering to medical devices DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 8836, Suction catheters for use in the respiratory tract DIN EN ISO 10079-1, Medical suction equipment Part 1: Electrically powered suction equipment Safety
14、 requirements DIN EN ISO 10079-3, Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source DIN EN ISO 10651-4, Lung ventilators Part 4: Particular requirements for operator-powered resuscitators DIN EN ISO 14155, Clinical investigation of medical devi
15、ces for human subjects Good clinical practice DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 80369-
16、1, Small bore connectors for liquids and gases in healthcare applications Part 1: General requirements DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 10079-2:2014-09 4 A comma is used as the decimal marker. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO
17、10079-2 May 2014 ICS 11.040.10 Supersedes EN ISO 10079-2:2009English Version Medical suction equipment - Part 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: Handbe
18、triebene Absauggerte (ISO 10079-2:2014) 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 standard without any alteration.
19、 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 any other language made by tr
20、anslation 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 Republic, Denmark, Estonia, Fin
21、land, 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. EUROPEAN COMMITTEE FOR STANDARDIZAT
22、ION 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 10079-2:2014 EContents PageForeword .31 Sco
23、pe . 42 Normative references 43 Terms and definitions . 44 General requirements . 64.1 Risk management . 64.2 Usability 74.3 Clinical investigation 74.4 Biophysical or modelling research 75 Cleaning, disinfection and sterilization 76 Design requirements 76.1 Collection container 76.2 Connections . 8
24、6.3 Suction tubing 86.4 Vacuum level indicators 97 Operational requirements . 97.1 Ease of operation 97.2 Dismantling and reassembly . 97.3 Mechanical shock 97.4 Stability 97.5 Protection devices .107.6 Immersion in water .108 Physical requirements for field and transport use suction equipment .108.
25、1 (*)Dimensions .108.2 Mass .109 Performance requirements for vacuum level and flowrate . 119.1 Vacuum level 119.2 Free air flowrate . 119.3 Pharyngeal suction . 1110 (*)Resistance to environment of suction equipment for field and/or transport use 1110.1 Operating conditions 1110.2 Storage 1111 Mark
26、ing . 1111.1 Use of symbols 1111.2 Equipment 1111.3 Equipment or carrying case 1212 Information to be supplied by the manufacturer 12Annex A (normative) Test methods .14Annex B (informative) Rationale statement 20Annex C (informative) Lumen size and its effect on flowrate 21Annex D (informative) Sch
27、ematic of suction equipment 22Bibliography .25Annex ZA Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 23DIN EN ISO 10079-2:2014-09 EN ISO 10079-2:2014 (E) 2.(informative)Foreword This document (EN ISO 10079-2:2014) has been prepared by Technical
28、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. This European Standard shall be given the status of a national standard, either by publication of an iden
29、tical 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 elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held re
30、sponsible for identifying 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 relationshi
31、p 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 countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Cz
32、ech 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, Sweden, Switzerland, Turkey and the United Kingd
33、om. Endorsement notice The text of ISO 10079-2:2014 has been approved by CEN as EN ISO 10079-2:2014 without any modification. DIN EN ISO 10079-2:2014-09 EN ISO 10079-2:2014 (E) 3 1 ScopeThis part of ISO 10079 specifies safety and performance requirements for manually powered suction equipment intend
34、ed for oro-pharyngeal suction. It applies to equipment operated by foot or by hand 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
35、field use or transport use. Use in these situations may involve extreme conditions 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
36、such as suction catheters, Yankauer sucker and suction tips;b) dental suction equipment;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.
37、For dated references, only the edition cited applies. For undated references, the 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 equipm
38、ent 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
39、supplied Part 1: General requirementsISO 80369 (all parts), Small-bore connectors 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 definiti
40、onsFor the purposes of this document, the following terms and definitions apply.1) 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.DIN EN ISO 10079-2:2014-09 EN ISO 10079-2:2014 (E) 4 3.1collection container
41、container in which liquids and solid particles are collected3.2end-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
42、 and a suction catheter.3.3exhaust portopening through which exhaust 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 unr
43、estricted flow of air through a designated inlet3.7inlet portopening 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 devi
44、cedevice 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: Maintenance of e
45、quipment is considered a normal condition.3.12suctionapplication of vacuum to remove liquid, solid particles or gas3.13suction tubingtubing for conduction of liquid, solid particles or gas between the end-piece and the collection container3.14transport useuse during patient transport outside of a he
46、alth care facility (e.g. in an ambulance or aeroplane)DIN EN ISO 10079-2:2014-09 EN ISO 10079-2:2014 (E) 5 3.15vacuum levelpressure less than atmospheric pressureNote 1 to entry: In this part of ISO 10079, vacuum level is expressed as a difference from atmospheric pressure.3.16vacuum level indicator
47、device for displaying the vacuum level3.17vacuum sourcecomponent of device for generating vacuum4 General requirements4.1 Risk management4.1.1 This part of ISO 10079 specifies requirements that are generally applicable to risks associated with manually powered suction equipment. An established risk management process shall be applied to the design of the device. The risk management process shall include the following elements: risk analysis; risk evaluation; risk control; production and post-production information.EXAMPLE ISO 14971.Check compli
