DIN EN ISO 80601-2-69-2014 Medical electrical equipment - Part 2-69 Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2.pdf

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1、December 2014Translation by DIN-Sprachendienst.English price group 21No 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).IC

2、S 11.040.10!%“2278890www.din.deDDIN EN ISO 80601-2-69Medical electrical equipment Part 2-69: Particular requirements for basic safety and essentialperformance of oxygen concentrator equipment (ISO 80601-2-69:2014);English version EN ISO 80601-2-69:2014,English translation of DIN EN ISO 80601-2-69:20

3、14-12Medizinische elektrische Gerte Teil 2-69: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichenLeistungsmerkmale fr Sauerstoff-Konzentratoren (ISO 80601-2-69:2014);Englische Fassung EN ISO 80601-2-69:2014,Englische bersetzung von DIN EN ISO 80601-2-69:2014-12Appareils lectromd

4、icaux Partie 2-69: Exigences particulires pour la scurit de base et les performancesessentielles des dispositifs concentrateurs doxygne (ISO 80601-2-69:2014);Version anglaise EN ISO 80601-2-69:2014,Traduction anglaise de DIN EN ISO 80601-2-69:2014-12SupersedesDIN EN ISO 8359:2009-08 andDIN EN ISO 83

5、59/A1:2012-10See start of applicationwww.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.5601.15 DIN EN ISO 80601-2-69:2014-12 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2

6、014-12-01. DIN EN ISO 8359:2009-08 and DIN EN ISO 8359/A1:2012-10 may be used in parallel until 2017-07-31. National foreword This standard includes safety requirements. This document (EN ISO 80601-2-69:2014) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment”

7、 (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescu

8、e Services and Hospital), Working Committee NA 053-03-01 AA Ansthesie und Beatmung. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International Standards referred to in this docume

9、nt are as follows: ISO 3744 DIN EN ISO 3744 ISO 4135 DIN EN ISO 4135 ISO 7000 DIN ISO 7000 ISO 7010 DIN EN ISO 7010 ISO 7396-1 DIN EN ISO 7396-1 ISO 8185 DIN EN ISO 8185 ISO 10083 DIN ISO 10083 ISO 10524-1 DIN EN ISO 10524-1 ISO 14159 DIN EN ISO 14159 ISO/DIS 14644-1 E DIN EN ISO 14644-1 ISO 14937 D

10、IN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 17664 DIN EN ISO 17664 ISO 80369-1 DIN EN ISO 80369-1 ISO 80601-2-67 DIN EN ISO 80601-2-67 IEC 60601-1 DIN EN 60601-1 (VDE 0750 Part 1) IEC 60601-1-2 DIN EN 60601-1-2 (VDE 0750 Part 1-2) IEC 60601-1-6 DIN EN 60601-1-6 (VDE

11、 0750 Part 1-6) IEC 60601-1-8 DIN EN 60601-1-8 (VDE 0750 Part 1-8) IEC 60601-1-11 DIN EN 60601-1-11 (VDE 0750 Part 1-11) IEC 62366 DIN EN 62366 DIN EN ISO 80601-2-69:2014-12 3 Amendments This standard differs from DIN EN ISO 8359:2009-08 and DIN EN ISO 8359:2009/A1:2012-10 as follows: a) the standar

12、d has been brought in line with IEC 60601-1:2005 and IEC 60601-1:2005/A1:2012 including relevant supplements; b) the scope has been extended to include accessories; c) the essential performance of an oxygen concentrator and its accessories has been identified; d) requirements for marking and informa

13、tion to be supplied by the manufacturer have been revised and supplemented; e) packaging requirements have been revised; f) requirements relating to appliance couplers for equipment not intended to be used in transit, which had been included in the draft standard, have been dropped; g) sound pressur

14、e level requirements and test method have been revised; h) requirements relating to the leaking of substances have been supplemented and marking requirements for phtalates which are classified as carcinogenic, mutagenic or toxic to reproduction have been included; i) requirements for cleaning and di

15、sinfection have been revised; j) requirements for power supply failure alarm condition including the test method have been revised; k) requirements for the internal electrical power source have been revised; l) the requirement has been inlcuded that integrated oxygen conserving equipment shall compl

16、y with ISO 80601-2-67; m) the requirement for accuracy of oxygen concentration including the test method has been revised; n) the requirement for the start-up period has been revised; o) the requirement for the low oxygen concentration alarm condition has been revised; p) requirements for the filter

17、 have been revised and a test method has been included; q) requirements for alarm systems have been revised; r) the requirement has been included that outlet connectors shall comply with ISO 80369-1; s) requirements for parts and accessories have been revised and supplemented; t) requirements for si

18、gnal input/output part have been revised; u) requirements for electromagnetic compatibility have been revised; v) requirements for usability have been revised; w) the standard has been editorially revised. Previous editions DIN EN ISO 8359: 1997-03, 2009-08 DIN EN ISO 8359:2009/A1:2012-11 DIN EN ISO

19、 80601-2-69:2014-12 4 National Annex NA (informative) Bibliography DIN EN 62366, Medical devices Application of usability engineering to medical devices DIN EN 60601-1 (VDE 0750 Part 1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601

20、-1-2 (VDE 0750 Part 1-2), Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests DIN EN 60601-1-6 (VDE 0750 Part 1-6), Medical electrical equipment Part 1-6: General requirements

21、 for basic safety and essential performance Collateral standard: Usability DIN EN 60601-1-8 (VDE 0750 Part 1-8), Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in m

22、edical electrical equipment and medical electrical systems DIN EN 60601-1-11 (VDE 0750 Part 1-11), Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems

23、 used in the home healthcare environment DIN EN ISO 3744, Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocab

24、ulary DIN EN ISO 7010, Graphical symbols Safety colours and safety signs Registered safety signs DIN EN ISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum DIN EN ISO 8185, Respiratory tract humidifiers for medical use Particular requirements for

25、 respiratory humidification systems DIN EN ISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices DIN EN ISO 14159, Safety of machinery Hygiene requirements for the design of machinery E DIN EN ISO 14644-1, Cleanroom

26、s and associated controlled environments Part 1: Classification of air cleanliness by particle concentration DIN EN ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization

27、 process for medical devices 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 80601-2-69:2014-12 5 DI

28、N EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices DIN EN ISO 80369-1, Small bore connectors for liquids and gases in healthcare applications Part 1: General requirements DIN EN ISO 80601-2-67, Medical

29、electrical equipment Part 267: Particular requirements for basic safety and essential performance of oxygen conserving equipment DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN ISO 10083, Oxygen concentrator supply systems for use with medical gas pipeline systems DIN EN

30、ISO 80601-2-69:2014-12 6 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80601-2-69 July 2014 ICS 11.040.10 Supersedes EN ISO 8359:2009English Version Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performanc

31、e of oxygen concentrator equipment (ISO 80601-2-69:2014) Appareils lectromdicaux - Partie 2-69: Exigences particulires pour la scurit de base et les performances essentielles des dispositifs concentrateurs doxygne Medizinische elektrische Gerte - Teil 2-69: Besondere Festlegungen fr die Sicherheit e

32、inschlielich der wesentlichen Leistungsmerkmale fr Sauerstoff-Konzentratoren (ISO 80601-2-69:2014) This European Standard was approved by CEN on 28 May 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the

33、 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 official versions (English, Frenc

34、h, 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 Austria, Belgium, Bulgaria,

35、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, Sweden, Switzerland, Turkey a

36、nd 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 reserved worldwide for CEN national Members. Ref.

37、No. EN ISO 80601-2-69:2014 E(ISO 80601-2-69:2014) Contents Page Foreword Introduction 5 201.1 Scope, object and related standards 201.2 Normative references 8 201.3 Terms and definitions 9 201.4 General requirements 11 201.5 General requirements for testing of ME EQUIPMENT 11 201.6 Classification of

38、 ME EQUIPMENT and ME SYSTEMS . 11 201.7 ME EQUIPMENT identification, marking and documents . 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS 17 201.10 Protection against unwanted and excessive radiation

39、HAZARDS . 18 201.11 Protection against excessive temperatures and other HAZARDS . 1201.12 Accuracy of controls and instruments and protection against hazardous outputs . 2201.13 HAZARDOUS SITUATIONS and fault conditions 25 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 25 201.15 Construction

40、of ME EQUIPMENT 25 201.16 ME SYSTEMS . 2201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 2201.101 Outlet connector 2201.102 Requirements for parts and ACCESSORIES . 26 201.102. 1 * General . 26 201.102. 2 Labelling 26 201.102. 3 * Fire RISK reduction in ACCESSORIES 2201.103 Sign

41、al input/output part 2201.103. 1 General . 27 201.103. 2 * Connection to a distributed alarm system . 27 201.103. 3 * Connection for remote control 28 201.104 * Indication of duration of operation 28 201.105 Integrated conserving equipment . 28 202 Medical electrical equipment Part 1-2: General requ

42、irements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests . 2202.6.2.1.10 * Compliance criteria 28 206 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral Standard: Usabi

43、lity 28 208 Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems . 2 2 EN ISO 80601-2-69:2014 (E)DIN EN ISO

44、 80601-2-69:2014-12 468 1 65 7 7 8 96 211 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 29 211.4.2.2 Env

45、ironmental operating conditions 29 ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS . 30 Annex D (informative) Symbols on marking 34 Annex AA (informative) Particular guidance and rationale . 3 Annex BB (informative) Reference to the Essential Princip

46、les . 42 3 EN ISO 80601-2-69:2014 (E)DIN EN ISO 80601-2-69:2014-12 5Bibliography . 44 Annex ZA (informative) Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC 48 Figures Figure 201.101 Standard resistance . 18 Foreword This document (EN ISO 80601-2-69:2014)

47、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 BSI. This European Standard shall be given the status of a national standard, e

48、ither by publication of an identical text or by endorsement, at the latest by January 2015, and conflicting national standards shall be withdrawn at the latest by July 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/

49、or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8359:2009. 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(s). For relationship with EU Directive(s), see informative Ann