DIN EN ISO 17510-2-2009 Sleep apnoea breathing therapy - Part 2 Masks and application accessories (ISO 17510-2 2007) English version of DIN EN ISO 17510-2 2009-07《睡眠呼吸暂停治疗 第2部分 面罩和.pdf
《DIN EN ISO 17510-2-2009 Sleep apnoea breathing therapy - Part 2 Masks and application accessories (ISO 17510-2 2007) English version of DIN EN ISO 17510-2 2009-07《睡眠呼吸暂停治疗 第2部分 面罩和.pdf》由会员分享,可在线阅读,更多相关《DIN EN ISO 17510-2-2009 Sleep apnoea breathing therapy - Part 2 Masks and application accessories (ISO 17510-2 2007) English version of DIN EN ISO 17510-2 2009-07《睡眠呼吸暂停治疗 第2部分 面罩和.pdf(39页珍藏版)》请在麦多课文档分享上搜索。
1、July 2009DEUTSCHE NORM English price group 16No part of this standard 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).ICS 11.040.10!$Xk“1539472www.
2、din.deDDIN EN ISO 17510-2Sleep apnoea breathing therapy Part 2: Masks and application accessories (ISO 17510-2:2007)English version of DIN EN ISO 17510-2:2009-07Schlafapnoe-Atemtherapie Teil 2: Masken und Anwendungszubehr (ISO 17510-2:2007)Englische Fassung DIN EN ISO 17510-2:2009-07SupersedesDIN EN
3、 ISO 17510-2:2008-05See start of validitywww.beuth.deDocument comprises pages39DIN EN ISO 17510-2:2009-07 Start of validity This standard takes effect on 1 July 2009. DIN EN ISO 17510-2:2008-05 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technica
4、l Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: BSI, United Kingdom) 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 Normenaus
5、schuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical 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. DIN EN ISO 17510 consis
6、ts of the following parts, under the general title Sleep apnoea breathing therapy: Part 1: Sleep apnoea breathing therapy equipment Part 2: Masks and application accessories The DIN Standards corresponding to the International Standards referred to in clause 2 and in the bibliography of the EN are a
7、s follows: ISO 3744 DIN EN ISO 3744 ISO 4135 DIN EN ISO 4135 ISO 4871 DIN EN ISO 4871 ISO 5356-1 DIN EN ISO 5356-1 ISO 5356-2 DIN EN ISO 5356-2 ISO 10993 (all parts) DIN EN ISO 10993 (all parts) ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 17510-1 DIN EN ISO 17510-1 ISO 17664 DIN EN ISO
8、 17664 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-1 DIN EN 60601-1-1 (VDE 0750-1-1) IEC 61672-1 DIN EN 61672-1 Amendments This standard differs from DIN EN ISO 17510-2:2008-05 as follows: a) Annex ZA (informative) concerning the relationship between this European Standard and the essential
9、requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implant
10、able medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN ISO 17510-2: 2003-05, 2008-01, 2008-05 2 DIN EN ISO 17510-2:2009-07 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Med
11、ical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-1 (VDE 0750-1-1), Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems DIN EN 61672-1, Electroaco
12、ustics Sound level meters Part 1: Specifications DIN EN ISO 3744, Acoustics Determination of sound power levels of noise sources using sound pressure Engineering method in an essential free field over a reflecting plane DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 487
13、1, Acoustics Declaration and verification of noise emission values of machinery and equipment DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weigh
14、t-bearing connectors DIN EN ISO 10993 (all parts), Biological evaluation of medical devices DIN EN ISO 14937, Sterilization of health care products General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical
15、devices DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 17510-1, Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment DIN EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the pr
16、ocessing of resterilizable medical devices 3 DIN EN ISO 17510-2:2009-07 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 17510-2March 2009ICS 11.040.10 Supersedes EN ISO 17510-2:2007 English VersionSleep apnoea breathing therapy - Part 2: Masks and application
17、accessories (ISO 17510-2:2007)Thrapie respiratoire de lapne du sommeil - Partie 2:Masques et accessoires dapplication (ISO 17510-2:2007)Schlafapnoe-Atemtherapie - Teil 2: Masken undAnwendungszubehr (ISO 17510-2:2007)This European Standard was approved by CEN on 24 February 2009.CEN members are bound
18、 to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN M
19、anagement 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as
20、 theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovaki
21、a, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN
22、 national Members.Ref. No. EN ISO 17510-2:2009: EContents Page Foreword 3 Introduction 4 1 Scope . 5 2 Normative references . 5 3 Terms and definitions. 6 4 Information to be supplied by the manufacturer. 7 5 Construction requirements 8 5.1 Mask connectors. 8 5.2 Biocompatibility 8 5.3 * Protection
23、against rebreathing 9 5.4 Cleaning, disinfection and sterilization 9 5.5 * Breathing during single fault condition 9 5.6 Breathing system filter. 9 6 Vibration and noise. 10 Annex A (informative) Rationale . 11 Annex B (normative) Exhaust flow test procedure. 15 Annex C (normative) Resistance to flo
24、w (pressure drop) 17 Annex D (normative) Anti-asphyxia valve pressure testing 19 Annex E (normative) Breathing during single fault condition Determination of the inspiratory and expiratory resistance 21 Annex F (normative) CO2rebreathing . 22 Annex G (normative) Vibration and noise . 26 Annex H (inf
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