1、July 2009DEUTSCHE NORM English price group 19DIN 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!$XRf“1534767www.din.deDDIN EN ISO 17510-1Sleep apnoea breathing therapy Part 1: Sleep
2、 apnoea breathing therapy equipment (ISO 17510-1:2007)English version of DIN EN ISO 17510-1:2009-07Schlafapnoe-Atemtherapie Teil 1: Schlafapnoe-Atemtherapiegerte (ISO 17510-1:2007)Englische Fassung DIN EN ISO 17510-1:2009-07SupersedesDIN EN ISO 17510-1:2008-01See start of validitywww.beuth.deDocumen
3、t comprises pages49DIN EN ISO 17510-1:2009-07 Start of validity This standard takes effect on 1 July 2009. DIN EN ISO 17510-1:208-01 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment
4、” (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 Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Ho
5、spital 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 consists of the following parts, under the general title Sleep apno
6、ea 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 as follows: ISO 3744 DIN EN ISO 3744 ISO 4135 DIN EN ISO 4135
7、ISO 4871 DIN EN ISO 4871 ISO 5356-1 DIN EN ISO 5356-1 ISO 5356-2 DIN EN ISO 5356-2 ISO 8185 DIN EN ISO 8185 ISO 9360 (all parts) DIN EN ISO 9360 (all parts) ISO 10651-2 DIN EN ISO 10651-2 ISO 10651-4 DIN EN ISO 10651-4 ISO 10651-6 DIN EN ISO 10651-6 ISO 11135-1 DIN EN ISO 11135-1 ISO 11137 (all part
8、s) DIN EN ISO 11137 (all parts) ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 17510-2 DIN EN ISO 17510-2 ISO 17664 DIN EN ISO 17664 ISO 17665-1 DIN EN ISO 17665-1 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-1 DIN EN 60601-1-1 (VDE 0750-1-1) IEC 60601-1-2 DIN EN 60601-1-2 (VDE 075
9、0-1-2) IEC 60601-1-4 DIN EN 60601-1-4 (VDE 0750-1-4) IEC 60601-1-6 DIN EN 60601-1-6 (VDE 0750-1-6) IEC 60601-1-8 DIN EN 60601-1-8 (VDE 0750-1-8) IEC 60601-2-12 DIN EN 60601-2-12 (VDE 0750-2-12) IEC 61672 (all parts) DIN EN 61672 (all parts) 2DIN EN ISO 17510-1:2009-07 Amendments This standard differ
10、s from DIN EN ISO 17510-1:2008-01 as follows: a) Annex ZA (informative) concerning the relationship between this European Standard and the essential 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 th
11、e Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable 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
12、 EN ISO 17510-1:2002-05, 2008-01 3DIN EN ISO 17510-1:2009-07 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-1 (VDE 0750-1-1), Medical electrical equipment Pa
13、rt 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems DIN EN 60601-1-2 (VDE 0750-1-2), Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility R
14、equirements and tests DIN EN 60601-1-4 (VDE 0750-1-4), Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems DIN EN 60601-1-6 (VDE 0750-1-6), Medical electrical equipment Part 1-6: General requirements for basic safety and
15、 essential performance Collateral standard: Usability DIN EN 60601-1-8 (VDE 0750-1-8), Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
16、 DIN EN 60601-2-12 (VDE 0750-2-12), Medical electrical equipment Part 2-12: Particular requirements for the safety of lung ventilators Critical care ventilators DIN EN 61672 (all parts), Electroacoustics Sound level meters DIN EN ISO 3744, Acoustics Determination of sound power levels of noise sourc
17、es 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 4871, Acoustics Declaration and verification of noise emission values of machinery and equipment DIN EN ISO 5356-1, Anaesthetic a
18、nd respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors DIN EN ISO 8185, Respiratory tract humidifiers for medical use Particular requirements for respiratory hu
19、midification systems DIN EN ISO 9360 (all parts), Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans DIN EN ISO 10651-2, Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home ca
20、re ventilators for ventilator-dependent patients DIN EN ISO 10651-4, Lung ventilators Part 4: Particular requirements for operator-powered resuscitators 4DIN EN ISO 17510-1:2009-07 DIN EN ISO 10651-6, Lung ventilators for medical use Particular requirements for basic safety and essential performance
21、 Part 6: Home-care ventilatory support devices DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137 (all parts), Sterilization of health care p
22、roducts Radiation 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 devices DIN EN ISO 14971, Medical devices Application of risk management t
23、o medical devices DIN EN ISO 17510-2, Sleep apnoea breathing therapy Part 2: Masks and application accessories DIN EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices DIN EN ISO 17665-1, Sterilization of h
24、ealth care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 5DIN EN ISO 17510-1:2009-07 This page is intentionally blank 6EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17510-1 March 2009 ICS 11.040.
25、10 Supersedes EN ISO 17510-1:2007 English Version Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) Thrapie respiratoire de lapne du sommeil Partie 1: quipement de thrapie respiratoire de lapne du sommeil (ISO 17510-1:2007) Schlafapnoe-Atemtherapie Te
26、il 1: Schlafapnoe-Atemtherapiegerte (ISO 17510-1:2007) This European Standard was approved by CEN on 24 February 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without a
27、ny alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN 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
28、 by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France
29、, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NO
30、RMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17510-1:2009: EEN ISO 17510-1:2009 (E) DIN EN ISO 17510-1:2009-07 Contents Page Foreword. 4 Introduction 5 1 * Scop
31、e 6 2 Normative references . 6 3 Terms and definitions. 8 4 Requirements 9 5 Classification and designation 9 6 Marking, labelling and packaging . 9 7 Power input . 13 8 Basic safety categories 13 9 Removable protective means 13 10 Environmental conditions 13 11 Not used. 14 12 Not used. 14 13 Gener
32、al. 14 14 Requirements related to classification. 14 15 Limitation of voltage and/or energy 14 16 Enclosures and protective covers 14 17 Separation . 14 18 Protective earthing, functional earthing and potential equalization . 14 19 Continuous leakage currents and patient auxiliary currents. 14 20 Di
33、electric strength 15 21 Mechanical strength . 15 22 Moving parts 15 23 Surfaces, corners and edges. 15 24 Stability in normal use 15 25 Expelled parts . 15 26 * Vibration and noise . 15 27 Pneumatic and hydraulic power 16 28 Suspended masses 16 29 X-radiation . 16 30 Alpha, beta, gamma, neutron radi
34、ation and other particle radiation 16 31 Microwave radiation . 16 32 Light radiation (including lasers) 17 33 Infra-red radiation . 17 2EN ISO 17510-1:2009 (E) DIN EN ISO 17510-1:2009-07 nnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive
35、93/42/EECA34 Ultra-violet radiation . 17 35 Acoustical energy (including ultra-sonics) 17 36 Electromagnetic compatibility. 17 37 Locations and basic requirements 17 38 Marking, accompanying documents. 17 39 Common requirements for Category AP and Category APG equipment 17 40 Requirements and tests
36、for category AP equipment, parts and components thereof 17 41 Requirements and tests for category APG equipment, parts and components thereof . 18 42 Excessive temperatures . 18 43 Fire prevention 18 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfecti
37、on 18 45 Pressure vessels and parts subject to pressure . 19 46 Human errors. 19 47 Electrostatic charges 19 48 Biocompatibility 20 49 Interruption of the power supply. 20 50 Accuracy of operating data 20 51 Protection against hazardous output . 20 52 Abnormal operation and fault conditions. 21 53 E
38、nvironmental tests 21 54 General . 21 55 Enclosures and covers. 22 56 Components and general assembly . 22 57 Mains parts, components and layout 24 58 Protective earthing Terminals and connections . 24 59 Construction and layout. 24 Annex AA (informative) Rationale. 25 Annex BB (normative) * Pressur
39、e accuracy in normal use test methods . 30 Annex CC (normative) Maximum flowrate test method 32 Annex DD (informative) Environmental aspects . 33 Annex EE (informative) Reference to the essential principles 35 Annex FF (informative) Terminology Alphabetized index of defined terms 37 Bibliography . 3
40、9 . 40 3Foreword The text of ISO 17510-1:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 17510-1:2009 by Technical Committee CEN/TC 215 “Respiratory and anae
41、sthetic 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 September 2009, and conflicting national standards shall be withdrawn at the latest by M
42、arch 2010. 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 17510-1:2007. This document has been prepar
43、ed under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Reg
44、ulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Net
45、herlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 17510-1:2007 has been approved by CEN as a EN ISO 17510-1:2009 without any EN ISO 17510-1:2009 (E) DIN EN ISO 17510-1:2009-07 4Introduction Sleep apn
46、oea is the clinically significant intermittent absences of normal respiration occurring during sleep. The awareness of the risks associated with sleep apnoea has grown significantly in recent years. As a result, the use of sleep apnoea breathing therapy equipment has become common. This document cov
47、ers basic safety and essential performance requirements needed to protect patients in the use of this equipment. This document is a Particular Standard based on IEC 60601-1:1988, including Amendments 1 (1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the ba
48、sic document for the safety of medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. It also contains certain requirements for reliable operation to ensure safety. The General Standard has associated Collateral Standards
49、and Particular Standards. The Collateral Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment, such as medical electrical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc. NOTE Definitions of Collateral Sta
