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
25、ormative) Guide to information to be supplied by the manufacturer 27 Annex I (informative) Reference to the essential principles 28 Annex J (informative) Environmental aspects 30 Annex K (informative) Terminology Alphabetized index of defined terms 31 Bibliography . 35 Annex ZA (informative) Relatio
26、nship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 33 EN ISO 17510-2:2009 (E) DIN EN ISO 17510-2:2009-07 2.Foreword The text of ISO 17510-2:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International
27、 Organization for Standardization (ISO) and has been taken over as EN ISO 17510-2:2009 by 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, either by publication of
28、an identical text or by endorsement, at the latest by September 2009, and conflicting national standards shall be withdrawn at the latest by March 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
29、be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 17510-2:2007. 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 EC Directive. For r
30、elationship with EC 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, Cyprus, C
31、zech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 17510-2
32、:2007 has been approved by CEN as a EN ISO 17510-2:2009 without any modification. EN ISO 17510-2:2009 (E) DIN EN ISO 17510-2:2009-07 3Introduction Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during sleep. The awareness of the risks associated with
33、 sleep apnoea has grown significantly in recent years. As a result, the use of sleep apnoea breathing therapy equipment has become common. This document covers basic safety and essential performance requirements needed to protect patients during use of this equipment. ISO 17510-2 is a Particular Sta
34、ndard 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 basic document for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and
35、 patient environment; it also contains certain requirements for reliable operation to ensure safety. The General Standard has associated Collateral Standards and Particular Standards. The Collateral Standards include requirements for specific technologies and/or hazards and apply to all applicable e
36、quipment, 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 Collater
37、al Standard and Particular Standard can be found in IEC 60601-1:1988, 1.5 and A.2, respectively. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*). EN ISO 17510-2:2009 (E) DIN EN ISO 17510-2:2009-07 41 Scope This part of ISO 17510 applies to
38、masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient connection port of sleep apnoea breathing therapy equi
39、pment to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear. Sleep apnoea breathing therapy equipment is covered by ISO 17510-1. See Figure A.1 for typical elements of the two parts of ISO 17510. This part of ISO 17510 does not
40、 cover oral appliances. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IS
41、O 3744:1994, Acoustics Determination of sound power levels of noise sources using sound pressure Engineering method in an essentially free field over a reflecting plane ISO 4135:2001, Anaesthetic and respiratory equipment Vocabulary ISO 4871, Acoustics Declaration and verification of noise emission
42、values of machinery and equipment ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors ISO 10993 (all parts), Biological evaluation of medic
43、al devices 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 process for medical devices ISO 14971:2007, Medical devices Application of risk management to medical de
44、vices ISO 15223-1:2007, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements ISO 17510-1:2007, Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment EN ISO 17510-2:2009 (E) DIN EN ISO 17510-2:20
45、09-07 5ISO 17664:2004, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 23328-1, Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance ISO 23328-2,
46、 Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for basic safety and essential performance; Amendment A1:1991; Amendment A2:1995 IEC 60601-1-1:2000, Medical electrical equipment P
47、art 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems IEC 61672-1, Electroacoustics Sound level meters Part 1: Specifications 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 4135, ISO 17510-1
48、, ISO 17664, ISO 23328-2, IEC 60601-1, IEC 60601-1-1 and the following apply. NOTE For convenience, an alphabetized list of the sources of all defined terms used in this document is given in Annex K. 3.1 anti-asphyxia valve valve used on a naso-oral mask, which is open to atmosphere when the sleep a
49、pnoea breathing therapy equipment is not providing adequate pressure at the mask and that is closed to atmosphere when the sleep apnoea breathing therapy equipment is providing adequate pressure at the mask 3.2 exhaust flow flow from the mask or application accessories to atmosphere other than the leak due to improper seal to the face NOTE 1 The exhaust flow can pass through openings in the mask, the connecting element and the mask, or through the anti-asphyxia
