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1、BS EN ISO 17510-2:2009 ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Sleep apnoea breathing therapy Part 2: Masks and application accessories (ISO 17510-2:2007) Licensed CopyChinese University of Hong Kong, 13/06/2009 08:01, Uncontrolled Copy,
2、(c) BSI This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2009 BSI 2009 ISBN 978 0 580 65193 9 Amendments/corrigenda issued since publication DateComments BS EN ISO 17510-2:2009 National foreword This British Standard is the UK impleme
3、ntation of EN ISO 17510-2:2009. It is identical to ISO 17510-2:2003. It supersedes BS EN ISO 17510-2:2007 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Lung ventilators, tracheal tubes and related equipment. A list of organizations represe
4、nted on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Licensed C
5、opyChinese University of Hong Kong, 13/06/2009 08:01, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17510-2 March 2009 ICS 11.040.10Supersedes EN ISO 17510-2:2007 English Version Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 175
6、10-2:2007) Thrapie respiratoire de lapne du sommeil - Partie 2: Masques et accessoires dapplication (ISO 17510-2:2007) Schlafapnoe-Atemtherapie - Teil 2: Masken und Anwendungszubehr (ISO 17510-2:2007) This European Standard was approved by CEN on 24 February 2009. CEN members are bound to comply wit
7、h the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the 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 Management Ce
8、ntre or to any CEN member. This European Standard exists in three official versions (English, French, 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 Management Centre has the same status as the offic
9、ial 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, Slovakia, Slo
10、venia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN n
11、ational Members. Ref. No. EN ISO 17510-2:2009: E Licensed CopyChinese University of Hong Kong, 13/06/2009 08:01, Uncontrolled Copy, (c) BSI BS EN ISO 17510-2:2009 EN ISO 17510-2:2009 (E) 3 Foreword The text of ISO 17510-2:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and resp
12、iratory equipment” of the International 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 natio
13、nal 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 March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of paten
14、t rights. CEN and/or CENELEC shall not 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 essent
15、ial 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 Regulations, the national standards organizations of the following countries are bound to implement this European Standard
16、: 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, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. End
17、orsement notice The text of ISO 17510-2:2007 has been approved by CEN as a EN ISO 17510-2:2009 without any modification. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:01, Uncontrolled Copy, (c) BSI BS EN ISO 17510-2:2009 EN ISO 17510-2:2009 (E) 4 Annex ZA (informative) Relationship bet
18、ween this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach
19、 Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within
20、 the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Clause(s)/sub-clau
21、se(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes All 1, 2, 3 - 6a This relevant Essential Requirement is not addressed in this European Standard 4 13.1, 13.6 a) 4 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this Europ
22、ean Standard 4 7.5 (2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 4 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 4 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed
23、 in this European Standard - 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard 4.1 a) 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 4.1 b) 13.3 b) Licensed CopyChinese University of Hong Kong, 13/06/2009 08:01, Un
24、controlled Copy, (c) BSI BS EN ISO 17510-2:2009 EN ISO 17510-2:2009 (E) 5 4.1 c) 9.1, 13.6 b) , 13.6 c) 4.1 d) 9.1, 13.6 b) 4.1 e) 8.6, 13.6 h) 4.1 f) 13.3 i) 4.1 g) 13.3 j) 4.1 h) 13.3 k) 4.1 i) 13.3 b), 13.6 i) 4.1 j) 13.6 k) 4.1 l) 9.1, 13.6 b) 4.1 o) 9.1, 13.6 b) 4.1 m) 13.6 c) 4.1 n) 13.6 n) 4.
25、1 q) 13.6 i) 4.1 r), s) 13.6 d) 4.2 a) 13.2, 13.3 d), 13.5 4.2 b) 13.2, 13.3 e), 13.4 4.2 c) 9.1 4.2 d) 8.7, 13.2, 13.3 c), 13.3 m) 4.2 e) 13.6 g) 5 7.5 (3rd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 5 4, 7.2, 7.5, 7.6 5.1 12.7.4 5.2 7.1, 7.3 5.3
26、 9.2, 12.8.2 5.4 7.1, 7.3, 8.1, 8.3, 8.4, 8.5 5.5 9.2, 12.8.1, 12.8.2 5.6 8.1 6 12.7.2, 12.7.3 Warning Other requirements and other EU Directives may be applicable to the products falling within the scope of this International standard. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:01,
27、 Uncontrolled Copy, (c) BSI BS EN ISO 17510-2:2009 ISO 17510-2:2007(E) ISO 2007 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Information to be supplied by the manufacturer. 3 5 Construction requirements 4 5.1 Mask
28、 connectors. 4 5.2 Biocompatibility 4 5.3 * Protection against rebreathing 5 5.4 Cleaning, disinfection and sterilization 5 5.5 * Breathing during single fault condition 5 5.6 Breathing system filter. 5 6 Vibration and noise. 6 Annex A (informative) Rationale. 7 Annex B (normative) Exhaust flow test
29、 procedure. 11 Annex C (normative) Resistance to flow (pressure drop) 13 Annex D (normative) Anti-asphyxia valve pressure testing 15 Annex E (normative) Breathing during single fault condition Determination of the inspiratory and expiratory resistance 17 Annex F (normative) CO2 rebreathing. 19 Annex
30、 G (normative) Vibration and noise . 22 Annex H (informative) Guide to information to be supplied by the manufacturer 23 Annex I (informative) Reference to the essential principles 24 Annex J (informative) Environmental aspects 26 Annex K (informative) Terminology Alphabetized index of defined terms
31、 27 Bibliography. 29 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:01, Uncontrolled Copy, (c) BSI BS EN ISO 17510-2:2009 ISO 17510-2:2007(E) iv ISO 2007 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards
32、 bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organiza
33、tions, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in t
34、he ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of
35、 the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 17510-2 was prepared by Technical Committee ISO/TC 121, Anaest
36、hetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. This second edition cancels and replaces the first edition (ISO 17510-2:2003) which has been technically revised. ISO 17510 consists of the following parts, under the general title Sleep apnoea breathing ther
37、apy : Part 1: Sleep apnoea breathing therapy equipment Part 2: Masks and application accessories Licensed CopyChinese University of Hong Kong, 13/06/2009 08:01, Uncontrolled Copy, (c) BSI BS EN ISO 17510-2:2009 ISO 17510-2:2007(E) ISO 2007 All rights reserved v Introduction Sleep apnoea is the clini
38、cally 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 covers basic safety
39、 and essential performance requirements needed to protect patients during use of this equipment. ISO 17510-2 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 basic document for t
40、he safety of all 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 and Particular
41、 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 t
42、ypes, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc. NOTE Definitions of Collateral 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
43、 is indicated by an asterisk (*). Licensed CopyChinese University of Hong Kong, 13/06/2009 08:01, Uncontrolled Copy, (c) BSI BS EN ISO 17510-2:2009 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:01, Uncontrolled Copy, (c) BSI BS EN ISO 17510-2:2009 INTERNATIONAL STANDARD ISO 17510-2:200
44、7(E) ISO 2007 All rights reserved 1 Sleep apnoea breathing therapy Part 2: Masks and application accessories 1 Scope This part of ISO 17510 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for m
45、asks and accessories, including any connecting element, that are required to connect the patient connection port of sleep apnoea breathing therapy equipment to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear. Sleep apnoea br
46、eathing 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 cover oral appliances. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated r
47、eferences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 3744:1994, Acoustics Determination of sound power levels of noise sources using sound pressure Engineering method in an essentially free field over
48、 a reflecting plane ISO 4135:2001, Anaesthetic and respiratory equipment Vocabulary ISO 4871, Acoustics Declaration and verification of noise emission values of machinery and equipment ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets ISO 5356-2, Anaesthe
49、tic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors ISO 10993 (all parts), Biological evaluation of medical 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 devices ISO 15223-1:2007, Medical devices Symbols
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