EN ISO 17510-2-2009 en Sleep apnoea breathing therapy - Part 2 Masks and application accessories《睡眠窒息呼吸治疗 第2部分 面罩和应用附件》.pdf

1、BS EN ISO17510-2:2009ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSleep apnoeabreathing therapyPart 2: Masks and applicationaccessories (ISO 17510-2:2007)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCo

2、mmittee on 30 April2009 BSI 2009ISBN 978 0 580 65193 9Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 17510-2:2009National forewordThis British Standard is the UK implementation of EN ISO17510-2:2009. It is identical to ISO 17510-2:2003. It supersedes BS ENISO 17510-2:2007 which

3、 is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all

4、the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 17510-2March 2009ICS 11.040.10 Supersedes EN ISO 17510-2:2007 English Version

5、Sleep apnoea breathing therapy - Part 2: Masks and applicationaccessories (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

6、 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 any alteration. Up-to-date lists and bibliographical references concerning such

7、 nationalstandards 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 by translationunder the responsibility of a CEN member into its own language an

8、d 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, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,

9、 Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, 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 explo

10、itation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 17510-2:2009: EBS EN ISO 17510-2:2009EN 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 respiratory equipment” of the Inte

11、rnational 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 public

12、ation 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 patent rights. CEN and/or CENELEC s

13、hall 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 essential requirements of EC Directi

14、ve. 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: Austria, Belgium, Bulgaria,

15、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. Endorsement notice The text of IS

16、O 17510-2:2007 has been approved by CEN as a EN ISO 17510-2:2009 without any modification. BS EN ISO 17510-2:2009EN ISO 17510-2:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepa

17、red 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 Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities u

18、nder 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 the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of th

19、at 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-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes All 1, 2, 3 - 6a This releva

20、nt 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 European Standard 4 7.5 (2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 4 1

21、3.3 (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 in this European Standard - 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard 4.1 a)

22、 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 4.1 b) 13.3 b) BS EN ISO 17510-2:2009EN 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.

23、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) 4.1 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 ful

24、ly addressed in this European Standard 5 4, 7.2, 7.5, 7.6 5.1 12.7.45.2 7.1, 7.35.3 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, 12.7.3Warning Other requirements and other EU Directives may be applicable to the products falling within the scope of this Inter

25、national standard. BS EN ISO 17510-2:2009ISO 17510-2:2007(E) ISO 2007 All rights reserved iiiContents 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 connector

26、s. 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 procedur

27、e. 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) CO2rebreathing . 19 Annex G (norma

28、tive) 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 27 Bibli

29、ography . 29 BS EN ISO 17510-2:2009ISO 17510-2:2007(E) iv ISO 2007 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out th

30、rough 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 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collab

31、orates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Stan

32、dards. 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 the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of

33、 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, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. This seco

34、nd 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 therapy : Part 1: Sleep apnoea breathing therapy equipment Part 2: Masks and application accessories BS E

35、N ISO 17510-2:2009ISO 17510-2:2007(E) ISO 2007 All rights reserved vIntroduction Sleep apnoea 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

36、, 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 Standard based on IEC 60601-1:1988, including Amendments 1 (1991) and

37、 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 patient environment; it also contains certain requirements for re

38、liable 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 equipment, such as medical electrical systems, EMC, radiation prote

39、ction 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 Standard and Particular Standard can be found in IEC 60601-1:19

40、88, 1.5 and A.2, respectively. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*). BS EN ISO 17510-2:2009BS EN ISO 17510-2:2009INTERNATIONAL STANDARD ISO 17510-2:2007(E) ISO 2007 All rights reserved 1Sleep apnoea breathing therapy Part 2: Mask

41、s 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 masks and accessories, including any connecting element, that are required to co

42、nnect 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 breathing therapy equipment is covered by ISO 17510-1. See Figure A.1 for typical

43、 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 references, only the edition cited applies. For undated references, the latest e

44、dition 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 a reflecting plane ISO 4135:2001, Anaesthetic and respiratory equipment Vocabu

45、lary 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, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-

46、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

47、14971:2007, Medical devices Application of risk management to medical devices 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 b

48、reathing therapy equipment BS EN ISO 17510-2:2009ISO 17510-2:2007(E) 2 ISO 2007 All rights reservedISO 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 anaestheti

49、c and respiratory use Part 1: Salt test method to assess filtration performance ISO 23328-2, 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 Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems IEC 6167