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1、 Reference number ISO 17510-2:2007(E) ISO 2007 INTERNATIONAL STANDARD ISO 17510-2 Second edition 2007-10-01 Sleep apnoea breathing therapy Part 2: Masks and application accessories Thrapie respiratoire de lapne du sommeil Partie 2: Masques et accessoires dapplication Copyright International Organiza
2、tion for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007 02:55:34 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 17510-2:2007(E) PDF disclaimer This PDF file may contain embedded typ
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5、imized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 All rights reserved.
6、Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. I
7、SO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee
8、=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007 02:55:34 MDTNo reproduction or networking permitted without license from IHS -,-,- 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 d
9、efinitions. 2 4 Information to be supplied by the manufacturer. 3 5 Construction requirements 4 5.1 Mask 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 fil
10、ter. 5 6 Vibration and noise. 6 Annex A (informative) Rationale. 7 Annex B (normative) Exhaust flow test 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 Det
11、ermination of the inspiratory and expiratory resistance 17 Annex F (normative) CO2 rebreathing. 19 Annex 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 (inf
12、ormative) Environmental aspects 26 Annex K (informative) Terminology Alphabetized index of defined terms 27 Bibliography. 29 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007
13、 02:55:34 MDTNo reproduction or networking permitted without license from IHS -,-,- 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 bodies (ISO member bodies). The work of preparing
14、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 organizations, governmental and non-governmental, in liaiso
15、n 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 the ISO/IEC Directives, Part 2. The main task of tec
16、hnical 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 the member bodies casting a vote. Attention is dra
17、wn 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, Anaesthetic and respiratory equipment, Subcommittee SC 3,
18、 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 therapy : Part 1: Sleep apnoea breathing therapy equipm
19、ent Part 2: Masks and application accessories Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007 02:55:34 MDTNo reproduction or networking permitted without license from IHS -
20、,-,- ISO 17510-2:2007(E) ISO 2007 All rights reserved v Introduction 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, the use of
21、 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 2 (1995), h
22、ereafter 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 reliable opera
23、tion 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 protection in dia
24、gnostic 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 60601-1:1988, 1.5 and
25、A.2, respectively. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*). Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2
26、007 02:55:34 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007 02:55:34 MDTNo reproduction or networ
27、king permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 17510-2:2007(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 slee
28、p 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 equipment to a patient, and are used for the application of sleep apn
29、oea 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 cover oral appliances. 2 Normative references The following refe
30、renced 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. ISO 3744:1994, Acoustics Determination of sound power levels of noi
31、se 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 values of machinery and equipment ISO 5356-1, Anaesthetic and res
32、piratory 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 medical devices ISO 14937, Sterilization of health care products Gener
33、al 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 to be used with m
34、edical 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 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS E
35、mployees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007 02:55:34 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 17510-2:2007(E) 2 ISO 2007 All rights reserved ISO 17664:2004, Sterilization of medical devices Information to be provided by the manufacturer for
36、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, Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects IEC 60601-1:19
37、88, 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 sy
38、stems 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, ISO 17664, ISO 23328-2, IEC 60601-1, IEC 60601-1-1 and the following apply. NOTE For convenience, an alph
39、abetized 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 apnoea breathing therapy equipment is not providing adequate pressure at the mask and that is closed to atmo
40、sphere 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 con
41、necting element and the mask, or through the anti-asphyxia valve. NOTE 2 The exhaust flow discharges exhaled gases to atmosphere to reduce rebreathing of CO2. 3.3 headgear part that is used to fix the mask to the patient 3.4 mask part which provides the interface between the patient and the patient
42、connection port NOTE According to their application, masks are divided into: nasal masks, oral masks or nasal-oral masks. 3.5 multi-patient re-use capable of being re-used multiple times on multiple patients 3.6 oral appliance device intended to maintain the oral airway by mechanical means and which
43、 achieves its purpose independently of sleep apnoea breathing therapy equipment Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007 02:55:34 MDTNo reproduction or networking pe
44、rmitted without license from IHS -,-,- ISO 17510-2:2007(E) ISO 2007 All rights reserved 3 3.7 * patient connection port port where the breathing gas pathway connects to the mask 3.8 single-patient reuse capable of being used multiple times on the same patient 4 Information to be supplied by the manu
45、facturer NOTE Annex H contains a guide to assist the reader in locating the marking and labelling requirements contained in other clauses of this part of ISO 17510. 4.1 The label of the packaging, marking on the mask or accessory, and/or the accompanying documents shall contain the following informa
46、tion: a) the name or trade name and address of the manufacturer and the name and address of the person responsible or of the authorized representative of the manufacturer or importer; b) the identity and intended purpose of the mask and any application accessories; c) * the pressure-flow curve of th
47、e exhaust flow throughout the working pressure range as determined in Annex B; d) the rated pressure range of the mask including any connecting element; e) if re-usable: the information specified in ISO 17664:2004, 3.9, if sterilizable; a warning that frequency of cleaning, methods of cleaning or th
48、e use of cleaning agents, other than those specified in the accompanying documents, or exceeding the number of processing cycles can have an adverse effect on the materials used or performance; f) any special storage and/or handling conditions; g) any special operating instructions; h) any special warnings and/or precautions to be taken; i) information necessary for correct assembly of the components if the packaging contains more than one c