BS ISO 27427-2013 Anaesthetic and respiratory equipment Nebulizing systems and components《麻醉和呼吸设备 雾化系统和部件》.pdf

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1、BSI Standards PublicationBS ISO 27427:2013Anaesthetic and respiratoryequipment Nebulizingsystems and componentsCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS ISO

2、27427:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 27427:2013.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 committ

3、ee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 74997 1ICS 11.040.10Com

4、pliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 28 February 2014.Amendments issued since publicationDate Text affectedCopyright British Standards Institution Provided

5、 by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS ISO 27427:2013 ISO 2013Anaesthetic and respiratory equipment Nebulizing systems and componentsMatriel danesthsie et de ranimation respiratoire Systmes de nbulisati

6、on et ses composantsINTERNATIONAL STANDARDISO27427Third edition2013-12-15Reference numberISO 27427:2013(E)Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS ISO 27427

7、:2013ISO 27427:2013(E)ii ISO 2013 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2013All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on

8、the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgW

9、eb www.iso.orgPublished in SwitzerlandCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS ISO 27427:2013ISO 27427:2013(E) ISO 2013 All rights reserved iiiContents Page

10、Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 General requirements and requirements for test . 44.1 Risk management . 44.2 Test methods and alternatives 54.3 Electrical safety 54.4 Mechanical safety 54.5 Pneumatic safety . 64.6 Protection against inadverten

11、t adjustments . 64.7 Usability 65 Marking 65.1 Symbols . 65.2 Marking on the device 65.3 Labelling on the packaging or individual pack 75.4 Instructions for use, inserts, and accompanying documents . 86 Construction requirements 116.1 Materials 116.2 Connectors . 116.3 Rotary controls 137 Cleaning,

12、sterilization, and disinfection .148 Biocompatibility 14Annex A (informative) Rationale .15Annex B (normative) Diameters of respirable fraction particles 19Annex C (normative) Test methods for aerosol output and aerosol output rate 20Annex D (normative) Test methods for particle sizing 23Annex E (in

13、formative) Hazard identification for risk assessment .32Annex F (informative) Classification of general purpose nebulizers 38Annex G (informative) Environmental aspects .40Annex AA (informative) Conformance to essential principles .42Bibliography .46Copyright British Standards Institution Provided b

14、y IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS ISO 27427:2013ISO 27427:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bo

15、dies). 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 organizations, governmental an

16、d 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.The procedures used to develop this document and those intended for its further maintenance are de

17、scribed in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn

18、 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on th

19、e ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,

20、 as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and rela

21、ted equipment.This third edition cancels and replaces the second edition (ISO 27427:2010), of which it constitutes a major revision.iv ISO 2013 All rights reservedCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or netwo

22、rking permitted without license from IHS-,-,-BS ISO 27427:2013ISO 27427:2013(E)IntroductionNebulizers are widely used to deliver drugs and vaccines in an aerosol form to humans through the respiratory system. Nebulizers are also used for diagnostic purposes using radioisotopes for lung challenge tes

23、ts. These drugs can be in the form of a solution, suspension or emulsion. Aerosol inhalation is the preferred route of administration for some drugs. Some drugs are intended for treatment of systemic diseases and other drugs are intended to treat respiratory diseases. To achieve the intended treatme

24、nt, aerosol particles have to be deposited in specific parts of the respiratory tract. Different size particles tend to deposit in different parts of the respiratory system; therefore, the performance profile and the intended use of the nebulizer have to be defined by the manufacturer and specified

25、in the accompanying documentation.This International Standard is based on Reference.29This International Standard was developed to cover “general purpose” nebulizers and is based on adult test parameters which are likely to be different than stated when testing for paediatric or infant patient popul

26、ations. It was specifically written to ensure that the results of the various tests declared by the manufacturer are meaningful to the users and buyers of nebulizers.The objectives of this International Standard are to ensure suitability of the nebulizers for the intended use as disclosed by the man

27、ufacturer, safety, particularly for electrically powered nebulizers, compatibility between the materials of the components and the dispensed liquid, and biocompatibility of the materials of the components that come into contact with the human body.Important changes were made to the original EN stand

28、ard in recognition of the advances in test devices such as lasers and low-flow impactors that allow manufacturers to use different test methods, provided these alternate methods are validated against the methods specified in this International Standard.Terms defined in this International Standard ar

29、e set in bold type.Throughout this International Standard, text for which rationale is provided in Annex A is indicated by an asterisk (*). ISO 2013 All rights reserved vCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction o

30、r networking permitted without license from IHS-,-,-BS ISO 27427:2013Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS ISO 27427:2013Anaesthetic and respiratory equi

31、pment Nebulizing systems and components1 Scope*This International Standard specifies requirements for the safety and performance testing of general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.Thi

32、s International Standard includes gas-powered nebulizers which can be powered by, e.g., compressors, pipeline systems, cylinders, etc., and electrically powered nebulizers e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices or manually powered nebulizers.This

33、International Standard does not specify the minimum performance of nebulizing systems.*This International Standard does not apply to devices intended for nasal deposition.This International Standard does not apply to devices intended solely to provide humidification or hydration by providing water i

34、n aerosol form.NOTE ISO 8185 covers this.3*This International Standard does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).2 Normative referencesThe following documents, in whole or in part, are normatively refere

35、nced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1:

36、 Cones and socketsISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectorsISO 5367, Anaesthetic and respiratory equipment Breathing sets and connectorsISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical

37、 gases and vacuumISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuumISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devicesISO 10524-3, P

38、ressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valvesISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requ

39、irements for development, validation and routine control of a sterilization process for medical devicesINTERNATIONAL STANDARD ISO 27427:2013(E) ISO 2013 All rights reserved 1Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproducti

40、on or networking permitted without license from IHS-,-,-BS ISO 27427:2013ISO 27427:2013(E)ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-2, Sterilization of heal

41、th care products Radiation Part 2: Establishing the sterilization doseISO 11137-3, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspectsISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and pa

42、ckaging systemsISO 14971, Medical devices Application of risk management to medical devicesISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygenISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General re

43、quirementsISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 23328-1, Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess

44、filtration performanceISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirementsIEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC 60601-1-2:2006+A1:2012, Medical electrical e

45、quipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and testsIEC 60601-1-6, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usabi

46、lityIEC 60601-1-8, Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsIEC 62366, Medical devices Applicati

47、on of usability engineering to medical devicesEN 556-1, Sterilization of medical devices Requirements for medical devices to be designated “STERILE” Part 1: Requirements for terminally sterilized medical devicesEN 13544-2, Respiratory therapy equipment Part 2: Tubing and connectorsEN 15908, Anaesthe

48、tic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gasesENV 737-6, Medical gas pipeline systems Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuumCGA V-5-2005, Diameter Index Safety System Noninterchangeable Low Pressure Connections for Medical Gas Applications3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2 ISO 2013 All rights reservedCop