BS ISO 27427-2014 Anaesthetic and respiratory equipment Nebulizing systems and components《麻醉和呼吸器 雾化系统和元部件》.pdf

1、BSI Standards PublicationBS ISO 27427:2013Anaesthetic and respiratoryequipment Nebulizingsystems and componentsBS ISO 27427:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 27427:2013.The UK participation in its preparation was entrusted to TechnicalCommitt

2、ee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of organizations represented on this committee 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

3、 The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 74997 1ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on

4、28 February 2014.Amendments issued since publicationDate Text affectedBS ISO 27427:2013 ISO 2013Anaesthetic and respiratory equipment Nebulizing systems and componentsMatriel danesthsie et de ranimation respiratoire Systmes de nbulisation et ses composantsINTERNATIONAL STANDARDISO27427Third edition2

5、013-12-15Reference numberISO 27427:2013(E)BS ISO 27427:2013ISO 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

6、 or mechanical, including photocopying, or posting on 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

7、749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 27427:2013ISO 27427:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 General requirements and requirements f

8、or 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 inadvertent adjustments . 64.7 Usability 65 Marking 65.1 Symbols . 65.2 Marking on the device 65.3 Labelling on the packaging or individua

9、l 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, sterilization, and disinfection .148 Biocompatibility 14Annex A (informative) Rationale .15Annex B (normative) Diameters of resp

10、irable fraction particles 19Annex C (normative) Test methods for aerosol output and aerosol output rate 20Annex D (normative) Test methods for particle sizing 23Annex E (informative) Hazard identification for risk assessment .32Annex F (informative) Classification of general purpose nebulizers 38Ann

11、ex G (informative) Environmental aspects .40Annex AA (informative) Conformance to essential principles .42Bibliography .46BS ISO 27427:2013ISO 27427:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The

12、 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 and non-gove

13、rnmental, 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 described in

14、 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 to the po

15、ssibility 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 the ISO list

16、 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, as well a

17、s 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 related equipm

18、ent.This third edition cancels and replaces the second edition (ISO 27427:2010), of which it constitutes a major revision.iv ISO 2013 All rights reservedBS ISO 27427:2013ISO 27427:2013(E)IntroductionNebulizers are widely used to deliver drugs and vaccines in an aerosol form to humans through the res

19、piratory system. Nebulizers are also used for diagnostic purposes using radioisotopes for lung challenge tests. 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 s

20、ystemic diseases and other drugs are intended to treat respiratory diseases. To achieve the intended treatment, 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 per

21、formance profile and the intended use of the nebulizer have to be defined by the manufacturer and specified 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

22、 parameters which are likely to be different than stated when testing for paediatric or infant patient populations. 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 Int

23、ernational Standard are to ensure suitability of the nebulizers for the intended use as disclosed by the manufacturer, safety, particularly for electrically powered nebulizers, compatibility between the materials of the components and the dispensed liquid, and biocompatibility of the materials of th

24、e components that come into contact with the human body.Important changes were made to the original EN standard 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

25、against the methods specified in this International Standard.Terms defined in this International Standard are 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 vBS ISO 27427:2013BS IS

26、O 27427:2013Anaesthetic and respiratory equipment 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,

27、to humans through the respiratory system.This 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

28、devices or manually powered nebulizers.This 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 humi

29、dification or hydration by providing water in 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,

30、 in whole or in part, are normatively referenced 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 resp

31、iratory equipment Conical connectors Part 1: 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 Par

32、t 1: Pipeline systems for compressed medical 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 regulat

33、ors with flow-metering devicesISO 10524-3, Pressure 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 heal

34、th care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesINTERNATIONAL STANDARD ISO 27427:2013(E) ISO 2013 All rights reserved 1BS ISO 27427:2013ISO 27427:2013(E)ISO 11137-1, Sterilization of health care produc

35、ts Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization doseISO 11137-3, Sterilization of health care products Radiation Part 3:

36、 Guidance on dosimetric aspectsISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 14971, Medical devices Application of risk management to medical devicesISO 15001, Anaesthetic and respiratory equipmen

37、t Compatibility with oxygenISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine c

38、ontrol of a sterilization process for medical devicesISO 23328-1, Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performanceISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirementsIEC

39、60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC 60601-1-2:2006+A1:2012, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requ

40、irements and testsIEC 60601-1-6, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: UsabilityIEC 60601-1-8, Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral Stand

41、ard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsIEC 62366, Medical devices Application of usability engineering to medical devicesEN 556-1, Sterilization of medical devices Requirements for medical devices to be designated

42、 “STERILE” Part 1: Requirements for terminally sterilized medical devicesEN 13544-2, Respiratory therapy equipment Part 2: Tubing and connectorsEN 15908, Anaesthetic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gasesENV 737-6, Medical gas p

43、ipeline 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 follo

44、wing terms and definitions apply.2 ISO 2013 All rights reservedBS ISO 27427:2013ISO 27427:2013(E)3.1aerosolsuspension of particles in gasNote 1 to entry: Particles can be liquid or solid.Note 2 to entry: The gas can be the driving gas or ambient air.3.2aerosol outlet portoutlet of the nebulizing sys

45、tem through which the aerosol is emitted3.3*aerosol outputmass or volume of aerosol emitted by the nebulizing system at the aerosol outlet port for the given fill volume3.4*aerosol output ratemass or volume of aerosol emitted by the nebulizing system per unit of time3.5breath-actuated nebulizernebul

46、izer triggered by a respiratory parameterNote 1 to entry: Examples of this classification are found in Annex F.3.6continuous nebulizernebulizer in which aerosol is delivered continuously over multiple inhalation/exhalation breathing cycles or over long periods3.7electrically powered nebulizernebuliz

47、er that operates by means of electrical powerNote 1 to entry: Electrically powered nebulizers include ultrasonic, vibrating mesh and capillary-type devices.3.8gas-powered nebulizernebulizer in which the aerosol is generated by compressed gas3.9liquid containerpart of the nebulizer that contains the

48、liquid for nebulization3.10manually powered nebulizernebulizer that operates by means of human power3.11mass median aerodynamic diameterMMADparticle size at which 50 % of the mass of the active component are contained in droplets of smaller or equal aerodynamic diameter3.12maximum fill volumemaximum

49、 volume of liquid, expressed in millilitres, in the liquid container when the nebulizer is filled to its maximum filling level ISO 2013 All rights reserved 3BS ISO 27427:2013ISO 27427:2013(E)3.13nebulizerdevice that converts a liquid to an aerosolNote 1 to entry: A nebulizer is also known as an aerosol generator.3.14nebulizing systemdevice, including the nebulizer and all other components, up to and including the aerosol outlet port, required to make the aer