BS-EN-13544-1-2007.pdf
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1、BRITISH STANDARD BS EN 13544-1:2007 Respiratory therapy equipment Part 1: Nebulizing systems and their components The European Standard EN 13544-1:2007 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13
2、GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 13544-1:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2007 BSI 2007 ISBN 978 0 580 50791 5 National foreword This British Standard was published by BSI. It is the UK implementatio
3、n of EN 13544-1:2007. It supersedes BS EN 13544-1:2001 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/3, Lung ventilators and related equipment. A list of organizations represented
4、 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. Amendments iss
5、ued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13544-1 April 2007 ICS 11.040.10Supersedes EN 13544-1:2001 Englis
6、h Version Respiratory therapy equipment - Part 1: Nebulizing systems and their components Matriel respiratoire thrapeutique - Partie 1: Systmes de nbulisation et leurs composants Atemtherapiegerte - Teil 1: Verneblersysteme und deren Bauteile This European Standard was approved by CEN on 22 March 20
7、07. CEN members are bound to comply with 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
8、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 translation under the responsibility of a CEN member into its own language and notified to the CEN Management
9、Centre has the same status as the official 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, P
10、oland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and
11、by any means reserved worldwide for CEN national Members. Ref. No. EN 13544-1:2007: E Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 2 Contents Page Foreword5 Introduction.6 1 R) Scope .7 2
12、 Normative references7 3 Terms and definitions .9 4 General requirements and general requirements for test.10 4.1 Modifications to Clause 3 of EN 60601-1:1990 .10 4.2 Clause 4 of EN 60601-1:199010 4.3 Alternative type-test methods11 5 Classification11 6 Identification, marking and documents.11 6.1 M
13、arking on the outside of equipment or equipment parts11 6.3 Marking of controls and instruments 12 6.4 Symbols12 6.8.2 Instructions for use .12 6.8.3 Technical description14 7 Power input 14 8 Basic safety categories.14 9 Removable protective means.14 10 Environmental conditions.15 11 Not used15 12
14、Not used15 13 General15 14 Requirements related to classification15 15 Limitation of voltage and/or energy.15 16 Enclosures and protective covers.15 17 Separation 15 18 Protective earthing, functional earthing and potential equalization15 19 Continuous leakage currents and patient auxiliary currents
15、15 20 Dielectric strength .16 21 Mechanical strength16 22 Moving parts.16 23 Surfaces, corners and edges16 24 Stability in normal use 16 25 Expelled parts 16 26 Vibration and noise16 27 Pneumatic and hydraulic power.17 Licensed Copy: London South Bank University, London South Bank University, Fri Ju
16、n 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 3 28 Suspended masses.17 29 X-radiation17 30 Alpha, beta, gamma, neutron radiation and other particle radiation.17 31 Microwave radiation17 32 Light radiation (including lasers).17 33 Infra-red radiation17 34 Ultra-violet r
17、adiation17 35 Acoustical energy (including ultra-sonics).17 36 Electromagnetic compatibility .18 37 R Locations and basic requirements 18 38 R Marking, accompanying documents18 39 R Common requirements for category AP and category APG equipment18 40 R Requirements and tests for Category AP equipment
18、, parts and components thereof18 41 R Requirements and tests for Category APG equipment, parts and components thereof .18 42 Excessive temperatures .18 43 R) Fire prevention18 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 19 45 Pressure vessel
19、s and parts subject to pressure .19 46 Human errors.19 47 Electrostatic charges19 48 Biocompatibility.20 49 Interruption of the power supply .20 50 Accuracy of operating data20 51 Protection against hazardous output20 52 Abnormal operation and fault conditions.21 53 Environmental tests21 54 General
20、.21 55 Enclosures and covers.21 56 Components and general assembly21 57 Mains parts, components and layout23 58 Protective earthing - Terminals and connections23 59 Construction and layout.23 Annex A A (informative) Rationale 24 Annex B B (informative) Diameters of the particles depositable fraction
21、.27 Annex C C (normative) Test methods for the aerosol output rate, the aerosol output and for particle sizing.28 CC.1 Method of test for the aerosol output rate28 CC.1.1 Test conditions28 CC.1.2 R) Principle of test.28 CC.1.3 Test equipment28 Licensed Copy: London South Bank University, London Sout
22、h Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 4 Annex D D (normative) Mass balance checks on cascade impactor tests36 DD.1 Aerosol output rate and aerosol output tests: .36 DD.2 Particle sizing test .36 Annex E E (informative) Environmental asp
23、ects37 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices .39 Bibliography41 Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (
24、c) BSI EN 13544-1:2007 (E) 5 Foreword This document (EN 13544-1:2007) has been prepared 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 publication o
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