1、BRITISH STANDARDBS EN 13544-1:2007+A1:2009 Respiratory therapy equipment Part 1: Nebulizing systems and their componentsICS 11.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g5
2、0g51g60g53g44g42g43g55g3g47g36g58National forewordThis British Standard is the UK implementation of EN 13544-1:2007+A1:2009. It supersedes BS EN 13544-1:2007 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes t
3、o CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by !“.The UK participation in its preparation was entrusted to Technical Committee CH/121, Anaesthetic and respiratory equipment.A list of organizations represented on this committee can be o
4、btained 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.BS EN 13544-1:2007+A1:2009This British Stand
5、ard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2007 BSI 2010Amendments/corrigenda issued since publicationDate Comments 30 April 2010 Implementation of CEN amendment A1:2009ISBN 978 0 580 64554 9EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1354
6、4-1:2007+A1 August 2009 ICS 11.040.10 Supersedes EN 13544-1:2007English 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 de
7、ren Bauteile This European Standard was approved by CEN on 22 March 2007 and includes Amendment 1 approved by CEN on 23 July 2009. 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 stand
8、ard without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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
9、language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management 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, F
10、inland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHE
11、S KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13544-1:2007+A1:2009: EEN 13544-1:2007+A1:2009 (E) 2 Contents Page Foreword 5Introduction .61 R) Scope .
12、72 Normative references 73 Terms and definitions .94 General requirements and general requirements for test 104.1 Modifications to Clause 3 of EN 60601-1:1990 104.2 Clause 4 of EN 60601-1:1990 . 114.3 Alternative type-test methods . 115 Classification . 116 Identification, marking and documents 116.
13、1 Marking on the outside of equipment or equipment parts . 116.3 Marking of controls and instruments . 126.4 Symbols . 126.8.2 Instructions for use 126.8.3 Technical description . 147 Power input . 158 Basic safety categories 159 Removable protective means 1510 Environmental conditions 1511 Not used
14、 . 1512 Not used . 1513 General . 1514 Requirements related to classification . 1515 Limitation of voltage and/or energy 1616 Enclosures and protective covers 1617 Separation . 1618 Protective earthing, functional earthing and potential equalization . 1619 Continuous leakage currents and patient aux
15、iliary currents . 1620 Dielectric strength 1621 Mechanical strength . 1622 Moving parts 1623 Surfaces, corners and edges . 1624 Stability in normal use . 1725 Expelled parts . 1726 Vibration and noise. 1727 Pneumatic and hydraulic power 17BS EN 13544-1:2007+A1:2009EN 13544-1:2007+A1:2009 (E) 3 28 Su
16、spended masses . 1729 X-radiation 1730 Alpha, beta, gamma, neutron radiation and other particle radiation . 1731 Microwave radiation 1832 Light radiation (including lasers) . 1833 Infra-red radiation 1834 Ultra-violet radiation 1835 Acoustical energy (including ultra-sonics) . 1836 Electromagnetic c
17、ompatibility . 1837 R) Locations and basic requirements . 1838 R) Marking, accompanying documents 1839 R) Common requirements for category AP and category APG equipment . 1840 R) Requirements and tests for Category AP equipment, parts and components thereof . 1941 R) Requirements and tests for Categ
18、ory APG equipment, parts and components thereof 1942 Excessive temperatures . 1943 R) Fire prevention 1944 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 1945 Pressure vessels and parts subject to pressure . 2046 Human errors . 2047 Electrostatic
19、charges 2048 Biocompatibility . 2049 Interruption of the power supply . 2050 Accuracy of operating data 2051 Protection against hazardous output 2152 Abnormal operation and fault conditions . 2153 Environmental tests 2154 General . 2155 Enclosures and covers . 2256 Components and general assembly 22
20、57 Mains parts, components and layout 2358 Protective earthing - Terminals and connections 2359 Construction and layout . 23Annex A A (informative) Rationale 24Annex B B (informative) Diameters of the particles depositable fraction . 27Annex C C (normative) Test methods for the aerosol output rate,
21、the aerosol output and for particle sizing . 28CC.1 Method of test for the aerosol output rate 28CC.1.1 Test conditions 28CC.1.2 R) Principle of test . 28CC.1.3 Test equipment 28BS EN 13544-1:2007+A1:2009EN 13544-1:2007+A1:2009 (E) 4 Annex D D (normative) Mass balance checks on cascade impactor test
22、s 36DD.1 Aerosol output rate and aerosol output tests: 36DD.2 Particle sizing test 36Annex E E (informative) Environmental aspects 37Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices 39Bibliography . 43BS EN
23、 13544-1:2007+A1:2009EN 13544-1:2007+A1:2009 (E) 5 Foreword This document (EN 13544-1:2007+A1:2009) 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 sta
24、ndard, either by publication of an identical text or by endorsement, at the latest by February 2010 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.
25、CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document includes Amendment 1, approved by CEN on 2009-07-23. This document supersedes !EN 13544-1:2001“. The start and finish of text introduced or altered by amendment is indicated in the text by t
26、ags ! “. 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 EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this documen
27、t. This European Standard applies to respiratory therapy equipment and has been prepared in three parts. This Part addresses nebulizing systems; Parts 2 and 3 address respectively tubing and connectors, and air entrainment devices. According to the CEN/CENELEC Internal Regulations, the national stan
28、dards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, P
29、ortugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. BS EN 13544-1:2007+A1:2009EN 13544-1:2007+A1:2009 (E) 6 Introduction This European Standard is based on EN 60601-1:1990. In EN 60601-1:1990, this type of European Standard is referred to as a “Particular Standard”.
30、As stated in 1.3 of EN 60601-1:1990 the requirements of this European Standard take precedence over those of EN 60601-1:1990. Clauses, subclauses, tables and figures additional to those in EN 60601-1:1990 are numbered beginning at 101. Additional annexes are lettered beginning at AA except for Annex
31、 ZA. Additional items in lettered lists are lettered beginning aa). Rationales for some of the requirements of this European Standard are given in Annex AA. Such requirements are indicated by the letter R after the clause number. BS EN 13544-1:2007+A1:2009EN 13544-1:2007+A1:2009 (E) 7 Section one Ge
32、neral 1 R) Scope The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following: 1.1 This European Standard specifies requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system. This European Sta
33、ndard includes gas-powered nebulizers which may be derived from e.g. compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e.g. ultrasonic and membrane devices) or manually-powered nebulizers. NOTE Requirements for nebulizers having also a humidification function are spe
34、cified in EN ISO 8185:1997 + AC: 2002 “Humidifiers” (see 56.102). This European Standard does not apply to nebulizers precharged with a specific medicinal product (e.g. MDI, DPI). 2 Normative references The following referenced documents are indispensable for the application of this document. For da
35、ted references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 556 (all parts), Sterilization of medical devices Requirements for medical devices to be designated “STERILE” EN 737-1, Medical gas pipeline sy
36、stems Part 1: Terminal units for compressed medical gases and vacuum ENV 737-6, Medical gas pipeline systems Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum EN 739, Low pressure hose assemblies for use with medical gases EN 980, !Symbols“ for us
37、e in the labelling of medical devices EN 1041, Information supplied by the manufacturer !of“ medical devices EN 1281-21), Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified) EN 1707, Conical fittings with a 6 % (Luer) t
38、aper for syringes, needles and certain other medical equipment Lock fittings EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements (ISO 594-1:1986) EN 60601-1:1990, Medical electrical equipment Part 1: General requ
39、irements for basic safety and essential performance (IEC 60601-1:1988) 1)Will be superseded by EN ISO 5356-2, which is currently under preparation. BS EN 13544-1:2007+A1:2009EN 13544-1:2007+A1:2009 (E) 8 EN 60601-1-2, Medical electrical equipment Part 1-2: General requirements for safety Collateral
40、Standard: Electromagnetic compatibility Requirements and tests !(IEC 60601-1-2:2007, modified)“ !EN 60601-1-6, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral Standard: Usability (IEC 60601-1-6:2006)“ EN 61000-4-2:1995, Electromagneti
41、c compatibility (EMC) Part 4: Testing and measurement techniques Section 2: Electrostatic discharge immunity test Basic EMC publication (IEC 61000-4-2:1995) EN 61672-1, Electroacoustics Sound level meters Part 1: Specifications (IEC 61672-1:2002) EN 61672-2, Electroacoustics Sound level meters Part
42、2: Pattern evaluation tests (IEC 61672-2:2003) !EN 62304, Medical device software Software life-cycle processes (IEC 62304:2006) EN 62366, Medical devices Application of usability engineering to medical devices (IEC 62366:2007)“ EN ISO 3744, Acoustics Determination of sound power levels of noise sou
43、rces using sound pressure Engineering method in an essentially free field over a reflecting plane (ISO 3744:1994) EN ISO 4135:2001, Anaesthetic and respiratory equipment Vocabulary (ISO 4135:2001) EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets (ISO
44、5356-1:2004) EN ISO 7396-1, Medical gas pipeline systems Part 1: Pipelines for compressed medical gases and vacuum !(ISO 7396-1:2007)“ EN ISO 8185, Humidifiers for medical use General requirements for humidification systems !(ISO 8185:2007)“ EN ISO 10524-1, Pressure regulators for use with medical g
45、ases Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) EN ISO 10524-3, Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) EN ISO 11135-1, Sterilization of health care products E
46、thylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization
47、 process for medical devices (ISO 11137-1:2006) EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose (ISO 11137-2:2006) EN ISO 11137-3, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) EN
48、ISO 14971, Medical devices Application of risk management to medical devices !(ISO 14971:2007)“ EN ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen (ISO 15001:2003) EN ISO 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 devices (ISO 17665-1:2006) BS EN 13544-1:2007+A1:2009EN 13544-1:2007+A1:2009 (E) 9 IEC 60079-4, Electrical
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