1、December 2009DEUTSCHE NORM English price group 18No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!$7y“1562086
2、www.din.deDDIN EN 13544-1Respiratory therapy equipment Part 1: Nebulizing systems and their components (includes AmendmentA1:2009)English version of DIN EN 13544-1:2009-12Atemtherapiegerte Teil 1: Verneblersysteme und deren Bauteile (enthlt nderung A1:2009)Englische Fassung DIN EN 13544-1:2009-12Sup
3、ersedesDIN EN 13544-1:2007-07See start of validitywww.beuth.deDocument comprises pages47DIN EN 13544-1:2009-12 Start of validity This standard takes effect on 1 December 2009. DIN EN 13544-1:2007-07 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Tec
4、hnical Committee CEN/TC 215 “Respiratory and anaesthetic equipment“ (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical Committee NA 053-03-01
5、AA Ansthesie und Beatmung. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN (and/or DKE) shall not be held responsible for identifying any or all such patent rights. This European Standard includes Amendment A1, approved by CEN
6、 on 23 July 2009. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. This standard contains specifications meeting the essential requirements set out in EU Directives 93/42/EEC on medical devices and 2006/42/EC on machines. DIN EN 13544 consists of t
7、he following parts, under the general title Respiratory therapy equipment: Part 1: Nebulizing systems and their components Part 2: Tubing and connectors Part 3: Air entrainment devices The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 927
8、6-1:1998 DIN ISO 9276-1:2004-09 ISO 9276-2:2001 DIN ISO 9276-2:2006-02 Amendments This standard differs from DIN EN 13544-1:2007-07 as follows: a) The following clauses, subclauses and Annexes have been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of
9、5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products: 1) Clause 2 “Normative references”
10、 has been updated. The information to be supplied by the manufacturer has been supplemented as follows: 2) The requirement has been included that for devices imported into the European Union, the name and address of the person responsible and of the authorized representative of the manufacturer esta
11、blished within the European Community are to be provided with the device or with the accompanying document (6.1 e). 2 DIN EN 13544-1:2009-12 3) The requirement has been included that for single use devices the manufacturer shall disclose in the instructions for use the risks associated with reuse in
12、cluding a NOTE that single use devices should be consistently marked across the Community (6.1 cc). 4) The requirement has been included that for medical devices which incorporate software or which are medical software in themselves, the software development process shall comply with EN 62304 (6.8.2
13、 hh). 5) The requirement has been included that if phthalates are incorporated in medical devices coming into contact with the patient, these devices are to be labelled accordingly by the manufacturer and, if such devices are used for particular patient groups, the residual risk has to be identified
14、 and stated in the instructions for use (6.8.2 ii). 6) The requirement has been included that the instructions for use shall contain the date of issue or the latest revision (6.8.2 jj). 7) A NOTE has been included drawing attention to substances which are carcinogenic, mutagenic or toxic to reproduc
15、tion (48). 8) Requirements relating to usability (54.103) and clinical evaluation (4.1) have been included. 9) Table ZA.1 (Correspondence between clauses/subclauses of this standard and the essential requirements of Directive 93/42/EEC on medical devices) has been revised and Table ZA.2 (Corresponde
16、nce between clauses/subclauses of this standard and the essential requirements of Directive 2006/42/EC on machines) has been added. Previous editions DIN EN 13544-1: 2002-01, 2004-09, 2007-07 DIN EN 13544-1 Corrigendum 1: 2005-02 National Annex NA (informative) Bibliography DIN ISO 9276-1:2004-09, R
17、epresentation of results of particle size analysis Part 1: Graphical representation DIN ISO 9276-2:2006-02, Representation of results of particle size analysis Part 2: Calculation of average particle sizes/diameters and moments from particle size distributions 3 DIN EN 13544-1:2009-12 4 This page is
18、 intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13544-1:2007+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 nbuli
19、sation et leurs composants Atemtherapiegerte - Teil 1: Verneblersysteme und deren 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 t
20、he 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 on application to the CEN Management Centre or to any CEN member. This European Standard exists
21、 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 Centre has the same status as the official versions. CEN members are the national standards bod
22、ies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EU
23、ROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES 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
24、13544-1:2007+A1:2009 (E) 2 Contents Page Foreword 5Introduction .61 R) Scope .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
25、 methods . 115 Classification . 116 Identification, marking and documents 116.1 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 categor
26、ies 159 Removable protective means 1510 Environmental conditions 1511 Not used . 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
27、 and potential equalization . 1619 Continuous leakage currents and patient auxiliary 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 h
28、ydraulic power 17DIN EN 13544-1:2009-12 EN 13544-1:2007+A1:2009 (E) 3 28 Suspended 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 radiati
29、on 1835 Acoustical energy (including ultra-sonics) . 1836 Electromagnetic compatibility . 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 equipme
30、nt, parts and components thereof . 1941 R) Requirements and tests for Category 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 vess
31、els and parts subject to pressure . 2046 Human errors . 2047 Electrostatic 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 Gen
32、eral . 2155 Enclosures and covers . 2256 Components and general assembly 2257 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 fr
33、action . 27Annex C C (normative) Test methods for the aerosol output rate, 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 28DIN EN 13544-1:2009-12 EN 13544-1:2007+A1:2009
34、(E) 4 Annex D D (normative) Mass balance checks on cascade impactor tests 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 Requiremen
35、ts of EU Directive 93/42 EEC on medical devices 39Bibliography . 43DIN EN 13544-1:2009-12 EN 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 BS
36、I. This European Standard shall be given the status of a national standard, 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 o
37、f the elements of this document may be the subject of patent rights. 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
38、text introduced or altered by amendment is indicated in the text by tags ! “. 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)
39、, see informative Annex ZA, which is an integral part of this document. 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.
40、 According to the CEN/CENELEC Internal Regulations, the national standards 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,
41、 Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. DIN EN 13544-1:2009-12 EN 13544-1:2007+A1:2009 (E) 6 Introduction This European Standard is based on EN 60601-1:1990. In EN 60601-1:1990, this typ
42、e of European Standard is referred to as a “Particular Standard”. 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
43、. Additional annexes are lettered beginning at AA except for Annex 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. DIN
44、EN 13544-1:2009-12 EN 13544-1:2007+A1:2009 (E) 7 Section one General 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 f
45、orm to humans through the respiratory system. This European Standard 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 Requiremen
46、ts for nebulizers having also a humidification function are specified 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
47、 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. EN 556 (all parts), Sterilization of medical devices Requirements for medical devic
48、es to be designated “STERILE” EN 737-1, Medical gas pipeline systems 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 use in the labelling of medical devices EN 1041, Information supplied by the manufacturer !of“ medical devices EN 1281-21), Anaesthetic and respiratory equipment Con
