DIN EN 794-3-2009 Lung ventilators - Part 3 Particular requirements for emergency and transport ventilators(includes Amendment A2 2009) English version of DIN EN 794-3 2009-12《肺呼吸机.pdf

1、December 2009DEUTSCHE NORM English price group 17No 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; 11.160!$(5

2、“1560518www.din.deDDIN EN 794-3Lung ventilators Part 3: Particular requirements for emergency and transport ventilators(includes Amendment A2:2009)English version of DIN EN 794-3:2009-12Lungenbeatmungsgerte Teil 3: Besondere Anforderungen an Notfall- und Transportbeatmungsgerte (enthlt nderung A2:20

3、09)Englische Fassung DIN EN 794-3:2009-12SupersedesDIN EN 794-3:1998-10 andDIN EN 794-3/A1:2005-09See start of validitywww.beuth.deDocument comprises pages49DIN EN 794-3:2009-12 Start of validity This standard takes effect on 1 December 2009. DIN EN 794-3:1998-10 may be used in parallel until 21 Mar

4、ch 2010. National foreword This standard has been prepared by Technical 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

5、 Hospital Standards Committee), Technical Committee NA 053-03-01 AA Ansthesie und Beatmung. This European Standard includes Amendment A1, approved by CEN on 25 May 2005 and Amendment A2, approved by CEN on 23 July 2009. The start and finish of text introduced or altered by amendment is indicated in

6、the text by tags !“ and #$. 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. In addition, standards series DIN EN ISO 10651, Lung ventilators for medical use and DIN EN 60601-2-12, Medical elect

7、rical equipment Part 2-12: Particular requirements for the safety of lung ventilators Critical care ventilators (currently under revision) are also applicable. The DIN Standards corresponding to the International Standards referred to in this document are as follows: IEC 60068-2-6 DIN EN 60068-2-6 I

8、EC 60068-2-29 DIN EN 60068-2-29 IEC 61000-4-2 DIN EN 61000-4-2 (VDE 0847 Part 4-2) Amendments This standard differs from DIN EN 794-3:1998-10 as follows: a) The scope now expressly states that the standard also applies to gas-powered resuscitators. b) The following clauses, subclauses and Annexes ha

9、ve been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 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 E

10、U Directive 98/8/EC on the placing on the market of biocidal products: 1) Clause 2 “Normative references” and “Bibliography” have been updated. 2) The information to be supplied by the manufacturer has been supplemented as follows: Requirement that the labelling and marking of the packages of the de

11、vices shall contain the name or trade name and address of the manufacturer and the name and address of the authorized representative (6.1 dd). Information relating to the attachments (6.1 dd). 2 DIN EN 794-3:2009-12 Requirement that for single use devices the manufacturer shall disclose in the instr

12、uctions for use the risks associated with reuse including a NOTE that single use devices should be consistently marked across the Community (6.1 d.d). Requirement that if phthalates are incorporated in medical devices coming into contact with the patient, these devices are to be labelled accordingly

13、 by the manufacturer and, if such devices are used for particular patient groups, the residual risk has to be identified and stated in the instructions for use (6.1 d.d). Requirement that the instructions for use shall contain the date of issue or the latest revision (6.8.2 c.c). 3) Subclause 6.8.2

14、bb) now includes the requirement that for medical devices which incorporate software or which are medical software in themselves, the software development process shall comply with EN 62304. 4) A NOTE has been included drawing attention to substances which are carcinogenic, mutagenic or toxic to rep

15、roduction (48). 5) Requirements relating to usability (54.104) and clinical evaluation (3.10) have been included. 6) 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 (Corre

16、spondence between clauses/subclauses of this standard and the essential requirements of Directive 2006/42/EC on machines) has been added. Previous editions DIN EN 794-3: 1998-10 DIN EN 794-3/A1: 2005-09 National Annex NA (informative) Bibliography DIN EN 60068-2-6, Environmental testing Part 2-6: Te

17、sts Test Fc: Vibration (sinusoidal) DIN EN 60068-2-29, Basic environmental testing procedures Part 2: Tests; test Eb and guidance: Bump DIN EN 61000-4-2, Electromagnetic compatibility (EMC) Part 4-2 : Testing and measurement techniques Electrostatic discharge immunity test 3 DIN EN 794-3:2009-12 4 T

18、his page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 794-3:1998+A2 August 2009 ICS 11.040.10; 11.160 Supersedes EN 794-3:1998English Version Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators Ventilateurs pulmonaires - Partie 3:

19、 Rgles particulires pour les ventilateurs durgence et de transport Lungenbeatmungsgerte - Teil 3: Besondere Anforderungen an Notfall- und TransportbeatmungsgerteThis European Standard was approved by CEN on 1 July 1998 and includes Amendment 1 approved by CEN on 25 May 2005 and Amendment 2 approved

20、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 standard without any alteration. Up-to-date lists and bibliographical references concerning such national standa

21、rds 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 language made by translation under the responsibility of a CEN member into its own language and notified to

22、 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, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Ne

23、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitati

24、on in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 794-3:1998+A2:2009: EEN 794-3:1998+A2:2009 (E) 2 Contents Page Foreword 4Introduction .5Section one. General 61 Scope 62 Normative references 63 Terminology and definitions .74 General requirements and general r

25、equirements for tests .85 Classification 96 Identification, marking and documents .97 Power input . 158 Basic safety categories 169 Removable protective means 1610 Environmental conditions 1611 Not used. 1712 Not used. 1713 General . 1814 Requirements related to classification . 1815 Limitation of v

26、oltage and/or energy 1816 Enclosures and protective covers 1817 Separation . 1818 Protective earthing, functional earthing and potential equalization . 1819 Continuous leakage currents and patient auxiliary currents . 1820 Dielectric strength 1821 Mechanical strength . 1922 Moving parts 2023 Surface

27、s, corners and edges . 2024 Stability in normal use . 2025 Expelled parts . 2026 Vibration and noise. 2027 Pneumatic and hydraulic power 2028 Suspended masses 2029 X-radiation . 2130 Alpha, beta, gamma, neutron radiation and other particle radiation 2131 Microwave radiation . 21DIN EN 794-3:2009-12

28、EN 794-3:1998+A2:2009 (E) 3 32 Light radiation (including lasers) . 2133 Infra-red radiation 2134 Ultra-violet radiation 2135 Acoustical energy (including ultra-sonics) . 2136 Electromagnetic compatibility . 2137 Locations and basic requirements 2338 Marking, accompanying documents . 2339 Common req

29、uirements for Category AP and Category APG equipment 2340 Requirements and test for Category AP equipment, parts and components thereof 2341 Requirements and test for Category APG equipment, parts and components thereof . 2342 Excessive temperatures . 2443 R) Fire prevention 2444 Overflow, spillage,

30、 leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 2445 Pressure vessels and parts subject to pressure . 2446 Not used . 2547 Not used . 2548 Biocompatibility . 2549 Interruption of the power supply . 2550 Accuracy of operating data 2651 Protection against hazardous out

31、put 2652 Abnormal operation and fault conditions . 3053 Environmental tests 3054 General . 3155 Enclosures and covers . 3156 Components and general assembly 3157 Mains parts, components and layout 3458 Protective earthing Terminals and connections . 3459 Construction and layout . 34Annex AA (informa

32、tive) Rationale . 35Annex BB (normative) Legibility and visibility 40Annex CC (informative) Bibliography . 41Annex DD (normative) Special national conditions 42Annex ZA (informative) #Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC$ 43DIN EN 794-3

33、:2009-12 EN 794-3:1998+A2:2009 (E) 4 Foreword This document (EN 794-3:1998+A2:2009) 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 standard, either by

34、 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. CEN and/or CEN

35、ELEC shall not be held responsible for identifying any or all such patent rights. This document includes Amendment 1, approved by CEN on 2005-05-25 and Amendment 2, approved by CEN on 2009-07-23. This document supersedes EN 794-3:1998. The start and finish of text introduced or altered by amendment

36、is indicated in the text by tags !“ and # $. This European Standard 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

37、ZA, which is an integral part of this standard. See annex DD for Special National Conditions. This European Standard applies to lung ventilators and has been prepared in three parts. This Part addresses lung ventilators for emergency and transport use. Parts 1 and 2 address lung ventilators for crit

38、ical care and lung ventilators for home care respectively. Annexes BB and DD are normative and form part of this Part of this European Standard. Annexes AA, CC and ZA are for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following co

39、untries 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, Portugal, Romania, Slovakia, Slovenia, S

40、pain, Sweden, Switzerland and United Kingdom. DIN EN 794-3:2009-12 EN 794-3:1998+A2:2009 (E) 5 Introduction This European Standard is one of a series based on European Standard EN 60601-1:1990. In EN 60601-1:1990 this type of European Standard is referred to as a “Particular Standard“. As stated in

41、1.3 of EN 60601-1:1990, the requirements of this European Standard take precedence over those of EN 60601-1:1990. Clauses and subclauses additional to those in EN 60601-1:1990 are numbered beginning 101. Additional annexes are lettered beginning AA. Additional items in lettered lists are lettered be

42、ginning aa). Additional tables and figures are numbered beginning 101. Annex AA contains rationale statements for this Part of this European Standard. The clauses and subclauses which have corresponding rationale statements are marked with R) after their number. DIN EN 794-3:2009-12 EN 794-3:1998+A2

43、:2009 (E) 6 Section one. General 1 Scope The scope given in clause 1 of EN 60601-1:1990 applies with the following addition: 1.101 R) This part of this European Standard specifies requirements for ventilators, driven by a power source and intended for emergency and transport use. This covers a range

44、 of devices, from relatively simple ventilators intended, primarily, for use with a face mask and for limited periods (e.g. gas powered ventilators) through to devices for pre-planned longer term use. !This includes gas-powered resuscitators, which are generally used by first responders.“ This part

45、does not cover operator-powered ventilators (i.e. manual resuscitators). Ventilators aboard aircraft are likely to be subject to additional requirements and national/international regulations. Additional parts, e.g. concerning lung ventilators for critical care (see EN 794-1), home care ventilators

46、(see EN 794-2), operator powered resuscitators and recent developments such as jet and very high frequency ventilation and oscillation are published or under consideration. 2 Normative references This European Standard incorporates, by dated or undated reference, provisions from other publications.

47、These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For un

48、dated references the latest edition of the publication referred to applies. EN 475, Medical devices Electrically-generated alarm signals EN 550, Sterilization of medical devices Validation and routine control of ethylene oxide sterilization EN 552, Sterilization of medical devices Validation and routine control of sterilization by irradiation EN 554, Sterilization of medical devices Validation and routine control of sterilization by moist heat EN 556, Sterilization of medical devices Requirements for medical devices to be labelled “STERILE“ EN 737-1, Medical gas pipel