1、BRITISH STANDARDBS EN 794-3:1998+A2:2009 Lung ventilators Part 3: Particular requirements for emergency and transport ventilatorsICS 11.040.10; 11.160g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g
2、39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58National forewordThis British Standard is the UK implementation of EN 794-3:1998+A2:2009. It supersedes BS EN 794-3:1999 which is withdrawn.The start and finish of text introduced or altered by CEN amendment is indicated in the text by tags !“. Tags
3、indicating changes to 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, to Subcommittee CH/121/5, Lung ventilator
4、s, tracheal tubes and related equipment.A list of organizations represented on this subcommittee 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 Br
5、itish Standard cannot confer immunity from legal obligations.BS EN 794-3:1998+A2:2009Amendments/corrigenda issued since publicationAmd. No. Date Comments 16094 28 April 2006 Implementation of CEN amendment A1:200530 November 2009Implementation of CEN amendment A2:2009; alignment of BSI and CEN publi
6、cation datesThis British Standard, havingbeen published under thedirection of the EnvironmentSector Committee, waspublished under the authorityof the Standards Committeeand comes into effecton 1 January 1999 BSI 2009ISBN 978 0 580 65092 5EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 794-3:199
7、8+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: Rgles particulires pour les ventilateurs durgence et de transport Lungenbeatmungsgerte - Teil
8、 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 by CEN on 23 July 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulati
9、ons 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 on application to the CEN Management Centre or to any CEN member. This Eur
10、opean 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 Centre has the same status as the official versions. CEN members are the n
11、ational 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland a
12、nd 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 exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 794-3
13、: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 requirements for tests .85 Classification 96 Identification, marking and documents .97 Power in
14、put . 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 voltage and/or energy 1816 Enclosures and protective covers 1817 Separation . 1818 Protective e
15、arthing, functional earthing and potential equalization . 1819 Continuous leakage currents and patient auxiliary currents . 1820 Dielectric strength 1821 Mechanical strength . 1922 Moving parts 2023 Surfaces, corners and edges . 2024 Stability in normal use . 2025 Expelled parts . 2026 Vibration and
16、 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 . 21BS EN 794-3:1998+A2:2009EN 794-3:1998+A2:2009 (E) 3 32 Light radiation (including lasers) . 2133 Infra-red radiatio
17、n 2134 Ultra-violet radiation 2135 Acoustical energy (including ultra-sonics) . 2136 Electromagnetic compatibility . 2137 Locations and basic requirements 2338 Marking, accompanying documents . 2339 Common requirements for Category AP and Category APG equipment 2340 Requirements and test for Categor
18、y 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, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 2445 Press
19、ure 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 output 2652 Abnormal operation and fault conditions . 3053 Environmental tests 3054 General .
20、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 (informative) Rationale . 35Annex BB (normative) Legibility and visibility 40Annex CC (informative)
21、 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$ 43BS EN 794-3:1998+A2:2009EN 794-3:1998+A2:2009 (E) 4 Foreword This document (EN 794-3:1998+A2:2009) has
22、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 of an identical text or by endorsement, at the latest by February 2010, and
23、 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 CENELEC shall not be held responsible for identifying any or all such patent rights. This d
24、ocument 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 is indicated in the text by tags !“ and # $. This European Standard has been prepared un
25、der 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 standard. See annex DD for Special National Condit
26、ions. 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 critical care and lung ventilators for home care respectively. Annexes BB and DD are normati
27、ve 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 countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cypru
28、s, 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. BS EN 794-3:1998+A2:2009EN 794-3:1998+A2:2
29、009 (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 1.3 of EN 60601-1:1990, the requirements of this European Standard take precedence ov
30、er 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 beginning aa). Additional tables and figures are numbered beginning 101. Annex AA conta
31、ins 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. BS EN 794-3:1998+A2:2009EN 794-3:1998+A2:2009 (E) 6 Section one. General 1 Scope The scope given in clause 1 of EN 60601-1
32、: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 of devices, from relatively simple ventilators intended, primarily, for use with
33、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 does not cover operator-powered ventilators (i.e. manual resuscitators). Ventilato
34、rs 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 (see EN 794-2), operator powered resuscitators and recent developments such as jet
35、 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. These normative references are cited at the appropriate places in the text and the
36、 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 undated references the latest edition of the publication referred to applies. EN 475
37、, 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 devi
38、ces 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 pipeline systems Part 1: Terminal units for compressed medical gases and vacuum prEN 737-3:1994, Medical gas pipe
39、line systems Part 3: Pipelines for compressed medical gases and vacuum prEN 737-6:1996, Medical gas pipeline systems Part 6: Dimensions of probes for terminal units for compressed medical gases and vacuum EN 738-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressu
40、re regulators with flow-metering devices EN 739, Low pressure hose assemblies for use with medical gases EN 980, Graphical symbols for use in the labelling of medical devices BS EN 794-3:1998+A2:2009EN 794-3:1998+A2:2009 (E) 7 EN 1281-1, Anaesthetic and respiratory equipment Conical connectors Part
41、1: Cones and sockets EN 1281-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified) EN 1820, Anaesthetic reservoir bags EN ISO 4135:1996, Anaesthesiology Vocabulary (ISO 4135:1995) EN ISO 8185, Humidifiers for medical u
42、se General requirements for humidification systems (ISO 8185:1997) EN 12342, Breathing tubes intended for use with anaesthetic apparatus and ventilators prEN 12598:1996, Oxygen monitors for patient breathing mixtures Particular requirements EN 60601-1:1998, Medical electrical equipment Part 1: Gener
43、al requirements for safety EN 60601-1-2, Medical electrical equipment Part 1: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests #EN 62304, Medical device software - Software life-cycle processes$ IEC 60068-2-6, Environmental testing Tests metho
44、d Test Fc Vibration (sinusoidal) IEC 60068-2-29, Environmental testing procedures Test Test Eband guidance Bump IEC 60068-2-32:1975, Basic environmental testing procedures Tests methods Part 2: Tests Test Ed: Free fall IEC 60068-2-36, Basic environmental testing procedures Tests methods Part 2: Test
45、s Test Fdb: Random vibration wide band Reproducibility medium IEC 60079-4, Electrical apparatus for explosive gas atmospheres Pat 4: Method of test for ignition temperature IEC 61000-4-2, Electrostatic discharge immunity test Basic EMC publication ISO 32:1977, Gas cylinders for medical use Marking f
46、or identification of content ISO 9360:1992, Anaesthetic and respiratory equipment Heat and moisture exchangers for use in humidifying respired gases in humans 3 Terminology and definitions Clause 2 of EN 60601-1:1990 applies with the following additions, and the definitions given in EN ISO 4135:1996
47、 apply: 2.1.5 applied part R): Add the following item: All parts of the ventilator intended to be connected to the patient or to the breathing system. 3.1 clearly legible visual attribute of information displayed by the equipment that allows the operator to discern (or identify) qualitative or quant
48、itative values or functions under a specific set of environmental conditions BS EN 794-3:1998+A2:2009EN 794-3:1998+A2:2009 (E) 8 3.2 cyling pressure pressure in the ventilator breathing system which initiates an inspiratory or expiratory phase 3.3 emergency and transport ventilator portable active medical device for lung ventilation intended for emergency use and/or transportation NOTE Hereinafter called ventilator. 3.4 label printed or graphic information applied to a medical device or any of its containers or wrappers 3.5 marking inscript
