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1、BRITISH STANDARD BS EN ISO 11197:2004 Medical supply units The European Standard EN ISO 11197:2004 has the status of a British Standard ICS 11.040.01 ? BS EN ISO 11197:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2005 BSI 3
2、1 January 2005 ISBN 0 580 45366 9 National foreword This British Standard is the official English language version of EN ISO 11197:2004. It is identical with ISO 11197:2004. It supersedes BS EN 793:1998 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee
3、CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement internati
4、onal or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport
5、to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee an
6、y enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, pages 2 to 46,
7、an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11197 December 2004 ICS 11.040.01 Supersedes EN 7
8、93:1997 English version Medical supply units (ISO 11197:2004) Gaines techniques usage mdical (ISO 11197:2004) Medizinische Versorgungseinheiten (ISO 11197:2004) This European Standard was approved by CEN on 23 September 2004. CEN members are bound to comply with the CEN/CENELEC Internal Regulations
9、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 Central Secretariat or to any CEN member. This European
10、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 Central Secretariat has the same status as the official versions. CEN members are the national
11、standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN
12、 COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11197:2004: E EN ISO 11197
13、:2004 (E) 2 Contents page Foreword5 Introduction.6 SECTION ONE - GENERAL 7 1 Scope 7 2 Normative references7 3 Terms and definitions .8 4 General requirements and requirements for tests.8 5 Classification9 6 Identification, marking and documents.9 7 Power input 13 SECTION TWO - ENVIRONMENTAL CONDITI
14、ONS14 8 Basic safety categories.14 9 Removable protection means.14 10 Environmental conditions.14 11 Not Used .14 12 Not Used .14 SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS.15 13 General15 14 Requirements related to classification15 15 Limitation of voltage and/or energy.15 16 Enclosu
15、res and protective covers.15 17 Separation 15 18 Protective earthing, functional earthing and potential equalization15 19 Continuous leakage current and patient auxiliary currents15 20 Dielectric strength .16 SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS 17 21 Mechanical strength17 22 Moving
16、parts.17 23 Surfaces, corners and edges17 24 Stability in normal use 17 25 Expelled parts 18 26 Vibration and noise18 27 Pneumatic and hydraulic power.18 28 Suspended masses .18 EN ISO 11197:2004 (E) 3 SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION.19 29 X-Radiation.1
17、9 30 Alpha, beta, gamma, neutron radiation and other particle radiation .19 31 Microwave radiation19 32 Light radiation (including lasers).19 33 Infra-red radiation19 34 Ultraviolet radiation.19 35 Acoustical energy (including ultrasonics)19 36 Electromagnetic compatibility .19 SECTION SIX - PROTECT
18、ION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES 21 37 Locations and basic requirements 21 38 Marking and accompanying documents.21 39 Common requirements for Category AP and Category APG Equipment21 40 Requirements and tests for Category AP Equipment, parts and components thereof .
19、21 41 Requirements and tests for Category APG Equipment, parts and components thereof.21 SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS .22 42 Excessive temperatures22 43 R Fire prevention.22 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
20、sterilization and disinfection.22 45 Pressure vessels and parts subject to pressure22 46 Human errors .23 47 Electrostatic charges 23 48 Material in applied parts in contact with the body of the patient .23 49 Interruption of the power supply .23 SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTEC
21、TION AGAINST HAZARDOUS OUTPUT24 50 Accuracy of operating data 24 51 Protection against hazardous output24 SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS, ENVIRONMENTAL TESTS25 52 Abnormal operation and fault conditions.25 53 Environmental tests 25 SECTION TEN - CONSTRUCTIONAL REQUIREMENTS25
22、54 General25 55 Enclosures and covers .25 56 Components and general assembly25 57 Mains parts, components and layout25 58 Protective earthing - terminals and connections.26 59 Construction and layout .27 Annexes.39 EN ISO 11197:2004 (E) 4 Annex A A (normative) Special National Conditions.40 Annex B
23、B (informative) Rationale.41 Annex ZA (Informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives43 Annex ZB (Informative) Normative references to international publications with their relevant European publications45 Bibliography46 EN ISO 1
24、1197:2004 (E) 5 Foreword This document (EN ISO 11197:2004) has been prepared by CEN /TC 215, “Respiratory and anaesthetic equipment“, the secretariat of which is held by BSI, in collaboration with ISO/TC121/SC6 “Medical gas systems“. This European Standard shall be given the status of a national sta
25、ndard, either by publication of an identical text or by endorsement, at the latest by June 2005, and conflicting national standards shall be withdrawn at the latest by June 2005. This document supersedes EN 793: 1997. This European Standard has been prepared under a mandate given to CEN by the Europ
26、ean Commission and the European Free Trade Association and supports essential requirements of EU Directive(s). For special national conditions for Clauses 6.1 k), 6.1 bb), 6.2 aa) and 57.1, see Annex AA. For relationship with EU Directives, see informative Annex ZA, which is an integral part of this
27、 standard. For a list of International Standards identical to the European Standards referred to in this European Standard, see informative Annex ZB. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europea
28、n Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN ISO 11197:200
29、4 (E) 6 Introduction This particular standard applies in conjunction with EN 60601-1 “Medical electrical equipment Part 1: General requirements for safety“. As stated in EN 60601-1 the requirements of this Particular Standard take priority over those of EN 60601-1. As in EN 60601-1 the requirements
30、are followed by the relevant tests. The structure of this particular standard corresponds to that of EN 60601-1 and the sections, clauses and sub-clauses refer to those of EN 60601-1. Clauses, subclauses, Tables and Figures additional to those in EN 60601-1 are numbered beginning at “101“. Additiona
31、l annexes are lettered beginning at “AA“ except for annexes “ZA“ and “ZB“. Additional items in lettered lists are lettered beginning “aa)“. Annex BB contains rationale statements for some of the requirements of EN ISO 11197. It is included to provide additional insight into the reasoning that led to
32、 the requirements and recommendations that have been incorporated into EN ISO 11197. The clauses and subclauses marked with R after their number have corresponding rationale contained in Annex BB. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper
33、 application of this standard, but will expedite any subsequent revision. In any health care facility it is strongly recommended that terminal units of only one type (i.e. with the same set of specific dimensions) are used for each medical gas system, anaesthetic gas scavenging system and liquid sys
34、tem. EN ISO 11197:2004 (E) 7 SECTION ONE - GENERAL 1 Scope Clause 1 of EN 60601-1:1990 applies with the following addition: This document applies to medical supply units as defined in 3.5. This particular document applies in conjunction with EN 60601-1. The requirements of this particular document t
35、ake priority over those of EN 60601-1. 2 Normative references The following referenced documents 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 amendmen
36、ts) applies. EN 737-1, Medical gas pipeline systems Part 1: Terminal units for compressed medical gases and vacuum. EN 737-2, Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems Basic requirements. EN 737-3, Medical gas pipeline systems Part 3: Pipelines for compressed m
37、edical gases and vacuum. EN 737-4, Medical gas pipeline systems Part 4: Terminal units for anaesthetic gas scavenging systems. EN 739:1998, Low-pressure hose assemblies for use with medical gases. EN ISO 3744, Acoustics Determination of sound power levels of noise sources using sound pressure - Engi
38、neering method in an essentially free field over a reflecting plane (ISO 3744:1994). EN ISO 14971, Medical devices - Application of risk management to medical devices (ISO 14971:2000). IEC 60079-4, Electrical apparatus for explosive gas atmospheres Part 4: Method of test for ignition temperature. EN
39、 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989). EN 60598-1, Luminaires Part 1: General requirements and tests (IEC 60598-1:1999, modified). EN 60601-1:1990, Medical electrical equipment Part 1: General requirements for safety (IEC 60601- 1:1988). EN 60601-1-2, Medica
40、l electrical equipment - Part 1-2: General requirements for safety; Collateral standard: Electromagnetic compatibility; Requirements and tests (IEC 60601-1-2:2001). EN 60669-1, Switches for household and similar fixed electrical installations Part 1: General requirements (IEC 60669-1:1998, modified)
41、. EN 61386-1, Conduit systems for electrical installations Part 1: General requirements (IEC 61386- 1:1996+A1:2000). EN ISO 11197:2004 (E) 8 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 60601-1:1990 and the following apply. 3.1 compartment part of
42、an enclosure with openings necessary for interconnection, control or ventilation 3.2 enclosure surrounding case constructed to provide a degree of protection to personnel against accidental contact with live parts and also the equipment enclosed against specified environmental conditions (IEC 61950:
43、1997) NOTE An enclosure can be subdivided into compartments. 3.3 junction point connection point(s) between the medical supply unit and the system(s) already installed 3.4 medical gas any gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic purp
44、oses, or for driving surgical tools NOTE In some applications this term includes medical vacuum. 3.5 medical supply unit fixed equipment intended to supply electric power and/or medical gases and/or liquids and anaesthetic gas scavenging systems to medical areas of a health-care facility NOTE Medica
45、l supply units can include medical electrical equipment or medical electrical systems or parts thereof. Medical supply units can also consist of modular sections for electrical supply, lighting for therapy or illumination, communication, supply of medical gases and liquids, anaesthetic gas scavengin
46、g systems. Some typical examples of medical supply units are bed head services modules, ceiling pendants, beams, booms, columns and pillars. Examples of configurations are given in Figures 101, 102 and 103. 4 General requirements and requirements for tests 4.1 Modifications to clause 3 of EN 60601-1
47、:1990 Clause 3 of EN 60601-1:1990 applies with the following addition: 3.6 Add the following items: 3.6 aa) R An oxidant leak which is not detected by e.g. an alarm or periodic inspection shall be considered a normal condition and not a single fault condition. 3.6 bb) Medical supply units shall, whe
48、n transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis procedures in accordance with EN ISO 14971 and which is connected with its intended application, in normal con
49、dition and in single fault condition. 3.101 Equipment and components incorporated into the medical supply unit shall comply with the relevant standard(s) for such equipment or components. EN ISO 11197:2004 (E) 9 4.2 Clause 4 of EN 60601-1:1990 Clause 4 of EN 60601-1:1990 applies. 5 Classification Clause 5 of EN 60601-1:1990 applies. 6 Identification, marking and documents Clause 6 of EN 60601-1:1990 applies with the following amendments: 6.1 Marking on the outside o