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1、Medical electrical e.quipment- Part 1 : General requirements for safety- 1. Collateral standard : Safety requirements for medical electrical systems J IS JAPANESE I N DUSTR IAL STANDARD Translated and Published by Japanese Standards Association . ICs 11.040.01 Descriptors : electrical medical equipm
2、ent, electrotherapy equipment, safety measures, Reference number : JIS T 0601-1-1 : 1999 (E) safety 15 S Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 02:17:21 MDTNo reproduction or netwo
3、rking permitted without license from IHS -,-,- T 0601-1-1 : 1999 Foreword This translation has been made based on the original Japanese Industrial Standard established by the Minister of International Trade and Industry and the Minister of Health and Welfare through deliberations at the Japanese Ind
4、ustrial Standards Committee in accordance with the Industrial Standardization Law: Date of Establishment: 1999-12-27 Date of Public Notice in Official Gazette: 1999-12-27 Investigated by: Japanese Industrial Standards Committee Divisional Council on Medical and Safety JIS T 0601-1-1 : 1999, First En
5、glish edition published in 2001-09 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. a t t, O JSA 2001 All rights reserved. Unless otherwi
6、se specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. Printed in Japan Copyright Japanese Standards Association Provided by IHS under licen
7、se with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 02:17:21 MDTNo reproduction or networking permitted without license from IHS -,-,- . t T 0601-1-1 : 1999 Contents Page Introduction . 1 Section One General 1 Scope and object 1.201 Scope 2 Terminology and defi
8、nitions 2.201 COUPLING 2.202 INDIRECT CONTACT . 2.203 MEDICAL ELECTRICAL SYSTEM 2.204 PATIENT ENVIRONMENT 2.205 SEPARATION DEVICE 2.206 MULTIPLE PORTABLE SOCKET-OUTLET 3 General requirements . 3.201 4 4.201 6 General requirements for the SYSTEM General requirements for tests for the SYSTEM Identific
9、ation, marking and documents 6.1.201 Marking General requirements for tests . 6.8.201 Accompanying documents . 1 1 1 1 1 1 1 2 2 2 2 2 3 3 3 3 3 Section Two Environmental conditions 4 Section Three Protection against electric shock hazards 16 ENCLOSURES and PROTECTIVE COVERS . 16.201 ENCLOSURES . 17
10、 Separation . 17.201 Electrical separation . 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 19.201 LEAKAGE CURRENTS . 19.201.1 ENCLOSURE LEAKAGE CURRENT . 19.201.2 PATIENT LEAKAGE CURRENT . 19.201.3 Connection O f SIGNAL INPUT PARTS or SIGNAL OUTPUT PARTS . 4 4 4 4 4 5 5 5 5 5 Secti
11、on Four Protection against mechanical hazards 6 22 Moving parts 6 Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 02:17:21 MDTNo reproduction or networking permitted without license from IH
12、S -,-,- T 0601-1-1 : 1999 22.7.201 Protective means Section Five Protection against hazards from unwanted or excessive radiation . Section Six Protection against hazards of ignition of flammable anaesthetic mixtures Section Seven Protection against excessive temperatures and other safety hazards . 4
13、3.201 Fire prevention 44.7.201 49.201 Cleaning. sterilization and disinfection . Interruption of the power supply . Section Eight Accuracy of operating data and protection against hazard.ous output Section Nine Abnormal operation and fault conditions; environmental tests Section Ten Constructional r
14、equirements . MAINS CONNECTORS. APPLIANCE INLETS and the like 56.3.201 Connections . 57.2 57.2.201 MULTIPLE PORTABLE SOCKET-OUTLET . 57.10 CREEPAGE DISTANCES and AIR CLEARANCES . 57.10.201 SEPARATION DEVICE 58.201 PROTECTIVE EARTH CONDUCTOR 59.201 Protection of wiring Figures 201 Example of PATIENT
15、ENVIRONMENT 202 Symbol 14. Table D1 of JIS T 0601-1 . Annexes AAA (informative) General guidance and rationale BBB (informative) Examples of combinations of MEDICAL ELECTRICAL EQUIPMENT and non-medical electrical equipment . CCC (normative) Normative references DDD (informative) Bibliography . EEE (
16、normative) Requirements for MULTIPLE PORTABLE SOCKET-OUTLETS FFF (informative) Examples of application of MULTIPLE PORTABLE SOCKET-OUTLETS 6 6 e 6 i 6 a 7 8 8 9 14 18 19 20 22 t (ii) Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, Use
17、r=Wing, Bernie Not for Resale, 03/14/2007 02:17:21 MDTNo reproduction or networking permitted without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS T 0601-1-1 : 1999 Medical electrical equipment- Part 1 : General requirements for safety- 1. Collateral standard : Safety requirements for med
18、ical electrical systems Introduction This Japanese Industrial Standard has been prepared based on IEC 60601-1-1 Medical electrical equipment-Part 1 : General requirements for safety- I. Collateral standard : Safety requirements for medical electrical systems published in 1992 as the first edition an
19、d the Amendment 1 (1995) without any modification in the technical contents. The mark * located on the upper left side of the subclause number means that In this Standard, the portions underlined with dots mean the matter not stated the rough statement or explanation is given in Annex AAA (informati
20、ve). in the original International Standard. 0 Section One-General 1 Scope and object “1.201 This Standard applies to the safety of MEDICAL ELECTRICAL SYSTEMS. It describes the safety requirements for MEDICAL ELECTRICAL SYSTEMS to provide pro- tection for the PATIENT, the OPERATOR and surroundings.
21、NOTE -It is presumed that the party assembling or modifying the MEDICAL ELECTRICAL SYSTEMS will take the necessary steps to assure compliance with this Standard. 2 Terminology and definitions Where the terms “voltage” and “urrent are used, they mean the r.m.s. values of an alternating, direct or com
22、posite voltage or cur- rent. For the purpose of this Standard the following additional definitions apply: Scope a 2.201 COUPLING All functional connections between different items of equipment. 2.202 INDIRECT CONTACT Contact of persons or livestock with exposed conductive parts which have become liv
23、e under fault conditions (IEV 826-03-06). “2.203 MEDICAL ELECTRICAL SYSTEM (hereafter referred to as “SYSTEM”) Combination of either more than one item of MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRI- CAL EQUIPMENT and other non-medical electrical equipment having a specified func- tion and inter
24、-connected by: - COUPLING, and/or - a MULTIPLE PORTABLE SOCKET OUTLET. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 02:17:21 MDTNo reproduction or networking permitted without license fr
25、om IHS -,-,- 2 T 0601-1-1 : 1999 NOTE - The SYSTEM includes those accessories which are needed for operating the SYSTEM and are to be specified by the manufacturer. (See also examples given in Annexes BBB and FFF.) “2.204 PATIENT ENVIRONMENT Any volume in which intentional or unintentional contact b
26、etween PATIENT and parts of the SYSTEM or some other persons touching parts of the SYSTEM can occur (see Fig. 201). 2 . 2 0 5 SEPARATION DEVICE A component or arrangement of components with a SIGNAL INPUT PART and SIGNAL OUTPUT PART that prevents for safety reasons a transfer of unwanted voltage or
27、current between parts of a SYSTEM. “2.206 MULTIPLE PORTABLE SOCKET-OUTLET A combination of two or more socket- outlets intended to be connected to, or integral with, flexible cables or cords, and which can easily be moved from one place to another while connected to the supply. 3 General requirement
28、s 3 . 2 0 1 General requirements for the SYSTEM A SYSTEM after installation or sub- sequent modification shall not cause a SAFETY HAZARD for the PATIENT, the OPERATOR or surroundings. A SYSTEM as a whole shall provide: within the PATIENT ENVIRONMENT the same level of safety as MEDICAL ELECTRICAL EQU
29、IPMENT complying with JIS I 0601-1, IEC 60601-1, and relevant detail speci- fications, and outside the PATIENT ENVIRONMENT the level of safety appropriate for non-medical electrical equipment complying with other IEC or IS0 safety standards. . Non-medical electrical equipment outside the PATIENT ENV
30、IRONMENT may be such that it complies with the relevant JIS, technical standard stated in the Electrical Appliance and Material Control Law or it provides equivalent safety thereto. (Test) 3 . 2 0 1 . 2 and 3 . 2 0 1 . 3 are met. Compliance is considered to exist if the requirements of subclauses 3
31、. 2 0 1 . 1 , 3 . 2 0 1 . 1 MEDICAL ELECTRICAL EQUIPMENT shall comply with the general safety require- ments according to JIS T 0601-1, IEC 60601-1 and its relevant particular standards. The equipment may be the one which complies with JIS T 1001 JIS T 1002 and relevant detail specification. (Test)
32、? . . Compliance is checked by inspection of appropriate documents or certificates. “3.201.2 Non-medical electrical equipment shall comply with IEC and IS0 safety standards that are relevant for the equipment in question. See also Annex DDD: Bibliography. Equipment of class O shall not be used in a
33、SYSTEM. However equipment of class O or class 01 may be used, if the equipment is combined with means which ensure safety, for example, an isolating transformer (DOUBLE INSULATION or REINFORCED INSULATION). (Test) Compliance is checked by inspection of appropriate documents or certificates. Copyrigh
34、t Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 02:17:21 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 T 0601-1-1 : 1999 *3.201.3 the PATIENT that is inferior to the l
35、evel given in JIS T 0601-1. COUPLING of equipment in a SYSTEM shall not result in a safety level for 3.201.4 A SYSTEM using equipment, components or forms of construction different from those detailed in relevant standards as mentioned in subclauses 3.201.1 and 3.201.2 shall be accepted if it can be
36、 demonstrated that an equivalent degree of safety is obtained. 4 General requirements for tests “4.201 General requirements for tests for the SYSTEM After installation or sub- sequent modification the SYSTEM shall be in compliance with the requirements of this . Standard. (Test) Compliance is checke
37、d by inspection, by testing or by analysis, as specified in the relevant subclause. - Only hazards arising from the interconnection of different equipment to consti- tute a SYSTEM shall be considered. O - Safety tests, on individual equipment of the SYSTEM, already carried out to the relevant standa
38、rds used, shall not be repeated. - Tests shall be carried out: in NORMAL CONDITION unless otherwise specified in this Standard, and under operating conditions as specified by the manufacturer of the SYSTEM. 6 Identification, marking and documents 6.1.201 Marking Where in the ACCOMPANYING DOCUMENTS a
39、 warning is given re- lated to a particular SAFETY HAZARD from a non-medical electrical equipment, symbol 14, Table D1, Annex D of JIS T 0601-1 (see Fig. 202) shall be provided on that par- ticular non-medical electrical equipment or on a particular part of that equipment. NOTE - The party assemblin
40、g or modifying the SYSTEM should calculate the power consumption of the SYSTEM, make sure that this consumption is consistent with the power that the MULTIPLE PORTABLE SOCKET- OUTLET) can support and document it. (Test) Compliance is checked by inspection. “6.8.201 Accompanying documents A SYSTEM (i
41、ncluding a modified SYSTEM) shall be accompanied by documents containing all the data necessary for safe and reli- able use. NOTE -It is the responsibility of the assembler of a SYSTEM (including a modified SYSTEM), that it is accompanied by documents containing all the data necessary for safe and r
42、eliable use. These documents shall include: a) The ACCOMPANYING DOCUMENTS for each item of MEDICAL ELECTRICAL EQUIPMENT (see 6.8 of JIS T 0601-1). The accompanying documents for each item of non-medical electrical equipment. b) Copyright Japanese Standards Association Provided by IHS under license w
43、ith JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 02:17:21 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 T 0601-1-1 : 1999 c) The following information: instructions for cleaning and, where applicable, sterilizing and disinfecting ea
44、ch item of equipment forming part of the SYSTEM; additional safety measures which should be applied, during installation of the SYSTEM; which parts of the SYSTEM are suitable for use within the PATIENT ENVIRONMENT; additional measures which should be applied during preventive maintenance; a warning
45、that MULTIPLE PORTABLE SOCKET-OUTLETS shall not be placed on the floor; the maximum permitted load for any MULTIPLE PORTABLE SOCKET-OUTLET( S); an instruction that MULTIPLE PORTABLE SOCKET-OUTLETS provided with the SYSTEM shall only be used for powering equipment which forms part of the SYSTEM; an e
46、xplanation of the risks of connecting a non-medical electrical equipment, which has been supplied as a part of the SYSTEM, directly to the wall outlet when the SYSTEM is supplied via a MULTIPLE PORTABLE SOCKET-OUTLET with a separating transformer; an explanation of the risks of connecting electrical
47、 equipment which has not been supplied as a part of the SYSTEM, to the MULTIPLE PORTABLE SOCKET-OUT- LET. Compliance is checked by inspection. Section Two-Environmental conditions Section Three-Protection against electric shock hazards 16 ENCLOSURES and PROTECTIVE COVERS 16.201 ENCLOSURES Within the
48、 PATIENT ENVIRONMENT parts of non-medical elec- trical equipment which, after removal of covers, connectors, etc. without the use of a TOOL, may be contacted by the OPERATOR during routine maintenance, calibration, etc. shall operate at a voltage not exceeding 25 V a.c. or 60 V d.c. or peak value supplied from a source which is separated from the SUPPLY MAINS by one of the methods de- scribed in subclauses 17 g) l) to 5) of JIS T 0601-1. Additionally the instructions for use shall instruct the OPERATOR not to touch such a part and the PATIENT simultaneou