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1、JIS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS T 0601-2-205:2005 (JIPU JSA) Medical electrical equipment - Particular requirements for the safety of medical practice massager ICs 11.040.60;97. 170 Reference number : JIS T 0601-2-205 : 2005 (E) PROTECT
2、EDBYCOPYRIGHT 6 s Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 07:51:30 MDTNo reproduction or networking permitted without license from IHS -,-,- T 0601-2-205 : 2005 Foreword This transl
3、ation has been made based on the original Japanese Industrial Standard established by the Minister of Health, Labour and Welfare and the Minister of Economy, Trade and Industry through deliberations at the Japanese Industrial Standards Committee according to the proposal of establishing a Japanese I
4、ndustrial Standard from Japan Industries Association of Physical Therapy Device (JIPT)/Japanese Standards Association (JSA), with a draft of Industrial Standard based on the provision of Article 12 Clause 1 of the Industrial Standardization Law. Attention is drawn to the possibility that some parts
5、of this Standard may conflict with a patent right, application for a patent after opening to the public, utility model right or application for registration of utility model after opening to the public which have technical properties. The relevant Ministers and the Japanese Industrial Standards Comm
6、ittee are not responsible for identi&ing the patent right, application for a patent after opening to the public, utility model right or application for registration of utility model after opening to the public which have the said technical properties. Date of Establishment: 2005-03-25 Date of Public
7、 Notice in Official Gazette: 2005-03-25 Investigated by: Japanese Industrial Standards Committee Standards Board Technical Committee on Medical Equipment JIS T 0601-2-205 : 2005, First English edition published in 2005-10 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, M
8、inato-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. C JSA2005 All rights reserved. Uiiless otl-ierwise specified, no part of this publication may be reproduced or utilized in any forin or by any means, electronic or me
9、chanical, including photocopying and microfilm, without permission in writing from the publisher. Printed in Japan MT PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007
10、07:51:30 MDTNo reproduction or networking permitted without license from IHS -,-,- T 0601-2-205 2005 Contents Page Introduction . 1 Section 1 General 1 1 Scope and object . 1 1.1 Scope 1 1.2 Object . 2 1.3 Particular standards 2 1.5 Collateral standards 2 2 Definitions . 2 2.1 Equipment parts, auxil
11、iaries and accessories . 2 6 Identification, marking and documents . 2 7 Power input . 3 Section 2 Environmental conditions 3 Section 3 Protection against electric shock hazards 3 Section 4 22 Moving parts 3 22.101 Safety of massage mechanical section . 3 Section 5 Protection against hazards from un
12、wanted or excessive radiation . 3 36 Electromagnetic compatibility,.,. . 4 Section 6 Protection against mechanical hazards . 3 Protection against hazards of ignition of flammable anesthetic mixtures 4 Section 7 Protection against excessive temperatures and other safety hazards . 4 Section 8 Accuracy
13、 of operating data and protection against hazardous output . 4 Protection against hazardous output . 4 51 51.101 Limitation of massaging force, etc 4 51.102 Timer . 4 Section 9 Abnormal operation and fault conditions : environmental tests . 4 Section 10 Constructional requirements . 5 (i) PROTECTEDB
14、YCOPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 07:51:30 MDTNo reproduction or networking permitted without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS T 0601-2-205 :
15、 2005 Medical electrical equipment - Particular requirements for the safety of medical practice massager Introduction This Japanese Industrial Standard shall be read along with the general standard JIS T 0601- 1 Medical electrical equipment-Part I : General requirements for safety because this Stand
16、ard is composed by referring to JIS T 0601-1. The numbering of sections, clauses and subclauses of this Standard corresponds with that of JIS T 0601-1. The changes to the text of JIS T 0601-1 are specified by the use of the following words: “Replacement” means that the clause or subclause of JIS T 0
17、601-1 is replaced completely by the text of this Standard. “Addition” means that the text of this Standard is additional to the requirements of JIS T 0601-1. “Amendment” means that the clause or subclause of JIS T 0601-1 is amended as indicated by the text of this Standard. Subclauses or figures whi
18、ch are additional to those of JIS T 0601-1 are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Terms defined in clause 2 of this Standard or of JIS T 0601-1 are boldfaced. Section 1 General Section 1 of JIS T 0601-1 is applied here with t
19、he following changes. 1 Scope and object 1.1 Scope Addition This Standard specifies requirements for the safety of beachair electrical massager used by practitioners for physical therapy, which are defined in 2.1.10. This Standard does not apply to: - home massager (see JIS T 2002), intermittent pne
20、umatic massager, sequential pneumatic massager, pressurized pneumatic massager, - pneumatic massager with vibro-head, - massager for physical therapy, - electric massager with vibro-head. PROTECTEDBYCOPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS
21、 Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 07:51:30 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 T 0601-2-205 2005 1.2 Object Replacement The object of this Standard is to speci& particular requirements for the safety of bedchair electrical mas
22、sager for practitioners for physical therapy, which are defined in 2.1.101. 1.3 Particular standards Addition The requirements of this Standard take priority over those of JIS T 0601-1 and collateral standards mentioned below. 1.5 Collateral standards Addition The following collateral standards appl
23、y: JIS T 0601- 1- 1 Medical electrical equipment-Part i: General requirements for safety-I. Collateral standard: Safety requirements for medical electrical systems Medical electrical equipment-Part i: General requirements for safety-2. Collateral standard: Electromagnetic compatibility-Requirements
24、and Tests JIS T 0601- 1-2 2 Definitions 2.1 Equipment parts, auxiliaries and accessories Addition 2.1.101 bed/chair electrical massager (hereafter referred to as ?equipment?) equipment, which is either bed-type or chair-type, capable of massaging patients by giving them physical force This equipment
25、 consists of mechanical (also referred to as ?electric?) massagers which massage by giving patients mechanical force with motors, etc., and hydraulic massagers which massage by giving patients spouting pressure by water pumps, etc. through waterproof sheets. 6 Identification, marking and documents 6
26、.8.2 Instructions for use Additional terms aa) The following matters shall be added in the instructions for use. i) Cautions to users which are required for regular maintenance. Especially, Prior-to-use check of breaks, blemishes and deformation of sheets, pads and such touched by patients, Necessit
27、y of cleaning sheets, pads and such touched by patients before and after use, and cautions about disinfections, if necessary. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/
28、11/2007 07:51:30 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 T 0601-2-205 : 2005 2) Warnings to the following potential hazards: - Prohibition of using equipment for patients with severe osteoporosis, Prohibition of using equipment for patients with potential clinical
29、 deterioration through physical pressure or vibration caused by massages, Operation in proximity of equipment which emit powerful electromagnetic wave such as short wave therapy equipment, microwave therapy equipment and electric cauterizes, equipment which emit powerful magnetic field lines, and eq
30、uipment which emit X radiation (e.g. the distance of 1 m) causes unstable behavior of equipment. 3) The following in-use prohibition - Prohibition of patients getting on and off, and moving patients position on equipment, during operation. 7 Power input Addition 7.1.101 Equipment shall have rated in
31、put exceeding 300 VA. Section 2 Environmental conditions Section 2 of JIS T 0601-1 is applied here. Section 3 Section 3 of JIS T 0601-1 is applied here. Protection against electric shock hazards Section 4 Protection against mechanical hazards Section 4 of JIS T 0601-1 is applied here with the follow
32、ing changes. 22 Moving parts 22.101 Safety of massage mechanical section Equipment with massage mechanical section (massage function) which sandwiches patients bodies for massaging, shall not pinch the specimen with the massage section locked when the specimen is pressed against the massage section
33、under the following conditions. For massage of necks, circular cylinders 100 mm in diameter shall be used as specimen, and the curved surface of cylinders shall be pressed against the massage mechanical section with 100 N force in a direction where pinching is most likely to occur. - For massage of
34、legs, circular cylinders 45 mm in diameter shall be used as specimen, and the curved surface of cylinders shall be pressed against the massage section with 100 N force in a direction where pinching is most likely to occur. Remarks : Specimen shall be made of materials (such as metal) which do not ge
35、nerate deformation upon pinching. Moreover? the length of specimen shall be sufficient long so that the mechanical section can move around. PROTECTEDBYCOPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for
36、 Resale, 03/11/2007 07:51:30 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 T 0601-2-205 2005 (Testing) Compliance is checked by testing. Section 5 Protection against hazards from unwanted or excessive radiation Section 5 of JIS T 0601-1 is applied here with the followin
37、g changes. 36 Electromagnetic compatibility Replacement Equipment shall comply with JIS T 0601-1-2. Section 6 Protection against hazards of ignition of flammable anesthetic mixtures Section 6 of JIS T 0601-1 is applied here. Section 7 Protection against excessive temperatures and other safety hazard
38、s Section 7 of JIS T 0601-1 is applied here. Section 8 Accuracy of operating data and protection against hazardous output Section 8 of JIS T 0601-1 is applied here with the following changes. 51 Protection against hazardous output Addition 51.101 Limitation of massaging force, etc. Massaging force,
39、etc. shall be limited as follows: - Maximum pressure of water pump discharging parts of hydraulic equipment shall not exceed i80 kPa. Maximum lifting distance of mechanical sections of mechanical equipments (such as rollers) which lift and massage patients bodies shall not exceed 270 mm on the point
40、 at which the mechanical section start to touch patients bodies (the point at which pressure for bodies starts to increase) when patients weighing 135 kg (normal load) are massaged by the method specified by accompanying documents, When manufacturers speci& maximum allowable weight of patients, test
41、ing shall be performed based on the specified weight. Maximum vibrational frequency of mechanical sections (such as vibrators) of mechanical equipments which give vibration and massage patients bodies shall not exceed 60 Hz. - - (Testing) Compliance is checked by measurement. 51.102 Timer Equipment
42、shall be provided with timers which turn off massaging. Maximum settable time of timers shall be 30 min or over up to and including 100 min, Error shall be f 5 % of maximum settable time in each setup time. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license
43、 with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 07:51:30 MDTNo reproduction or networking permitted without license from IHS -,-,- 5. T 0601-2-205 : 2005 (Testing) Compliance is checked by measuring operation time. Section 9 Abnormal operation and fault condi
44、tions : environmental tests Section 9 of JIS T 0601-1 is applied here. Section 1 O Constructional requirements Section 10 of JIS T 0601-1 is applied here. Annex Annexes C, D, E, F, G, K and L of JIS T 0601-1 are applied here(Annexes A and B of JIS T 0601-1 are referred as informative). PROTECTEDBYCO
45、PYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 07:51:30 MDTNo reproduction or networking permitted without license from IHS -,-,- Errata for JIS (English edition) aie printed in St
46、aiidardizatiuii JuuriiaL published monthly by the Japanese Standards Association, and also provided to subscribers of JIS (English edition) in Monthly hiformation. Errata will be provided upon request, please contact: Standardization Promotion Department, Japanese Standards Association 4-1-24, Akasa
47、ka, Minato-ku, Tokyo, 107-8440 JAPAN TEL. 03-3583-8002 FAX. 03-3583-0462 PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 07:51:30 MDTNo reproduction or networking permitted without license from IHS -,-,-