JIS T 0601-1:2017
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
01-03-2017
23-10-2025
Introduction1 Scope, object and related standards2 Normative references3 Terms and definitions4 General requirements5 General requirements for testing ME EQUIPMENT6 Classification of ME EQUIPMENT and ME SYSTEMS7 ME EQUIPMENT identification, marking and documents8 Protection against electrical HAZARDS from ME EQUIPMENT9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME SYSTEMS10 Protection against unwanted and excessive radiation HAZARDS11 Protection against excessive temperatures and other HAZARDS12 Accuracy of controls and instruments and protection against hazardous outputs13 HAZARDOUS SITUATIONS and fault conditions14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS15 Construction of ME EQUIPMENT16 ME SYSTEMS17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMSAnnex A (informative) - General guidance and rationaleAnnex B (informative) - Sequence of testingAnnex C (informative) - Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMSANNEX D (informative) - Symbols on markingAnnex E (informative) - Examples of the connection of the measuring device (MD) for measurement of the PATIENT LEKAGE CURRENT and PATIENT AUXILIARY CURRENTAnnex F (informative) - Suitable measuring supply circuitsAnnex G (normative) - Protection against HAZARDS of ignition of flammable anaesthetic mixturesAnnex H (informative) - PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentationAnnex I (informative) - ME SYSTEMS aspectsAnnex J (informative) - Survey of insulation pathsAnnex K (informative) - Simplified PATIENT LEAKAGE CURRENT diagramsAnnex L (normative) - Insulated winding wires for use without interleavedBibliographyAnnex JA (informative) - Index of defined terms Annex JB (informative) - Index of abbreviations and acronymsAnnex JC (informative) - Comparison table between JIS and corresponding International Standard
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS.
| DocumentType |
Standard
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| ProductNote |
Supersedes JIS T1001, JIS T1002, JIS T1005 and JIS T1309. (01/2007)
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| PublisherName |
Japanese Standards Association
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
2017 [01/03/2017]2012 AMD 1 2014 [01/03/2014]2012 [01/06/2012]1999(R2009) [25/04/2009]1999 ERRATA 2008 [01/08/2008]1999 [27/12/1999]
| JIS Z 4951:2017 | Medical electrical equipment -- Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| JIS Z 4751-2-54:2021 | Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| JIS Z 4751-2-45:2017 | Medical electrical equipment -- Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
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