Document Details |
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| Name of Department/Committee : | MHD 15 | ||||
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| Document Number : | MHD 15 ( 24688) | ||||
| Document Title [English] : | Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 33 Magnetic resonance equipment for medical diagnosis IEC 60601-2-33: 2022 MOD First Revision | ||||
| Document Title [Hindi] : | चिकित्सा विद्युत् उपकरण भाग 2 बुनियादी सुरक्षा और आवश्यक प्रदर्शन के लिए विशेष आवश्यकताएं अनुभाग 33 चिकित्सा निदान के लिए चुंबकीय अनुनाद उपकरण (IEC 60601-2-33: 2022, संशोधित) (पहला पुनरीक्षण) | ||||
| Document Type : | Revision | ||||
| Language : | English | ||||
| Priority : | 3 | ||||
| ICS Code : | 11.040.55 | ||||
| Date of Project Approval : | 18-01-2024 | ||||
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| Standards to be Superseded : |
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Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Diagnostic Instruments |
| Sub Sub Group : | Imaging and Radiotherapy equipment |
| Aspects : | Product Specification |
| Risk : | High |
| Certification : | Voluntary Certification |
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| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : | |
| Degree of Equivalence : | Modified/Technically Equivalent |
| Identical/Equivalent Standards : | IEC 60601-2-33: 2022 |
| Organization Type: | IEC |
| Sl.No. | Synosis Points | |
| 1 | This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS. | |
| 2 | If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MR EQUIPMENT and to MR SYSTEMS, as relevant. | |
| 3 | This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS. | |
Timeline Details |
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Stages |
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| Sl. No. |
Stage | Date of Occurence | Remarks | Circulated to | Files |
| 1 | Generation of Document Number | 18-01-2024 | ------- | ||
| 2 | P-Draft Waived | 18-01-2024 | IEC Adoption | ------- | |
| 3 | WC Draft | 18-01-2024 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 19-01-2024 | WC rejected by HOD Remarks: reject |
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| 5 | WC Draft | 24-01-2024 | Duration : 30 Days Submitted for HOD approval |
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| 6 | WC Draft | 24-01-2024 | WC approved by HOD |
MHDC MHD 15, | ------- |