Document Details |
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Name of Department/Committee : | MHD 15 |
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Document Number : | MHD 15 ( 25315) |
Document Title [English] : | Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 75 Photodynamic therapy and photodynamic diagnosis equipment |
Document Title [Hindi] : | चिकित्सा विद्युत उपकरण भाग 2 बुनियादी सुरक्षा और आवश्यक प्रदर्शन के लिए विशेष आवश्यकताएँ अनुभाग 75 फोटोडायनामिक थेरेपी और फोटोडायनामिक निदान उपकरण की बुनियादी सुरक्षा और आवश्यक प्रदर्शन के लिए विशेष आवश्यकताएं |
Document Type : | New |
Language : | English |
Priority : | 3 |
ICS Code : | 11.040.01 |
Date of Project Approval : | 18-04-2024 |
Standards to be Superseded : |
Classification Details |
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Group : | Medical and Hospital Equipments |
Sub Group : | Diagnostic Instruments |
Sub Sub Group : | Equipment/Instruments used for diagnostic and clinical purpose |
Aspects : | Product Specification |
Risk : | Medium |
Certification : | Voluntary Certification |
Short Commom Man's Title : | |
ITCHS Code : | |
Ministry : |
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Sustainable development Goals : | |
Degree of Equivalence : | Modified/Technically Equivalent |
Identical/Equivalent Standards : | IEC 60601-2-75: 2023 |
Organization Type: | IEC |
Sl.No. | Synosis Points | |
1 | This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT. | |
2 | It includes PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT used for compensation or alleviation of disease, injury or disability. | |
3 | This particular standard does not apply to: • Light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia; • Low-level laser therapy equipment not intended for use with a PHOTOSENSITIZER; • Illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a PHOTOSENSITIZER. |
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 | 18-04-2024 | ------- | ||
2 | P-Draft Waived | 18-04-2024 | IEC Adoption | ------- | |
3 | WC Draft | 18-04-2024 | Duration : 30 Days Submitted for HOD approval |
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4 | WC Draft | 19-04-2024 | WC approved by HOD |
MHDC MHD 15, | ------- |
5 | Skipped to Finalization | 08-07-2024 | Stage-Changed | ------- | |
6 | Finalization | 08-07-2024 | Approved for finalization in the 13th meeting | ------- |