Document Details |
|
| Name of Department/Committee : | MHD 15 |
|---|---|
| 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| Standards to be Superseded : | |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 |
|
| 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 : |
|
| 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 |
|||||||
|
|
|||||||
|
|||||||
|
|||||||
Stages |
|||||
| 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 |
------- | |
| 4 | WC Draft | 19-04-2024 | WC approved by HOD |
MHDC MHD 15, | ------- |