Document Details |
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| Name of Department/Committee : | MHD 15 |
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| Document Number : | MHD 15 ( 25327) |
| Document Title [English] : | Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 83 Home light therapy equipment |
| Document Title [Hindi] : | चिकित्सा विद्युत उपकरण भाग 2 बुनियादी सुरक्षा और आवश्यक प्रदर्शन के लिए विशेष आवश्यकताएँ अनुभाग 83 आवासीय प्रकाश चिकित्सा उपकरण |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.60 |
| Date of Project Approval : | 19-04-2024 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Health care facilities |
| Sub Sub Group : | Therapeutic equipments |
| 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 60601-2-83: 2022 |
| Organization Type: | IEC |
| Sl.No. | Synosis Points | |
| 1 | HOME LIGHT THERAPY EQUIPMENT provides light therapy by means of eye-mediated photobiological effects (which can be visual or non-visual) and skin-mediated photobiological effects (non-visual only). Possible applications include pain relief, psoriasis treatment, and treatment of winter depression (seasonal affective disorder, SAD). | |
| 2 | This document is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR. | |
| 3 | The scope of this document includes all light sources except laser. | |
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 | 19-04-2024 | ------- | ||
| 2 | P-Draft Waived | 19-04-2024 | IEC Adoption | ------- | |
| 3 | WC Draft | 19-04-2024 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 19-04-2024 | WC approved by HOD |
MHDC | ------- |