Document Details |
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| Name of Department/Committee : | MHD 02 | ||||
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| Document Number : | MHD 02 ( 28550) | ||||
| Document Title [English] : | Non-Active Surgical Implants General Requirements | ||||
| Document Title [Hindi] : | गैर-सक्रिय सर्जिकल प्रत्यारोपण — सामान्य आवश्यकताएँ | ||||
| Document Type : | New | ||||
| Language : | English | ||||
| Priority : | 3 | ||||
| ICS Code : | 11.040.40 | ||||
| Date of Project Approval : | 19-08-2025 | ||||
| Standards to be Superseded : |
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Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Implants |
| Sub Sub Group : | Orthopaedic Implants |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | Non-Active Surgical Implants — General Requirements |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Modified/Technically Equivalent |
| Identical/Equivalent Standards : | ISO 14630 : 2024 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies general requirements for non-active surgical implants. It does not apply to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue. | |
| 2 | This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements | |
Timeline Details |
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