Document Details |
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| Name of Department/Committee : | MHD 02 |
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| Document Number : | MHD 02 ( 28422) |
| Document Title [English] : | Non-active Surgical Implants Implants for Osteosynthesis Particular Requirements |
| Document Title [Hindi] : | गैर-सक्रिय सर्जिकल प्रत्यारोपण — अस्थिसंश्लेषण के लिए प्रत्यारोपण — विशेष आवश्यकताएं |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.40 |
| Date of Project Approval : | 25-07-2025 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Implants |
| Sub Sub Group : | Orthopaedic Implants |
| Aspects : | Others |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | Implants for Osteosynthesis — Particular Requirements |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 14602:2010 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies particular requirements for non-active surgical implants for osteosynthesis. | |
| 2 | This document also gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. | |
Timeline Details |
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