Document Details |
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| Name of Department/Committee : | MHD 02 |
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| Document Number : | MHD 02 ( 28483) |
| Document Title [English] : | Implants for Surgery Wear of Total Intervertebral Spinal Disc Prostheses Part 2 Nucleus Replacements |
| Document Title [Hindi] : | सर्जरी के लिए प्रत्यारोपण — कुल इंटरवर्टेब्रल स्पाइनल डिस्क प्रोस्थेसिस का पहनना भाग 2 नाभिक प्रतिस्थापन |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.40 |
| Date of Project Approval : | 05-08-2025 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Implants |
| Sub Sub Group : | Orthopaedic Implants |
| Aspects : | Methods of tests |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | Wear of Total Intervertebral Spinal Disc Prostheses |
| 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 18192-2:2010 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document defines a test procedure for spinal nucleus prostheses under the relative angular movement conditions specified by ISO 18192-1. | |
| 2 | This document is applicable to both lumbar and cervical prostheses. It is not applicable to total disc replacements and facet joint replacements. The method includes wear and fatigue testing. Additional mechanical tests such as creep tests can be required. | |
| 3 | This document does not reproduce the complex in vivo loads and motions. The wear and fatigue data obtained with this test method will enable comparison between different types of implant but can differ from the clinical wear performance. | |
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