Document Details |
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| Name of Department/Committee : | MHD 02 |
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| Document Number : | MHD 02 ( 28482) |
| Document Title [English] : | Implants for Surgery Wear of Total Intervertebral Spinal Disc Prostheses Part 1 Loading and Displacement Parameters for Wear Testing and Corresponding Environmental Conditions for Test |
| Document Title [Hindi] : | सर्जरी के लिए प्रत्यारोपण — कुल इंटरवर्टेब्रल स्पाइनल डिस्क प्रोस्थेसिस का पहनना भाग 1 पहनने के परीक्षण के लिए लोडिंग और विस्थापन पैरामीटर और परीक्षण के लिए संबंधित पर्यावरणीय स्थितियां |
| 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| Standards to be Superseded : | |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 : | Loading and Displacement Parameters for Wear Testing and Corresponding Environmental Conditions for |
| 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 18192-1:2011 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This part standard defines a test procedure for the relative angular movement between articulating components, and specifies the pattern of the applied force, speed and duration of testing, sample configuration and test environment for use for the wear testing of total intervertebral spinal disc prostheses. | |
| 2 | Both lumbar and cervical prostheses are addressed. This standard does not apply to partial disc replacements, such as nucleus replacements or facet joint replacements. The test method focuses on wear testing. Additional mechanical tests, such as fatigue testing, can be required. | |
| 3 | This standard does not reproduce the complex in vivo loads and motions. The wear data obtained with this test method enables comparison between different types of implants, but can differ from the clinical wear performance. The user of this standard can consider running additional wear tests addressing specific safety issues of the individual implant design under test. | |
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