Document Details |
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| Name of Department/Committee : | MHD 02 |
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| Document Number : | MHD 02 ( 28423) |
| Document Title [English] : | Implants for Surgery Test Solutions and Environmental Conditions for Static and Dynamic Corrosion Tests on Implantable Materials and Medical Devices |
| Document Title [Hindi] : | सर्जरी के लिए प्रत्यारोपण — प्रत्यारोपण योग्य सामग्रियों और चिकित्सा उपकरणों पर स्थैतिक और गतिशील संक्षारण परीक्षणों के लिए परीक्षण समाधान और पर्यावरणीय स्थितियाँ |
| 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| Standards to be Superseded : | |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 : | Methods of tests |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | Test Solutions and Environmental Conditions for Static and Dynamic Corrosion Tests on Implantable Ma |
| 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 16428:2005 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This standard specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The test conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution. | |
| 2 | These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered. Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests. | |
| 3 | Typical articulating joint simulator tests and aspects particular to the dental field are not considered by this International Standard. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of this International Standard. | |
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