Document Details |
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| Name of Department/Committee : | MHD 02 |
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| Document Number : | MHD 02 ( 28424) |
| Document Title [English] : | Implants for Surgery Measurements of Open-circuit Potential to Assess Corrosion Behaviour of Metallic Implantable Materials and Medical Devices Over Extended Time Periods |
| Document Title [Hindi] : | सर्जरी के लिए प्रत्यारोपण — विस्तारित समय अवधि में धातु प्रत्यारोपण योग्य सामग्रियों और चिकित्सा उपकरणों के संक्षारण व्यवहार का आकलन करने के लिए ओपन-सर्किट क्षमता का मापन |
| 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| Standards to be Superseded : | |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 : | Measurements of Open-circuit Potential to Assess Corrosion Behaviour of Metallic Implantable Materia |
| 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 16429:2004 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This standard specifies a test method for measurements over extended time periods of the open-circuit potential of implant materials and surgically implantable devices immersed in a test environment related to body fluid, using a standard corrosion test cell to study the electrochemical corrosion properties of the devices. | |
| 2 | This method of monitoring the open-circuit potential can also be combined with mechanical static or dynamic loading tests. | |
| 3 | This standard is applicable in particular to metallic materials which form passive layers with protective properties against corrosion, as typical for surgical implant materials. | |
| 4 | This test method is intended for the investigation of single metallic materials or alloys. It is not applicable to dissimilar material combinations, which require particular considerations in measuring and interpreting the results. | |
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