Document Details |
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| Name of Department/Committee : | MHD 02 | ||||
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| Document Number : | MHD 02 ( 25875) | ||||
| Document Title [English] : | Non-Active Surgical Implants Joint Replacement Implants Specific Requirements for Knee-Joint Replacement Implants First Revision | ||||
| Document Title [Hindi] : | गैर-सक्रिय सर्जिकल प्रत्यारोपण - संयुक्त प्रतिस्थापन प्रत्यारोपण - घुटने के जोड़ प्रतिस्थापन प्रत्यारोपण के लिए विशिष्ट आवश्यकताएं (पहला पुनरीक्षण) | ||||
| Document Type : | Revision | ||||
| Language : | English | ||||
| Priority : | 3 | ||||
| ICS Code : | 11.040.10 | ||||
| Date of Project Approval : | 18-12-2023 | ||||
| Standards to be Revised : |
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| Standards to be Superseded : | |||||
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Implants |
| Sub Sub Group : | Orthopaedic Implants |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | Requirements for Knee-Joint Replacement Implants |
| 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 21536 : 2023 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies requirements for knee-joint replacement implants. Regarding safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test. | |
| 2 | This document applies to both total and partial knee joint replacement implants. It applies to these replacements both with and without the replacement of the patella-femoral joint. It applies to components made of metallic and non-metallic materials. | |
| 3 | This document applies to a wide variety of knee replacement implants, but for some specific knee replacement implant types, some considerations, not specifically covered in this document, can be applicable. | |
| 4 | The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use. | |
Timeline Details |
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Stages |
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| Sl. No. |
Stage | Date of Occurence | Remarks | Circulated to | Files |
| 1 | Generation of Document Number | 18-12-2023 | ------- | ||
| 2 | P-Draft Waived | 18-06-2024 | ------- | ||
| 3 | WC Draft | 18-06-2024 | Duration : 30 Days Submitted for HOD approval Remarks : Submitted for kind consideration |
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| 4 | WC Draft | 18-06-2024 | WC approved by HOD |
MHDC MHD 02, | ------- |