Document Details |
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Name of Department/Committee : | MHD 02 | ||||
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Document Number : | MHD 02 ( 25876) | ||||
Document Title [English] : | Non-active surgical implants Joint replacement implants Specific requirements for hip-joint Replacement implants First Revision | ||||
Document Title [Hindi] : | गैर-सक्रिय सर्जिकल प्रत्यारोपण - संयुक्त प्रतिस्थापन प्रत्यारोपण - कूल्हे-संयुक्त 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Standards to be Superseded : |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 : | Specific requirements for hip-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 21535 : 2007 |
Organization Type: | ISO |
Sl.No. | Synosis Points | |
1 | This document specifies requirements for hip-joint replacement implants. With regard to 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 hip joint replacement implants. It applies to components made of metallic and non-metallic materials. | |
3 | This document applies to a wide variety of hip replacement implants, but for some specific hip 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 retesting 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 | ------- |