Document Details |
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| Name of Department/Committee : | MHD 02 |
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| Document Number : | MHD 02 ( 25919) |
| Document Title [English] : | Instruments for Use in Association with Non-Active Surgical Implants General Requirements |
| Document Title [Hindi] : | गैर-सक्रिय सर्जिकल प्रत्यारोपण के साथ उपयोग के लिए उपकरण - सामान्य आवश्यकताएँ |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.40, 11.040.99 |
| Date of Project Approval : | 18-12-2023 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Implants |
| Sub Sub Group : | Orthopaedic Implants |
| Aspects : | Others |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | Instruments for Use in Association with Non-Active Surgical 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 16061: 2021 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment. | |
| 2 | This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves. | |
| 3 | With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer. | |
| 4 | This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. | |
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 | 21-06-2024 | ------- | ||
| 3 | WC Draft | 21-06-2024 | Duration : 30 Days Submitted for HOD approval Remarks : Submitted for kind consideration |
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| 4 | WC Draft | 22-06-2024 | WC approved by HOD |
MHDC | ------- |