Document Details |
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| Name of Department/Committee : | MHD 07 | ||||
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| Document Number : | MHD 07 ( 25977) | ||||
| Document Title [English] : | Neurosurgical Implants Self Closing Intracranial Aneurysm Clips | ||||
| Document Title [Hindi] : | न्यूरोसर्जिकल अन्त्यरोपन - स्व-समापन इंट्राक्रैनियल एन्यूरिज्म क्लिप | ||||
| Document Type : | New | ||||
| Language : | English | ||||
| Priority : | 2 | ||||
| ICS Code : | 11.040.30 | ||||
| Date of Project Approval : | 24-06-2024 | ||||
| Standards to be Superseded : |
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Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Implants |
| Sub Sub Group : | Neurosurgery instruments and implants |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : | |
| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | 9713:2022 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, and sterilization for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force. | |
| 2 | This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips). | |
| 3 | NOTE In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips. | |
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 | 24-06-2024 | ------- | ||
| 2 | P-Draft Waived | 24-06-2024 | ------- | ||
| 3 | WC Draft | 24-06-2024 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 24-06-2024 | WC approved by HOD |
MHDC | ------- |
| 5 | WC Draft | 24-06-2024 | WC approved by HOD |
MHDC | ------- |
| 6 | WC-Draft | 25-06-2024 | WC-Draft Email Notifications Sent | MHDC, MHD 7, | ------- |