Document Details |
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| Name of Department/Committee : | MHD 07 | ||||
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| Document Number : | MHD 07 ( 27389) | ||||
| Document Title [English] : | Neurosurgical implants Sterile single-use hydrocephalus shunts First Revision | ||||
| Document Title [Hindi] : | न्यूरोसर्जिकल प्रत्यारोपण - बाँझ, एकल-उपयोग हाइड्रोसिफ़लस शंट | ||||
| Document Type : | Revision | ||||
| Language : | English | ||||
| Priority : | 2 | ||||
| ICS Code : | 11.040.40 | ||||
| Date of Project Approval : | 17-01-2025 | ||||
| Standards to be Revised : |
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| Standards to be Superseded : |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 : | Medium |
| 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 : | ISO 7197:2024 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies the performance requirements for sterile, single-use non-active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs. | |
| 2 | This document does not provide any recommendations on which type of valve is most suitable for any specific context of use. | |
| 3 | This document specifies the mechanical and technical requirements to manufacture shunts and the technical information of the valve to be supplied by the manufacturer. | |
| 4 | This document does not apply to active implants for the treatment of hydrocephalus. | |
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 | 17-01-2025 | ------- | ||
| 2 | P-Draft Waived | 17-01-2025 | ------- | ||
| 3 | WC Draft | 17-01-2025 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 19-01-2025 | WC approved by HOD |
MHDC MHD 07, | ------- |
| 5 | WC-Draft | 21-01-2025 | WC-Draft Email Notifications Sent | MHDC, MHD 7, | ------- |