Document Details |
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| Name of Department/Committee : | MHD 12 |
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| Document Number : | MHD 12 ( 25424) |
| Document Title [English] : | Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles |
| Document Title [Hindi] : | चिकित्सीय उपयोग के लिए इन्फ्यूजन उपकरण भाग 6 इन्फ्यूजन बोतलों के लिए फ़्रीज़ ड्राइंग क्लोजर |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.20 |
| Date of Project Approval : | 25-04-2024 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Medical and Hospital Equipments |
| Sub Sub Group : | Allied hospital equipment |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| 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 8536-6:2016 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in Part 1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials. | |
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 | 25-04-2024 | ------- | ||
| 2 | P-Draft Waived | 28-04-2024 | ISO Adoption | ------- | |
| 3 | WC Draft | 07-05-2024 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 07-05-2024 | WC approved by HOD |
MHDC | ------- |