Document Details |
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| Name of Department/Committee : | MHD 12 | ||||
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| Document Number : | MHD 12 ( 27038) | ||||
| Document Title [English] : | Prefilled Syringes Part 4 Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling (First Revision) | ||||
| Document Title [Hindi] : | प्रीफिल सिरिंज भाग 4 भरने के लिए तैयार इंजेक्टिबल और विसंक्रमित सबअसेंबल्ड सिरिंज के लिए ग्लास बैरल (पहला पुनरीक्षण) | ||||
| Document Type : | Revision | ||||
| Language : | English | ||||
| Priority : | 3 | ||||
| ICS Code : | 11.040.25 | ||||
| Date of Project Approval : | 03-12-2024 | ||||
| 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| Standards to be Superseded : |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 : | Medical and Hospital Equipments |
| Sub Sub Group : | Allied hospital equipment |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
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| 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 11040-4:2024 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods. This document also specifies components that are part of the sterilized subassembled syringe ready for filling. | |
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 | 03-12-2024 | ------- | ||
| 2 | P-Draft Waived | 03-12-2024 | ISO Adoption | ------- | |
| 3 | WC Draft | 03-12-2024 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 05-12-2024 | WC approved by HOD |
MHDC | ------- |