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 | ||||
| Document Title [Hindi] : | प्रीफिल सिरिंज भाग 4 भरने के लिए तैयार इंजेक्टिबल और विसंक्रमित सबअसेंबल्ड सिरिंज के लिए ग्लास बैरल | ||||
| Document Type : | New | ||||
| Language : | English | ||||
| Priority : | 3 | ||||
| ICS Code : | 11.040.25 | ||||
| Date of Project Approval : | 03-12-2024 | ||||
| Standards to be Superseded : |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 |
| 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 11040-4:2024 |
| Organization Type: | ISO |
::Cross Referenced Indian Standard:: |
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| Sl. No. | Is No & Year | IS Title | |
| 1 | IS 2303 : Part 1 : Sec 2: 2021 | GRADING GLASS FOR ALKALINITY PART 1 HYDROLYTIC RESISTANCE OF GLASS GRAINS SECTION 2 DETERMINATION AND CLASSIFICATION OF HYDROLYTIC RESISTANCE AT 121C | |
| 2 | IS 10654: 2018 | Sterile hypodermic needles for single use - Requirements and test methods (Fourth Revision) | |
| 3 | IS 18866 : 2024 | Stainless Steel Needle Tubing for the Manufacture of Medical Devices � Requirements and Test Methods | |
| 4 | IS 17932 : Part 1: 2023 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) | |
| 5 | IS 17932 : Part 5: 2024 | Biological Evaluation of Medical Devices Part 5 Ethylene oxide sterilization residuals | |
| 6 | IS/ISO 11040 : Part 5: 2012 | Prefilled syringes Part 5 Plunger stoppers for injectables | |
| 7 | IS/ISO 80369 : Part 1: 2018 | Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements | |
| Sl. No. | Document No | Document Title | |
| 1 | MHD/12 / 25955 | Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications | |
::Cross Referenced International Standard(s) & Standard(s) Of National SDO(s) :: |
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| Sl. No. | Prefix | Number | Part | Section | Year | |
| 1 | ISO | 4802 | 1 | - | - | |
| 2 | ISO | 4802 | 2 | - | - | |
| 3 | ISO | 8871 | 1 | - | - | |
| 4 | ISO | 80369 | 20 | - | - | |
| 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 | ------- |
| 5 | Skipped to Finalization | 09-04-2025 | Stage-Changed | ------- | |
| 6 | Finalization | 09-04-2025 | ------ | ------- | |
| 7 | Final Draft | 09-04-2025 | Submited for HOD approval |
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| 8 | Final Draft draft accepted by HOD and sent to Publication | 11-04-2025 | Final Draft approved by HOD | ------- | |
| 9 | Final Draft draft accepted by HOD and sent to Publication | 11-04-2025 | Final Draft approved by HOD | ------- | |
| 10 | Final Draft draft accepted by HOD and sent to Publication | 11-04-2025 | Final Draft approved by HOD | ------- | |
| 11 | Accepted by Publication | 16-04-2025 | Final Draft accepted by Publication Remarks: Accepted by Publication |
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| 12 | Skipped to Pdf Stage | 16-04-2025 | Proof to Technial Department Stage-Skipped | ------- | |
| 13 | Pdf sent by Publication to Technical Department | 16-04-2025 | It should be single numbering not dual numbering on portal, please check and confirm. As other part was published as single numbering. Also check other comments and reply to proceed for the PDF. | ------- | |