Document Details |
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| Name of Department/Committee : | MHD 12 |
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| Document Number : | MHD 12 ( 23655) |
| Document Title [English] : | Plastic Containers for Intravenous Injections |
| Document Title [Hindi] : | इंट्रावेनस इंजेक्शन के लिए प्लास्टिक कंटेनर |
| Document Type : | New |
| Language : | English |
| Priority : | 2 |
| ICS Code : | 11.040.20 |
| Date of Project Approval : | 25-09-2023 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Health care facilities |
| Sub Sub Group : | Surgical dressings and Disposable products |
| 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 15747:2018 |
| Organization Type: | ISO |
::Cross Referenced Indian Standard:: |
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| Sl. No. | Is No & Year | IS Title | |
| 1 | IS 2102 : Part 1: 1993 | General tolerances: Part 1 tolerances for linear and angular dimensions without individual tolerance indications (Third Revision) | |
| 2 | IS 17894 : 2022 | Geometrical product specifications GPS - Geometrical tolerancing - General geometrical specifications and general size specifications | |
| 3 | IS/ISO 8536 : Part 4: 2019 | Infusion equipment for medical use Part 4: Infusion sets for single use gravity feed | |
| 4 | IS 17932 : Part 1: 2023 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | |
| 5 | IS/ISO 10993 : Part 5: 2009 | Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity | |
| Sl.No. | Synosis Points | |
| 1 | This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. | |
| 2 | This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. | |
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 | 25-09-2023 | ------- | ||
| 2 | P-Draft Waived | 25-09-2023 | ------- | ||
| 3 | WC Draft | 25-09-2023 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 25-09-2023 | WC approved by HOD |
MHDC MHD 12, | ------- |
| 5 | WC-Draft | 03-10-2023 | WC-Draft Email Notifications Sent | MHDC, MHD 12, | ------- |
| 6 | WC-Draft | 03-10-2023 | WC-Draft Email Notifications Sent | MHDC, MHD 12, | ------- |
| 7 | Skipped to Finalization | 18-04-2024 | Stage-Changed | ------- | |
| 8 | Finalization | 18-04-2024 | ------ | ------- | |
| 9 | Final Draft | 18-04-2024 | Submited for HOD approval |
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| 10 | Final Draft draft accepted by HOD and sent to Publication | 19-04-2024 | Final Draft approved by HOD | ------- | |
| 11 | Accepted by Publication | 22-04-2024 | Final Draft accepted by Publication Remarks: Accepted by Publication |
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