Document Details |
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| Name of Department/Committee : | MHD 12 |
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| Document Number : | MHD 12 ( 20820) |
| Document Title [English] : | Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps |
| Document Title [Hindi] : | एक बार प्रयोग में आने वाले जीवाणु रहित हाइपोडर्मिक सिरिंज भाग 2 बिजली से चलने वाले सिरिंज पंपों के साथ प्रयोग के लिए सिरिंज |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.25 |
| Date of Project Approval : | 21-06-2022 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Surgical instruments and accessories |
| Sub Sub Group : | Transfusion, infusion, injection equipment and Catheters |
| 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 7886-2:2020 |
| Organization Type: | ISO |
::Cross Referenced Indian Standard:: |
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| Sl. No. | Is No & Year | IS Title | |
| 1 | IS 1070: 2023 | Reagent Grade Water Specification (Fourth Revision) | |
| 2 | IS 10258 : Part 1: 2022 | Sterile hypodermic syringes for single use Part 1: Syringes for manual use Third Revision | |
| 3 | IS/ISO 80369 : Part 7: 2016 | Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications | |
| Sl.No. | Synosis Points | |
| 1 | This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps. This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3] ), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids | |
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 | 21-06-2022 | ------- | ||
| 2 | P-Draft Waived | 17-10-2022 | ------- | ||
| 3 | WC Draft | 17-10-2022 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 25-11-2022 | WC rejected by HOD Remarks: Please see remarks for internal use |
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| 5 | WC Draft | 30-11-2022 | Duration : 30 Days Submitted for HOD approval Remarks : Corrections done file uploaded again and word file sent by Email |
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| 6 | WC Draft | 12-12-2022 | WC rejected by HOD Remarks: Please see remarks for internal use |
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| 7 | WC Draft | 12-07-2023 | Duration : 30 Days Submitted for HOD approval |
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| 8 | WC Draft | 13-07-2023 | WC approved by HOD |
MHDC | ------- |
| 9 | WC-Draft | 25-07-2023 | WC-Draft Email Notifications Sent | MHDC, MHD 12, | ------- |
| 10 | Skipped to Finalization | 23-04-2024 | Stage-Changed | ------- | |
| 11 | Finalization | 23-04-2024 | ------ | ------- | |
| 12 | Final Draft | 23-04-2024 | Submited for HOD approval |
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| 13 | Final Draft draft accepted by HOD and sent to Publication | 23-04-2024 | Final Draft approved by HOD | ------- | |
| 14 | Final Draft draft accepted by HOD and sent to Publication | 23-04-2024 | Final Draft approved by HOD | ------- | |
| 15 | Accepted by Publication | 25-04-2024 | Final Draft accepted by Publication Remarks: Accepted by Publication |
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