Document Details |
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Name of Department/Committee : | MHD 12 |
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Document Number : | MHD 12 ( 25430) |
Document Title [English] : | Infusion Equipment for Medical Use Part 11 Infusion Filters for Single Use with Pressure Infusion Equipment |
Document Title [Hindi] : | चिकित्सीय उपयोग के लिए इन्फ्यूजन उपकरण भाग 11 दबाव इन्फ्यूजन उपकरण के साथ एकल उपयोग के लिए इन्फ्यूजन फिल्टर |
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Standards to be Superseded : |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 8536-11:2015 |
Organization Type: | ISO |
Sl.No. | Synosis Points | |
1 | This document applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in Part 8. It does not include the effectiveness of filters for separation of particles or germs. |
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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 | P-Draft Waived | 28-04-2024 | ISO adoption | ------- | |
4 | WC Draft | 07-05-2024 | Duration : 30 Days Submitted for HOD approval |
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5 | WC Draft | 07-05-2024 | WC approved by HOD |
MHDC | ------- |