Document Details |
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Name of Department/Committee : | MHD 12 |
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Document Number : | MHD 12 ( 25439) |
Document Title [English] : | Aseptic Processing of Health Care Products Part 6 Isolator Systems |
Document Title [Hindi] : | स्वास्थ्य देखभाल उत्पादों का कीटाणु-नाशक प्रसंस्करण भाग 6 आइसोलेटर प्रणालियाँ |
Document Type : | New |
Language : | English |
Priority : | 3 |
ICS Code : | 11.080.01 |
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Standards to be Superseded : |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 : | Process 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 13408-6:2021 |
Organization Type: | ISO |
Sl.No. | Synosis Points | |
1 | This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. |
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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 | WC Draft | 08-05-2024 | Duration : 30 Days Submitted for HOD approval |
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4 | WC Draft | 08-05-2024 | WC approved by HOD |
MHDC | ------- |