Document Details |
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| Name of Department/Committee : | MHD 12 |
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| Document Number : | MHD 12 ( 25446) |
| Document Title [English] : | Sterilization of Health Care Products — Microbiological Methods Part 3 Bacterial Endotoxin Testing |
| Document Title [Hindi] : | स्वास्थ्य देखभाल उत्पादों का विसंक्रमण — सूक्ष्मजैविकीय विधियाँ भाग 3 बैक्टीरियल एंडोटॉक्सिन परीक्षण |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 07.100.10, 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| Standards to be Superseded : | |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 : | Methods of tests |
| 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 11737-3:2023 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. | |
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 | 25-04-2024 | ------- | ||
| 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 | ------- |