Document Details |
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Name of Department/Committee : | MHD 12 | ||||
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Document Number : | MHD 12 ( 25586) | ||||
Document Title [English] : | Sterilization of Health Care Products — Moist Heat — Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | ||||
Document Title [Hindi] : | स्वास्थ्य देखभाल उत्पादों का विसंक्रमण — नम गर्मी — चिकित्सा उपकरणों के लिए विसंक्रमण प्रक्रिया के विकास, सत्यापन और नियमित नियंत्रण के लिए आवश्यकताएँ | ||||
Document Type : | New | ||||
Language : | English | ||||
Priority : | 3 | ||||
ICS Code : | 11.080.01 | ||||
Date of Project Approval : | 08-05-2024 | ||||
Standards to be Superseded : |
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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 17665:2024 |
Organization Type: | ISO |
Sl.No. | Synosis Points | |
1 | This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices |
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 | 08-05-2024 | ------- | ||
2 | P-Draft Waived | 08-05-2024 | 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 | ------- |