History
Document Details
Name of Department/Committee : MHD 12
Document Number : MHD 12 ( 25585)
Document Title [English] : Sterilization of Health Care Products — Radiation — Substantiation of Selected Sterilization Dose: Method VDmaxSD
Document Title [Hindi] : स्वास्थ्य देखभाल उत्पादों का विसंक्रमण — विकिरण — चयनित विसंक्रमण खुराक की पुष्टि: वी डी मैक्स एस डी विधि विधि
Document Type : New
Language : English
Priority : 3
ICS Code : 11.080.01
Date of Project Approval : 08-05-2024
Standards to be Superseded :

Classification Details
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 :
  • Ministry of Health and Family Welfare - Department of Health and Family Welfare
Sustainable development Goals :
  • GOOD HEALTH AND WELL BEING
Degree of Equivalence : Identical under dual numbering
Identical/Equivalent Standards : ISO 13004:2022
Organization Type: ISO
Sl.No. Synosis Points
1 This document describes a method for substantiating a selected sterilization dose that achieves a sterility assurance level for radiation sterilization of health care products
Timeline Details


S.No. P-Draft
Completion Date		 WC-Draft
Completion Date		 Final-Draft
Completion Date		 Project
Completion Date(Gazette)		 Entered By Entered On
1 08-05-2024 08-10-2024 23-12-2024 08-05-2025 Ms. UROOSA WARSI 08-05-2024
Stages
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 -------
3 WC Draft 08-05-2024 Duration : 30 Days
Submitted for HOD approval 		-------
4 WC Draft 08-05-2024 WC approved by HOD
 MHDC   -------