Document Details
Name of Department/Committee : MHD 12
Document Number : MHD 12 ( 25954)
Document Title [English] : Aseptic Processing of Health Care Products Part 1 General Requirements (First Revision)
Document Title [Hindi] : स्वास्थ्य देखभाल उत्पादों के एसेप्टिक प्रसंस्करण भाग 1 सामान्य अपेक्षाएँ (पहला पुनरीक्षण)
Document Type : Revision
Language : English
Priority : 3
ICS Code : 11.080.01
Date of Project Approval : 24-06-2024
Standards to be Revised :
Sl.No. Is No & Year
1 IS/ISO 13408 : Part 1: 2008
Standards to be Superseded :
Sl.No. Is No & Year
1 IS/ISO 13408 : Part 1: 2008


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 13408-1:2023
Organization Type: ISO

Sl.No. Synosis Points
1 This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing 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 24-06-2024 24-11-2024 08-02-2025 23-06-2025 Ms. UROOSA WARSI 24-06-2024
Stages
Sl.
No.
Stage Date of Occurence Remarks Circulated to Files
1 Generation of Document Number 24-06-2024 -------
2 P-Draft Waived 06-08-2024 -------
3 WC Draft 06-08-2024 Duration : 30 Days
Submitted for HOD approval
-------
4 WC Draft 06-08-2024 WC approved by HOD
MHDC   -------