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Document Details
Name of Department/Committee : MHD 12
Document Number : MHD 12 ( 23587)
Document Title [English] : Injection containers and accessories Part 5: Freeze drying closures for injection vials
Document Title [Hindi] : इंजेक्शन कंटेनर और सहायक उपकरण - भाग 5: इंजेक्शन शीशियों के लिए फ्रीज सुखाने वाले क्लोजर
Document Type : New
Language : English
Priority : 2
ICS Code : 11.040.20
Date of Project Approval : 18-09-2023
Standards to be Superseded :


Classification Details
Group : Health, Sports and Fitness Services
Sub Group : Health, Sports and Fitness Services
Sub Sub Group : Health Services
Aspects : Product Specification
Risk : Low
Certification : Voluntary Certification
Short Commom Man's Title :
ITCHS Code :
Ministry :
  • Ministry of Health and Family Welfare
Sustainable development Goals :
Degree of Equivalence : Identical under dual numbering
Identical/Equivalent Standards : ISO 8362-5
Organization Type: ISO

Sl.No. Synosis Points
1 This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.
2 The dimensional requirements are not applicable to barrier-coated closures.
3 Closures specified in this part of ISO 8362 are intended for single use only.

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 18-09-2023 18-01-2024 18-02-2024 18-06-2024 Ms. HARSHADA GANESH KADAM 18-09-2023