Document Details
Name of Department/Committee : MHD 12
Document Number : MHD 12 ( 25590)
Document Title [English] : Needle-Based Injection Systems for Medical Use — Requirements and Test Methods Part 2 Double-Ended Pen Needles
Document Title [Hindi] : चिकित्सा उपयोग के लिए सुई-आधारित इंजेक्शन प्रणाली — अपेक्षाएँ और परीक्षण पद्धतियाँ भाग 2 डबल-एंडेड पेन सुई
Document Type : New
Language : English
Priority : 3
ICS Code : 11.040.25
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Standards to be Superseded :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 : Product 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 11608-2:2022
Organization Type: ISO

Sl.No. Synosis Points
1 This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle

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 ISO Adoption -------
3 WC Draft 08-05-2024 Duration : 30 Days
Submitted for HOD approval
-------
4 WC Draft 08-05-2024 WC approved by HOD
MHDC   -------