History
Document Details
Name of Department/Committee : MHD 12
Document Number : MHD 12 ( 27039)
Document Title [English] : Needle-Based Injection Systems for Medical Use — Requirements and Test Methods Part 1 Needle-Based Injection Systems
Document Title [Hindi] : चिकित्सा उपयोग के लिए सुई-आधारित इंजेक्शन प्रणाली — अपेक्षाएँ और परीक्षण पद्धतियाँ भाग 1 सुई-आधारित इंजेक्शन प्रणाली
Document Type : New
Language : English
Priority : 3
ICS Code : 11.040.25
Date of Project Approval : 03-12-2024
Standards to be Superseded :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 11608-1:2022
Organization Type: ISO
Sl.No. Synosis Points
1 This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
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 03-12-2024 03-05-2025 18-07-2025 03-12-2025 Ms. UROOSA WARSI 03-12-2024
Stages
Sl.
No.		 Stage Date of Occurence Remarks Circulated to Files
1 Generation of Document Number 03-12-2024 -------
2 P-Draft Waived 03-12-2024 ISO Adoption -------
3 WC Draft 03-12-2024 Duration : 30 Days
Submitted for HOD approval 		-------
4 WC Draft 05-12-2024 WC approved by HOD
 MHDC   -------