Document Details
Name of Department/Committee : MHD 02
Document Number : MHD 02 ( 28422)
Document Title [English] : Non-active Surgical Implants Implants for Osteosynthesis Particular Requirements
Document Title [Hindi] : गैर-सक्रिय सर्जिकल प्रत्यारोपण — अस्थिसंश्लेषण के लिए प्रत्यारोपण — विशेष आवश्यकताएं
Document Type : New
Language : English
Priority : 3
ICS Code : 11.040.40
Date of Project Approval : 25-07-2025
Standards to be Superseded :


Classification Details
Group : Medical and Hospital Equipments
Sub Group : Implants
Sub Sub Group : Orthopaedic Implants
Aspects : Others
Risk : Low
Certification : Voluntary Certification
Short Commom Man's Title : Implants for Osteosynthesis — Particular Requirements
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 14602:2010
Organization Type: ISO

Sl.No. Synosis Points
1 This document specifies particular requirements for non-active surgical implants for osteosynthesis.
2 This document also gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

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 25-07-2025 25-12-2025 12-03-2026 27-07-2026 Mr. VINIT VIDYADHAR BANSOD 25-07-2025