Document Details
Name of Department/Committee : MHD 02
Document Number : MHD 02 ( 28421)
Document Title [English] : Implants for Surgery Mechanical Testing of Implantable Spinal Devices Fatigue Test Method for Spinal Implant Assemblies Using an Anterior Support
Document Title [Hindi] : सर्जरी के लिए प्रत्यारोपण — प्रत्यारोपण योग्य स्पाइनल उपकरणों का यांत्रिक परीक्षण — पूर्वकाल समर्थन का उपयोग करके स्पाइनल इम्प्लांट असेंबली के लिए थकान परीक्षण विधि
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Standards to be Superseded :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 : Methods of tests
Risk : Low
Certification : Voluntary Certification
Short Commom Man's Title : Fatigue Test Method for Spinal Implant Assemblies Using an Anterior Support
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 12189:2008
Organization Type: ISO

Sl.No. Synosis Points
1 This document specifies methods for fatigue testing of spinal implant assemblies (for fusion or motion preservation) using an anterior support. It is intended to provide a basis for assessing the intrinsic static and dynamic strength of spinal implants.

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