Document Details
Name of Department/Committee : MHD 02
Document Number : MHD 02 ( 28708)
Document Title [English] : Implants for Surgery Pre-Clinical Mechanical Assessment of Spinal Implants and Particular Requirements Part 2 Spinal Intervertebral Body Fusion Devices
Document Title [Hindi] : सर्जरी के लिए प्रत्यारोपण — रीढ़ की हड्डी के प्रत्यारोपण का पूर्व-नैदानिक यांत्रिक मूल्यांकन और विशेष अपेक्षाएँ भाग 2 स्पाइनल इंटरवर्टेब्रल बॉडी फ्यूजन डिवाइस
Document Type : New
Language : English
Priority : 3
ICS Code : 11.040.40
Date of Project Approval : 18-09-2025
Standards to be Superseded :


Classification Details
Group : Medical and Hospital Equipments
Sub Group : Implants
Sub Sub Group : Orthopaedic Implants
Aspects : Product Specification
Risk : Low
Certification : Voluntary Certification
Short Commom Man's Title : Pre-Clinical Mechanical Assessment for Spinal Intervertebral Body Fusion Devices
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 23089 - 2 : 2021
Organization Type: ISO

Sl.No. Synosis Points
1 This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures
2 This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs

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 18-09-2025 18-02-2026 03-05-2026 18-09-2026 Mr. VINIT VIDYADHAR BANSOD 18-09-2025