History
Document Details
Name of Department/Committee : MHD 02
Document Number : MHD 02 ( 25918)
Document Title [English] : Non-Active Surgical Implants Mammary Implants Particular Requirements
Document Title [Hindi] : गैर-सक्रिय सर्जिकल प्रत्यारोपण - स्तन प्रत्यारोपण - विशेष आवश्यकताएँ
Document Type : New
Language : English
Priority : 3
ICS Code : 11.040.40
Date of Project Approval : 18-12-2023
Standards to be Superseded :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 : Mammary Implants — 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 14607: 2018
Organization Type: ISO
Sl.No. Synosis Points
1 This document specifies particular requirements for mammary implants.
2 With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, 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 21-06-2024 21-11-2024 05-02-2025 20-06-2025 Mr. VINIT VIDYADHAR BANSOD 21-06-2024
Stages
Sl.
No.		 Stage Date of Occurence Remarks Circulated to Files
1 Generation of Document Number 18-12-2023 -------
2 P-Draft Waived 21-06-2024 -------
3 WC Draft 21-06-2024 Duration : 30 Days
Submitted for HOD approval
Remarks : Submitted for kind consideration 		-------
4 WC Draft 21-06-2024 WC approved by HOD
 MHDC   -------