Document Details
Name of Department/Committee : MHD 08
Document Number : MHD 08 ( 28020)
Document Title [English] : Dentistry General Requirements for Instruments and Related Accessories Used in Dental Implant Placement and Treatment
Document Title [Hindi] : दंत चिकित्सा — दंत इम्प्लांट स्थापना और उपचार में उपयोग किए जाने वाले उपकरणों और संबंधित सहायक उपकरणों के लिए सामान्य अपेक्षाएँ
Document Type : New
Language : English
Priority : 3
ICS Code : 11.060.25
Date of Project Approval : 08-05-2025
Standards to be Superseded :


Classification Details
Group : Medical and Hospital Equipments
Sub Group : Dentistry instruments/equipment and accessories
Sub Sub Group : Dental instruments
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 :
Degree of Equivalence : Identical under dual numbering
Identical/Equivalent Standards : ISO 13504:2012
Organization Type: ISO

Sl.No. Synosis Points
1 This International Standard specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.
2 It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.
3 It is not applicable to the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant.
4 With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be 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 08-05-2025 08-10-2025 23-12-2025 08-05-2026 Ms. HARSHADA GANESH KADAM 08-05-2025