Document Details
Name of Department/Committee : MHD 05
Document Number : MHD 05 ( 25357)
Document Title [English] : Ophthalmic instruments Indirect ophthalmoscopes
Document Title [Hindi] : नेत्र संबंधी उपकरण – अप्रत्यक्ष नेत्रदर्शी
Document Type : Revision
Language : English
Priority : 2
ICS Code : 11.040.70
Date of Project Approval : 23-04-2024
Standards to be Revised :
Sl.No. Is No & Year
1 IS/ISO 10943 : 2011
Standards to be Superseded :
Sl.No. Is No & Year
1 IS/ISO 10943 : 2011


Classification Details
Group : Medical and Hospital Equipments
Sub Group : Diagnostic Instruments
Sub Sub Group : General ophthalmic equipment
Aspects : Product Specification
Risk : Low
Certification : Voluntary Certification
Short Commom Man's Title :
ITCHS Code :
Ministry :
  • Ministry of Health and Family Welfare
Sustainable development Goals :
  • GOOD HEALTH AND WELL BEING
Degree of Equivalence : Modified/Technically Equivalent
Identical/Equivalent Standards : ISO 10943:2023
Organization Type: ISO

Sl.No. Synosis Points
1 This document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus. This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist. This document is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories. This document is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.

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 23-04-2024 23-08-2024 23-09-2024 23-01-2025 Mr. KATIPALLY KARTHIK REDDY 23-04-2024
Stages
Sl.
No.
Stage Date of Occurence Remarks Circulated to Files
1 Generation of Document Number 23-04-2024 -------
2 P-Draft Waived 23-04-2024 This is an ISO Adoption. -------
3 WC Draft 23-04-2024 Duration : 30 Days
Submitted for HOD approval
-------
4 WC Draft 23-04-2024 WC approved by HOD
MHDC  MHD 05, -------