MHD 19-In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices Sectional Committee

MEMBER SECRETARY : Ms. NAGAVARSHINI M (SCIENTIST-C)
CHAIR PERSON :

Dr. Reba Chhabra ()
SCOPE : To formulate Indian Standards on: i) Biological tests, biological stains, immuno-biological and diagnostic kits. ii) Biological and clinical evaluation of medical and dental materials, devices, implants together with standardization of biological test methods applicable to those materials and devices, and iii) Good clinical practice principles to clinical investigations in humans of those devices"
LIAISONS : ISO TC 194 - Biological and clinical evaluation of medical devices - Principle (P)
ISO TC 194 - Material characterization
ISO TC 194 - Cytotoxicity
ISO TC 194 - Irritation, sensitization
ISO TC 194 - Effects on blood
ISO TC 212 - In vitro diagnostic products
ISO TC 212 - Microbiology and molecular diagnostics
Sr.No. Technical Committe TITLE TYPE COMPOSITION
1 MHD 19 : 19 Biological Evaluation of Medical Devices Sub Committee View
2 MHD 19 : 1 Biological Evaluation of Medical Devices Sub Committee View
3 MHD 19 : WG1 HIV Diagnostic Test Kit Working Group View
4 MHD 19 : WG2 Urine Analyzer Working Group View
5 MHD 19 : WG3 TB Diagnostic Test Kit Working Group View
6 MHD 19 : WG4 Clincal Biochemistry Working Group View
7 MHD 19 : WG5 Pathology Working Group View
8 MHD 19 : WG6 Microbiology Working Group View
9 MHD 19 : WG7 Immunology Working Group View
10 MHD 19 : WG8 Molecular Biology Working Group View
11 MHD 19 : WG9 Hematology Working Group View
12 MHD 19 : P1 HIV Diagnostic Test Kit Working Pannel View
13 MHD 19 : P2 Biological Evaluation of Medical Devices Working Pannel View
14 MHD 19 : P3 In-vitro Diagnostic Medical Devices Working Pannel View
Date Location Detail
13th Mar 2025 India, New Delhi, Delhi, MHD 19 - In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices