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 |
| 20th Dec 2024 | India, Delhi, Delhi, | MHD 19 - In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices |
