Total Standards : 18
| S.No | IS Number | IS Title | Aspect | Degree of Equivalence (E) |
Date of Pub. (F) |
Document | Action |
|---|---|---|---|---|---|---|---|
| 1 | IS 17715 : 2023 |
In-vitro Diagnostic Device - ELISA Plate Washer | Product Specification | Indigenous | 05-12-2023 | ||
| 2 | IS 17713 : 2023 |
In-Vitro Diagnostic Devices - ELISA Plate Reader | Product Specification | Indigenous | 05-12-2023 | ||
| 3 | IS 17714 : 2023 |
In-Vitro Diagnostic Devices - Automated ELISA Processor | Product Specification | Indigenous | 05-12-2023 | ||
| 4 | IS 17784 (Part 1) : 2023 |
Electrical Equipment for Measurement, Control and Laboratory Use - EMC Requirements Part 1 General Requirements (IEC 61326-1: 2020, MOD) | Methods of tests | Modified/Technically Equivalent | 06-12-2023 | ||
| 5 | IS 17932 (Part 6) : 2023 |
Biological Evaluation of Medical Devices Part 6 Tests for skin sensitization (ISO 10993-10 : 2021, MOD) | Methods of tests | Modified/Technically Equivalent | 06-12-2023 | ||
| 6 | IS 17724 (Part 2) : 2023 IEC 61010-2-051: 2018 |
Safety Requirements for Electrical Equipment for Measurement, Control, And Laboratory Use Part 2 Particular Requirements for Laboratory Equipment used in Mixing and Stirring | Safety Standard | Identical under dual numbering | 06-12-2023 | ||
| 7 | IS 17724 (Part 1) : 2023 |
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1 General Requirements (IEC 61010-1: 2010 + AMD1:2016 + COR1:2019, MOD) | Product Specification | Modified/Technically Equivalent | 06-12-2023 | ||
| 8 | IS 17724 (Part 4) : 2023 |
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 4 Particular Requirements for In-Vitro Diagnostic (IVD) Medical Equipment (IEC 61010-2-101 : 2018, MOD) | Safety Standard | Modified/Technically Equivalent | 14-12-2023 | ||
| 9 | IS 17719 : 2023 |
In-Vitro Diagnostic (IVD) Medical Device - Automatic Slide Staining Instrument | Product Specification | Indigenous | 22-12-2023 | ||
| 10 | IS 17717 (Part 1) : 2023 |
In-Vitro Diagnostic Device - Automated Clinical chemistry Analyzer - Part 1 Wet Chemistry Analyzer | Product Specification | Indigenous | 02-01-2024 | ||
| 11 | IS 17717 (Part 2) : 2023 |
In-Vitro Diagnostic (IVD) Device - Automated Clinical Chemistry Analyzer Part 2 Dry Chemistry Analyzer | Product Specification | Indigenous | 02-01-2024 | ||
| 12 | IS 17784 (Part 2) : 2023 |
Electrical equipment for measurement, control and laboratory use - EMC requirements Part 2 Particular requirements for In-vitro diagnostic (IVD) medical equipment (IEC 61326-2-6 : 2020, MOD) | Methods of tests | Modified/Technically Equivalent | 04-01-2024 | ||
| 13 | IS 17720 : 2023 |
In-vitro Diagnostic Device - Automated Blood Culture and Microbial Detection System | Product Specification | Indigenous | 02-01-2024 | ||
| 14 | IS 17724 (Part 3) : 2024 |
Safety Requirements for Electrical Equipment for Measurement, Control, And Laboratory Use Part 3 Particular Requirements of Automatic and Semi-Automatic Laboratory Equipment used for Analysis and Other Purposes | Safety Standard | Modified/Technically Equivalent | 26-06-2024 | ||
| 15 | IS 17932 (Part 2) : 2024 |
Biological Evaluation of Medical Devices Part 2 Framework for identification and quantification of potential degradation products | Methods of tests | Modified/Technically Equivalent | 26-06-2024 | ||
| 16 | IS 17932 (Part 3) : 2024 |
Biological Evaluation of Medical Devices Part 3 Identification and quantification of degradation products from metals and alloys | Methods of tests | Modified/Technically Equivalent | 26-06-2024 | ||
| 17 | IS 17932 (Part 4) : 2024 |
Biological Evaluation of Medical Devices Part 4 Physico-chemical morphological and topographical characterization of materials | Methods of tests | Modified/Technically Equivalent | 26-06-2024 | ||
| 18 | IS 17932 (Part 7) : 2024 |
Biological Evaluation of Medical Devices Part 7 Tests for irritation ISO 10993-23:2021 MOD | Methods of tests | Modified/Technically Equivalent | 18-07-2024 |