| S.No | Document Number | Document Title | Doc Type | Priority | Language | Document Stage | Last Action Date |
|---|---|---|---|---|---|---|---|
| 1 |
MHD/19/00339 (Identical To: ISO 10993-11:2003) |
Biological evaluation of medical devices- Part 11 Tests for systemic toxicity | New | 3 | English | 06-12-2012 | |
| 2 |
MHD/19/00340 (Identical To: ISO 22442-1:2007) |
Medical devices utilizing animal tissues and their derivatives- Part 1: Application of risk management | New | 3 | English | 06-12-2012 | |
| 3 |
MHD/19/00341 (Identical To: ISO 22442-3:2007) |
Medical devices utilizing animal tissues and their derivatives- Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE ) agents | New | 3 | English | Dropped | 12-03-2021 |
| 4 |
MHD/19/00270 (Identical To: ISO 10993-1:2009) |
Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk Management process | New | 3 | English | F-Draft | 10-01-2017 |
| 5 |
MHD/19/00338 (Identical To: ISO 10993-10:2010) |
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | New | 3 | English | F-Draft | 10-01-2017 |
| 6 |
MHD/19/00368 (Identical To: ISO 10993-6:2007) |
Biological evaluation of medical devices-Part 6: Tests for local effects after implantation | New | 3 | English | F-Draft | 11-01-2017 |
| 7 |
MHD/19/00369 (Identical To: ISO 10993-7:2008 ) |
Biological evaluation of medical devices-Part 7: Ethylene oxide Sterilization residuals | New | 3 | English | F-Draft | 11-01-2017 |
| 8 |
MHD/19/00370 (Identical To: ISO 7405:2008) |
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | New | 3 | English | F-Draft | 11-01-2017 |
| 9 |
MHD/19/00318 (Identical To: IEC 61010-2-101: 200) |
Safety requirements for electrical equipment for measurement, control and laboratory use- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment | New | 3 | English | Dropped | 18-03-2021 |
| 10 |
MHD/19/00316 (Identical To: IEC 61010-2-051: 200) |
Safety requirements for electrical equipment for measurement, control and laboratory use- Part 2-051: Particular requirements for laboratory equipment for mixing and stirring | New | 3 | English | Dropped | 12-03-2021 |
| 11 |
MHD/19/00315 (Identical To: IEC 61010-1: 2010) |
Safety Requirements for Electrical Equipment For Measurement, Control and Laboratory Use Part 1 General Requirements | New | 3 | English | Proof to OSA | 19-09-2013 |
| 12 | MHD/19/00288 | Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials | New | 3 | English | Dropped | 12-03-2021 |
| 13 | MHD/19/00289 | Biological Evaluation of Medical Devices Part 18 Chemical Characterization of Materials | New | 3 | English | Dropped | 12-03-2021 |
| 14 |
MHD/19/00290 (Identical To: ISO/TS 10993-20:2006) |
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices | New | 3 | English | Proof to OSA | 27-04-2010 |
| 15 |
MHD/19/00271 IS 12572 : Part 2: 1995 (Identical To: ISO 10993-2:2006) |
Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements ( First Revision ) | Revision | 3 | English | Proof to OSA | 27-04-2010 |
| 16 |
MHD/19/00273 IS 12572 : Part 14: 1994 (Identical To: ISO 10993-4:2002) |
Biological Evaluation of Medical Devices Part 4 Selection of Tests for Interaction with Blood ( First Revision ) | Revision | 3 | English | 27-04-2010 | |
| 17 |
MHD/19/00274 (Identical To: ISO 10993-5:2009) |
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | New | 3 | English | Proof to OSA | 27-04-2010 |
| 18 |
MHD/19/00291 (Identical To: ISO 14155:2011) |
Clinical investigation of medical devices for human subjects- Good Clinical Practice | New | 3 | English | Proof to OSA | 06-12-2012 |
| 19 |
MHD/19/00272 IS 12572 : Part 13: 1995 (Identical To: ISO 10993-3:2003) |
Biological Evaluation of Medical Devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ( First Revision ) | Revision | 3 | English | 27-04-2010 | |
| 20 |
MHD/19/00444 IS 12572 : Part 14: 1994 |
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood Amendment No. 1 | Amendment | 3 | English | Manuscritp for editing (with Publication) | 27-03-2017 |
| 21 |
MHD/19/00445 (Identical To: ISO 10993-9:2009) |
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products | New | 3 | English | F-Draft | 11-01-2017 |
| 22 |
MHD/19/00446 (Identical To: ISO 10993-13:2010) |
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices | New | 3 | English | F-Draft | 11-01-2017 |
| 23 |
MHD/19/00447 (Identical To: ISO 10993-14:2001) |
Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics | New | 3 | English | F-Draft | 11-01-2017 |
| 24 |
MHD/19/00448 (Identical To: ISO 10993-15:2000) |
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys | New | 3 | English | F-Draft | 10-01-2017 |
| 25 |
MHD/19/00449 (Identical To: ISO 10993-16:2010) |
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables | New | 3 | English | Finalization | 21-12-2016 |
| 26 |
MHD/19/00450 (Identical To: ISO 10993-17:2002) |
Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances | New | 3 | English | F-Draft | 10-01-2017 |
| 27 |
MHD/19/00451 (Identical To: ISO/TR 37137:2014) |
Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants | New | 3 | English | Dropped | 20-11-2021 |
| 28 |
MHD/19/00483 (Identical To: ISO/TS 10993-19:2006) |
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials | New | 3 | English | F-Draft | 10-01-2017 |
| 29 |
MHD/19/00484 (Identical To: ISO 13022:2012) |
Medical products containing viable human cells -- Application of risk management and requirements for processing practices | New | 3 | English | F-Draft | 10-01-2017 |
| 30 |
MHD/19/00486 (Identical To: ISO/TR 15499:2012) |
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process | New | 3 | English | F-Draft | 10-01-2017 |
| 31 |
MHD/19/00487 (Identical To: ISO 22442-2:2007) |
Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling | New | 3 | English | F-Draft | 10-01-2017 |
| 32 |
MHD/19/00488 (Identical To: ISO/TR 22442-4:2010) |
Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes | New | 3 | English | F-Draft | 10-01-2017 |
| 33 |
MHD/19/10352 IS 12572 : Part 14: 1994 (Identical To: ISO 10993-3 :2014) |
Biological evaluation of medical devices-Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity | Revision | 3 | English | Manuscritp for editing (with Publication) | 21-08-2018 |
| 34 |
MHD/19/11487 IS 12572 : Part 4: 2016 |
Biological Evaluation of Medical Devices Part 4 Selection of Tests for Interaction with Blood ( First Revision ) Amendment - 1 | Amendment | 3 | English | F-Draft | 03-05-2017 |
| 35 |
MHD/19/12940 (Identical To: 10993-6:2016) |
Biological evaluation of medical devices Part 6: Tests for local effects after implantation | New | 3 | English | Manuscritp for editing (with Publication) | 02-01-2019 |
| 36 |
MHD/19/12941 (Identical To: 10993-11:2017) |
Biological evaluation of medical devices Part 11 Tests for systemic toxicity | New | 3 | English | Manuscritp for editing (with Publication) | 02-01-2019 |
| 37 |
MHD/19/12942 (Identical To: 10993-16:2017) |
Biological evaluation of medical devices Part 16 Toxicokinetic study design for degradation products and leachables | New | 3 | English | Manuscritp for editing (with Publication) | 02-01-2019 |
| 38 |
MHD/19/12943 (Identical To: 22442-1:2015) |
Medical devices utilizing animal tissues and their derivatives Part 1 Application of risk management | New | 3 | English | Manuscritp for editing (with Publication) | 02-01-2019 |
| 39 |
MHD/19/12944 (Identical To: 22442-2:2015) |
Medical devices utilizing animal tissues and their derivatives Part 2 Controls on sourcing collection and handling | New | 3 | English | Manuscritp for editing (with Publication) | 02-01-2019 |
| 40 |
MHD/19/12945 (Identical To: 15499:2016) |
Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process | New | 3 | English | F-Draft | 18-12-2018 |
| 41 |
MHD/19/12986 IS 12572 : Part 4: 2016 (Identical To: 10993-4:2017) |
Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood Second Revision | Revision | 3 | English | Manuscritp for editing (with Publication) | 02-01-2019 |
| 42 |
MHD/19/13646 (Identical To: ISO/TR 10993-22:2017) |
Biological evaluation of medical devices Part 22: Guidance on nano-materials | New | 2 | English | Manuscritp for editing (with Publication) | 09-10-2019 |
| 43 | MHD/19/15611 | In-vitro Diagnostic (IVD) Devices - Blood Gas Analyzers | New | 1 | English | Ready for Gazette | 12-12-2024 |
| 44 | MHD/19/15612 | In-Vitro Diagnostic Device - Automated Clinical chemistry Analyzer - Part 1 Wet Chemistry Analyzer | New | 3 | English | Ready for Gazette | 29-12-2023 |
| 45 | MHD/19/15613 | In-vitro Diagnostic (IVD) Devices - Electrolyte Analyzer | New | 3 | English | Ready for Gazette | 29-07-2024 |
| 46 | MHD/19/15615 | Performance Testing of In-Vitro Diagnostic IVD Instruments ELISA Plate Reader | New | 1 | English | Dropped | 15-09-2020 |
| 47 | MHD/19/15616 | In-Vitro Diagnostic Devices - ELISA Plate Reader | New | 1 | English | Ready for Gazette | 17-10-2023 |
| 48 | MHD/19/15617 | In-Vitro Diagnostic Devices - Automated ELISA Processor | New | 3 | English | Ready for Gazette | 17-10-2023 |
| 49 | MHD/19/15618 | Performance testing of In-vitro Diagnostics IVD Reagents/ Kits ?-Amylase CNP-G3 Liquid Stable Clinical Chemistry Reagents/ Kits | New | 3 | English | Ready for Gazette | 06-10-2022 |
| 50 | MHD/19/16146 | In-Vitro Diagnostic (IVD) Medical Device - Automatic Slide Staining Instrument | New | 3 | English | Ready for Gazette | 17-10-2023 |
| 51 | MHD/19/16147 | In-Vitro Diagnostic (IVD) Device - Automated Clinical Chemistry Analyzer Part 2 Dry Chemistry Analyzer | New | 3 | English | Ready for Gazette | 29-12-2023 |
| 52 | MHD/19/16241 | In-vitro Diagnostic Device - Automated Blood Culture and Microbial Detection System | New | 3 | English | Ready for Gazette | 17-10-2023 |
| 53 | MHD/19/16248 | In-vitro Diagnostic Device - ELISA Plate Washer | New | 3 | English | Ready for Gazette | 17-10-2023 |
| 54 |
MHD/19/16623 (Modified/Technically Equivalent To: ISO 10993-1:2018) |
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | New | 1 | English | Ready for Gazette | 01-02-2023 |
| 55 |
MHD/19/17262 (Identical To: 10993: Part 18) |
Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process | New | 2 | English | Pdf from Department | 11-01-2022 |
| 56 |
MHD/19/17263 (Identical To: 10993: Part 12) |
Biological evaluation of medical devices Part 12: Sample preparation and reference materials | New | 2 | English | Pdf from Department | 11-01-2022 |
| 57 |
MHD/19/17306 (Identical To: 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 | New | 2 | English | Ready for Gazette | 17-10-2023 |
| 58 |
MHD/19/17307 (Modified/Technically Equivalent To: IEC 61010-2-081: 2019) |
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 | New | 2 | English | Ready for Gazette | 20-05-2024 |
| 59 |
MHD/19/17308 (Modified/Technically Equivalent To: IEC 61010-2-101: 2018) |
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 4 Particular Requirements for In-Vitro Diagnostic (IVD) Medical Equipment | New | 2 | English | Ready for Gazette | 17-10-2023 |
| 60 |
MHD/19/17309 (Modified/Technically Equivalent To: IEC 61326-2-6: 2020) |
Electrical equipment for measurement, control and laboratory use - EMC requirements Part 2 Particular requirements for In-vitro diagnostic (IVD) medical equipment | New | 2 | English | Ready for Gazette | 29-12-2023 |
| 61 |
MHD/19/20252 (Modified/Technically Equivalent To: ISO 10993-9: 2019) |
Biological Evaluation of Medical Devices Part 2 Framework for identification and quantification of potential degradation products | New | 1 | English | Ready for Gazette | 20-05-2024 |
| 62 |
MHD/19/20253 (Modified/Technically Equivalent To: ISO 10993-10: 2021) |
Biological Evaluation of Medical Devices Part 6 Tests for skin sensitization | New | 1 | English | Ready for Gazette | 17-10-2023 |
| 63 |
MHD/19/20256 (Modified/Technically Equivalent To: ISO 10993-15: 2019) |
Biological Evaluation of Medical Devices Part 3 Identification and quantification of degradation products from metals and alloys | New | 1 | English | Ready for Gazette | 20-05-2024 |
| 64 |
MHD/19/20257 IS/ISO 10993 : Part 7: 2018 |
Biological Evaluation of Medical Devices Part 7 Ethylene oxide sterilization residuals AMENDMENT 1: Applicability of allowable limits for neonates and infants | Amendment | 1 | English | Dropped | 26-01-2023 |
| 65 |
MHD/19/20260 (Modified/Technically Equivalent To: ISO 10993-19: 2020) |
Biological Evaluation of Medical Devices Part 4 Physico-chemical morphological and topographical characterization of materials | New | 1 | English | Ready for Gazette | 20-05-2024 |
| 66 |
MHD/19/20261 IS/ISO 14155 : 2011 (Identical To: ISO 14155: 2020) |
Clinical investigation of medical devices for human subjects - Good clinical practice | Revision | 1 | English | Ready for Gazette | 17-10-2023 |
| 67 |
MHD/19/21334 (Modified/Technically Equivalent To: IEC 61326-1: 2020) |
Electrical Equipment for Measurement, Control and Laboratory Use — EMC Requirements Part 1 General Requirements (IEC 61326-1: 2020, MOD) | New | 3 | English | Ready for Gazette | 17-10-2023 |
| 68 |
MHD/19/21362 (Modified/Technically Equivalent To: IEC 61010-1: 2010 + AMD1:2016 + COR1:2019) |
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1 General Requirements (IEC 61010-1: 2010 + AMD1:2016 + COR1:2019, MOD) | New | 3 | English | Ready for Gazette | 17-10-2023 |
| 69 |
MHD/19/21867 (Modified/Technically Equivalent To: ISO 10993-7:2019) |
Biological Evaluation of Medical Devices Part 5 Ethylene oxide sterilization residuals | New | 3 | English | Ready for Gazette | 23-07-2024 |
| 70 |
MHD/19/22473 (Modified/Technically Equivalent To: ISO 10993-23:2021) |
Biological Evaluation of Medical Devices Part 7 Tests for irritation ISO 10993-23:2021 MOD | New | 3 | English | Ready for Gazette | 19-06-2024 |
| 71 | MHD/19/25234 | Blood Cell Counter Analyzer | New | 2 | English | Project-Approval | 11-04-2024 |
| 72 | MHD/19/25235 | Hemoglobin Analyzer | New | 2 | English | Project-Approval | 11-04-2024 |
| 73 |
MHD/19/25236 (Identical To: ISO/TS 37137-1:2021) |
Biological evaluation of absorbable medical devices Part 1: General requirements | New | 2 | English | Project-Approval | 11-04-2024 |
| 74 |
MHD/19/25237 (Identical To: ISO/TR 10993-33:2015) |
Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity | New | 2 | English | Project-Approval | 11-04-2024 |
| 75 |
MHD/19/25238 (Identical To: ISO/TR 10993-55:2023) |
Biological evaluation of medical devices Part 55: Interlaboratory study on cytotoxicity | New | 2 | English | Project-Approval | 11-04-2024 |
| 76 | MHD/19/26476 | Urine Analyzer | New | 2 | English | Project-Approval | 31-08-2024 |