Total Standards : 35
Revised Standards
New Standards
| S.No | IS Number | IS Title | Amendment | Reaffirmation Year | Document | Action |
|---|---|---|---|---|---|---|
| 1 | IS/IEC 61010 : Part 2-081 : 2009/IEC 61010-2-81 : 2009 |
Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-081 Particular Requirements for Automatic and Semi-automatic Laboratory Equipment for Analysis and Other Purposes | 0 | ---- | Buy | |
| 2 | IS/ISO 10993 : Part 12 : 2021/ISO 10993-12:2021 |
Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials | 0 | ---- | Buy | |
| 3 | IS/ISO 7405 : 2008/ISO 7405:2008 |
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | 0 | ---- | Buy | |
| 4 | IS/ISO 10993 : Part 3 : 2014/ISO 10993-3 : 2014 |
Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity (First Revision) | 0 | ---- | Buy | |
| 5 | IS/ISO 10993 : Part 2 : 2006/ISO 10993-2:2006 |
Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements (First Revision) | 0 | ---- | Buy | |
| 6 | IS/ISO 10993 : Part 9 : 2009/ISO 10993-9:2009 |
Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products | 0 | ---- | Buy | |
| 7 | IS 17932 : Part 4 : 2024 |
Biological Evaluation of Medical Devices Part 4 Physico-chemical morphological and topographical characterization of materials | 0 | ---- | Buy | |
| 8 | IS/ISO 10993 : Part 16 : 2017/ISO 10993-16 : 2017 |
Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables | 0 | ---- | Buy | |
| 9 | IS/ISO 10993 : Part 5 : 2009/ISO 10993-5 : 2009 |
Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity | 0 | ---- | Buy | |
| 10 | IS/ISO 10993 : Part 18 : 2020/ISO 10993-18:2020 |
Biological evaluation of medical devices Part 18 Chemical characterization of medical device materials within a risk management process | 0 | ---- | Buy | |
| 11 | IS/IEC/TS 10993 : Part 19 : 2006/ISO/TS 109993-19 : 2006 |
Biological Evaluation of Medical Devices Part 19 Physico-Chemical, Morphological and Topographical Characterization of Materials | 0 | ---- | Buy | |
| 12 | IS/ISO 10993 : Part 6 : 2016/ISO 10993-6 : 2016 |
Biological evaluation of medical devices Part 6 Tests for local effects after implantation | 0 | ---- | Buy | |
| 13 | IS/ISO/TS 10993 : Part 20 : 2006/ISO/TS 10993-20:2006 |
Biological evaluation of medical devices Part 20 Principles and methods for immunotoxicology testing of medical devices | 0 | ---- | Buy | |
| 14 | IS/ISO 13022 : 2012/ISO 13022:2012 |
Medical products containing viable human cells - Application of risk management and requirements for processing practices | 0 | ---- | Buy | |
| 15 | IS 17932 : Part 3 : 2024 |
Biological Evaluation of Medical Devices Part 3 Identification and quantification of degradation products from metals and alloys | 0 | ---- | Buy | |
| 16 | IS/ISO 10993 : Part 11 : 2017/ISO 10993-11 : 2017 |
Biological evaluation of medical devices Part 11 Tests for systemic toxicity | 0 | ---- | Buy | |
| 17 | IS/ISO 17511 : 2020/ISO 17511:2020 |
In Vitro Diagnostic Medical Devices - Requirements for Establishing Metrological Traceability of Values Assigned to Calibrators, Trueness Control Materials and Human Samples | 0 | ---- | Buy | |
| 18 | IS/ISO 10993 : Part 13 : 2010/ISO 10993-13:2010 |
Biological evaluation of medical devices Part 13 Identification and quantification of degradation products from polymeric medical devices | 0 | ---- | Buy | |
| 19 | IS/ISO/TR 37137 : 2014/ISO/TR 37137:2014 |
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants | 0 | ---- | Buy | |
| 20 | IS/ISO 22442 : Part 2 : 2015/ISO 22442-2:2007 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 2 Controls on Sourcing, Collection and Handling | 0 | ---- | Buy | |
| 21 | IS/ISO 10993 : Part 17 : 2002/ISO 10993-17 : 2002 |
Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances | 0 | ---- | Buy | |
| 22 | IS/ISO 15197 : 2013/ISO 15197 : 2013 (1 Revision) |
In vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring System for Self-Testing in Managing Diabetes Mellitus (First Revision) | 0 | Jan, 2020 | Buy | |
| 23 | IS 17720 : 2023 |
In-vitro Diagnostic Device - Automated Blood Culture and Microbial Detection System | 0 | ---- | Download | |
| 24 | IS/ISO 10993 : Part 4 : 2017/ISO 10993-4 : 2017 |
Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood | 0 | ---- | Buy | |
| 25 | IS/ISO/TR 10993 : Part 22 : 2017/ISO/TR 10993-22:2017 |
Biological Evaluation of Medical Devices Part 22 Guidance on Nanomaterials | 0 | ---- | Buy | |
| 26 | IS/ISO 22442 : Part 3 : 2007/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 | 0 | ---- | Buy | |
| 27 | IS/ISO 10993 : Part 7 : 2018/ISO 10993-7:2008 |
Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals | 0 | ---- | Buy | |
| 28 | IS/ISO 22442 : Part 1 : 2015/ISO 22442-1 : 2015 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management | 0 | ---- | Buy | |
| 29 | IS/ISO 10993 : Part 15 : 2000/ISO 10993-15:2000 |
Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys | 0 | ---- | Buy | |
| 30 | 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 | 0 | ---- | Buy | |
| 31 | IS/ISO 23640 : 2011/ISO 23640 : 2011 |
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents | 0 | ---- | Buy | |
| 32 | IS/ISO 15198 : 2004/ISO 15198:2004 |
Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer | 0 | ---- | Buy | |
| 33 | IS/ISO 10993 : Part 14 : 2001/ISO 10993-14:2001 |
Nuclear fuel technology - Determination of uranium : Part 2 Determination of uranium in solutions, uranium hexafluoride and solids - Iron (II) reduction cerium (IV) oxidation titrimetric method | 0 | ---- | Buy | |
| 34 | IS/ISO/TR 22442 : Part 4 : 2010/ISO/TR 22442-4:2010 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 4 Principles for Elimination and/or Inactivation of Transmissble Spongifrom Encephalopathy (TSE) Agents and Validation Assays for those Processes | 0 | ---- | Buy | |
| 35 | IS/ISO/TR 15499 : 2016/ISO/TR 15499 : 2016 |
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process | 0 | ---- | Buy |