Know Your Standard Standards under Mandatory Certification Group Wise Classification Ministry/Department Wise Classification
Total Standards : 51
Revised Standards
New Standards
| S.No | IS Number | IS Title | Amendment | Reaffirmation Year | Document | Action |
|---|---|---|---|---|---|---|
| 1 |
IS/ISO 10993-2 : 2006 ISO 10668: 2010 |
Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements (First Revision) | 0 | ---- | Buy | |
| 2 |
IS/ISO 10993-3 : 2014 ISO 10993-3 : 2014 |
Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity (First Revision) | 0 | ---- | Buy | |
| 3 |
IS/ISO 10993-4 : 2017 ISO 10993-4 : 2017 |
Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood | 0 | ---- | Buy | |
| 4 |
IS/ISO 10993-5 : 2009 ISO 10993-5 : 2009 |
Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity | 0 | ---- | Buy | |
| 5 |
IS/ISO 10993-6 : 2016 ISO 10993-6 : 2016 |
Biological evaluation of medical devices Part 6 Tests for local effects after implantation | 0 | ---- | Buy | |
| 6 |
IS/ISO 10993-7 : 2018 ISO 10993-7:2008 |
Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals | 0 | ---- | Buy | |
| 7 |
IS/ISO 10993-9 : 2009 ISO 10993-9:2009 |
Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products | 0 | ---- | Buy | |
| 8 |
IS/ISO 10993-11 : 2017 ISO 10993-11 : 2017 |
Biological evaluation of medical devices Part 11 Tests for systemic toxicity | 0 | ---- | Buy | |
| 9 |
IS/ISO 10993-12 : 2021 ISO 10993-12 : 2021 |
Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials | 0 | ---- | Buy | |
| 10 |
IS/ISO 10993-13 : 2010 ISO 22514-8 :2014 ISO 22514-8 :2014 |
Biological evaluation of medical devices Part 13 Identification and quantification of degradation products from polymeric medical devices | 0 | ---- | Buy | |
| 11 |
IS/ISO 10993-14 : 2001 |
Biological evaluation of medical devices Part 14 Identification and quantification of degradation products from ceramics | 0 | ---- | Buy | |
| 12 |
IS/ISO 10993-15 : 2000 ISO 10993-15:2000 |
Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys | 0 | ---- | Buy | |
| 13 |
IS/ISO 10993-16 : 2017 ISO 10993-16 : 2017 |
Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables | 0 | ---- | Buy | |
| 14 |
IS/ISO 10993-17 : 2002 ISO 10993-17 : 2002 |
Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances | 0 | ---- | Buy | |
| 15 |
IS/ISO 10993-18 : 2020 ISO 4126-2:2018 ISO 4126-2:2018 |
Biological evaluation of medical devices Part 18 Chemical characterization of medical device materials within a risk management process | 0 | ---- | Buy | |
| 16 |
IS/IEC/TS 10993-19 : 2006 ISO/TS 109993-19 : 2006 |
Biological Evaluation of Medical Devices Part 19 Physico-Chemical, Morphological and Topographical Characterization of Materials | 0 | ---- | Buy | |
| 17 |
IS/ISO/TS 10993-20 : 2006 ISO 26262-9:2018 |
Biological evaluation of medical devices Part 20 Principles and methods for immunotoxicology testing of medical devices | 0 | ---- | Buy | |
| 18 |
IS/ISO/TR 10993-22 : 2017 ISO/TR 10993-22:2017 |
Biological Evaluation of Medical Devices Part 22 Guidance on Nanomaterials | 0 | ---- | Buy | |
| 19 |
IS/ISO 13022 : 2012 ISO 13022:2012 |
Medical products containing viable human cells - Application of risk management and requirements for processing practices | 0 | ---- | Buy | |
| 20 |
IS/ISO 14155 : 2020 (First Revision) |
Clinical investigation of medical devices for human subjects - Good clinical practice | 0 | ---- | Buy | |
| 21 |
IS/ISO 15197 : 2013 Reviewed In : 2020 ISO 15197 : 2013 (First 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 | |
| 22 |
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 | |
| 23 |
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 | |
| 24 |
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 | |
| 25 |
IS 17713 : 2023 |
In-Vitro Diagnostic Devices - ELISA Plate Reader | 0 | ---- | Buy | |
| 26 |
IS 17714 : 2023 |
In-Vitro Diagnostic Devices - Automated ELISA Processor | 0 | ---- | Buy | |
| 27 |
IS 17715 : 2023 |
In-vitro Diagnostic Device - ELISA Plate Washer | 0 | ---- | Buy | |
| 28 |
IS 17717 (Part 1) : 2023 |
In-Vitro Diagnostic Device - Automated Clinical chemistry Analyzer - Part 1 Wet Chemistry Analyzer | 0 | ---- | Buy | |
| 29 |
IS 17717 (Part 2) : 2023 |
In-Vitro Diagnostic (IVD) Device - Automated Clinical Chemistry Analyzer Part 2 Dry Chemistry Analyzer | 0 | ---- | Buy | |
| 30 |
IS 17718 : 2022 |
Performance testing of In-vitro Diagnostics IVD Reagent Kit alpha - Amylase CNP-G3 Liquid Stable Clinical Chemistry Reagents/ Kits | 0 | ---- | Buy | |
| 31 |
IS 17719 : 2023 |
In-Vitro Diagnostic (IVD) Medical Device - Automatic Slide Staining Instrument | 0 | ---- | Buy | |
| 32 |
IS 17720 : 2023 |
In-vitro Diagnostic Device - Automated Blood Culture and Microbial Detection System | 0 | ---- | Buy | |
| 33 |
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) | 0 | ---- | Buy | |
| 34 |
IS 17724 (Part 2) : 2023 |
Safety Requirements for Electrical Equipment for Measurement, Control, And Laboratory Use Part 2 Particular Requirements for Laboratory Equipment used in Mixing and Stirring | 0 | ---- | Buy | |
| 35 |
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 | 0 | ---- | Buy | |
| 36 |
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) | 0 | ---- | Buy | |
| 37 |
IS 17784 (Part 1) : 2023 |
Electrical Equipment for Measurement, Control and Laboratory Use - EMC Requirements Part 1 General Requirements (IEC 61326-1: 2020, MOD) | 0 | ---- | Buy | |
| 38 |
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) | 0 | ---- | Buy | |
| 39 |
IS 17932 (Part 1) : 2023 |
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) | 0 | ---- | Buy | |
| 40 |
IS 17932 (Part 2) : 2024 |
Biological Evaluation of Medical Devices Part 2 Framework for identification and quantification of potential degradation products | 0 | ---- | Buy | |
| 41 |
IS 17932 (Part 3) : 2024 |
Biological Evaluation of Medical Devices Part 3 Identification and quantification of degradation products from metals and alloys | 0 | ---- | Buy | |
| 42 |
IS 17932 (Part 4) : 2024 |
Biological Evaluation of Medical Devices Part 4 Physico-chemical morphological and topographical characterization of materials | 0 | ---- | Buy | |
| 43 |
IS 17932 (Part 6) : 2023 |
Biological Evaluation of Medical Devices Part 6 Tests for skin sensitization (ISO 10993-10 : 2021, MOD) | 0 | ---- | Buy | |
| 44 |
IS/ISO 22442-1 : 2015 ISO 22442-1 : 2015 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management | 0 | ---- | Buy | |
| 45 |
IS/ISO 22442-2 : 2015 ISO 22442-2:2007 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 2 Controls on Sourcing, Collection and Handling | 0 | ---- | Buy | |
| 46 |
IS/ISO 22442-3 : 2007 IEC 60068-2-55:2013 |
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 | |
| 47 |
IS/ISO/TR 22442-4 : 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 | |
| 48 |
IS/ISO 23640 : 2011 ISO 23640 : 2011 |
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents | 0 | ---- | Buy | |
| 49 |
IS/ISO/TR 37137 : 2014 ISO/TR 37137:2014 |
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants | 0 | ---- | Buy | |
| 50 |
IS/IEC 61010-2-081 : 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 | |
| 51 |
IS/ISO 7405 : 2008 ISO 7405:2008 |
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | 0 | ---- | Buy |