Know Your Standard Standards under Mandatory Certification Group Wise Classification Ministry/Department Wise Classification
Total Standards : 57
Revised Standards
New Standards
| S.No | IS Number | IS Title | Amendment | Reaffirmation Year | Document | Action |
|---|---|---|---|---|---|---|
| 1 |
IS 10905 (Part 1) : 1984 Reviewed In : 2018 |
Recommendations for basic requirements of general hospital buildings: Part 1 Administrative and hospital services department buildings | 0 | Download | ||
| 2 |
IS 10905 (Part 2) : 1984 Reviewed In : 2018 |
Recommendations for basic requirements of general hospital buildings: Part 2 medical services department buildings | 0 | Download | ||
| 3 |
IS 10905 (Part 3) : 1984 Reviewed In : 2018 |
Recommendations for basic requirements of general hospital buildings: Part 3 engineering services department buildings | 0 | Download | ||
| 4 |
IS 12377 : 2016 (First Revision) |
Classification and matrix for various categories of hospitals (First Revision) | 0 | ---- | Download | |
| 5 |
IS 12433 (Part 1) : 1988 Reviewed In : 2018 |
Basic requirements for hospital planning: Part 1 up to 30 bedded hospital | 2 | Download | ||
| 6 |
IS 12433 (Part 2) : 2001 Reviewed In : 2018 |
Basic requirements for hospital planning: Part 2 up to 100 bedded hospital | 0 | Download | ||
| 7 |
IS/ISO 13485 : 2016 ISO 13485:2016 (First Revision) |
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) | 0 | ---- | Buy | |
| 8 |
IS 13808 (Part 1) : 1993 Reviewed In : 2018 |
Quality management procedures for out - Patient department (OPD) and emergency services - Guidelines: Part 1 upto 30 bedded hospitals | 1 | Download | ||
| 9 |
IS 13808 (Part 2) : 1993 Reviewed In : 2018 |
Quality management procedures for diagnostic and blood transfusion services - Guidelines: Part 1 up to 30 - Bedded hospitals | 1 | Download | ||
| 10 |
IS 13808 (Part 3) : 1995 Reviewed In : 2016 |
Quality management for hospital services (Upto 30 - Bedded Hospitals) - Guidelines: Part 3 wards, nursing services and operation theatre | 0 | Dec, 2016 | Download | |
| 11 |
IS 13808 (Part 4) : 1996 Reviewed In : 2016 |
Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 4 hospital support services | 0 | Dec, 2016 | Download | |
| 12 |
IS 13808 (Part 5) : 1996 Reviewed In : 2016 |
Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 5 hospital equipment management | 0 | Dec, 2016 | Download | |
| 13 |
IS/ISO 14971 : 2019 (First Revision) |
Medical devices - Application of risk management to medical devices First Revision | 0 | ---- | Download | |
| 14 |
IS/ISO 15189 : 2022 (Third Revision) |
Medical Laboratories Requirements for Quality and Competence Third Revision | 0 | ---- | Buy | |
| 15 |
IS/ISO 15190 : 2003 ISO 15190:2003 |
Medical Laboratories - Requirements for Safety | 0 | ---- | Buy | |
| 16 |
IS 15195 : 2002 Reviewed In : 2017 |
Performance guidelines for quality assurance in hospital services up to 30 - Bedded hospitals | 0 | Oct, 2017 | Download | |
| 17 |
IS/ISO 15195 : 2018 ISO 15195:2018 |
Laboratory Medicine - Requirements for the Competence of Calibration Laboratories Using Reference Measurement Procedures | 0 | ---- | Buy | |
| 18 |
IS/ISO 15223-1 : 2016 ISO 15223-1:2016 (Second Revision) |
Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision ) | 0 | ---- | Buy | |
| 19 |
IS/ISO 15223-2 : 2010 ISO 15223-2 : 2010 |
Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection and validation | 0 | ---- | Buy | |
| 20 |
IS 15461 : 2004 Reviewed In : 2019 |
Performance guidelines for quality assurance in hospital services up to 100 - Bedded hospitals | 0 | Jul, 2019 | Download | |
| 21 |
IS 15551 : 2003 Reviewed In : 2019 |
Quality management systems - Guidelines for process improvements in health service organizations | 0 | Dec, 2019 | Download | |
| 22 |
IS 15784 : 2007 Reviewed In : 2017 |
Healthcare facilities - Particular requirements | 0 | Sep, 2017 | Download | |
| 23 |
IS 15902 : 2011 Reviewed In : 2020 |
Guidelines For Nursing Home | 0 | Nov, 2020 | Download | |
| 24 |
IS 15903 : 2010 Reviewed In : 2020 |
Guidelines For Maternity Nursing Home | 0 | Nov, 2020 | Download | |
| 25 |
IS 15904 : 2011 Reviewed In : 2020 |
Guidelines For Single Doctor Clinic--Including Dental Clinic | 0 | Nov, 2020 | Download | |
| 26 |
IS/ISO 16142-1 : 2016 ISO 16142-1 : 2016 |
Medical Devices - Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards | 0 | ---- | Buy | |
| 27 |
IS/ISO 16142-2 : 2017 IS/ISO 16142-2: 2017 |
Medical devices - Recognized essential principles of safety and performance of medical devices: Part 2 General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards | 0 | ---- | Buy | |
| 28 |
IS 17722 : 2021 |
Guidance for supervisors and operators of point-of-care testing POCT devices | 0 | ---- | Download | |
| 29 |
IS/ISO 17822-1 : 2014 ISO 17822-1 : 2014 |
In vitro diagnostic test systems - Qualitative nucleic acid - Based in vitro examination procedures for detection and identification of microbial pathogens: Part 1 general requirements, terms and definitions | 0 | ---- | Buy | |
| 30 |
IS 17898 : 2023 |
Medical laboratories Requirements for safety (First Revision) | 0 | ---- | Buy | |
| 31 |
IS 17922 (Part 1) : 2023 |
Medical Devices Part 1: Application of Usability Engineering | 0 | ---- | Buy | |
| 32 |
IS 17964 (Part 20) : 2023 |
Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods | 0 | ---- | Buy | |
| 33 |
IS 18105 (Part 1) : 2023 |
Medical devices Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements | 0 | ---- | Buy | |
| 34 |
IS 18131 : 2023 |
In vitro diagnostic test systems Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens Laboratory quality practice guide (First Revision) | 0 | ---- | Buy | |
| 35 |
IS 18132 : 2023 |
Medical laboratories - Application of risk management | 0 | ---- | Buy | |
| 36 |
IS/ISO 18250-1 : 2018 ISO 11416 :1995 ISO 11416 :1995 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1 General requirements and common test methods | 0 | ---- | Buy | |
| 37 |
IS/ISO 18250-3 : 2018 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3 Enteral Applications | 1 | ---- | Buy | |
| 38 |
IS/ISO 18250-6 : 2019 IEC 61196-8:2012 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6 Neural Applications | 0 | ---- | Buy | |
| 39 |
IS/ISO 18250-7 : 2018 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 7 Connectors for intravascular infusion | 0 | ---- | Download | |
| 40 |
IS/ISO 18250-8 : 2018 19036 19036 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 8 Citrate-based anticoagulant solution for apheresis applications | 0 | ---- | Buy | |
| 41 |
IS 18325 : 2023 |
Medical laboratories Practical guidance for the estimation of measurement uncertainty | 0 | ---- | Buy | |
| 42 |
IS 18374 : 2023 |
Basic semen examination Specification and test methods | 0 | ---- | Buy | |
| 43 |
IS 18376 : 2023 |
Medical devices Post-market surveillance for manufacturers | 0 | ---- | Buy | |
| 44 |
IS/ISO 20417 : 2021 |
Medical devices Information to be supplied by the manufacturer | 0 | ---- | Buy | |
| 45 |
IS/ISO/TS 20658 : 2017 ISO/TS 20658:2017 |
Medical Laboratories - Requirements for Collection, Transport, Receipt, and Handling of Samples | 0 | ---- | Buy | |
| 46 |
IS/ISO 20776-1 : 2019 ISO 20776-1:2019 |
Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 1 Broth Micro-Dilution Reference Method for Testing the in vitro Activity of Antimicrobial Agents Against Rapidly Growing Aerobic Bacteria Involved in Infectious Diseases | 0 | ---- | Buy | |
| 47 |
IS/ISO 20776-2 : 2007 ISO 20776-2:2007 |
Clinical Laboratory Testing and In-vitro Diagnostic Test Systems - Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 2 Evaluation of Performance of Antimicrobial Susceptibility Test Devices | 0 | ---- | Buy | |
| 48 |
IS/ISO/TS 22367 : 2008 ISO/TS 22367:2008 |
Medical Laboratories - Reduction of Error through Risk Management and Continual Improvement | 0 | ---- | Buy | |
| 49 |
IS 23485 : 2019 |
Medical devices - Quality management system requirements and essential principles of safety and performance for medical devices | 0 | ---- | Download | |
| 50 |
IS/ISO/TR 24971 : 2020 (First Revision) |
Medical Devices Guidance on the Application of ISO 14971 (First Revision) | 0 | ---- | Buy | |
| 51 |
IS/ISO 35001 : 2019 ISO/IEC 29140:2021 |
Biorisk management for laboratories and other related organisations | 0 | ---- | Buy | |
| 52 |
IS/ISO 62304 : 2015 ISO 62304 : 2015 |
Medical device software - Software life cycle processes | 0 | ---- | Buy | |
| 53 |
IS/IEC/TR 62366-2 : 2016 IEC/TR 62366-2:2016 |
Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices | 0 | ---- | Buy | |
| 54 |
IS/ISO/TR 80002-2 : 2017 ISO/TR 80002-2:2017 |
Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems | 0 | ---- | Buy | |
| 55 |
IS/ISO 80369-1 : 2018 ISO 80369-1:2018 |
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements | 0 | ---- | Buy | |
| 56 |
IS/IEC 80369-5 : 2016 |
Small-bore connectors for liquids and gases in healthcare applications Part 5 Connectors for limb cuff inflation applications | 0 | ---- | Download | |
| 57 |
IS/IEC 80369-6 : 2016 |
Small bore connectors for liquids and gases in healthcare applications Part 6 Connectors for neuraxial applications | 0 | ---- | Buy |