Total Standards : 47
Revised Standards
New Standards
| S.No | IS Number | IS Title | Amendment | Reaffirmation Year | Document | Action |
|---|---|---|---|---|---|---|
| 1 | IS/ISO/TR 80002 : Part 2 : 2017/ISO/TR 80002-2:2017 |
Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems | 0 | ---- | Buy | |
| 2 | IS/ISO 18250 : Part 3 : 2018/ISO 18250-3:2018 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3 Enteral Applications | 1 | ---- | Buy | |
| 3 | IS 13808 : Part 1 : 1993 |
Quality management procedures for out - Patient department (OPD) and emergency services - Guidelines: Part 1 upto 30 bedded hospitals | 1 | Download | ||
| 4 | IS 15902 : 2011 |
Guidelines For Nursing Home | 0 | Nov, 2020 | Download | |
| 5 | IS/ISO 15190 : 2003/ISO 15190:2003 |
Medical Laboratories - Requirements for Safety | 0 | ---- | Buy | |
| 6 | IS/ISO 13485 : 2016/ISO 13485:2016 (1 Revision) |
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) | 0 | ---- | Buy | |
| 7 | IS 10905 : Part 2 : 1984 |
Recommendations for basic requirements of general hospital buildings: Part 2 medical services department buildings | 0 | Download | ||
| 8 | IS/IEC 80369 : Part 5 : 2016/IEC 80369-5:2016 |
Small-bore connectors for liquids and gases in healthcare applications Part 5 Connectors for limb cuff inflation applications | 0 | ---- | Buy | |
| 9 | IS 13808 : Part 5 : 1996 |
Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 5 hospital equipment management | 0 | Dec, 2016 | Download | |
| 10 | IS/ISO 62304 : 2015/ISO 62304 : 2015 |
Medical device software - Software life cycle processes | 0 | ---- | Buy | |
| 11 | IS/ISO/TS 22367 : 2008/ISO/TS 22367:2008 |
Medical Laboratories - Reduction of Error through Risk Management and Continual Improvement | 0 | ---- | Buy | |
| 12 | IS/ISO 18250 : Part 6 : 2019/ISO 18250-6:2019 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6 Neural Applications | 0 | ---- | Buy | |
| 13 | IS 12433 : Part 2 : 2001 |
Basic requirements for hospital planning: Part 2 up to 100 bedded hospital | 0 | Download | ||
| 14 | IS 15784 : 2007 |
Healthcare facilities - Particular requirements | 0 | Sep, 2017 | Download | |
| 15 | IS/ISO 20417 : 2021/ISO 20417:2021 |
Medical devices Information to be supplied by the manufacturer | 0 | ---- | Buy | |
| 16 | IS/ISO 16142 : Part 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 | |
| 17 | IS/ISO 15223 : Part 1 : 2016/ISO 15223-1:2016 (2 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 | |
| 18 | IS 10905 : Part 1 : 1984 |
Recommendations for basic requirements of general hospital buildings: Part 1 Administrative and hospital services department buildings | 0 | Download | ||
| 19 | IS/IEC 80369 : Part 6 : 2016/ISO 80369-6:2016 |
Small bore connectors for liquids and gases in healthcare applications Part 6 Connectors for neuraxial applications | 0 | ---- | Buy | |
| 20 | IS 13808 : Part 4 : 1996 |
Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 4 hospital support services | 0 | Dec, 2016 | Download | |
| 21 | IS/ISO 15223 : Part 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 | |
| 22 | IS/ISO 20776 : Part 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 | |
| 23 | IS/ISO 18250 : Part 1 : 2018/ISO 18250-1:2018 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1 General requirements and common test methods | 0 | ---- | Buy | |
| 24 | IS 12433 : Part 1 : 1988 |
Basic requirements for hospital planning: Part 1 up to 30 bedded hospital | 2 | Download | ||
| 25 | IS 15551 : 2003 |
Quality management systems - Guidelines for process improvements in health service organizations | 0 | Dec, 2019 | Download | |
| 26 | IS/ISO 35001 : 2019/ISO 35001:2019 |
Biorisk management for laboratories and other related organisations | 0 | ---- | Buy | |
| 27 | IS 23485 : 2019 |
Medical devices - Quality management system requirements and essential principles of safety and performance for medical devices | 0 | ---- | Download | |
| 28 | IS/ISO 80369 : Part 1 : 2018/ISO 80369-1:2018 |
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements | 0 | ---- | Buy | |
| 29 | IS/ISO 18250 : Part 8 : 2018/ISO 18250-8:2018 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 8 Citrate-based anticoagulant solution for apheresis applications | 0 | ---- | Buy | |
| 30 | IS 13808 : Part 3 : 1995 |
Quality management for hospital services (Upto 30 - Bedded Hospitals) - Guidelines: Part 3 wards, nursing services and operation theatre | 0 | Dec, 2016 | Download | |
| 31 | IS 15904 : 2011 |
Guidelines For Single Doctor Clinic--Including Dental Clinic | 0 | Nov, 2020 | Download | |
| 32 | IS/ISO 20776 : Part 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 | |
| 33 | IS/IEC/TR 62366 : Part 2 : 2016/IEC/TR 62366-2:2016 |
Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices | 0 | ---- | Buy | |
| 34 | IS 12377 : 2016 (1 Revision) |
Classification and matrix for various categories of hospitals (First Revision) | 0 | ---- | Download | |
| 35 | IS 15461 : 2004 |
Performance guidelines for quality assurance in hospital services up to 100 - Bedded hospitals | 0 | Jul, 2019 | Download | |
| 36 | IS 17723 : 2021/ISO 22870:2016 |
Point-of-care testing POCT Requirements for quality and competence | 0 | ---- | Buy | |
| 37 | IS/ISO 14971 : 2019/ISO 14971 : 2019 (1 Revision) |
Medical devices - Application of risk management to medical devices First Revision | 0 | ---- | Buy | |
| 38 | IS/ISO 15195 : 2018/ISO 15195:2018 |
Laboratory Medicine - Requirements for the Competence of Calibration Laboratories Using Reference Measurement Procedures | 0 | ---- | Buy | |
| 39 | IS/ISO 18250 : Part 7 : 2018/ISO 18250-7:2018 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 7 Connectors for intravascular infusion | 0 | ---- | Buy | |
| 40 | IS 13808 : Part 2 : 1993 |
Quality management procedures for diagnostic and blood transfusion services - Guidelines: Part 1 up to 30 - Bedded hospitals | 1 | Download | ||
| 41 | IS 15903 : 2010 |
Guidelines For Maternity Nursing Home | 0 | Nov, 2020 | Download | |
| 42 | IS/ISO/TS 20658 : 2017/ISO/TS 20658:2017 |
Medical Laboratories - Requirements for Collection, Transport, Receipt, and Handling of Samples | 0 | ---- | Buy | |
| 43 | IS/ISO 17822 : Part 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 | |
| 44 | IS 10905 : Part 3 : 1984 |
Recommendations for basic requirements of general hospital buildings: Part 3 engineering services department buildings | 0 | Download | ||
| 45 | IS 17722 : 2021/ISO/TS 22583:2019 |
Guidance for supervisors and operators of point-of-care testing POCT devices | 0 | ---- | Buy | |
| 46 | IS 15195 : 2002 |
Performance guidelines for quality assurance in hospital services up to 30 - Bedded hospitals | 0 | Oct, 2017 | Download | |
| 47 | IS/ISO 16142 : Part 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 |