Revised Standards    New Standards

Standards List

S.No IS Number IS Title Category Reaffirmation Year Scope
1 IS 10905 : Part 1 : 1984
Recommendations for basic requirements of general hospital buildings: Part 2 medical services department buildings Code of Practice 2018 Download
2 IS 10905 : Part 2 : 1984
Recommendations for basic requirements of general hospital buildings: Part 2 medical services department buildings Code of Practice 2018 Download
3 IS 10905 : Part 3 : 1984
Recommendations for basic requirements of general hospital buildings: Part 3 engineering services department buildings Code of Practice 2018 Download
4 IS 12377 : 2016
(1 Revision)
Classification and matrix for various categories of hospitals (First Revision) Code of Practice 0 Download
5 IS 12433 : Part 1 : 1988
Basic requirements for hospital planning: Part 1 up to 30 bedded hospital Code of Practice 2018 Download
6 IS 12433 : Part 2 : 2001
Basic requirements for hospital planning: Part 2 up to 100 bedded hospital Code of Practice 2018 Download
7 IS 13808 : Part 1 : 1993
Quality management procedures for out - Patient department (OPD) and emergency services - Guidelines: Part 1 upto 30 bedded hospitals System Standard 2018 Download
8 IS 13808 : Part 2 : 1993
Quality management procedures for diagnostic and blood transfusion services - Guidelines: Part 1 up to 30 - Bedded hospitals System Standard 2018 Download
9 IS 13808 : Part 3 : 1995
Quality management for hospital services (Upto 30 - Bedded Hospitals) - Guidelines: Part 3 wards, nursing services and operation theatre System Standard 2016, Dec Download
10 IS 13808 : Part 4 : 1996
Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 4 hospital support services System Standard 2016, Dec Download
11 IS 13808 : Part 5 : 1996
Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 5 hospital equipment management System Standard 2016, Dec Download
12 IS 15195 : 2002
Performance guidelines for quality assurance in hospital services up to 30 - Bedded hospitals System Standard 2017, Oct Download
13 IS 15461 : 2004
Performance guidelines for quality assurance in hospital services up to 100 - Bedded hospitals System Standard 2019, Jul Download
14 IS 15551 : 2003
Quality management systems - Guidelines for process improvements in health service organizations System Standard 2019, Dec Download
15 IS 15784 : 2007
Healthcare facilities - Particular requirements System Standard 2017, Sep Download
16 IS 15902 : 2011
Guidelines For Nursing Home Code of Practice 2020, Nov Download
17 IS 15903 : 2010
Guidelines For Maternity Nursing Home Code of Practice 2020, Nov Download
18 IS 15904 : 2011
Guidelines For Single Doctor Clinic--Including Dental Clinic Code of Practice 2020, Nov Download
19 IS 23485 : 2019
Medical devices - Quality management system requirements and essential principles of safety and performance for medical devices System Standard 0 Download
20 IS/IEC 62366 : Part 1 : 2015/IEC 62366-1:2015
Medical Devices Part 1 Application of Usability Engineering to Medical Devices Code of Practice 0 Buy
21 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 Code of Practice 0 Buy
22 IS/ISO 13485 : 2016/ISO 13485:2016
(1 Revision)
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) System Standard 0 Buy
23 IS/ISO 14971 : 2019/ISO 14971 : 2007
(1 Revision)
Medical devices - Application of risk management to medical devices First Revision Code of Practice 0 Buy
24 IS/ISO 15189 : 2012/ISO 15189 : 2012
(2 Revision)
Medical laboratories - Requirements for quality and competence (Second Revision) System Standard 2019, May Buy
25 IS/ISO 15190 : 2003/ISO 15190:2003
Medical Laboratories — Requirements for Safety Code of Practice 0 Buy
26 IS/ISO 15195 : 2018/ISO 15195:2018
Laboratory Medicine — Requirements for the Competence of Calibration Laboratories Using Reference Measurement Procedures Methods of tests 0 Buy
27 IS/ISO 15197 : 2013/ISO 15197 : 2013
(1 Revision)
In vitro Diagnostic Test Systems —Requirements for Blood-GlucoseMonitoring System for Self-Testingin Managing Diabetes Mellitus Methods of tests 2020, Jan Buy
28 IS/ISO 15198 : 2004/ISO 15198:2004
Clinical Laboratory Medicine — In vitro Diagnostic Medical Devices — Validation of User Quality Control Procedures by the Manufacturer Code of Practice 0 Buy
29 IS/ISO 15223 : Part 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 ) Code of Practice 0 Buy
30 IS/ISO 15223 : Part 2 : 2010/ISO 15223-2 : 20
Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection and validation Code of Practice 0 Buy
31 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 Saftey Standard 0 Buy
32 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 Methods of tests 0 Buy
33 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 Terminology 0 Buy
34 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 Methods of tests 0 Buy
35 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 Methods of tests 0 Buy
36 IS/ISO 23640 : 2011/ISO 23640 : 2011
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents Methods of tests 0 Buy
37 IS/ISO 62304 : 2015/IEC 62220-1-1:2015
Medical device software - Software life cycle processes Methods of tests 0 Buy
38 IS/ISO 80369 : Part 1 : 2018/ISO 80369-1:2018
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements Product Specification 0 Buy
39 IS/ISO/TR 24971 : 2013/ISO 23640 : 2011
Medical devices - Guidance on the application of ISO 14971 Methods of tests 0 Buy
40 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 Code of Practice 0 Buy
41 IS/ISO/TS 20658 : 2017/ISO/TS 20658:2017
Medical Laboratories — Requirements for Collection, Transport, Receipt, and Handling of Samples Code of Practice 0 Buy
42 IS/ISO/TS 22367 : 2008/ISO/TS 22367:2008
Medical Laboratories — Reduction of Error through Risk Management and Continual Improvement System Standard 0 Buy