Revised Standards : MHD 15


S.No. IS Number IS Title Revision Number Category Document Comment
1 IS 11789 : 2024 Determination of the Maximum Symmetrical Radiation Field of X-Ray Tube Assemblies and X-Ray Source Assemblies for Medical Diagnosis (IEC 60806 : 2022, MOD) (First Revision) 1 ------  Buy
2 IS 13450 : Part 1 : 2024 Medical electrical equipment Part 1 General requirements for basic safety and essential performance (Third Revision) 3 ------  Buy
3 IS 13450 : Part 1 : SEC 2 : 2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 2 Electromagnetic disturbances Requirements and tests (Second Revision) 2 ------  Buy
4 IS 13450 : Part 1 : Sec 3 : 2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 3 Radiation protection in diagnostic X-ray equipment (First Revision) 1 ------  Buy
5 IS 13450 : Part 1 : Sec 6 : 2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 6 Usability (First revision) 1 ------  Buy
6 IS 13450 : Part 1 : Sec 8 : 2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 8 General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (First Revision) 1 ------  Buy
7 IS 13450 : Part 1 : Sec 10 : 2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 10 Requirements for the development of physiologic closed-loop controllers (First Revision) 1 ------  Buy
8 IS 13450 : Part 1 : Sec 11 : 2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance , Section 11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (First Revison) 1 ------  Buy
9 IS 13450 : Part 2 : Sec 1 : 2018 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 1 Electron accelerators in the range 1 MeV to 50 MeV (First Revision) 1 Safety Standard  Buy
10 IS 13450 : PART 2 : SEC 4 : 2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators (First Revision) 1 Product Specification  Buy
11 IS 13450 : PART 2 : SEC 5 : 2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 5 ultrasonic physiotherapy equipment (First Revision) 1 Product Specification  Buy
12 IS 13450 : Part 2 : Sec 11 : 2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 11 gamma beam therapy equipment (First Revision) 1 Product Specification  Buy
13 IS 13450 : Part 2 : Sec 17 : 2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 17 automatically - Controlled brachytherapy afterloading equipment (First Revision) 1 Safety Standard  Buy
14 IS 13450 : Part 2 : Sec 19 : 2023 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 19 Infant Incubators First Revision 1 ------  Buy
15 IS 13450 : Part 2 : Sec 20 : 2023 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 20 Infant Transport Incubators First Revision 1 ------  Buy
16 IS 13450 : Part 2 : Sec 21 : 2023 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision 1 ------  Buy
17 IS 13450 : Part 2 : Sec 22 : 2021 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 22 surgical cosmetic therapeutic and diagnostic laser equipment First Revision 1 Product Specification  Download
18 IS 13450 : PART 2 : SEC 24 : 2019 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 24 infusion pumps and controllers (First Revision) 1 Product Specification  Buy
19 IS 13450 : Part 2 : Sec 26 : 2021 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 26 Electroencephalographs 1 Methods of tests  Buy
20 IS 13450 : Part 2 : Sec 29 : 2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 29 radiotherapy simulators (First Revision) 1 Product Specification  Buy
21 IS 13450 : Part 2 : Sec 31 : 2021 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 31 External Cardiac Pacemakers with Internal Power Source First Revision 1 Code of Practice  Buy
22 IS 13450 : Part 2 : Sec 43 : 2016 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 43 X-ray equipment for interventional procedures (First Revision) 1 Safety Standard  Buy
23 IS 13450 : Part 2 : Sec 44 : 2016 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 44 X-ray equipment for computed tomography (First Revision) 1 Safety Standard  Buy
24 IS 13450 : Part 2 : Sec 45 : 2016 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 45 mammographic X-ray equipment and mammographic stereotactic devices (First Revision) 1 Safety Standard  Buy
25 IS 14180 : 2019 Graphical symbols for electrical equipment in medical practice (First Revision) 1 Terminology  Buy
26 IS/ISO 14708 : Part 2 : 2019 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers First Revision 1 Methods of tests  Buy
27 IS/IEC 61675 : Part 1 : 2022 Radionuclide Imaging Devices — Characteristics and Test Conditions Part 1 Positron Emission Tomographs (First Revision) 1 ------  Buy
28 IS/IEC62353 : 2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (First Revision) 1 Others  Buy
29 IS 7620 : Part 1 : 1986 Specification for diagnostic medical X-ray equipment: Part 1 general and safety requirements (First Revision) 1 Product Specification  Download
30 IS 7620 : Part 2 : 1986 Specification for diagnostic medical X-ray equipment: Part 2 performance requirements (First Revision) 1 Product Specification  Download
31 IS/ISO 80601 : Part 2 : Sec 61 : 2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 1 Methods of tests  Buy