MHD 15-Electromedical, Diagnostic Imaging and Radiotherapy Equipment  Standards List



Total Standards :  97

Revised Standards    New Standards
S.No IS Number IS Title Amendment Reaffirmation Year Document Action
1 IS 13450 : Part 2 : Sec 34 : 2019/IEC 60601-2-34_2011
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 34 Invasive blood pressure monitoring equipment 0 ---- Buy
2 IS/IEC 80601 : Part 2 : Sec 49 : 2018/IEC 80601-2-49:2018
Medical electrical equipment Part 2- Particular requirements for basic safety and essential performance- Sec 49 Multifunction patient monitors 0 ---- Buy
3 IS 11478 : 2018/IEC/TR 60930 : 2008
Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems (First Revision) 0 Aug, 2023 Buy
4 IS/IEC/TS 62566 : 2014/IEC TS 62556 : 2014
Ultrasonics — Field Characterization — Specification and Measurement of Field Parameters for High Intensity Therapeutic Ultrasound ( HITU ) Transducers and Systems 0 ---- Buy
5 IS 13450 : Part 1 : Sec 11 : 2024
(1 Revision)
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) 0 ---- Buy
6 IS 13450 : Part 2 : Sec 45 : 2016/IEC 60601-2-45:2011
(1 Revision)
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) 0 May, 2021 Buy
7 IS 13450 : Part 2 : Sec 31 : 2021/IEC 60601-2-31:2020
(1 Revision)
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 0 ---- Buy
8 IS 13450 : Part 2 : Sec 25 : 2018/IEC 60601-2-25:2011 Medical electrical equipment - Part 2 Particular requirements for the basic safe
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs 1 Mar, 2023 Buy
9 IS/IEC 60336 : 2005/IEC 60336:2005
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots 0 Oct, 2020 Buy
10 IS 14180 : 2019/IEC 878
(1 Revision)
Graphical symbols for electrical equipment in medical practice (First Revision) 0 ---- Buy
11 IS/IEC 60335 : Part 2 : Sec 27 : 2009/IEC 60335-2-27 : 200
Household and Similar Electrical Appliances Safety Part 2-27 Particular Requirements for Appliances for Skin Exposure to Optical Radiation 0 ---- Buy
12 IS 13450 : Part 2 : Sec 47 : 2018/IEC 60601-1-2 : 2014
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 47 ambulatory electrocardiographic systems 0 Jun, 2023 Buy
13 IS 13450 : Part 2 : Sec 68 : 2020/IEC 60601-2-68 : 201
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 68 X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment 0 ---- Buy
14 IS 11393 : 1985
Specification for scintillation counters 0 Dec, 2021 Download
15 IS 13450 : Part 2 : Sec 11 : 2018/IEC 60601-2-11 : 201
(1 Revision)
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 11 gamma beam therapy equipment (First Revision) 0 Aug, 2023 Buy
16 IS/IEC 61675 : Part 2 : 2015/IEC 61675-2 : 2015
Radionuclide imaging devices - Characteristics and test conditions: Part 2 gamma cameras for planar, whole body, and spect imaging 0 ---- Buy
17 IS 13450 : Part 2 : Sec 54 : 2016/IEC 60601-2-54:2009
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 54 X-ray equipment for radiography and radioscopy 2 May, 2021 Buy
18 IS 7620 : Part 3 : 1991
Medical electrical equipment - Diagnostic X-ray equipmbnts: Part 3 radiation safety requirements 0 Dec, 2016 Download
19 IS/IEC 61685 : 2001/IS/IEC 61685:2001
Ultrasonics - Flow measurement systems - Flow test object 0 ---- Buy
20 IS 13450 : Part 2 : Sec 62 : 2018/IEC 60601-2-62 : 2013
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 62 high intensity therapeutic ultrasound (Hitu) equipment 0 Aug, 2023 Buy
21 IS/ISO 80601 : Part 2 : Sec 61 : 2017/ISO 80601-2-61:2017
(1 Revision)
Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 0 ---- Buy
22 IS 13450 : Part 2 : Sec 8 : 2019/IEC 60601-2-8_2010
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 8 Therapeutic X-ray equipment operating in the range 10 kV to 1 MV 0 ---- Buy
23 IS/IEC 80601 : Part 2 : Sec 58 : 2016/IEC 80601-2-58:2016
Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 58 Lens removal devices and vitrectomy devices for ophthalmic surgery 0 ---- Buy
24 IS 13450 : PART 2 : SEC 4 : 2018/IEC 60601-2-4 : 2010
(1 Revision)
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators (First Revision) 1 Aug, 2023 Buy
25 IS/IEC 61168 : 1993/IEC 61168:1993
Radiotherapy simulators - Functional performance characteristics 0 ---- Buy
26 IS 13450 : Part 1 : Sec 6 : 2024
(1 Revision)
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 6 Usability (First revision) 0 ---- Buy
27 IS 13450 : Part 2 : Sec 43 : 2016/IEC 6060-2-43:2010
(1 Revision)
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 43 X-ray equipment for interventional procedures (First Revision) 2 May, 2021 Buy
28 IS 13450 : PART 2 : SEC 24 : 2019/IEC 60601-2-24 : 201
(1 Revision)
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 24 infusion pumps and controllers (First Revision) 0 ---- Buy
29 IS/ISO 14708 : Part 2 : 2019/ISO 14708-2:2019
(1 Revision)
Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers First Revision 0 ---- Buy
30 IS/IEC 61262 : PART 1 : 1994/IEC 61262-1:1994
Medical Electrical Equipment - Characteristics of Electro-Optical X-Ray Image Intensifiers 0 Feb, 2020 Buy
31 IS/ISO 80601-2-56 : 2017 : 2017/ISO 80601-2-56 : 201
Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 56 clinical thermometers for body temperature measurement 1 ---- Buy
32 IS/IEC 61331 : Part 3 : 2014/IEC 61331-3 : 2014
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS 0 ---- Buy
33 IS 13450 : Part 1 : SEC 2 : 2024
(2 Revision)
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 2 Electromagnetic disturbances Requirements and tests (Second Revision) 0 ---- Buy
34 IS 13450 : Part 2 : Sec 52 : 2020/IEC 60601-2-52_2018
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 52 Medical beds 0 ---- Buy
35 IS 7620 : Part 1 : 1986
(1 Revision)
Specification for diagnostic medical X-ray equipment: Part 1 general and safety requirements (First Revision) 3 Dec, 2019 Download
36 IS 13450 : Part 1 : Sec 12 : 2024
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 12 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment 0 ---- Buy
37 IS/ISO 13450 : Part 2 : Sec 10 : 2018/IEC 60601-2-10 : 2012
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 10 Nerve and muscle stimulators 0 Mar, 2023 Buy
38 IS 13450 : Part 2 : Sec 10 : 2018/IEC 60601-2-10 : 2012
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 10 nerve and muscle stimulators 0 Jul, 2023 Buy
39 IS/IEC 61217 : 2011/IEC 61217:2011
Radiotherapy Equipment - Coordinates, Movements and Scales 0 ---- Buy
40 IS 7620 : Part 2 : 1986
(1 Revision)
Specification for diagnostic medical X-ray equipment: Part 2 performance requirements (First Revision) 1 Dec, 2019 Download
41 IS 13450 : Part 2 : Sec 76 : 2019/IS/IEC 60601-2-76
Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 76 low energy ionized gas haemostasis equipment 0 ---- Buy
42 IS 13450 : Part 2 : Sec 26 : 2021/IEC 60601-2-26 : 2012
(1 Revision)
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 26 Electroencephalographs 0 ---- Buy
43 IS 13450 : Part 1 : Sec 3 : 2024
(1 Revision)
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 3 Radiation protection in diagnostic X-ray equipment (First Revision) 0 ---- Buy
44 IS 13450 : Part 1 : Sec 10 : 2024
(1 Revision)
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) 0 ---- Buy
45 IS/IEC 62083 : 2009/IEC 62083:2009
Medical electrical equipment Requirements for the safety of radiotherapy treatment planning systems 0 ---- Buy
46 IS 13450 : Part 2 : Sec 17 : 2018/IEC 60601 -2-17 : 2018
(1 Revision)
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 17 automatically - Controlled brachytherapy afterloading equipment (First Revision) 0 Aug, 2023 Buy
47 IS/IEC62353 : 2014/IEC 62353:2014
(1 Revision)
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (First Revision) 0 Dec, 2017 Buy
48 IS/IEC 62220 : Part 1 : Sec 1 : 2015/IEC 62220-1-1:2015
Medical Electrical Equipment — Characteristics of Digital X-ray Imaging Devices Part 1-1 Determination of the Detective Quantum Efficiency — Detectors Used in Radiographic Imaging 0 ---- Buy
49 IS 13450 : Part 1 : 2024
(3 Revision)
Medical electrical equipment Part 1 General requirements for basic safety and essential performance (Third Revision) 0 ---- Buy
50 IS 13450 : Part 2 : Sec 22 : 2021/IEC 60601-2-22:2019
(1 Revision)
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 22 surgical cosmetic therapeutic and diagnostic laser equipment First Revision 0 ---- Buy
51 IS/IEC 62220 : Part 1 : Sec 2 : 2007/IEC 62220-1-2 : 2007
Medical electrical equipment - Characteristics of digital X-ray imaging devices: Part 1 - 2 determination of the detective quantum efficiency detectors used in mammography 0 May, 2022 Buy
52 IS/IEC 61262 : PART 2 : 1994/IEC 61262-2:1994
Medical electrical equipment characteristics of electro - Optical X-ray image intensifiers: Part 2 determination of the conversion factor 0 Dec, 2019 Buy
53 IS/IEC/TS 62556 : 2014/IEC TS 62556 : 2014
Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems 0 ---- Buy
54 IS/IEC 61331 : Part 1 : 2014/IEC 61331-1 : 2014
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 1: DETERMINATION OF ATTENUATION PROPERTIES OF MATERIALS 0 ---- Buy
55 IS 13450 : Part 2 : Sec 1 : 2018/IEC 60601-2-1 :2009
(1 Revision)
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) 0 Mar, 2023 Buy
56 IS 13450 : Part 2 : Sec 46 : 2020/IEC 60601-2-46_2016
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 46 Operating tables 0 ---- Buy
57 IS 13450 : Part 2 : Sec 3 : 2022/60601-2-3:2012
Medical electrical equipment Part 2- Particular requirements for basic safety and essential performance- Sec 3 Short wave therapy equipment 0 ---- Buy
58 IS 13450 : Part 2 : Sec 6 : 2018/IEC 60601-2-6 : 2012
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 6 microwave therapy equipment 0 Aug, 2023 Buy
59 IS 13450 : Part 2 : Sec 33 : 2018/IEC 60601-2-33:2010
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 33 magnetic resonance equipment for medical diagnosis 0 Dec, 2023 Buy
60 IS 13450 : Part 2 : Sec 41 : 2020/IEC 60601-2-41:2009
Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis 0 ---- Buy
61 IS 15584 : 2005
Medical X-ray films 0 Jul, 2022 Download
62 IS 13450 : Part 2 : Sec 39 : 2019/IEC 60601-2-39_2018
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 39 peritoneal dialysis equipment 0 ---- Buy
63 IS/IEC 61331 : Part 2 : 2014
Protective Devices Against Diagnostic Medical X-Radiation Part 2 Translucent Protective Plates 0 ---- Buy
64 IS/IEC 61262 : PART 3 : 1994/IEC 61262-1:1994
Medical electrical equipment - Characteristics of Electro - Optical X-ray image intensifiers: Part 3 determination of the luminance distribution and luminance non - Uniformity 0 Dec, 2021 Buy
65 IS 13450 : Part 1 : Sec 8 : 2024
(1 Revision)
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) 0 ---- Buy
66 IS/IEC 61676 : 2002/IEC 61676:2002
Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology 0 ---- Buy
67 IS 13450 : Part 2 : Sec 23 : 2018/IEC 60601-2-23 : 2011
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 23 transcutaneous partial pressure monitoring equipment 1 Aug, 2023 Buy
68 IS 13450 : Part 2 : Sec 29 : 2018/IEC 60601-2-29:2008
(1 Revision)
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 29 radiotherapy simulators (First Revision) 0 Oct, 2023 Buy
69 IS 13450 : Part 2 : Sec 40 : 2020/IEC 60601-2-40_2016
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 40 Electromyographs and evoked response equipment 0 ---- Buy
70 IS 11789 : 2024
(1 Revision)
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) 0 ---- Buy
71 IS 13450 : Part 2 : Sec 16 : 2019/IEC 60601-2-2_2017
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 16 haemodialysis, haemodiafiltration and haemofiltration equipment 0 ---- Buy
72 IS 13450 : Part 2 : Sec 65 : 2016/IEC 60601-2-65:2012
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 65 dental intra - Oral X-ray equipmen 1 May, 2021 Buy
73 IS 13450 : Part 2 : Sec 44 : 2016/IEC 60601-2-44:2009
(1 Revision)
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 May, 2021 Buy
74 IS/IEC/TR 61948 : Part 3 : 2018/IS/IEC TR 61948-3:20
Nuclear medicine instrumentation - Routine tests: Part 3 positron emission tomographs 0 Apr, 2023 Buy
75 IS/IEC 62220 : Part 1 : Sec 3 : 2008/IEC 62220-1-3:2008
Medical electrical equipment-characteristics of digital X-ray imaging devices – Part:1-3 Determination of the detective quantum efficiency - Detectors used in dynamic imaging 0 ---- Buy
76 IS/IEC 61262 : Part 4 : 1994/IEC 61262-4:1994
Medical Electrical Equipment - Characteristics of Electro-Optical X-Ray Image Intensifiers Part 4 Determination of the Image Distortion 0 Apr, 2020 Buy
77 IS/IEC 80601 : Part 2 : Sec 59 : 2017/IEC 60601-2-59:2017
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 59 Screening thermographs for human febrile temperature screening 0 ---- Buy
78 IS 13450 : Part 2 : Sec 50 : 2022/IEC 60601-2-50:2020
Medical electrical equipment Part 2 Particular requirements for the Basic Safety and essential performance Section 50 Infant Phototherapy Equipment 0 ---- Buy
79 IS 13450 : PART 2 : SEC 5 : 2018/IEC 60601-2-5 : 2009
(1 Revision)
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 5 ultrasonic physiotherapy equipment (First Revision) 0 Aug, 2023 Buy
80 IS/IEC 61170 : 1993/IEC 61170:1993
Radiotherapy simulators - Guidelines for functional performance characteristics 0 ---- Buy
81 IS/IEC 80601 : Part 2 : Sec 35 : 2009/IEC 80601-2-35:2009
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets, pads or mattresses and intended for heating in medical use 0 ---- Buy
82 IS 13709 : 1993
Medical electrical equipment - Dental X-ray equipment radiation safety 0 Download
83 IS 13450 : Part 2 : Sec 37 : 2019/IEC 60601-2-37_2007
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 37 ultrasonic medical diagnostic and monitoring equipment 0 ---- Buy
84 IS 13450 : Part 2 : Sec 27 : 2018/IEC 60601-2-27:2011
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment 0 Mar, 2023 Buy
85 IS/IEC/TR 60788 : 2004/IEC/TR 60788:2004
Medical electrical equipment - Glossary of defined terms 0 Apr, 2020 Buy
86 IS/ISO/TS 10974 : 2018/ISO 10974 : 2018
Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device 0 ---- Buy
87 IS/IEC 60580 : 2019/IEC 60580:2019
Medical electrical equipment Dose area product meters 0 ---- Buy
88 IS/IEC 61689 : 2013/IEC 61689 : 2013
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 mhz to 5 mhz 0 Jun, 2023 Buy
89 IS/IEC 61675 : Part 1 : 2013/IEC 61675-1 : 2013
Radionuclide imaging devices - Characteristics and test conditions: Part 1 positron emission tomographs 0 Mar, 2023 Buy
90 IS/IEC 62563 : Part 1 : 2016
Medical Electrical Equipment — Medical Image Display System Part 1 Evaluation Method 0 ---- Buy
91 IS 11753 : 1986
Specification for electrical impedance plethysmograph 0 Dec, 2021 Download
92 IS 13450 : Part 2 : Sec 2 : 2019/IEC 60601-2-28:2010
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 2 high frequency surgical equipment and high frequency surgical accessories 0 ---- Buy
93 IS 13450 : Part 2 : Sec 63 : 2016/IEC 60601-2-63:2012
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 63 dental extra - Oral X-ray equipment 1 May, 2021 Buy
94 IS/ISO 4090 : 2001
Photography - Medical radiographic cassettes/screens/films and hard - Copy imaging films - Dimensions and specifications 0 Jul, 2023 Download
95 IS/IEC 61847 : 1998/IS/IEC 61847:1998
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics 0 ---- Buy
96 IS 13450 : Part 2 : Sec 36 : 2019/IEC 60601-2-36:2014
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 36 equipment for extra corporeally induced lithotripsy 0 ---- Buy
97 IS 13450 : Part 2 : Sec 18 : 2014/IEC 60601-2-18 : 2009
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 18 endoscopic equipment 0 Nov, 2019 Buy