Revised Standards    New Standards

Standards List

S.No IS Number IS Title Category Reaffirmation Year Scope
1 IS 10550 : 1983
Specification for medical treatment lamps Product Specification 2016, Dec Download
2 IS 11302 : Part 2 : 1985
Specification for electroencephalograph (EEG): Part 2 performance requirements Product Specification 2016, Dec Download
3 IS 11393 : 1985
Specification for scintillation counters Product Specification 2016, Dec Download
4 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 Buy
5 IS 11701 : 1986
Guide for testing and calibration of ultrasonic therapeutic equipment Code of Practice 2021, Feb Download
6 IS 11753 : 1986
Specification for electrical impedance plethysmograph Product Specification 2016, Dec Download
7 IS 11789 : 1986
Determination of the maximum symmetrical radiation field in the radiation beam from a rotating anode X-ray tube for medical diagnosis Methods of tests 2016, Dec Download
8 IS 13450 : Part 1 : 2018/IEC 60601-1:2012 (Ed
(2 Revision)
Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) Methods of tests 0 Buy
9 IS 13450 : Part 1 : Sec 10 : 2019/IEC 60601-1-10_2007
Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral standard: Requirements for the development of physiologic closed-loop controllers Product Specification 0 Buy
10 IS 13450 : Part 1 : Sec 11 : 2020/IEC 60601-1-11:2015
Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment System Standard 0 Buy
11 IS 13450 : Part 1 : SEC 2 : 2018
(1 Revision)
Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision) Saftey Standard 0 Buy
12 IS 13450 : Part 1 : Sec 3 : 2014/IEC60601-3 : 2008
Medical electrical equipment: Part 1 general requirements for basic safety and essential performance: Sec 3 collateral standard: radiation protection in diagnostic X-ray equipment Product Specification 2019, Dec Buy
13 IS 13450 : Part 1 : Sec 6 : 2020/IEC 60601-1-6:2013
Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 6 Collateral standard: Usability Others 0 Buy
14 IS 13450 : Part 1 : Sec 8 : 2019/IEC 60601-1-8:2006
Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 8 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Product Specification 0 Buy
15 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) Saftey Standard 0 Buy
16 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 Buy
17 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) Product Specification 0 Buy
18 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 Product Specification 0 Buy
19 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) Saftey Standard 0 Buy
20 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 Product Specification 2019, Nov Buy
21 IS 13450 : Part 2 : Sec 19 : 2018/IEC 60601-2-19 : 2009
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 19 baby incubator 0 Buy
22 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 Product Specification 0 Buy
23 IS 13450 : Part 2 : Sec 20 : 2018/IEC 60601-2-20 : 2009
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 20 infant transport incubators 0 Buy
24 IS 13450 : Part 2 : Sec 21 : 2018/IEC 60601-2-21:2009
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 21 infant radiant warmer Product Specification 0 Buy
25 IS 13450 : Part 2 : Sec 22 : 2019/IS/IEC 60601-2-22:20
Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 22 surgical, cosmetic, therapeutic and diagnostic laser equipment Product Specification 0 Buy
26 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 0 Buy
27 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) Product Specification 0 Buy
28 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 Product Specification 0 Buy
29 IS 13450 : Part 2 : Sec 26 : 2018/IEC 60601-2-26 : 2012
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 26 Electroencephalographs 0 Buy
30 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 Product Specification 0 Buy
31 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) Product Specification 0 Buy
32 IS 13450 : Part 2 : Sec 30 : 2008/IEC 60601-2-30
Medical electrical equipment: Part 2 particular requirements for the safety: Sec 30 essential performance of automatic cycling non - Invasive blood pressure monitoring equipmen Saftey Standard 2018, Apr Buy
33 IS 13450 : Part 2 : Sec 31 : 2019/IS/IEC 60601-2-31:20
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 31 external cardiac pacemakers with internal power source Product Specification 0 Buy
34 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 Product Specification 0 Buy
35 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 Product Specification 0 Buy
36 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 Product Specification 0 Buy
37 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 Product Specification 0 Buy
38 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 Product Specification 0 Buy
39 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) Saftey Standard 0 Buy
40 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 Product Specification 0 Buy
41 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 Product Specification 0 Buy
42 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) Saftey Standard 0 Buy
43 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) Saftey Standard 0 Buy
44 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) Saftey Standard 0 Buy
45 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 Product Specification 0 Buy
46 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 Buy
47 IS 13450 : Part 2 : Sec 49 : 2018/IEC 60601 Par 2 Section 49 : 2011
(1 Revision)
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 49 multifunction patient monitoring equipment (First Revision) Saftey Standard 0 Buy
48 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) Product Specification 0 Buy
49 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 Product Specification 0 Buy
50 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 Product Specification 0 Buy
51 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 Product Specification 0 Buy
52 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 Buy
53 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 Product Specification 0 Buy
54 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 Product Specification 0 Buy
55 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 Product Specification 0 Buy
56 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 Product Specification 0 Buy
57 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 Product Specification 0 Buy
58 IS 13709 : 1993
Medical electrical equipment - Dental X-ray equipment radiation safety Product Specification 2015 Download
59 IS 13812 : Part 19 : 1994/IEC 601-2-19
Medical electrical equipment - Particular requirements for safety Part 19 Baby incubators Saftey Standard 2015 Buy
60 IS 13814 : 1993/IEC 858
Determination of the image distortion of electro - Optical X-ray image intensifiers Methods of tests 2015 Buy
61 IS 14180 : 2019/IEC 878
(1 Revision)
Graphical symbols for electrical equipment in medical practice (First Revision) Terminology 0 Buy
62 IS 15584 : 2005
Medical X-ray films Product Specification 2017, Jul Download
63 IS 7352 : 1974
Specification for X-ray lead - Rubber protective aprons Product Specification 2017 Download
64 IS 7583 : 1991
(1 Revision)
Medical Electrical Equipment - High Frequency Surgical Equipment Product Specification 2016, Dec Buy
65 IS 7620 : Part 1 : 1986
(1 Revision)
Specification for diagnostic medical X-ray equipment: Part 1 general and safety requirements (First Revision) Product Specification 2014 Download
66 IS 7620 : Part 2 : 1986
(1 Revision)
Specification for diagnostic medical X-ray equipment: Part 2 performance requirements (First Revision) Product Specification 2014 Download
67 IS 7620 : Part 3 : 1991
Medical electrical equipment - Diagnostic X-ray equipmbnts: Part 3 radiation safety requirements Product Specification 2016, Dec Download
68 IS/IEC 60336 : 2005/IEC 60336:2005
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots Methods of tests 2020, Oct Buy
69 IS/IEC 61168 : 1993/IEC 61168:1993
Radiotherapy simulators - Functional performance characteristics Product Specification 0 Buy
70 IS/IEC 61170 : 1993/IEC 61170:1993
Radiotherapy simulators - Guidelines for functional performance characteristics Code of Practice 0 Buy
71 IS/IEC 61217 : 2011/IEC 61217:2011
Radiotherapy Equipment - Coordinates, Movements and Scales Dimensions 0 Buy
72 IS/IEC 61262 : PART 1 : 1994/IEC 61262-1:1994
Medical Electrical Equipment - Characteristics of Electro-Optical X-Ray Image Intensifiers Methods of tests 2020, Feb Buy
73 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 Methods of tests 2019, Dec Buy
74 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 Methods of tests 2016, Dec Buy
75 IS/IEC 61331 : Part 2 : 2014
Protective Devices Against Diagnostic Medical X-Radiation Part 2 Translucent Protective Plates 0 Buy
76 IS/IEC 61675 : Part 1 : 2013/IEC 61675-1 : 2013
Radionuclide imaging devices - Characteristics and test conditions: Part 1 positron emission tomographs Methods of tests 0 Buy
77 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 Product Specification 0 Buy
78 IS/IEC 61685 : 2001/IS/IEC 61685:2001
Ultrasonics - Flow measurement systems - Flow test object Product Specification 0 Buy
79 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 Buy
80 IS/IEC 61847 : 1998/IS/IEC 61847:1998
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Product Specification 0 Buy
81 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 Methods of tests 0 Buy
82 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 Methods of tests 2017, May Buy
83 IS/IEC 62563 : Part 1 : 2016
Medical Electrical Equipment — Medical Image Display System Part 1 Evaluation Method 0 Buy
84 IS/IEC 80601 : Part 2 : Sec 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
85 IS/IEC/TR 60788 : 2004/IEC/TR 60788:2004
Medical electrical equipment - Glossary of defined terms Terminology 2020, Apr Buy
86 IS/IEC/TR 61852 : 1998/IEC TR 61825 : 1998
Medical electrical equipment - Digital imaging and communications in medicine (DICOM) - Radiotherapy objects Others 0 Buy
87 IS/IEC/TR 61948 : Part 3 : 2018/IS/IEC TR 61948-3:20
Nuclear medicine instrumentation - Routine tests: Part 3 positron emission tomographs Methods of tests 0 Buy
88 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
89 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
90 IS/IEC62353 : 2014/IEC 62353:2014
(1 Revision)
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (First Revision) Others 2017, Dec Buy
91 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 Buy
92 IS/ISO 14708 : Part 2 : 2012/ISO 14708-2:2019
Implants for surgery - Active implantable medical devices: Part 2 cardiac pacemakers Product Specification 2018, Jan Buy
93 IS/ISO 4090 : 2001
Photography - Medical radiographic cassettes/screens/films and hard - Copy imaging films - Dimensions and specifications Product Specification 2018, Jul Download
94 IS/ISO 80601 : Part 2 : Sec 12 : 2011/ISO 80601-2-12:2011
Medical electrical equipment: Part 2 - 12 particular requirements for basic safety and essential performance of critical care ventilators Product Specification 0 Buy
95 IS/ISO 80601 : Part 2 : Sec 13 : 2011/ISO 80601-2-13_2011
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 13 anaesthetic workstation Product Specification 0 Buy
96 IS/ISO 80601 : Part 2 : Sec 61 : 2011/ISO 80601-2-61 : 2011
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 61 pulse oximeter equipment Saftey Standard 2019 Buy
97 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 Product Specification 0 Buy