BUREAU OF INDIAN STANDARDS
Programme of Work
MHD15 : Electromedical, Diagnostic Imaging and Radiotherapy Equipment
- Scope : To prepare Standards for: i) Electrical equipment concerning diagnostic, surgical, therapeutic and monitoring equipment for various specialties ; ii) Ionizing radiation imaging and radiotherapy, dentistry, equipment for radiotherapy, nuclear medicine and radiation dosimetry
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Liaison :IEC TC 62 - Medical equipment, software, and systems - Participating (P)
IEC TC 62 / SC 62 A - Common aspects of medical equipment, software, and systems - Participating (P)
IEC TC 62 / SC 62 B - Medical imaging equipment, software, and systems - Participating (P)
IEC TC 62 / SC 62 C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry - Participating (P)
IEC TC 62 / SC 62 D - Particular medical equipment, software, and systems - Participating (P)
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IS/ISO/TS 10974 : 2018 ISO TS 10974 : 2018 Reviewed In : 2024 |
Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device
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August, 2024
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Identical under single numbering
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IS 11393 : 1985 Reviewed In : 2021 |
Specification for scintillation counters
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December, 2021
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Indigenous
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IS 11478 : 2018 IEC/TR 60930 : 2008 Reviewed In : 2023 |
Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems (First Revision)
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August, 2023
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Identical under dual numbering
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IS 11753 : 1986 Reviewed In : 2021 |
Specification for electrical impedance plethysmograph
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December, 2021
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Indigenous
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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)
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Modified/Technically Equivalent
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IS 13450 (Part 1) : 2024 |
Medical electrical equipment Part 1 General requirements for basic safety and essential performance (Third Revision)
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Modified/Technically Equivalent
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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)
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Modified/Technically Equivalent
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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)
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Modified/Technically Equivalent
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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)
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Modified/Technically Equivalent
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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)
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Modified/Technically Equivalent
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IS 13450 (Part 1/Sec 9) : 2024 |
Medical electrical equipment Part 1 General requirements for basic safety and essential performance Section 9 Requirements for environmentally conscious design
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Modified/Technically Equivalent
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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)
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Modified/Technically Equivalent
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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)
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Modified/Technically Equivalent
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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
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Modified/Technically Equivalent
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IS 13450 (Part 2/Sec 1) : 2018 IEC 60601-2-1 :2009 Reviewed In : 2023 |
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)
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March, 2023
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Identical under dual numbering
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IS 13450 (Part 2/Sec 2) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 2 High frequency surgical equipment and high frequency surgical accessories First revision
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Modified/Technically Equivalent
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IS 13450 (Part 2/Sec 3) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 3 Short-wave therapy equipment First revision
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Modified/Technically Equivalent
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IS 13450 (Part 2/Sec 4) : 2018 IEC 60601-2-4 : 2010 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators (First Revision)
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August, 2023
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1
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Identical under dual numbering
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IS 13450 (Part 2/Sec 5) : 2018 IEC 60601-2-5 : 2009 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 5 ultrasonic physiotherapy equipment (First Revision)
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August, 2023
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Identical under dual numbering
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IS 13450 (Part 2/Sec 6) : 2018 IEC 60601-2-6 : 2012 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 6 microwave therapy equipment
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August, 2023
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Identical under dual numbering
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IS 13450 (Part 2/Sec 8) : 2019 IEC 60601-2-8 : 2015 |
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
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Identical under dual numbering
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IS 13450 (Part 2/Sec 10) : 2018 IEC 60601-2-10 : 2012 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 10 nerve and muscle stimulators
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July, 2023
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Identical under dual numbering
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IS 13450 (Part 2/Sec 11) : 2018 IEC 60601-2-11 : 2013 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 11 gamma beam therapy equipment (First Revision)
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August, 2023
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Identical under dual numbering
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IS 13450 (Part 2/Sec 16) : 2019 IEC 60601-2-16 : 2018 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 16 haemodialysis, haemodiafiltration and haemofiltration equipment
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Identical under dual numbering
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IS 13450 (Part 2/Sec 17) : 2018 IEC 60601 -2-17 : 2018 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 17 automatically - Controlled brachytherapy afterloading equipment (First Revision)
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August, 2023
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Identical under dual numbering
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IS 13450 (Part 2/Sec 18) : 2014 IEC 60601-2-18 : 2009 Reviewed In : 2019 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 18 endoscopic equipment
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November, 2019
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Identical under dual numbering
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IS 13450 (Part 2/Sec 19) : 2023 IEC 60601-2-19:2020 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 19 Infant Incubators First Revision
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Identical under dual numbering
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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
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Identical under dual numbering
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IS 13450 (Part 2/Sec 21) : 2023 IEC 60601-2-21:2020 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision
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Identical under dual numbering
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IS 13450 (Part 2/Sec 22) : 2021 IEC 60601-2-22:2019 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 22 surgical cosmetic therapeutic and diagnostic laser equipment First Revision
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Identical under dual numbering
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IS 13450 (Part 2/Sec 23) : 2018 IEC 60601-2-23 : 2011 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 23 transcutaneous partial pressure monitoring equipment
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August, 2023
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1
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Identical under dual numbering
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IS 13450 (Part 2/Sec 24) : 2019 IEC 60601-2-24 ; 2012 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 24 infusion pumps and controllers (First Revision)
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Identical under dual numbering
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IS 13450 (Part 2/Sec 25) : 2018 IEC 60601-2-25 : 2011 Reviewed In : 2023 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs
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March, 2023
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1
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Identical under dual numbering
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IS 13450 (Part 2/Sec 26) : 2021 IEC 80601-2-26 : 201 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 26 Electroencephalographs
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Identical under dual numbering
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IS 13450 (Part 2/Sec 27) : 2018 IEC 60601-2-27 : 2011 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment
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March, 2023
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Identical under dual numbering
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IS 13450 (Part 2/Sec 29) : 2018 IEC 60601-2-29 : 2008 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 29 radiotherapy simulators (First Revision)
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October, 2023
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Identical under dual numbering
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IS 13450 (Part 2/Sec 31) : 2021 IEC 60601-2-31:2020 |
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
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Identical under dual numbering
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IS 13450 (Part 2/Sec 33) : 2018 IEC 60601-2-33 : 2015 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 33 magnetic resonance equipment for medical diagnosis
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December, 2023
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Identical under dual numbering
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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
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Identical under dual numbering
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IS 13450 (Part 2/Sec 35) : 2023 IEC 60601-2-35:2020 |
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
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Identical under dual numbering
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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
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Identical under dual numbering
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IS 13450 (Part 2/Sec 37) : 2019 IEC 60601-2-37 : 2017 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 37 ultrasonic medical diagnostic and monitoring equipment
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Identical under dual numbering
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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
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Identical under dual numbering
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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
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Identical under dual numbering
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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
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Identical under dual numbering
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IS 13450 (Part 2/Sec 43) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 43 X-ray equipment for interventional procedures Second revision
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Modified/Technically Equivalent
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IS 13450 (Part 2/Sec 44) : 2016 IEC 60601-2-44 : 2009 Reviewed In : 2021 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 44 X-ray equipment for computed tomography (First Revision)
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May, 2021
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1
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Identical under dual numbering
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IS 13450 (Part 2/Sec 45) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 45 Mammographic X-ray equipment and mammographic stereotactic devices Second revision
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Modified/Technically Equivalent
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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
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Identical under dual numbering
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IS 13450 (Part 2/Sec 47) : 2018 IEC 60601-1-2 : 2014 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 47 ambulatory electrocardiographic systems
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June, 2023
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Identical under dual numbering
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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
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Identical under dual numbering
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IS 13450 (Part 2/Sec 52) : 2020 IEC 60601-2-52 : 2015 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 52 Medical beds
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Identical under dual numbering
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IS 13450 (Part 2/Sec 54) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 54 X-ray equipment for radiography and radioscopy First revision
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Modified/Technically Equivalent
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IS 13450 (Part 2/Sec 62) : 2018 IEC 60601-2-62 : 2013 Reviewed In : 2023 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 62 high intensity therapeutic ultrasound (Hitu) equipment
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August, 2023
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Identical under dual numbering
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IS 13450 (Part 2/Sec 63) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 63 Dental extra-oral X-ray equipment First revision
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Modified/Technically Equivalent
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IS 13450 (Part 2/Sec 63) : 2016 IEC 60601-2-63 : 2012 Reviewed In : 2021 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 63 dental extra - Oral X-ray equipment
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May, 2021
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1
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Modified/Technically Equivalent
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IS 13450 (Part 2/Sec 65) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 65 Dental intra-oral X-ray equipment First revision
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Modified/Technically Equivalent
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IS 13450 (Part 2/Sec 68) : 2020 IEC 60601-2-28 : 2014 |
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
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Identical under dual numbering
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IS 13450 (Part 2/Sec 76) : 2019 IEC 60601-2-76 : 2018 |
Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 76 low energy ionized gas haemostasis equipment
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Identical under dual numbering
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IS/ISO 13450-2-10) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 10 Nerve and muscle stimulators First revision
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Identical under dual numbering
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IS 13709 : 1993 Reviewed In : 2015 |
Medical electrical equipment - Dental X-ray equipment radiation safety
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Indigenous
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IS 14180 : 2019 IEC 60878 : 2015 |
Graphical symbols for electrical equipment in medical practice (First Revision)
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Identical under dual numbering
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IS/ISO 14708-2 : 2019 ISO 14708-2:2019 |
Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers First Revision
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Identical under single numbering
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IS 15584 : 2005 Reviewed In : 2022 |
Medical X-ray films
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July, 2022
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Indigenous
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IS 18448 (Part 1) : 2024 |
Medical electrical equipment Diagnostic X-rays Part 1 Determination of quality equivalent filtration and permanent filtration
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Modified/Technically Equivalent
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IS 18448 (Part 2) : 2024 |
Medical electrical equipment Diagnostic X-rays Part 2 Guidance and rationale on quality equivalent filtration and permanent filtration
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Modified/Technically Equivalent
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IS 18470 : 2024 |
Ultrasonics Physiotherapy Systems Field Specifications and Methods of Measurement in the Frequency Range 05 MHz to 5 MHz
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Modified/Technically Equivalent
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IS/ISO 4090 : 2001 Reviewed In : 2023 |
Photography - Medical radiographic cassettes/screens/films and hard - Copy imaging films - Dimensions and specifications
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July, 2023
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Indigenous
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IS/IEC 60335-2-27) : 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
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Identical under single numbering
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IS/IEC 60336 : 2005 Reviewed In : 2020 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
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October, 2020
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Identical under single numbering
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IS/IEC 60580 : 2019 IEC 60580:2019 |
Medical electrical equipment Dose area product meters
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Identical under single numbering
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IS/IEC/TR 60788 : 2004 IEC/TR 60788:2004 Reviewed In : 2020 |
Medical electrical equipment - Glossary of defined terms
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April, 2020
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Identical under single numbering
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IS/IEC 61168 : 1993 IEC 61168 : 1993 |
Radiotherapy simulators - Functional performance characteristics
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Identical under single numbering
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IS/IEC 61170 : 1993 IEC 61170 : 1993 |
Radiotherapy simulators - Guidelines for functional performance characteristics
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Identical under single numbering
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IS/IEC 61217 : 2011 IEC 61217 : 2011 |
Radiotherapy Equipment - Coordinates, Movements and Scales
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Identical under single numbering
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IS/IEC 61262-1 : 1994 Reviewed In : 2020 |
Medical Electrical Equipment - Characteristics of Electro-Optical X-Ray Image Intensifiers
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February, 2020
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Identical under single numbering
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IS/IEC 61262-2 : 1994 Reviewed In : 2019 |
Medical electrical equipment characteristics of electro - Optical X-ray image intensifiers: Part 2 determination of the conversion factor
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December, 2019
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Identical under single numbering
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IS/IEC 61262-3 : 1994 IEC 61262_3 : 1994 Reviewed In : 2021 |
Medical electrical equipment - Characteristics of Electro - Optical X-ray image intensifiers: Part 3 determination of the luminance distribution and luminance non - Uniformity
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December, 2021
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Identical under single numbering
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IS/IEC 61262-4 : 1994 IEC 61262-4:1994 Reviewed In : 2020 |
Medical Electrical Equipment - Characteristics of Electro-Optical X-Ray Image Intensifiers Part 4 Determination of the Image Distortion
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April, 2020
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Identical under dual numbering
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IS/IEC 61331-1 : 2014 IEC 61331-1 : 2014 Reviewed In : 2024 |
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 1: DETERMINATION OF ATTENUATION PROPERTIES OF MATERIALS
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March, 2024
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Identical under dual numbering
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IS/IEC 61331-2 : 2014 |
Protective Devices Against Diagnostic Medical X-Radiation Part 2 Translucent Protective Plates
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Identical under single numbering
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IS/IEC 61331-3 : 2014 IEC 61331-3 : 2014 |
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS
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Identical under dual numbering
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IS/IEC 61675-1 : 2022 IEC 61675-1:2022 |
Radionuclide Imaging Devices — Characteristics and Test Conditions Part 1 Positron Emission Tomographs (First Revision)
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Identical under single numbering
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IS/IEC 61675-2 : 2015 IEC 61675-2 : 2015 |
Radionuclide imaging devices - Characteristics and test conditions: Part 2 gamma cameras for planar, whole body, and spect imaging
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Identical under single numbering
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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
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-
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Identical under single numbering
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IS/IEC 61685 : 2001 IEC 61685 : 2001 |
Ultrasonics - Flow measurement systems - Flow test object
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-
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Identical under single numbering
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IS/IEC 61847 : 1998 IS/IEC 61847 : 1998 |
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
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Identical under single numbering
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IS/IEC/TR 61948-3 : 2018 IEC TR 61948-3 : 2018 Reviewed In : 2023 |
Nuclear medicine instrumentation - Routine tests: Part 3 positron emission tomographs
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April, 2023
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-
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Identical under single numbering
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IS/IEC 62083 : 2009 IEC 62083:2009 |
Medical electrical equipment Requirements for the safety of radiotherapy treatment planning systems
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Identical under single numbering
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IS/IEC 62220-1-1) : 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
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Identical under single numbering
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IS/IEC 62220-1-3 : 2008 IEC 62220-1-3:2008 Reviewed In : 2023 |
Medical electrical equipment-characteristics of digital X-ray imaging devices – Part:1-3 Determination of the detective quantum efficiency - Detectors used in dynamic imaging
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March, 2023
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Identical under dual numbering
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IS/IEC 62220-1- 2 : 2007 IEC 62220-1-2 : 2007 Reviewed In : 2022 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices: Part 1 - 2 determination of the detective quantum efficiency detectors used in mammography
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May, 2022
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Identical under single numbering
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IS/IEC 6235 : 2014 IEC 62353 : 2014 Reviewed In : 2022 |
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (First Revision)
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December, 2022
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Identical under single numbering
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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
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Identical under single numbering
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IS/IEC 62563-1 : 2016 IEC 62563-1 : 2016 |
Medical Electrical Equipment — Medical Image Display System Part 1 Evaluation Method
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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
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Identical under single numbering
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IS 7620 (Part 1) : 1986 Reviewed In : 2019 |
Specification for diagnostic medical X-ray equipment: Part 1 general and safety requirements (First Revision)
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December, 2019
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3
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Indigenous
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IS 7620 (Part 2) : 1986 Reviewed In : 2019 |
Specification for diagnostic medical X-ray equipment: Part 2 performance requirements (First Revision)
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December, 2019
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1
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Indigenous
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IS 7620 (Part 3) : 1991 Reviewed In : 2016 |
Medical electrical equipment - Diagnostic X-ray equipmbnts: Part 3 radiation safety requirements
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December, 2016
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Indigenous
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IS/IEC 80601-2-35) : 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
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Identical under single numbering
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IS/IEC 80601-2-49) : 2018 IEC 80601-2-49:2018 |
Medical electrical equipment Part 2- Particular requirements for basic safety and essential performance- Sec 49 Multifunction patient monitors
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Identical under single numbering
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IS/ISO 80601-2-56) : 2017 ISO 80601-2-56 : 2017 |
Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 56 clinical thermometers for body temperature measurement
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1
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Identical under single numbering
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IS/IEC 80601-2-58) : 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
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Identical under single numbering
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IS/IEC 80601-2-59) : 2017 IEC 80601-2-59 : 2017 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 59 Screening thermographs for human febrile temperature screening
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Identical under dual numbering
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IS/ISO 80601-2-61) : 2017 ISO 80601-2-61:2017 |
Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
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Identical under single numbering
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MHD 15 (24688)
Revision of: IS 13450:2018 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 33 Magnetic resonance equipment for medical diagnosis IEC 60601-2-33 2022 MOD First Revision |
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MHD 15 (24715)
Revision of: IS 13450:2020 |
Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis IEC 60601-2-41 2021 MOD First Revision |
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MHD 15 (24718)
Revision of: IS 13450:2020 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 46 Operating tables IEC 60601-2-46 2023 MOD First Revision |
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MHD 15 (24732)
Revision of: IS 13450:2018 |
Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 6 Particular requirements for the basic safety and essential performance of microwave therapy equipment IEC 60601-2-6 2022 MOD First Revision |
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MHD 15 (24734)
Revision of: IS/IEC 62563:2016 |
Medical Electrical Equipment Medical Image Display Systems Part 1 Evaluation methods First Revision |
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MHD 15 (25315)
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Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 75 Photodynamic therapy and photodynamic diagnosis equipment |
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MHD 15 (25327)
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Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 83 Home light therapy equipment |
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MHD 15 (25328)
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Medical electrical equipment Dosimeters with ionization chambers as used in Radiotherapy IEC 60731 2011AMD1 2016 CSV MOD |
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MHD 15 (22659)
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Medical electrical equipment X-ray tube assemblies for medical diagnosis Focal spot dimensions and related characteristics |
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IS 10550 : 1983 Reviewed In : 2016 |
Specification for medical treatment lamps |
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IS 10554 : 1983 Reviewed In : 2006 |
Radiographic intensifying screens for medical use - dimensions |
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IS 11302 (Part 1) : 1985 Reviewed In : 2016 |
Electro-encephalograph EEG - Part 1 General and Safety Requirements |
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IS 11302 (Part 2) : 1985 Reviewed In : 2016 |
Specification for electroencephalograph EEG Part 2 performance requirements |
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IS 11331 : 1985 Reviewed In : 2016 |
Electrical Muscle and Nerve Stimulators for Therapeutic Purpose |
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IS 11478 (Part 1) : 1985 Reviewed In : 2016 |
Application guide for medical electrical equipment Part 1 General requirements and electrical installations |
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IS 11478 (Part 2) : 1985 Reviewed In : 2016 |
Application guide for medical electrical equipment Part 2 Safety provisions application operation and maintenance |
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IS 11661 : 1986 Reviewed In : 2016 |
Safety of Lung Ventilator for Medical Use |
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IS 11701 : 1986 Reviewed In : 2021 |
Guide for testing and calibration of ultrasonic therapeutic equipment |
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IS 11754 : 1986 Reviewed In : 2016 |
Implantable Ventricular Pacemaker |
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IS 12311 : 1987 Reviewed In : 2016 |
Microwave Diathermy Equipment for Therapeutic Purposes |
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IS 13069 : 1991 |
Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment |
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IS 13450 (Part 1/Sec 1) : 2006 IEC 60601-1-1 Reviewed In : 2011 |
Medical Electrical Equipment Part 1 General Requirements for Safety Section 1 Collateral Standard - Safety Requirements for Medical Electrical System |
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IS 13450 (Part 1/Sec 4) : 2009 IEC 60601-1-1 Reviewed In : 2014 |
Medical Electrical Equipment Part 1 General Requirements for Safety Section 1 Collateral Standard - Safety Requirements for Medical Electrical System |
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IS 13450 (Part 2/Sec 7) : 2006 IEC 60601-2-7 Reviewed In : 2011 |
Medical Electrical Equipment Part 2 Particular Requirements for the Safety Section 7 High-Voltage Generators of Diagnostic X-Ray Generators |
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IS 13450 (Part 2/Sec 30) : 2008 IEC 60601-2-30 Reviewed In : 2018 |
Medical electrical equipment Part 2 particular requirements for the safety Sec 30 essential performance of automatic cycling non - Invasive blood pressure monitoring equipmen |
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IS 13450 (Part 2/Sec 32) : 2006 IEC 60601-2-32 Reviewed In : 2011 |
Medical Electrical Equipment Part 2 Particular requirements for safety Section 32 Associated equipment of X-Ray equipment |
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IS 13450 (Part 2/Sec 49) : 2018 IEC 60601 Par 2 Section 49 : 2011 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 49 multifunction patient monitoring equipment First Revision |
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IS 13523 (Part 1) : 1992 Reviewed In : 2016 |
Medical Electrical Equipment - Shortwave Therapy Equipment Part 1 General And Safety Requirements |
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IS 13523 (Part 2) : 1992 Reviewed In : 2016 |
Medical Electrical Equipment - Shortwave Therapy Equipment Part 2 Performance Requirements |
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IS 13812 (Part 19) : 1994 IEC 601-2-19 Reviewed In : 2015 |
Medical electrical equipment - Particular requirements for safety Part 19 Baby incubators |
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IS 13814 : 1993 IEC 858 Reviewed In : 2015 |
Determination of the image distortion of electro - Optical X-ray image intensifiers |
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IS/IEC 61689 : 2013 IEC 61689 : 2013 Reviewed In : 2023 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0 5 mhz to 5 mhz |
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IS/IEC/TR 61852 : 1998 IEC TR 61852 : 1998 |
Medical electrical equipment - Digital imaging and communications in medicine DICOM - Radiotherapy objects |
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IS/IEC/TR 61859 : 1997 IEC/TR 61859 : 1997 |
Guidelines for Radiotherapy Treatment Rooms Design |
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IS 6991 : 1985 |
Radiographic Cassettes |
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IS 7352 : 1974 Reviewed In : 2017 |
Specification for X-ray lead - Rubber protective aprons |
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IS 7583 : 1991 Reviewed In : 2016 |
Medical Electrical Equipment - High Frequency Surgical Equipment |
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IS 8048 : 1985 Reviewed In : 2016 |
Specification for electrocardiograph First Revision |
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IS 8607 (Part 1) : 1977 Reviewed In : 1987 |
General and safety requirements for electrical equipment used in medical practice Part 1 General |
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IS 8607 (Part 2) : 1978 Reviewed In : 1987 |
General and safety requirements for electrical equipment used in medical practice Part 2 Protection against electric shock |
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IS 8885 : 1994 Reviewed In : 2019 |
Medical electrical equipment electromyograph - Specification First Revision |
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IS 9286 (Part 1) : 1988 Reviewed In : 2010 |
Cardiac Defibrillators - Part 1 Safety Requirements |
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IS 11393 : 1985 Reviewed In : 2021 |
Specification for scintillation counters |
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IS 11753 : 1986 Reviewed In : 2021 |
Specification for electrical impedance plethysmograph |
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IS 13450 (Part 2/Sec 2) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 2 High frequency surgical equipment and high frequency surgical accessories First revision |
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IS 13450 (Part 2/Sec 3) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 3 Short-wave therapy equipment First revision |
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IS 13450 (Part 2/Sec 4) : 2018 IEC 60601-2-4 : 2010 Reviewed In : 2023 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 4 cardiac defibrillators First Revision |
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IS 13450 (Part 2/Sec 5) : 2018 IEC 60601-2-5 : 2009 Reviewed In : 2023 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 5 ultrasonic physiotherapy equipment First Revision |
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IS 13450 (Part 2/Sec 6) : 2018 IEC 60601-2-6 : 2012 Reviewed In : 2023 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 6 microwave therapy equipment |
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IS 13450 (Part 2/Sec 8) : 2019 IEC 60601-2-8 : 2015 |
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 |
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IS 13450 (Part 2/Sec 11) : 2018 IEC 60601-2-11 : 2013 Reviewed In : 2023 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 11 gamma beam therapy equipment First Revision |
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IS 13450 (Part 2/Sec 16) : 2019 IEC 60601-2-16 : 2018 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 16 haemodialysis haemodiafiltration and haemofiltration equipment |
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IS 13450 (Part 2/Sec 18) : 2014 IEC 60601-2-18 : 2009 Reviewed In : 2019 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 18 endoscopic equipment |
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IS 13450 (Part 2/Sec 19) : 2023 IEC 60601-2-19:2020 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 19 Infant Incubators First Revision |
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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 |
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IS 13450 (Part 2/Sec 21) : 2023 IEC 60601-2-21:2020 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision |
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IS 13450 (Part 2/Sec 22) : 2021 IEC 60601-2-22:2019 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 22 surgical cosmetic therapeutic and diagnostic laser equipment First Revision |
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IS 13450 (Part 2/Sec 24) : 2019 IEC 60601-2-24 ; 2012 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 24 infusion pumps and controllers First Revision |
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IS 13450 (Part 2/Sec 25) : 2018 IEC 60601-2-25 : 2011 Reviewed In : 2023 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs |
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IS 13450 (Part 2/Sec 26) : 2021 IEC 80601-2-26 : 201 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 26 Electroencephalographs |
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IS 13450 (Part 2/Sec 27) : 2018 IEC 60601-2-27 : 2011 Reviewed In : 2023 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 27 electrocardiographic monitoring equipment |
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IS 13450 (Part 2/Sec 29) : 2018 IEC 60601-2-29 : 2008 Reviewed In : 2023 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 29 radiotherapy simulators First Revision |
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IS 13450 (Part 2/Sec 31) : 2021 IEC 60601-2-31:2020 |
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 |
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IS 13450 (Part 2/Sec 33) : 2018 IEC 60601-2-33 : 2015 Reviewed In : 2023 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 33 magnetic resonance equipment for medical diagnosis |
|
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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 |
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IS 13450 (Part 2/Sec 35) : 2023 IEC 60601-2-35:2020 |
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 |
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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 |
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IS 13450 (Part 2/Sec 37) : 2019 IEC 60601-2-37 : 2017 |
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 37 ultrasonic medical diagnostic and monitoring equipment |
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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 |
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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 |
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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 |
|
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IS 13450 (Part 2/Sec 43) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 43 X-ray equipment for interventional procedures Second revision |
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IS 13450 (Part 2/Sec 45) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 45 Mammographic X-ray equipment and mammographic stereotactic devices Second revision |
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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 |
|
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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 |
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IS 13450 (Part 2/Sec 52) : 2020 IEC 60601-2-52 : 2015 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 52 Medical beds |
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IS 13450 (Part 2/Sec 54) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 54 X-ray equipment for radiography and radioscopy First revision |
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IS 13450 (Part 2/Sec 63) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 63 Dental extra-oral X-ray equipment First revision |
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IS 13450 (Part 2/Sec 65) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 65 Dental intra-oral X-ray equipment First revision |
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IS 13450 (Part 2/Sec 68) : 2020 IEC 60601-2-28 : 2014 |
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 |
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IS 13450 (Part 2/Sec 76) : 2019 IEC 60601-2-76 : 2018 |
Medical electrical equipment Part 2 particular requirements for basic safety and essential performance Sec 76 low energy ionized gas haemostasis equipment |
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IS/ISO 13450-2-10) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 10 Nerve and muscle stimulators First revision |
|
|
IS 13709 : 1993 Reviewed In : 2015 |
Medical electrical equipment - Dental X-ray equipment radiation safety |
|
|
IS/ISO 14708-2 : 2019 ISO 14708-2:2019 |
Implants for surgery Active implantable medical devices Part 2 Cardiac pacemakers First Revision |
|
|
IS 15584 : 2005 Reviewed In : 2022 |
Medical X-ray films |
|
|
IS/ISO 4090 : 2001 Reviewed In : 2023 |
Photography - Medical radiographic cassettes screens films and hard - Copy imaging films - Dimensions and specifications |
|
|
IS/IEC 60335-2-27) : 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 |
|
|
IS/IEC 60580 : 2019 IEC 60580:2019 |
Medical electrical equipment Dose area product meters |
|
|
IS/IEC 61168 : 1993 IEC 61168 : 1993 |
Radiotherapy simulators - Functional performance characteristics |
|
|
IS/IEC 61331-3 : 2014 IEC 61331-3 : 2014 |
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 3 PROTECTIVE CLOTHING EYEWEAR AND PROTECTIVE PATIENT SHIELDS |
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|
IS/IEC 61675-2 : 2015 IEC 61675-2 : 2015 |
Radionuclide imaging devices - Characteristics and test conditions Part 2 gamma cameras for planar whole body and spect imaging |
|
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IS/IEC 61685 : 2001 IEC 61685 : 2001 |
Ultrasonics - Flow measurement systems - Flow test object |
|
|
IS/IEC 61847 : 1998 IS/IEC 61847 : 1998 |
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics |
|
|
IS 7620 (Part 1) : 1986 Reviewed In : 2019 |
Specification for diagnostic medical X-ray equipment Part 1 general and safety requirements First Revision |
|
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IS 7620 (Part 2) : 1986 Reviewed In : 2019 |
Specification for diagnostic medical X-ray equipment Part 2 performance requirements First Revision |
|
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IS 7620 (Part 3) : 1991 Reviewed In : 2016 |
Medical electrical equipment - Diagnostic X-ray equipmbnts Part 3 radiation safety requirements |
|
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IS/IEC 80601-2-35) : 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 |
|
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IS/IEC 80601-2-49) : 2018 IEC 80601-2-49:2018 |
Medical electrical equipment Part 2- Particular requirements for basic safety and essential performance- Sec 49 Multifunction patient monitors |
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IS/ISO 80601-2-56) : 2017 ISO 80601-2-56 : 2017 |
Medical electrical equipment Part 2 particular requirements for basic safety and essential performance Sec 56 clinical thermometers for body temperature measurement |
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IS/IEC 80601-2-58) : 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 |
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IS/ISO 80601-2-61) : 2017 ISO 80601-2-61:2017 |
Medical electrical equipment Part 2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment |