Know Your Standard Standards under Mandatory Certification Group Wise Classification Ministry/Department Wise Classification
( Sub Sub Group : Imaging and Radiotherapy equipment )
Total Standards : 20
Revised Standards
New Standards
| S.No | IS Number | IS Title | Amendment | Reaffirmation Year | Document | Action |
|---|---|---|---|---|---|---|
| 1 | 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 | Aug, 2024 | Buy | |
| 2 | 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 | |
| 3 | 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 | |
| 4 | 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 | |
| 5 | 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 | |
| 6 | 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 | |
| 7 | 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 | |
| 8 | 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 | |
| 9 | 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 | |
| 10 | 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 | |
| 11 | 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 | |
| 12 | IS/IEC 60479 : Part 1 : 2018/IEC 80601-2-58:2016 (1 Revision) |
Effects of current on human beings and livestock - Part 1: General Aspects | 0 | ---- | Buy | |
| 13 | 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 | |
| 14 | 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 | |
| 15 | 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 | |
| 16 | IS/IEC 62226 : PART 1 : 2004/IEC 62226-1 : 2004 |
Exposure to electric or magnetic fields in the low and intermediate frequency range - Methods for calculating the current density and internal electric field induced in the human body Part 1 General | 0 | Mar, 2024 | Buy | |
| 17 | IS/ISO 62304 : 2015/ISO 62304 : 2015 |
Medical device software - Software life cycle processes | 0 | ---- | Buy | |
| 18 | IS/ISO 7240 : Part 25 : 2010/IEC 62220-1-3:2008 |
Fire Detection and Alarm Systems Part 25 Components Using Radio Transmission Paths | 0 | ---- | Buy | |
| 19 | 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 | |
| 20 | IS/ISO 8596 : 2017/IEC 62083:2009 (1 Revision) |
Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (First Revision) | 1 | ---- | Buy |