The Bureau of Indian Standards is India’s national standard body, it sets benchmarks for quality and safety standards for product development in India. A BIS certificate for Electromedical Diagnostic Imaging and Radiotherapy equipment is essential as these products directly affect patient health.
BIS certificate ensures regulatory compliance with Indian standards, enhancing users’ credibility, reliability, and trust. It is essential for manufacturers and importers planning to sell and market high-quality standard diagnostic devices for the healthcare industry.
Reach out today to learn more and secure a BIS certificate for your products. We will assist you in acquiring BIS certification for electromedical diagnostic imaging and radiotherapy equipment, and other products.
Understanding BIS Certificate For Electromedical Diagnostic Imaging And Radiotherapy Equipment
The BIS certificate is a benchmark of quality and safety for different products, ensuring they meet stringent regulatory frameworks in India. The procedure for obtaining the BIS certificate involves rigorous testing and evaluation of products to ensure compliance with regulatory standards. Due to strict guidelines, the BIS certificate protects patients and the public from harmful hazards.
What Are Electromedical Diagnostic Imaging And Radiotherapy Equipment?
Electromedical diagnostic imaging and radiotherapy equipment are vital tools in the healthcare sector. They rely on quality and precise equipment to ensure patient welfare. Electromedical Diagnostic Imaging involves diagnosing various medical conditions, including cancer, cardiac, and neurological diseases.
Some of the most common examples include X-ray machines, ultrasound, CT scans, and MRI. Radiotherapy equipment, on the other hand, is used in cancer treatment. Examples of radiotherapy equipment are a proton therapy system and a brachytherapy machine.
Also Read: BIS Certification For Hospital Equipment And Surgical Disposal
Who Needs BIS Certificate For Electromedical Diagnostic Imaging And Radiotherapy Equipment?
Following are the applicants who can apply for BIS certification for Electromedical Diagnostic Imaging And Radiotherapy Equipment:
- The product manufacturer is the primary applicant for applying for a BIS certificate For Electromedical Diagnostic Imaging And Radiotherapy Equipment.
- Importers who want to import and sell Electromedical Diagnostic Imaging And Radiotherapy Equipment in India can apply for a BIS certificate.
- Distributors or traders seeking BIS certificates for their products can apply for one, provided they have the manufacturer’s authorization.
- An authorized representative may submit a BIS certificate application for the manufacturer, importer, or foreign entity.
Also Read: BIS Certificate For Veterinary Hospital Planning And Surgical Instruments
What Are The Benefits Of Obtaining BIS Certification For Electromedical Diagnostic Imaging And Radiotherapy Equipment?
BIS certificate for Electromedical Diagnostic Imaging And Radiotherapy Equipment has several benefits, which are mentioned below:
- Compliance with Regulations: Ensure legal compliance with regulatory norms and adhere to Indian safety and performance standards.
- Product Quality: Ensures Electromedical Diagnostic Imaging And Radiotherapy Equipment meets quality and safety standards.
- Market Access: BIS-certified equipment and products get easy and fast market access in domestic and international markets.
- Market Expansion: BIS-certified equipment and products can be easily exported to other countries.
- Build Confidence: Build trust among healthcare professionals and doctors by guaranteeing high-quality standard equipment for patient safety.
- Patient Safety: The BIS certificate assures quality and safety, enhancing doctors’ and other healthcare professionals’ confidence and building trust in the brand for patient diagnosis and treatment.
Also Read: BIS Certificate For Health Informatics
Documentation Required For Obtaining BIS Certificate For Electromedical Diagnostic Imaging And Radiotherapy Equipment
To apply for a BIS certificate for Electromedical Diagnostic Imaging And Radiotherapy Equipment, an applicant must prepare and submit the following documents:
- Application Form
- Product Details
- Company Details
- Manufacturer Declaration
- Test Reports
- Manufacturing Facility Details
- Import Export Code
- Equipment Labels and Packaging
What Is The Process To Obtain BIS Certification For Electromedical Diagnostic Imaging And Radiotherapy Equipment?
Following are the essential steps in obtaining BIS certificate for Electromedical Diagnostic Imaging And Radiotherapy Equipment that an applicant must follow:
- Visit BIS Website: Visit the BIS website and select the application form related to electromedical diagnostic imaging and radiotherapy equipment. Fill out the form correctly and provide company details.
- Submission of Documents: Upload and submit the above documents through the BIS portal.
- Fee Payment: Pay the applicable fees for the BIS certificate based on the type and number of products.
- BIS Audit Inspection: BIS may conduct an on-site inspection of your manufacturing plant to verify and confirm safety and quality practices.
- Grant of Certification: After evaluating documents and the manufacturing facility, a BIS certificate will be granted if everything is found per the regulatory requirements.
Also Read: BIS Certification For Hospital Equipment And Surgical Disposal
What Are The Indian Standards For Electromedical Diagnostic Imaging And Radiotherapy Equipment?
Below, we’ve listed the Indian Standards for obtaining a BIS certificate for Electromedical Diagnostic Imaging And Radiotherapy Equipment:
| SI. No. | IS No. | TITLE |
|---|---|---|
| 1 | IS 11393: 1985 | Specification for scintillation counters |
| 2 | 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) |
| 3 | IS 11701: 1986 | Guide for testing and calibration of ultrasonic therapeutic equipment |
| 4 | IS 11753 : 1986 | Specification for electrical impedance plethysmograph |
| 5 | IS 11789 : 1986 | Determination of the maximum symmetrical radiation field in the radiation beam from a rotating anode X-ray tube for medical diagnosis |
| 6 | IS 13450: Part 1: 2018/IEC 60601-1:2012 (Ed | Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) |
| (2 Revision) | ||
| 7 | 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 |
| 8 | 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 |
| 9 | IS 13450: Part 1: SEC 2: 2018 | 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) |
| (1 Revision) | ||
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | IS 13450: Part 2: Sec 1 :2018/IEC 60601-2-1 :2009 | Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 1 Electron accelerators in the range 1 MeV to 50 MeV (First Revision) |
| (1 Revision) | ||
| 14 | 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 |
| 15 | IS 13450: Part 2: Sec 11 :2018/IEC 60601-2-11 : 201 | Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 11 gamma beam therapy equipment (First Revision) |
| (1 Revision) | ||
| 16 | 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 |
| 17 | IS 13450: Part 2: Sec 17 :2018/IEC 60601 -2-17 : 2018 | Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 17 automatically – Controlled brachytherapy afterloading equipment (First Revision) |
| (1 Revision) | ||
| 18 | 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 |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 |
| 22 | 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 |
| 23 | 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 |
| (1 Revision) | ||
| 24 | 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 |
| 25 | IS 13450: PART 2: SEC 24 :2019/IEC 60601-2-24 : 201 | Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 24 infusion pumps and controllers (First Revision) |
| (1 Revision) | ||
| 26 | IS 13450: Part 2: Sec 25 :2018/IEC 60601-2-25:2011Medical 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 |
| 27 | 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 |
| 28 | 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 |
| 29 | IS 13450: Part 2: Sec 29 :2018/IEC 60601-2-29:2008 | Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 29 radiotherapy simulators (First Revision) |
| (1 Revision) | ||
| 30 | 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 equipment |
| 31 | 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 |
| (1 Revision) | ||
| 32 | 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 |
| 33 | 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 |
| 34 | 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 extracorporeally induced lithotripsy |
| 35 | 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 |
| 36 | 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 |
| 37 | IS 13450: PART 2: SEC 4 :2018/IEC 60601-2-4 : 2010 | Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators (First Revision) |
| (1 Revision) | ||
| 38 | 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 |
| 39 | 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 |
| 40 | IS 13450: Part 2: Sec 43 :2016/IEC 6060-2-43:2010 | Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 43 X-ray equipment for interventional procedures (First Revision) |
| (1 Revision) | ||
| 41 | IS 13450: Part 2: Sec 44 :2016/IEC 60601-2-44:2009 | 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 Revision) | ||
| 42 | IS 13450: Part 2: Sec 45 :2016/IEC 60601-2-45:2011 | Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 45 mammographic X-ray equipment and mammographic stereotactic devices (First Revision) |
| (1 Revision) | ||
| 43 | 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 |
| 44 | 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 |
| 45 | IS 13450: PART 2: SEC 5 :2018/IEC 60601-2-5 : 2009 | Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 5 ultrasonic physiotherapy equipment (First Revision) |
| (1 Revision) | ||
| 46 | 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 |
| 47 | 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 |
| 48 | 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 |
| 49 | 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 |
| 50 | 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 |
| 51 | 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 equipment |
| 52 | 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 |
| 53 | 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 hemostasis equipment |
| 54 | 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 |
| 55 | IS 13523 : Part 1: 1992 | Medical Electrical Equipment – Shortwave Therapy Equipment: Part 1 General And Safety Requirements |
| 56 | IS 13523 : Part 2: 1992 | Medical Electrical Equipment – Shortwave Therapy Equipment: Part 2 Performance Requirements |
| 57 | IS 13709 : 1993 | Medical electrical equipment – Dental X-ray equipment radiation safety |
| 58 | IS 14180 : 2019/IEC 878 | Graphical symbols for electrical equipment in medical practice (First Revision) |
| (1 Revision) | ||
| 59 | IS 15584 : 2005 | Medical X-ray films |
| 60 | IS 7352: 1974 | Specification for X-ray lead – Rubber protective aprons |
| 61 | IS 7620: Part 1: 1986 | Specification for diagnostic medical X-ray equipment: Part 1 general and safety requirements (First Revision) |
| (1 Revision) | ||
| 62 | IS 7620: Part 2: 1986 | Specification for diagnostic medical X-ray equipment: Part 2 performance requirements (First Revision) |
| (1 Revision) | ||
| 63 | IS 7620: Part 3: 1991 | Medical electrical equipment – Diagnostic X-ray equipment: Part 3 radiation safety requirements |
| 64 | 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 |
| 65 | IS/IEC 60336 : 2005/IEC 60336:2005 | Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Characteristics of focal spots |
| 66 | IS/IEC 60580 : 2019/IEC 60580:2019 | Medical electrical equipment Dose area product meters |
| 67 | IS/IEC 61168 : 1993/IEC 61168:1993 | Radiotherapy simulators – Functional performance characteristics |
| 68 | IS/IEC 61170 : 1993/IEC 61170:1993 | Radiotherapy simulators – Guidelines for functional performance characteristics |
| 69 | IS/IEC 61217 : 2011/IEC 61217:2011 | Radiotherapy Equipment – Coordinates, Movements and Scales |
| 70 | IS/IEC 61262 : PART 1 :1994/IEC 61262-1:1994 | Medical Electrical Equipment – Characteristics of Electro-Optical X-Ray Image Intensifiers |
| 71 | 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 |
| 72 | 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 |
| 73 | 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 |
| 74 | IS/IEC 61331: Part 2: 2014 | Protective Devices Against Diagnostic Medical X- Radiation Part 2 Translucent Protective Plates |
| 75 | 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 |
| 76 | IS/IEC 61675 : Part 1 : 2013/IEC 61675-1 : 2013 | Radionuclide imaging devices – Characteristics and test conditions: Part 1 positron emission tomographs |
| 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 |
| 78 | 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 |
| 79 | IS/IEC 61685 : 2001/IS/IEC 61685:2001 | Ultrasonics – Flow measurement systems – Flow test object |
| 80 | 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 |
| 81 | IS/IEC 61847 : 1998/IS/IEC 61847:1998 | Ultrasonics – Surgical systems – Measurement and declaration of the basic output characteristics |
| 82 | IS/IEC 62083 : 2009/IEC 62083:2009 | Medical electrical equipment Requirements for the safety of radiotherapy treatment planning systems |
| 83 | 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 theDetective Quantum Efficiency — Detectors Used in Radiographic Imaging |
| 84 | 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 |
| 85 | 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 |
| 86 | IS/IEC 62563: Part 1: 2016 | Medical Electrical Equipment — Medical Image Display System Part 1 Evaluation Method |
| 87 | 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 |
| 88 | 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 |
| 89 | 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 |
| 90 | 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 |
| 91 | IS/IEC/TR 60788 : 2004/IEC/TR 60788:2004 | Medical electrical equipment – Glossary of defined terms |
| 92 | IS/IEC/TR 61852 : 1998/IEC TR 61825 : 1998 | Medical electrical equipment – Digital imaging and communications in medicine (DICOM) – Radiotherapy objects |
| 93 | IS/IEC/TR 61948: Part 3 :2018/IS/IEC TR 61948-3:20 | Nuclear medicine instrumentation – Routine tests: Part 3 positron emission tomographs |
| 94 | 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 |
| 95 | 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 |
| 96 | IS/IEC62353 : 2014/IEC 62353:2014 | Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment (First Revision) |
| (1 Revision) | ||
| 97 | 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 |
| 98 | IS/ISO 14708: Part 2: 2019/ISO 14708-2:2019 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers First Revision |
| (1 Revision) | ||
| 99 | IS/ISO 4090: 2001 | Photography – Medical radiographic cassettes/screens/films and hard – Copy imaging films – Dimensions and specifications |
| 100 | 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 |
| 101 | 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 anesthetic workstation |
| 102 | IS/ISO 80601: Part 2: Sec 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 |
| (1 Revision) | ||
| 103 | 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 |
How Long Is the BIS Certification Valid For Electromedical Diagnostic Imaging And Radiotherapy Equipment?
The BIS certificate for Electromedical Diagnostic Imaging And Radiotherapy Equipment is valid for one year. However, if the application is completed and the conditions are met, it can be renewed annually.
Timeline For Obtaining BIS Certificate For Electromedical Diagnostic Imaging And Radiotherapy Equipment
The timeline for granting a BIS certification for Electromedical Diagnostic Imaging And Radiotherapy Equipment takes around 30-40 days, based on the application and responsiveness of the manufacturer.
How Can ELT Corporate Assist You With Obtaining BIS Certificate?
At ELT Corporates, we understand the complete process of obtaining a BIS certificate and the regulatory requirements for medical devices and other products. Our expert team can make obtaining a BIS certificate For Electromedical Diagnostic Imaging And Radiotherapy Equipment simple and smooth through in-depth Industrial knowledge.
From initial consultation to certification issuance, we will be with you at every step and ready to address any challenge during the certification process.
Can I Sell Electromedical Diagnostic Imaging And Radiotherapy Equipment Without BIS Certificate?
You cannot sell or market electromedical diagnostic imaging and radiotherapy equipment without a BIS certificate. You must also ensure their safety and quality before using them for diagnosis and treatment.