The Bureau of Indian Standards (BIS) is making strides in enhancing the quality, safety, and affordability of medical devices in India. By developing robust standards, BIS is playing a crucial role in improving healthcare outcomes and patient safety. A press release on its endeavors was issued on November 25, 2024.
Prioritizing Medical Device Standards
In alignment with the National Medical Device Policy, 2023, BIS has identified 214 critical medical devices for standardization. This includes lifesaving devices like cardiac pacemakers, ventilators, and haemodialysis machines, as well as advanced diagnostic tools such as X-ray machines, CT scanners, and MRI systems.
Focus on Assistive Technology
BIS is also addressing the growing need for accessible and affordable assistive technology. By developing standards for products like therapeutic footwear, portable ramps, braille displays, and fall detectors, the Bureau is empowering individuals with disabilities and improving their quality of life.
Key Indian Standards for Medical Devices
- Cardiac Devices:
- Cardiac Pacemakers: IS 13450 (Part 2/Sec 31): 2021
- Heart Valves: IS 17840
- Orthopedic Implants:
- Hip and Knee Implants: IS 12375
- Respiratory Devices:
- Ventilators: IS 13450 (Part 2/Sec 12): 2023
- Infant Incubators and Radiant Warmers: IS 13450 (Part 2/Sec 19): 2023 and IS 13450 (Part 2/Sec 21): 2023
- Renal Devices:
- Haemodialysis Machines: IS 13450 (Part 2/Sec 16) : 2019
- Infusion Therapy:
- Infusion Pumps: IS 13450 (Part 2/Sec 24): 2019
- Diagnostic Imaging:
- X-ray and CT Machines: IS 7620 (Part 1) : 1986
- MRI Systems: IS 13450 (Part 2/Sec 33) : 2018
- Ultrasound Devices: IS 13450 (Part 2/Sec 37): 2019
- Patient Monitoring:
- Blood Pressure Monitors: IS 13450 (Part 2/Sec 34): 2019
- Blood Glucose Monitors: IS/ISO 15197: 2013
- Pulse Oximeters: IS/ISO 80601-2-61: 2017
BIS is contributing to the growth of India’s medical device industry and ensuring that patients have access to safe, effective, and affordable healthcare solutions.
