Bureau of Indian Standards addresses need for reliable, affordable medical assistive technology
Bureau of Indian Standards to prioritise development of standards for 214 critical medical devices; standards to be ready by December, 2025
The
Bureau of Indian Standards (BIS), India’s National Standards Body is addressing
growing need for reliable and affordable medical assistive technology. The
Bureau is developing standards for innovative products such as therapeutic
footwear, portable ramps, braille displays, and fall detectors, which support
individuals with disabilities and enhance their quality of life.
In line with the National Medical Device
Policy, 2023, BIS is prioritising standards development for 214 critical
medical devices. These have been identified in consultation with the Department
of Pharmaceuticals (DoP). It includes septal closure devices, plasma sterilisers,
and phototherapy machines. The initiative is set for phased completion by
December 2025.
The Bureau is also driving improvements in
healthcare quality, safety, and reliability by developing robust medical device
and service standards. By aligning with the Medical Devices Rules, 2017, and the
National Medical Device Policy, 2023, BIS is proving to be instrumental in
establishing a robust regulatory framework that prioritises public safety while
fostering innovation.
BIS
has published over 1,700 standards for the medical sector, covering
specialities such as cardiology, neurology, orthopaedics, ophthalmology, and
more. Of these, around 1,200 standards specifically focus on medical devices
critical to healthcare, including:
· Life-saving
devices: Cardiac pacemakers, heart valves, ventilators, and haemodialysis
machines.
· Advanced
diagnostic tools: X-ray machines, CT scanners, MRI systems, and blood glucose
monitors.
· Assistive
technology: Hearing aids, wheelchairs, Jaipur Foot, and tactile pathways for
visually impaired individuals.
BIS standards in this sector ensure that Indian
medical devices are safe, effective, and globally competitive. These efforts
build trust among healthcare providers, consumers, and international
stakeholders while solidifying India’s reputation as a leader in healthcare
innovation.
Key
Standards for Medical Devices:
Some of the key Indian Standards developed by
BIS include:
- Cardiac Pacemakers: IS 13450 (Part 2/Sec 31): 2021
- Heart Valves:
IS 17840
- Hip and Knee Implants: IS 12375
- Ventilators:
IS 13450 (Part 2/Sec 12): 2023
- Infant Incubators and Radiant Warmers: IS 13450 (Part 2/Sec 19): 2023 for incubators and IS 13450
(Part 2/Sec 21): 2023 for radiant warmers
- Haemodialysis Machines: IS 13450 (Part 2/Sec 16) : 2019
- Infusion Pumps: IS 13450 (Part 2/Sec 24): 2019
- Advanced Diagnostic Tools:
o
X-ray and CT Machines: IS 7620 (Part 1) : 1986
o
MRI Systems: IS 13450 (Part 2/Sec 33) : 2018
o
Ultrasound Devices: IS 13450 (Part 2/Sec 37): 2019
o
ECG: Covered under IS 13450 (Part 2/Sec 25): 2018
- Monitoring Devices:
o
Blood Pressure Monitors: IS 13450 (Part 2/Sec 34): 2019
o
Blood Glucose Monitors: IS/ISO 15197: 2013
o
Pulse Oximeters: IS/ISO 80601-2-61: 2017