BIS partners in COVID care by virtue of standardized medical devices
Bureau of Indian Standards (BIS) is the National Standard Body of India which plays a key role in the activities of standardisation, marking and quality certification of goods and related matters. The BIS mark is a widely accepted benchmark of quality assurance.
The COVID – 19 pandemic, a contagious disease has taken the world by storm and the number of cases is spiraling with each passing day. An unprecedented sudden increase in patient volume has pushed the healthcare resources to the edge. Not only the healthcare providers but also the related infrastructure are under tremendous pressure to provide the desired services. In such circumstances, the use of quality products in terms of medical devices including personal protective equipment plays an important role in ensuring the wellbeing of patients as well as health care providers. BIS is committed to developing Indian Standards for all such equipment and medical devices.
Some of such equipment and medical devices for which the BIS has already developed standards are as follows:
- IS 3390:1998 – Mercurial sphygmomanometermercurial, used for measuring arterial blood pressure in human beings.
- IS 3391:1965 – Stethoscope, binaural, used for auscultation of the heart, lungs and abdomen.
- IS/ISO 80601-2-56: 2017 Medical electrical equipment: Part 2 – Particular requirements for basic safety and essential performance, Section 56 Clinical thermometers for body temperature measurement
- IS/IEC 80601(Part 2/Sec 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
- IS 5029:1979 (First Revision) –Specification for bedsteads, hospital, general purposes.
- IS 9395: 1979 – Specification for bed, intensive care
- IS7620 (Part 1):1986 –Specification for diagnostic medical X-ray equipment: Part 1 general and safety requirements.
- IS13450 (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
- IS13450 (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
- IS / ISO 80601 – 2 – 12: 2011 Medical electrical equipment – Part 2 – 12 – Particular requirements for basic safety and essential performance of critical care ventilators.
- IS / ISO 10651 – 3: 1997 –Lung ventilators for medical use: Part 3 particular requirements for emergency and transport ventilators
- IS / ISO 10651-4: 2002 – Lung ventilators for medical use – Particular requirements for basic safety and essential performance: Part 4 particular requirements for the operator – Powered resuscitators
- IS / ISO 10651 – 5: 2006 –Lung ventilators for medical use? Particular requirements for basic safety and essential performance: Part 5 gas – Powered emergency resuscitators
- IS / ISO 10651- 6: 2004 –Lung ventilators for medical use – Particular requirements for basic safety and essential performance: Part 6 home – Care ventilatory support devices
- IS 17426: 2020 – ICU ventilators for use in COVID-19
- IS / ISO 10079 (Part 2): 2014 – Medical Suction Equipment: Part 2 Manually powered suction equipment.
- IS 6571: 1991 Rehabilitation Equipment – Wheelchairs, non – Folding, adult size, institutional model – Specification
- IS 7454: 1991 Rehabilitation Equipment – Wheelchairs, folding, adult size – Specification
- IS 8086: 1991 Rehabilitation Equipment – Wheelchairs, folding, junior size – Specification and
- IS 17063: 2018 – Specification for rehabilitation equipment- rough terrain active wheelchairs, folding, rider – I, adult and child size
Manufacturers who are interested in getting a BIS license (in accordance with the extant statute) for the above mentioned devices may register themselves and submit their applications online through the BIS website – www.bis.gov.in. Among the aforementioned standards, all the indigenous Indian Standards can be accessed free of cost through the BIS website.
Written by-
Mr. Prakash Bachani
Head (MHD Dept.)
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