Bureau of Indian Standards (BIS) is the National Standards Body of India, involved in the activities of standardisation, marking and quality certification of goods and related matters. The standard mark of BIS is a widely accepted benchmark of quality assurance.
BIS is actively involved in the standardization activity of medical devices and equipment and other related aspects. It has set standards for various medical devices and equipment used in various medical disciplines e.g. cardiology, orthopaedics, gynaecology, neurosurgery, anaesthesia, radiology, ENT, ophthalmology, dentistry etc. and other related aspects of healthcare e.g. hospital planning, biocompatibility of medical devices, medical nanotechnology, health informatics etc.
Some of the important standards on medical devices and equipment include IS/ISO 25539-2 : 2012 (Cardiac Stents), IS/ISO 21535 : 2007 (Hip-joint replacements), IS/ISO 21536 : 2007 (Knee-joint replacements), IS/ISO 11979 series (Intraocular lenses), IS 6112 : 1992 (Dental patient chair), IS 9395 : 1979 (ICU beds), IS/ISO 15197 : 2013 (Glucometers), IS/ISO 80601-2-56 : 2017 (IR thermometers) etc.
In addition to the above, Bureau is also actively engaged in standardization of condoms meant for males and females to promote family planning initiatives in the nation. The need for standardising medical textiles is also of paramount importance owing to the nature of its application areas. BIS specifies performance requirements for absorbent cotton (sterile and non-sterile), open weave bandages, adhesive tapes, non-woven bandage rolls, Salicylic acid adhesive plaster, elastic adhesive dressing, absorbent cotton ribbon gauze, surgical gowns and surgical drapes, coveralls for COVID-19 (medical textiles), shoe covers related to medical use, handloom cotton cloth for plaster of paris bandages and cut bandages, first-aid dressings and other types of bandages such as T-shaped, calico & triangular calico, swabs, surgical dressings and elastic bandages. The complete list of all such standards is available on the BIS website www.bis.gov.in.
Manufacturers who are interested in applying for BIS licence may register themselves and submit their applications online through BIS website – www.bis.gov.in
Written by:
Mr Prakash Bachani
Head (MHD Dept.)
Comments
Title : One thought on “BIS standards ensure the quality and performance of medical devices”
I am very much impressed with BIS standards.