Starting 1st October, the Bureau of Indian Standards (BIS) certification will be mandatory for a range of medical textile products. The BIS team at the southern regional office has begun sensitizing stakeholders on the necessity of the ISI mark for these products.
The certification will be required for products including hospital bed linens, pillow covers, shoe covers intended for medical use, and dental bibs. Sanitary napkins and baby diapers will also need to comply with six specific standards, such as IS 17630: 2021, for medical textiles.
The Medical Textiles (Quality Control) Order, 2023, mandates that manufacturers adhere to these Indian Standards to ensure the production of quality medical textiles. Officials highlighted that detailed specifications for materials, manufacturing processes, and packaging are provided to ensure better patient care and hygiene in healthcare settings.
Bhavani, Director and Head of the BIS Chennai branch office, noted that only a few manufacturers in the country have obtained BIS licenses so far. She also mentioned that no applications have been received from manufacturers in the state for BIS licenses covering the six standards.
BIS is actively engaging with stakeholders in government hospitals and the private sector to emphasize the importance of using BIS-certified products to protect patients and healthcare professionals. The agency has collaborated with various entities, including the Tamil Nadu Medical Services Corporation, the Association of Tamil Nadu Medical Device Industry, and self-help groups attached to the Tamil Nadu Corporation for Development of Women, to raise awareness about the use of BIS-certified products, the licensing process, and testing methods.
Officials also mentioned that government agencies might require BIS-certified products during tender processes, especially since the state government distributes products like sanitary napkins under welfare schemes.
