BIS Certification for Medical Textiles

BIS Certification for Medical Textiles

BIS Certification for Medical Textiles is now mandatory as per the recent Quality Control Order to ensure the quality, safety and performance of these products. These items, being critical in healthcare and personal hygiene, must meet stringent standards to ensure they are safe for use and effective in their purpose. Manufacturers of certain medical textiles have to obtain the BIS certification. This is a crucial step of the Bureau of Indian Standards towards the quality and safety of these products.

Quality Control Order for Medical Textiles

The Ministry of Textiles has issued a Quality Control Orders (QCO) on the date 23rd October, 2024, after consulting the Bureau of Indian Standards to regulate the quality and safety of certain medical textile products. These orders mandate that specific products comply with Indian Standards and obtain BIS certification.

(1) This Order may be called the Medical Textiles (Quality Control) Order, 2024.
(2) It shall come into force on the date of its publication in the Official Gazette.

For more information download Quality Control Order for Medical Textiles.

Products Covered in QCO for Medical Textiles

Sl. No. Goods or article Indian Standard (IS) Title of Indian Standard Timeline for implementation
                 1                  2                3              4             5
1. Sanitary napkins IS 5405:2019 Sanitary napkins – Specification (second revision). 1 st January 2025
2. Baby Diaper IS 17509:2021 Disposable baby diaper – Specification.  
3. Reusable Sanitary Pad Sanitary Napkin Period Panties IS 17514:2021 Reusable sanitary pad/ sanitary napkin/ period panties – Specification.  

 

 

 

 

 

 

1. Shoe covers IS 17349:2020 Medical textiles – Shoe covers – Specification 1st April, 2024
2. Dental bib/Napkins IS 17354:2020 Medical textiles – Dental Bib or Napkins-Specification  
3. Bedsheet and Pillow Cover IS 17630:2021 Medical Textiles – Bed sheet and pillow cover-Specification  

 

Conclusion

BIS license for medical textiles is mandatory for maintaining high standards of safety, quality and performance. BIS certification ensures that products meet national standards, protecting  both users and manufacturers. For manufacturers, BIS certification enhances the brand reputation in the market and strengthens consumer trust. By adhering to BIS certification, manufacturers can adhere to the ISI mark on their products which shows that the product is tested and certified.

If you are looking for BIS certification or for any further information for medical textiles, feel free to contact us at +91-7503304082 or email at [email protected] or visit us at www.induceindia.com.

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