Medical textiles play a crucial role in various healthcare applications, ranging from infection control in hospitals to ensuring hygiene, wound care, surgical support, and even artificial organ function. To assure consumers of the reliability and safety of these products, the Bureau of Indian Standards (BIS) certification is essential.
What is Bureau of Indian Standard (BIS) Certification?
The Bureau of Indian Standards (BIS) is responsible for setting standards, conducting quality tests, providing quality marks, and certifying product quality. It oversees several certification programs aimed at ensuring that customers receive high-quality and safe products. The ISI mark, granted by BIS, indicates that a product complies with the relevant Indian standard. Manufacturers who want to feature the ISI mark on their products and sell them in the Indian market must obtain BIS Certification for their products through BIS.
Documents Required for Obtaining ISI / BIS Certification for Medical Textile Products
To obtain BIS Certification for medical textile products in India, you need to provide the following documents:
· Factory Registration Documents · Certificate of Trademark (if officially registered) · Laboratory Test Report compliant with Product Standards · In-house Testing Facilities · Visual representation of the manufacturing process · Details about the Authorized Representative and other relevant documentation
How to Obtain BIS Certification for Medical Textiles
Here's a step-by-step guide to acquiring an ISI License for your medical textile products:
1. Document Preparation: Begin by compiling all the necessary documents required for BIS certification. 2. Application Submission: Once you have all the required documents, submit your application form along with the supporting documentation through the BIS Portal. 3. Scrutiny of Application: BIS officials will thoroughly examine each document and application you submit. 4. Inspection of Manufacturing Facilities: After the scrutiny phase, BIS will appoint an auditor to inspect your manufacturing premises. During this inspection, BIS officials will collect samples of your product, which will be sent to a BIS-approved laboratory for testing. 5. Sample Testing: All collected samples will undergo testing in a BIS-approved laboratory to ensure that your product meets the criteria outlined in the applicable Indian standards. 6. Issuance of BIS License: If your product aligns with the specified Indian standard, BIS will grant a BIS license to the manufacturer.
List of Medical Textile Products Covered Under BIS Certification
1. IS 5405:2019 - Sanitary Napkins: This standard pertains to feminine hygiene products used during menstruation. It covers aspects like size, absorption capacity, pH value, and materials used. 2. IS 17509:2021 - Disposable Baby Diapers: These are essential products for infants and toddlers, with requirements specified for size, absorbency, pH value, and materials used in their construction. 3. IS 17514:2021 - Reusable Sanitary Pads/Period Panties: Eco-friendly alternatives to disposable sanitary napkins, with requirements related to materials, durability, and washability. 4. IS 17349:2020 - Shoe Covers: Protective items worn over shoes in sterile environments like hospitals and labs, with specifications for size, material, and slip resistance. 5. IS 17354:2020 - Dental Bibs/Napkins: Disposable items used in dental clinics to protect patients' clothing, with standards for size, absorbency, and barrier properties. 6. IS 17630:2021 - Bed Sheets and Pillow Covers: These commonly used textiles in homes and healthcare settings have specifications for size, thread count, and material quality.
Conclusion
Brand Liaison offers valuable assistance and services to manufacturers and businesses seeking BIS (Bureau of Indian Standards) Certification. Our experts simplify and expedite the certification process for medical textile products, ensuring compliance with the required standards and regulations, making your products market-ready.
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