BIS Certification for Medicated Paraffin Gauze Dressing – IS 16291:2014

To ensure that these products are safe for public use and maintain consistent quality, the Bureau of Indian Standards (BIS) has formulated IS 16291:2014, which outlines the quality standards for Medicated Paraffin Gauze Dressing. BIS certification is not only a mark of quality but also a mandatory requirement for regulated products in India.

What is Medicated Paraffin Gauze Dressing?

Medicated Paraffin Gauze Dressing is a non-adherent wound dressing, typically used for treating burns, ulcers, skin grafts, and lacerations. It allows for pain-free dressing changes and promotes a moist wound-healing environment.

According to IS 16291:2014, the dressing must be:

Key Quality Requirements of IS 16291:2014

To qualify for BIS certification under this standard, the Medicated Paraffin Gauze Dressing must meet the following criteria:

Material & Construction: Leno weave fabric ensures proper flexibility and strength. Warp and weft threads must be clean, soft, and uniformly distributed.

Impregnation: The paraffin used must be medical-grade, non-toxic, and non-reactive. Should not contain substances that may cause irritation or allergic reactions.

Cleanliness & Hygiene: Products must be manufactured under hygienic and sanitary conditions. The dressing must be free from foreign particles, odors, and discoloration.

Marking & Packaging Guidelines

Each pack of Medicated Paraffin Gauze Dressing must be clearly labeled with the following details:

Packaging should be robust to protect the contents from tearing or contamination during handling and transport.

Why BIS Certification is Important

Obtaining BIS certification ensures that your product:

Under the BIS Conformity Assessment Scheme, both domestic and foreign manufacturers must obtain certification if their product falls within the scope of a notified Indian Standard. Non-compliance may lead to cancellation of the license and a ban on sales in India.

How to Get BIS Certification for Medicated Paraffin Gauze Dressing

Steps Involved:

1. Product Testing: Samples must be tested in a BIS-recognized lab for compliance with IS 16291:2014.
2. Application Filing: Submit a detailed application through the BIS portal, accompanied by the necessary supporting documents.
3. Factory Audit: BIS officials will inspect the manufacturing facility to verify the quality control measures in place.
4. Grant of License: After successful inspection and testing, the BIS license is issued for marking the product with the ISI mark.

Why Choose EVTL India?

EVTL India is a leading compliance consultant with extensive experience in regulatory approvals for medical products. We offer end-to-end support for BIS certification of Medicated Paraffin Gauze Dressing and other medical textiles.

Our services include:

With a proven track record and a client-first approach, EVTL India ensures a smooth, hassle-free certification process for both Indian and foreign manufacturers. Whether you're a manufacturer, importer, or a foreign entity, if your product falls under the purview of IS 16291:2014, obtaining BIS certification is mandatory.