BIS Certification for Medicated Paraffin Gauze Dressing – IS 16291:2014
In the modern healthcare industry, medical textiles have become
indispensable due to innovations in textile engineering and advancements in
medical science. Among these, medicated
paraffin gauze dressings play a crucial role in wound care management.
Given their direct interaction with human skin and tissues, ensuring their
safety, hygiene, and efficacy is of utmost importance.
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:
- Product Testing: Samples must be tested in a BIS-recognized lab for compliance with IS 16291:2014.
- Application Filing: Submit a detailed application through the BIS portal, accompanied by the necessary supporting documents.
- Factory Audit: BIS officials will inspect the manufacturing facility to verify the quality control measures in place.
- 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.