IS 16291:2014

Medical textile material has grown in importance in the healthcare sector as a result of recent discoveries and inventions in both textiles and medicines. However, in light of the user's health and safety, more emphasis should be put on their quality standards.

In this competitive scenario, it isn't easy to survive in the market without a standard quality and certified product. BIS license may also be required to sell products in the Indian market.

To get BIS certification and produce a standard quality product, the manufacturer must ensure that their product must follow the specified Indian standard.

Let’s have a look at IS 16291:2014 for BIS Certification of Medicated Paraffin Gauge Dressing.

Medicated Paraffin Gauge Dressing is covered by IS 16291:2014. This standard specifies the requirements for medical-grade paraffin gauze dressings. To ensure that Medicated Paraffin Gauge Dressing and other medical textiles meet Indian standards and are safe and reliable for customers, they must be BIS certified.

It is made of leno weave fabric with two picks in each shed and warp and weft threads of cotton, viscose, or a combination of cotton and viscose rayon impregnated with white or yellow soft paraffin.

Paraffin gauze dressings must meet the requirements of the standard. The dressing must be clean and free of anything that could cause tendering during storage. The product must be free of toxic or hazardous substances. The dressings' production and preparation must take place in sanitary conditions.

Marking & Packing:

The following information must be legibly marked on each pack of paraffin gauze dressings:

  • Product name
  • Manufacturer's name, or trade-mark, if any
  • Manufacturing month and year
  • Dimensions
  • Light, medium, or heavy loading
  • Any other statutory requirement imposed by the applicable law.

The Standard ISI Mark may also be applied to the product. The paraffin gauze dressings must be packed securely so that they can be handled and transported normally without tearing and exposing the contents.

Manufacturers must ensure that their products meet Indian standards in order to obtain a BIS licence for medicated paraffin gauge Dressing. The manufacturer is granted a BIS licence to use the standard ISI Mark on its product and sell it in the Indian market by the Bureau of Indian Standards. Medicated paraffin gauze dressing manufacturers must apply for a BIS certification for paraffin gauge dressing through the BIS portal. Only after verifying that the product meets Indian standards will the Bureau issue a BIS licence for medicated paraffin gauge dressing. For a free consultation on BIS certification for paraffin gauge dressing, contact Aleph INDIA.

isi mark


For Detailed Information about the Procedure for BIS ISI Certification, Visit :

  1. Procedure for Domestic Manufacturer
  2. Procedure for Foreign Manufacturer


If a product falls under the scope of the BIS Conformity Assessment Scheme, All the manufacturers, importers, and foreign entities must obtain BIS ISI Certification. The Bureau may cancel the License if the product fails to meet certification requirements.

Aleph INDIA has been serving the industry as a single-window operator for all product regulatory compliance. We can assist importers or manufacturers in meeting all criteria for importing or selling a product in the Indian market.

Know more about certification process, Request a callback Click here

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