BIS CERTIFICATION FOR MEDICAL TEXTILES NONWOVEN WIPES
IS 17787:2021

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 take a closer look at IS 17787:2021 for medical textiles – nonwoven wipes.

Medical textiles – nonwoven wipes are covered under IS 17787:2021. This standard cover the minimum performance requirements for single-use nonwoven dry or wet wipes for baby care and personal hygiene (baby, adult, facial, skin etc.). This standard does not apply to wet wipes impregnated with alcohol or wipes with a germicidal claim (numerical germ kill, disinfection etc.).

This standard does not address the need for chemicals, cleaning agents, moisturizing agents, aroma, preservatives, and other additives to be impregnated/coated on the product. The various types of chemicals/ingredients used in these items must be within the acceptable limits set by the FDA (Food and Drugs Authority of India) or another regularity authority for the purpose.

The non-woven fabric used in the manufacture of wipes must comply with IS 17788: 2021. The wipes must be clean and free of any compounds that could cause tendering during storage. The length and width of the wipes must be agreed upon by both the buyer and seller. The wipes must be manufactured in hygienic circumstances. Annex B of the standard contains general guidance for good manufacturing practice in order to maintain hygiene requirements at manufacturing facilities. Wipes must meet the specifications mentioned in the standard.

tests

The following test shall be carried out.

  • Length and width
  • pH
  • Total viable count
  • Pseudomonas aeruginosa
  • Staphylococcus aureus
  • Candida albicans
  • E. coli

The wipes must be packed securely so that they may be handled and transported normally without tearing and exposing the contents. Each packet of wipes must be legibly and indelibly labelled with the information as specified in the standard.

Conforming to the requirements of this standard, the product(s) may be certified under the terms of the Bureau of Indian Standards Act, 2016 and the Rules and Regulations formulated thereunder, and the product(s) may be marked with the Standard Mark (ISI Mark). The Manufacturer must obtain a BIS license from the Bureau of Indian Standards to use a standard mark (ISI Mark). The BIS grants a license based on a successful assessment of manufacturing infrastructure, quality control, testing capabilities, and production process.

isi mark

NOTE:

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

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

Conclusion:

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.