BIS Certification for Cotton Absorbent Gauze in India

BIS for cotton absorbent gauze is the conformity assessment process through which the Bureau of Indian Standards (BIS) verifies that cotton absorbent gauze produced by a manufacturer conforms to IS 758:2023 - the Indian Standard specification for cotton absorbent gauze used in medical applications.

Once certified, the manufacturer is granted a BIS ISI Mark licence (CM/L number) under Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018. The ISI Mark must appear on every certified pack of cotton absorbent gauze before it can be sold in India or supplied as raw material to BIS-regulated medical product manufacturers.

• Applies to both domestic manufacturers and foreign importers selling in India
• Samples tested at a BIS-recognized laboratory against all IS 758:2023 parameters
• Manufacturing facility must pass a BIS factory inspection
• Required for cotton gauze suppliers to sanitary napkin, surgical dressing, and bandage manufacturers

IS 758:2023 is the current version of the cotton absorbent gauze specification, having replaced the older IS 758:1988 (which covered handloom cotton gauze). The updated 2023 standard reflects modern manufacturing methods and aligned medical textile quality benchmarks.

IS 758:2023 applies to cotton absorbent gauze - woven cotton fabric used for medical and surgical applications where high absorbency, softness, and purity are required. The standard covers gauze in roll form, folded form, and as supplied to downstream medical product manufacturers.

BIS ISI Mark certification under IS 758:2023 is required by:

• Cotton gauze manufacturers producing absorbent gauze for direct medical use
• Raw material suppliers to sanitary napkin manufacturers (IS 5405:2019 mandates IS 758 compliance for cotton gauze used as raw material)
• Raw material suppliers to surgical dressing, bandage, and wound care product manufacturers
• Importers of cotton absorbent gauze into the Indian market
• Hospital and pharmaceutical supply chains seeking quality-assured cotton gauze for procurement

BIS-recognized laboratories test cotton absorbent gauze against the following parameters before a licence is granted. All results must conform to the limits specified in IS 758:2023:

For Indian Manufacturers (ISI Mark Route):

• GST registration certificate and company incorporation documents
• Factory layout plan showing weaving, bleaching, and quality control areas
• List of weaving looms, bleaching equipment, drying, and packing machinery
• Cotton yarn specifications and yarn supplier details with quality certificates
• Bleaching process flowchart and chemicals used in processing
• Quality control manual and in-process inspection records
• In-house testing equipment list with valid calibration certificates
• Product test reports from a BIS-recognized testing laboratory (IS 758:2023)
• Authorization letters, undertakings, and product packaging samples

Additional for Foreign Manufacturers (FMCS Route):

• Appointment letter for Authorized Indian Representative (AIR) - mandatory
• AIR's company registration and KYC documents
• Foreign manufacturer's authorization letter to AIR on company letterhead
• Factory location details and overseas BIS inspection readiness

Standphill India is a leading BIS certification consultancy with deep expertise in medical textiles certification including cotton absorbent gauze (IS 758:2023), sanitary napkins (IS 5405), surgical dressings, and other notified medical textile products. As a specialist BIS consultant for cotton absorbent gauze manufacturers, we manage the complete process from scope confirmation to ISI Mark grant.

• Medical textiles specialist team - direct experience with IS 758:2023 and TXD 36 standards
• BIS-recognized lab coordination - we arrange cotton gauze testing at the right labs
• Complete documentation - yarn specs, bleaching process docs, quality manuals in BIS format
• Factory inspection preparation - we prepare your weaving and bleaching facility for BIS audit
• Foreign manufacturer support - AIR services and FMCS route for overseas clients
• Supply chain support - we help sanitary napkin and surgical dressing manufacturers secure compliant cotton gauze suppliers
• Post-certification support - surveillance readiness, renewals, scope additions