BIS Certification for Medical Textile: Ensuring Safety and Quality in Healthcare

Published on: April 21, 2025

In the healthcare industry, where safety and hygiene are non-negotiable, medical textiles play a pivotal role. From surgical masks and gowns to drapes, bed linens, and wound dressings, these textile products are critical in maintaining infection control and ensuring patient and healthcare worker safety. To guarantee the quality and reliability of such materials, the Bureau of Indian Standards (BIS) offers a structured certification process under its scheme for medical textiles.

This blog explores the importance of BIS certification for medical textiles, the certification process, applicable standards, and how it benefits manufacturers, healthcare providers, and consumers.

What is BIS Certification?

BIS Certification is a quality assurance mark issued by the Bureau of Indian Standards, the national standards body of India. BIS certification confirms that a product conforms to the relevant Indian Standards (IS), ensuring consistency, safety, and performance.

For medical textiles, this certification is voluntary for some products and mandatory for others, especially those that have a direct impact on health and hygiene. It assures end-users that the textile products have undergone stringent quality checks and meet specified safety standards.

What are Medical Textiles?

Medical textiles, also known as healthcare or hygiene textiles, are textile materials specially designed and manufactured for medical and healthcare applications. These include:

• → Surgical gowns, masks, and drapes
• → Bed sheets and pillow covers used in hospitals
• → Wound care products like bandages and gauzes
• → Disposable wipes and sanitary napkins
• → Antimicrobial fabrics used in hospital environments
• → Protective clothing for healthcare workers

Importance of BIS Certification in Medical Textiles

• → Safety Assurance: BIS certification ensures that medical textiles are free from harmful chemicals and meet microbiological standards.
• → Quality Consistency: BIS-certified products are tested against national standards, ensuring uniformity in quality, performance, and reliability.
• → Compliance with Regulatory Requirements: Certain medical textile products require BIS certification under Indian regulations.
• → Enhanced Market Access: BIS-certified products are preferred in government tenders, exports, and healthcare procurement.
• → Consumer Trust: The ISI mark assures users of safety and compliance, boosting confidence in your brand.

Indian Standards for Medical Textiles

BIS has developed several Indian Standards (IS) for medical textiles. Some important ones include:

• → IS 16289:2014 – Textiles – Surgical Drapes, Gowns, and Clean Air Suits – Specification
• → IS 17423:2020 – Surgical Face Masks – Specification
• → IS 17334:2020 – Coveralls for COVID-19 Personal Protective Equipment
• → IS 16288:2014 – Antibacterial Finishing on Textiles – Test Methods and Requirements
• → IS 14716:1999 – Textiles for Healthcare Facilities – Requirements

BIS Certification Process for Medical Textiles

The BIS certification process typically follows the ISI mark scheme (Scheme-I of BIS Conformity Assessment Regulations). Here is a step-by-step overview:

1. Application Submission: Submit your application on the BIS portal (www.bis.gov.in) with product category and applicable IS standard.
2. Documentation: Upload documents like factory license, manufacturing process, quality control plan, test reports, and equipment details.
3. Product Testing: BIS draws samples and sends them to an approved lab. Manufacturer’s in-house testing setup is also evaluated.
4. Factory Audit: BIS officials inspect the facility to verify quality systems, sourcing, and compliance with standards.
5. Grant of License: If all checks are cleared, a license is issued allowing use of the ISI mark on certified products.
6. Surveillance and Renewal: BIS periodically audits the factory and retests samples for continued compliance and license renewal.

Who Needs BIS Certification for Medical Textiles?

• → Medical Textile Manufacturers (domestic and international)
• → Hospitals and Healthcare Providers
• → Government & Public Sector Units
• → Exporters to India (for regulated product categories)

For example, during the COVID-19 pandemic, BIS certification was critical for masks, gowns, and PPE kits to meet protection standards.

Benefits of BIS Certification for Manufacturers

• → Brand Credibility: Stand out with a government-backed quality mark.
• → Market Expansion: Unlock government contracts and exports.
• → Legal Compliance: Avoid penalties with regulatory adherence.
• → Product Differentiation: BIS-certified products are seen as high-quality and reliable.

Challenges in BIS Certification

• → Time-Consuming Process: Certification may take several weeks or months.
• → Cost of Compliance: Testing, audits, and certification fees may be high for small businesses.
• → Technical Knowledge Requirement: Understanding and implementing BIS standards requires expertise.

Working with a BIS certification consultant can simplify the process and minimize delays.

How to Get Support for BIS Certification?

For seamless certification, businesses often partner with BIS consultants who offer:

• → Documentation guidance
• → Application and audit support
• → Non-compliance resolution
• → Coordination with BIS officials

This approach accelerates the process and reduces risks.

Conclusion

BIS certification for medical textiles is not just a formality—it’s a necessity. With lives at stake, quality and safety can't be compromised. As demand for medical-grade textiles grows, BIS certification helps ensure reliability, regulatory compliance, and consumer trust.

Need Help with BIS Certification?
Our expert consultancy can guide you through the entire process—from documentation to audit to license approval. Contact us today to get started on your journey to BIS compliance for medical textiles.