BIS Certification for Medical Textile Products

Medical textile products play a crucial role in safeguarding human health, providing essential protection and care in both medical and everyday settings. These products encompass a wide range of items designed to meet specific hygienic and therapeutic needs. Some of the most common medical textile products include Baby Diapers, Sanitary Pads and Napkins, Dental Bibs, Surgical Caps, Surgical Face Masks, Bandages and Adhesive Plasters, Dressings, Bed sheets and Pillow covers, Shoe Covers and Caps and many more.

These products are vital in maintaining hygiene, providing therapeutic care, and protecting healthcare providers and patients alike. As they come into direct contact with the human body, ensuring their quality and safety is paramount. This is where the Bureau of Indian Standards (BIS) Certification becomes essential.

What is BIS Certification?

The Bureau of Indian Standards (BIS) is the national standards body of India, responsible for developing and enforcing standards across various industries. Established under the BIS Act 2016, the organization plays a critical role in maintaining quality and safety standards for products in the Indian market. BIS certification is a mark of quality and compliance with the relevant Indian Standards (IS), ensuring that the products meet safety, performance, and regulatory requirements.

The Ministry of Textiles, issued the Medical Textiles (Quality Control) Order, 2023 to ensure adherence to Indian Standards for specified products. To provide additional time for compliance, the Ministry has issued several extensions, culminating in the Medical Textiles (Quality Control) Amendment Order, 2025. The date of implementation of medical textile QCO is from 1st January 2025. 

As per this quality control order, it will be mandatory for these products to have BIS certification to carry the standard ISI mark. BIS certification is important for medical textile products, as these items are directly associated with health and hygiene. The certification process involves rigorous testing and evaluation, ensuring that the products meet the essential quality standards required for safe use in the medical environment.

Importance of BIS Certification for Medical Textile Products

Given the nature of medical textiles, where the safety and well-being of individuals are at stake, ensuring the highest quality standards is non-negotiable. BIS certification offers the following benefits for manufacturers and consumers alike:

1. Ensures Product Safety: BIS certification guarantees that medical textile products meet stringent safety standards, reducing the risk of infections or allergic reactions.
2. Enhances Product Credibility: Products with BIS certification are recognized as trustworthy and of high quality, giving both healthcare providers and patients confidence in their use.
3. Mandatory Compliance: For certain medical textile products, BIS certification is mandatory before they can be sold in the Indian market. This ensures that only products that meet the required safety standards are available to consumers.
4. Prevents Substandard Products: The certification process involves detailed testing to weed out substandard or unsafe products, thereby protecting consumers and improving the overall quality of goods in the market.
5. International Recognition: BIS certification helps Indian manufacturers meet international standards, making it easier to export medical textile products to global markets.

Medical Textile Products Covered by BIS Certification

Medical textile products come in various forms, each serving a different purpose. Each of these standards is designed to ensure that medical textile products meet high performance and safety criteria, crucial for their application in healthcare settings. BIS has developed standards for several Indian standards to cover these medical textile products:

Process of BIS Certification for Medical Textile Products

The BIS certification process for medical textiles involves multiple steps, designed to thoroughly evaluate a product's compliance with the required standards. Here is a general overview of the certification process:

1. Application Submission: Manufacturers must submit an application form along with required documentation to BIS.

2. Documentation Review: BIS reviews the submitted documents to ensure completeness and correctness.

3. Factory Inspection: BIS officials conduct an on-site inspection of the manufacturing facility to assess the production process and quality control measures.

4. Sample Testing: Product samples are taken and tested in BIS-approved laboratories to verify compliance with Indian standards.

5. Certification Grant: Upon successful completion of the inspection and testing, BIS grants certification, allowing the manufacturer to use the BIS mark on their products.

Documents Required for BIS Certification

To apply for BIS certification for medical textile products, manufacturers need to submit the following documents:

●  Application form

●  Manufacturing process details

●  Quality control plan

●  Test reports from BIS-approved laboratories

●  Factory layout and equipment details

●  Proof of business registration

●  Product specifications and technical details

●  Declaration of conformity to Indian standards

Additionally, manufacturers may be required to provide proof of compliance with environmental and safety regulations, depending on the specific type of product being certified.

BIS Certification Cost for Medical Textile Products

The cost of BIS certification includes several components:

●  Application Fee: A fee for submitting the application form.

●  Audit Fee: Costs associated with the on-site factory inspection by BIS officials.

●  Sample Testing Fee: Expenses for testing product samples in BIS-approved labs.

●  License Fee: A fee for granting the BIS certification.

●  Marking Fee: Costs for using the BIS mark on certified products.

Additionally, manufacturers may need to invest in factory facilities, particularly in installing testing machinery for in-house testing labs to ensure ongoing compliance with BIS standards.

Challenges in Obtaining BIS Certification

While BIS certification is crucial for ensuring the safety and quality of medical textile products, the process can be complex and time-consuming. Some of the common challenges faced by manufacturers include:

1. Lengthy Testing Procedures: The testing process for some medical textiles, particularly those with intricate designs or multiple layers of material, can be lengthy. This may delay product launches and distribution.
2. Stringent Quality Control: Manufacturers must maintain high levels of quality control throughout the production process. Any deviation from the BIS standards can result in certification being denied or revoked.
3. Cost of Certification: The cost of obtaining BIS certification, including testing fees and inspection charges, can be substantial for small or medium-sized manufacturers.
4. Ongoing Compliance: Even after certification is obtained, manufacturers must continue to meet the required standards through regular inspections and product testing. This requires ongoing investment in quality control and compliance.

Conclusion

The role of BIS certification in ensuring the quality and safety of medical textile products cannot be overstated. These products are vital for protecting health, whether in a hospital, a healthcare facility, or even a household setting. BIS certification ensures that consumers can trust the products they use for medical and hygienic purposes.

From baby diapers and sanitary pads to surgical face masks and bandages, medical textiles are used extensively in healthcare and everyday life. By ensuring that these products meet stringent safety and performance standards, BIS certification plays a key role in maintaining public health and safety.

Manufacturers looking to enter the Indian market or expand their operations must prioritize BIS certification to ensure their products are trusted, reliable, and compliant with national standards. While the process of obtaining certification may be rigorous, the benefits of enhanced credibility, consumer trust, and market access make it a worthwhile investment.

EVTL India specializes in assisting manufacturers of medical textiles in obtaining BIS certification (ISI Mark) for their products. Our comprehensive support includes application preparation, documentation review, factory inspection guidance, and product testing coordination. By partnering with EVTL India, manufacturers can ensure that their medical textile products meet Indian standards, providing assurance of quality and safety to their customers. For more information or to get started with the BIS certification process, contact EVTL India today and take the first step towards certifying your medical textile products.