BIS Certification for Medical Textiles Products

Medical textiles are an important category of textiles that have numerous applications in the health industry. These include but are not limited to, wound care dressings, surgical threads, orthopaedic implants and hygiene items. It is important to acknowledge the contribution that they make to the protection of the patient’s health. To label their products as meeting quality and safety requirements, all manufacturers are required to get a BIS certification. This certification is mandatory for a few products like surgical masks, baby diapers, sanitary napkins, eye pads and many more. In this article, you will find the overview of BIS Registration, its procedure, required documents, and the importance of getting certification for medical textile manufacturing companies. We will also discuss the kind of medical textiles that are under BIS standards.

What is BIS Certification?

The Bureau of Indian Standards BIS is a statutory body which makes standards, regulates the quality of the products, and controls many schemes. ISI mark or BIS certification assures a consumer that the product they are going to purchase meets basic safety and quality standards that are recognized in India.

Key Points about BIS Certification:

♦ ISI Mark: The ISI mark is the universal mark of quality which informs the common man that the product is of the right quality and safety standards.

♦ BIS License: For the ISI mark and to supply the products to India, the manufacturer has to get the BIS license. This will guarantee the consumers affordable and quality risk-free products in the market.

Importance of BIS Registration for Medical Textiles

Medical textile product is made with certification because the product comes in contact with the patient and other healthcare workers. Such accreditation enables the manufacturers of the products to guarantee customers that their products are safe and efficient, and are compliant with standard International standards as applied in the Indian market.

Process of Obtaining BIS Certification for Medical Textiles

It takes some time to obtain the BIS certificate online. Here’s an overview of the process:

1. Documentation: Manufacturers have to collect and organize all the papers such as certifications from laboratories, factory registration, and flow diagrams.

2. Application Submission: You are required to fill out the application form along with the documents submitted on the BIS portal.

4. Scrutiny of Application: BIS officials will read through the application and all documents that come with the particular application.

5. Audit of Manufacturing Premises: An auditor appointed by BIS will pay a visit to the above-mentioned manufacturing unit and they will take samples for testing as well.

5. Sample Testing: The samples that will be collected will then be analyzed in a laboratory that has been accredited by BIS so as to conform to the required standards.

6. Grant of BIS License: Should a manufacturer’s product satisfy all the outlined stipulations, BIS will issue the manufacturer with a license.

Documents Required for BIS Certification

Some documents need to be attached when applying for BIS certificate online by a manufacturer. Here’s a brief overview:

♦ Laboratory Test Reports

♦ Registration Documents of Factory

♦ Manufacturing process flow charts are useful tools in achieving a manufacturing objective in the sense that:

♦ In-house Testing Facilities

♦ List of Authorised Signatory

Standards for Medical Textiles Under BIS

BIS has established a number of standards that regulates the safety and quality of medical textile products. These standards focus on product areas such as absorbent cotton, surgical gowns, adhesive tapes and others. Here are a few examples:

♦ IS 16291: 2014 – Cream/stoma Medicated Paraffin Gauze Dressings

♦ IS 5405: 2019 – Sanitary Napkins

♦ IS 17334: Medical Uniforms 2019 – Surgical Gowns and Drapes

♦ IS 16467: 2016 – Medical Compression Stockings for Graduated Type

♦ IS 16289: 2014 – Surgical Face Masks

These standards help Medical textiles retain a common high quality and improved patient well being.

Cost of BIS Certification for Medical Textiles

The cost of BIS certification includes multiple components:

♦ Application Fee: These are incurred on certification application submission.

♦ Audit Fee: Connected with the comparative analysis of manufacturing premises to identify their compliance or otherwise with established requirements.

♦ Sample Testing Fee: It entails the expenses incurred on testing of some of the products to the consumers.

♦ License Fee: A fee to get the license of a banking institution and soon.

♦ Marking Fee: Tied to customer demands concerning the use of the ISI mark on products.

Further, manufacturers may also require expenditure for the installation of testing apparatus to meet BIS standards.

Benefits of BIS Certification for Medical Textiles

Obtaining BIS certification has multiple benefits:

♦ Enhanced Product Credibility: It is known if products are certified, they are safe and up to standard.

♦ Consumer Trust: Customers are assured of the quality and safety of products labelled BIS certified products/unsafe products.

♦ Market Access: Indian markets require BIS certification to sell products in the country.

Challenges in BIS Certification and the Role of a BIS Consultant

The process of BIS Registration may be quite complex because of numerous requirements and the complexity of the process. Manufacturers are expected to meet a number of requirements, to be audited and to produce a significant volume of paperwork. A BIS Consultant play a crucial role at this point Role of a BIS Consultant:

♦ Getting pre and post-application forms and documents filled up in the correct format.

♦ The joint organization of audits and the testing of samples.

♦ Meet compliance with other standard-related requirements.

It may take some time, especially if you try to handle it on your own; that is why it is always better to turn to an experienced consultant, such as PSR Compliance.

Conclusion

Being certified through BIS, medical textiles guarantee the customers that the product meets the Indian standard and benefits the end user. For manufacturers, getting a BIS certificate is more than just a governmental formality but it is a promise of reliability.

To some, a medical textile manufacturer getting BIS certification can be daunting and tiring. However, engaging professional consultants such as PSR Compliance will help to simplify the process and gain certification on time. Contact us now and make the process hassle-free for yourself.