BIS Certification For Medical Textiles

Whether you are a manufacturer, distributor, or healthcare provider getting BIS certification for medical textile is very important. Medical textiles products such as masks, drapes, surgical gowns, wound dressing, etc play a vital role in protecting patients’ health and hygiene. Therefore, guaranteeing these products meet the required BIS registration standards is crucial.

BIS certificate for medical textile products ensures compliance with national standards and enhances the credibility and marketability of these products. In this article, we will explore the significance of BIS certificate for medical textile products, the certification process, and the benefits.

What Is BIS Certification For Medical Textile?

BIS certification for medical textiles ensures the safety and quality of the medical textiles for consumer safety. For medical textiles such as masks, surgical gowns, etc BIS develop standards, test products stability, and then certify BIS certification to the manufacturers.

Once the BIS certificate is granted, the manufacturer can use the BIS mark on their products and ensure consumers the medical textile is reliable, high-quality and safe to use.

What Is The Process Of BIS Certification For Medical Textile?

Follow the below-listed steps to get the BIS certificate for medical textile products:

• Documentation: to get BIS certificate for medical textiles products first of all prepare all the necessary documentation before submitting your application.
• Application Submission: Submit the completed application form along with the supporting documents to the BIS Portal.
• Scrutiny of Application: BIS officials will thoroughly review the submitted documents and application before proceeding to the next step.
• Audit of Manufacturing Premises: After scrutiny, BIS will appoint an auditor to inspect the manufacturing premises. During the inspection, samples will be collected and sent to a BIS-approved laboratory for testing.
• Sample Testing: The collected samples will be tested in a BIS-approved laboratory to ensure they meet the requirements of the applicable Indian standards.
• Grant of BIS License: If the product complies with the specified Indian standards, BIS will grant a BIS license to the medical textile manufacturer.

Also read: Get BIS Certification For Medical Devices

Documents Required To Get BIS Certificate For Medical Textiles Products In India

There are several documents required to obtain BIS certification for medical textiles products in India, listed below:

• Laboratory test reports per product standards
• Factory registration documents
• Manufacturing process flowchart
• Details of in-house testing facilities
• Information on the authorized signatory and other relevant documents

List Of Medical Textile Products Under BIS Certification

The BIS has developed standards for each medical textile to ensure the consumer’s safety and health. Hence, read the full details of the Indian Standards of Medical Textile products list according to the products here:

S.No.	Indian Standard	Products
1	IS 16669: 2017	Medical Textiles – Elastic Adhesive Dressing – Specification
2	IS 16291:2014	Medicated Paraffin Gauze Dressings – Specification
3	IS 16290:2014	Medical Textiles – Knitted Viscose Primary Dressings – Specification
4	IS 16466:2016	Medical Textiles – Providone Iodine Ointment-Based Knitted Dressing – Specification
5	IS 16468:2016	Medical Textiles – Absorbent Cotton (Sterile and Non-Sterile) – Specification
6	IS 16470:2016	Medical Textiles – Elastic Surgical Adhesive Tapes – Specification
7	IS 16670:2017	Medical Textiles – Absorbent Cotton Ribbon Gauze – Specification
8	IS 16668:2017	Medical Textiles – Salicylic Acid Adhesive Plaster – Specification
9	IS 16948:2018	Medical Textiles – Permeable Nonwoven Surgical Adhesive Tape – Specification
10	IS 16950:2018	Medical Textiles – Xray Detectable Absorbent Cotton Gauze Specification
11	IS 757:1971	Specification For Handloom Cotton Lint, Absorbent, Bleached
12	IS 758:1988	Specification For Handloom Cotton Gauze, Absorbent, Non-Sterilized
13	IS 863:1988	Specification For Handloom Cotton Bandage Cloth, Non-Sterilized
14	IS 10829:1993	X-ray Detectable Gauze Swabs and Laparotomy Sponges – Specification
15	IS 14316:1995	Swabs, Small, In Bag Of 50 – Specification
16	IS 4605:1981	Specification For Crepe Bandage
17	IS 16469:2016	Medical Textiles – Open Weave Bandages – Specification
18	IS 16946:2018	Medical Textiles – Elasticated Tubular Bandages – Specification
19	IS 9751:1981	Specification For Bandage, Suspensory
20	IS 14274:1995	Bandage, T Shaped, Calico – Specification
21	IS 14306:1995	Bandage, Triangular, Calico – Specification
22	IS 4739:1986	Specification For Zinc Oxide Elastic Self-Adhesive Bandage
23	IS 16111:2013	Elastic Bandage
24	IS 16660:2017	Medical Textiles – Nonwoven Bandage Rolls – Specification
25	IS 16302:2014	Medical Textiles – Orthopedic Stockinet – Specification
26	IS 16303:2014	Medical Textiles – Cast Padding for Orthopedic Plaster – Specification
27	IS 16467:2016	Medical Textiles – Graduated Medical Compression Stockings – Specification
28	IS 16671:2017	Medical Textiles – Belladonna Adhesive Plaster – Specification
29	IS 16949:2018	Medical Textiles – Adhesive Extension Plaster – Specification
30	IS 6237:1971	Specification For Handloom Cotton Cloth for Plaster of Paris Bandages and Cut Bandage
31	IS 4717:1980	Specification For Zinc Oxide Self – Adhesive Plaster
32	IS 4738:1993	Bandage, Plaster of Paris – Specification
33	IS 11163:1985	Specifications For First Aid Dressings
34	IS 16289:2014	Medical Textiles – Surgical Face Masks – Specifications
35	IS 5405:2019	Sanitary Napkins – Specification (Second Revision)
36	IS 17334:2019	Medical Textiles – Surgical Gowns and Surgical Drapes – Specification
37	IS 17348:2020	Medical Textiles – Adhesive Incise Drape – Specification
38	IS 17349:2020	Medical Textile- Shoe Covers- Specification
39	IS 17350:2020	Medical Textiles – Abdominal Binder – Specification
40	IS 17351:2020	Medical Textiles – Dressing, Shell Compressed – Specification
41	IS 17352:2020	Medical Textiles – Foam Dressing – Specification
42	IS 17353:2020	Medical Textiles – Pressure Garment – Specification
43	IS 17354:2020	Medical Textiles – Dental Bib/Napkins – Specification
44	IS 17359:2020	Medical Textiles – Anti-Embolic Stocking for Post-Op Use Up to Thigh Medium — Specification
45	IS 17423:2021	Medical Textile – Bio Protective Coveralls- Specification
46	IS 17506:2020	Medical Textiles- Hydrocolloid Dressing- Specification
47	IS 17507:2020	Medical Textile – Cellulose Wading – Specification
48	IS 17508:2020	Disposable Adult Incontinence Diaper- Specification
49	IS 17509:2021	Disposable Baby Diaper- Specification
50	IS 17514:2021	Reusable Sanitary Pad/ Sanitary Napkin/ Period Panties – Specification
51	IS 17528:2021	Medical Textiles – Chlorhexidine Gauze Dressings – Specification
52	IS 17628:2021	Medical Textiles – Eye Pad – Specification
53	IS 17629:2021	Medical Textiles- Caps – Specification
54	IS 17630:2021	Medical Textiles – Bed Sheet and Pillow Cover – Specification

For more information, read our other blog to get a BIS license for crepe bandages, which covers all the major concerns and queries.

What Is The BIS Certification Cost For Medical Textile Products?

There is no fixed cost of BIS certificate for medical textiles products. However, the typical costs involved in obtaining BIS certification for medical textiles products lists generally include:

• Application fee
• Audit fee
• Sample testing fee
• License fee
• Marking fee

Since the exact costs can vary, we recommend contacting a BIS registration consultancy for detailed information. You can reach us by calling +917669172198 or emailing us at info@bisregistrationcertificate.com.

Is BIS Certification Mandatory For Medical Textiles Products?

Yes, BIS certification for medical textiles is mandatory for certain medical textiles in India, such as surgical gowns, face masks, and bandages, to ensure they meet quality and safety standards​.

Can I Export Medical Textiles Without BIS Certification?

No, you cannot export medical textiles products without getting BIS certification as they must meet Indian standards for safety and quality before exporting.