India is the 2nd largest player in textiles after China. Medical textiles play a vital protective role in the healthcare industry. Medical textiles are widely used to meet the diverse requirements of the medical sector. These products range from high-volume disposable products for infant diapers, feminine hygiene, and adult incontinence to highly specialised & expensive textiles used in blood filtration, prostheses, surgical sutures, and most recently, scaffolds for the growth of new tissue. To ensure the safety & health of the user, all manufacturer is required to obtain BIS Certification for medical textiles products.
The Indian standards specify the performance requirements for medical textiles in medical applications, and all medical textiles need to comply with the applicable Indian standard. BIS-certified medical textile products assure that the medical textile products meet all requirements of Indian standards. BIS Certification is required for each medical textile, such as eye pads, baby diapers, sanitary pads, dressings, napkins, and other medical textiles, to ensure that products meet Indian standards and are reliable & safe for customers. This blog will discuss the BIS Certification for Medical Textiles Products in India.
Overview of Bureau of Indian Standard (BIS)
BIS is an Indian Standard body responsible for the standard formulation, testing, marking, and quality certification of products. BIS manage several certification schemes to ensure that the customers receive high-quality, risk-free products. BIS allows using the ISI mark on the products and selling it in the Indian market. ISI Marked product ensures that it meets the requirements of applicable Indian Standard. To use the ISI mark and sell the product in the Indian market, a manufacturer needs to obtain BIS Certification for their products from BIS. BIS Certificate is issued only after confirming that the product meets every requirement of applicable Indian standards.
List of the Medical Textiles Products
Following is the list of medical textiles products in India:
|Sr. No.||Indian Standard||Product|
|1.||IS 16669: 2017||Medical Textiles Elastic Adhesive Dressing – Specification|
|2.||IS 16290:2014||Medical Textiles Knitted Viscose Primary Dressings – Specification|
|3.||IS 16468:2016||Medical Textiles Absorbent Cotton (Sterile and Non-Sterile) – Specification|
|4.||IS 16670:2017||Medical Textiles Absorbent Cotton Ribbon Gauze – Specification|
|5.||IS 16948:2018||Medical Textiles Permeable Nonwoven Surgical Adhesive Tape – Specification|
|6.||IS 757:1971||Specification For Handloom Cotton Lint, Absorbent, Bleached|
|7.||IS 863:1988||Specification For Handloom Cotton Bandage Cloth, Non-Sterilized|
|8.||IS 14316:1995||Swabs, Small, In Bag Of 50 Specification|
|9.||IS 16469:2016||Medical Textiles Open Weave Bandages – Specification|
|10.||IS 9751:1981||Specification For Bandage, Suspensory|
|11.||IS 14306:1995||Bandage, Triangular, Calico – Specification|
|12.||IS 16111:2013||Elastic Bandage|
|13.||IS 16302:2014||Medical Textiles – Orthopaedic Stockinet – Specification|
|14.||IS 16467:2016||Medical Textiles Graduated Medical Compression Stockings – Specification|
|15.||IS 16949:2018||Medical Textiles Adhesive Extension Plaster – Specification|
|16.||IS 4717:1980||Specification For Zinc Oxide Self-Adhesive Plaster|
|17.||IS 11163:1985||Specifications For First Aid Dressings|
|18.||IS 5405:2019||Sanitary Napkins – Specification (Second Revision)|
|19.||IS 17348:2020||Medical Textiles Adhesive Incise Drape – Specification|
|20.||IS 17350:2020||Medical Textiles – Abdominal Binder – Specification|
|21.||IS 17352:2020||Medical Textiles – Foam Dressing – Specification|
|22.||IS 17354:2020||Medical Textiles Dental Bib/Napkins – Specification|
|23.||IS 17423:2021||Medical Textile – Bio Protective Coveralls- Specification|
|24.||IS 17507:2020||Medical Textile – Cellulose Wading – Specification|
|25.||IS 17509:2021||Disposable Baby Diaper- Specification|
|26.||IS 17528:2021||Medical Textiles Chlorhexidine Gauze Dressings – Specification|
|27.||IS 17629:2021||Medical Textiles- Caps – Specification|
|28.||IS 16291:2014||Medicated Paraffin Gauze Dressings – Specification|
|29.||IS 16466:2016||Medical Textiles – Povidones Iodine Ointment Based Knitted Dressing – Specification|
|30.||IS 16470:2016||Medical Textiles Elastic Surgical Adhesive Tapes – Specification|
|31.||IS 16668:2017||Medical Textiles Salicylic Acid Adhesive Plaster – Specification|
|32.||IS 16950:2018||Medical Textiles – X-ray Detectable Absorbent Cotton Gauze Specification|
|33.||IS 758:1988||Specification For Handloom Cotton Gauze, Absorbent, Non-Sterilised|
|34.||IS 10829:1993||X-ray Detectable Gauze Swabs and Laparotomy Sponges – Specification|
|35.||IS 4605:1981||Specification For Crepe Bandage|
|36.||IS 16946:2018||Medical Textiles Elasticated Tubular Bandages – Specification|
|37.||IS 14274:1995||Bandage, T-Shaped, Calico – Specification|
|38.||IS 4739:1986||Specification For Zinc Oxide Elastic Self-Adhesive Bandage|
|39.||IS 16660:2017||Medical Textiles – Nonwoven Bandage Rolls Specification|
|40.||IS 16303:2014||Medical Textiles – Cast Padding for Orthopaedic Plaster – Specification|
|41.||IS 16671:2017||Medical Textiles Belladonna Adhesive Plaster – Specification|
|42.||IS 6237:1971||Specification For Handloom Cotton Cloth for Plaster of Paris Bandages & Cut Bandage|
|43.||IS 4738:1993||Bandage, Plaster of Paris – Specification|
|44.||IS 16289:2014||Medical Textiles Surgical Face Masks – Specifications|
|45.||IS 17334:2019||Medical Textiles Surgical Gowns & Surgical Drapes – Specification|
|46.||IS 17349:2020||Medical Textile- Shoe Covers- Specification|
|47.||IS 17351:2020||Medical Textiles Dressing, Shell Compressed – Specification|
|48.||IS 17353:2020||Medical Textiles – Pressure Garment – Specification|
|49.||IS 17359:2020||Medical Textiles Anti-Embolic Stocking for Post Op Use Up to Thigh Medium — Specification|
|50.||IS 17506:2020||Medical Textiles- Hydrocolloid Dressing- Specification|
|51.||IS 17508:2020||Disposable Adult Incontinence Diaper- Specification|
|52.||IS 17514:2021||Reusable Sanitary Pad/ Sanitary Napkin or Period Panties – Specification|
|53.||IS 17628:2021||Medical Textiles – Eye Pad – Specification|
|54.||IS 17630:2021||Medical Textiles Bed Sheet and Pillow Cover – Specification|
Documents Required to Obtain BIS Certification for Medical Textiles Products
Following are some essential documents for Obtaining BIS Certification for Medical Textiles Products in India:
- Factory Registration Documents;
- Trademark Certificate (if registered);
- Map Location Plan of the factory from the nearest railway station or bus stand;
- Laboratory Test Report according to Product Standard;
- In-house Testing Facilities;
- Flow Chart of Manufacturing Process;
- Information of Authorised Signatory & other related Documents.
Procedure of BIS Certification for Medical Textiles Products
Following are the Steps to Obtain BIS Certification for Medical Textiles Products:
Step 1: Documentation: To obtain BIS certification for medical textiles products, you must prepare all necessary documents before submitting your application.
Step 2: Application Submission: Once all relevant documents are prepared, the application form and supporting documents will be submitted to the BIS Portal.
Step 3: Scrutiny of application: BIS officials will carefully review each document and application submitted by the applicant.
Step 4: Audit of manufacturing Unit: Then, BIS will appoint an auditor to inspect manufacturing premises. During the inspection of manufacturing premises, BIS officials will draw a sample and send it to a BIS-approved laboratory for testing.
Step 5: Sample testing: All samples collected will be tested in a BIS-approved laboratory to ensure that the products meet the requirements of applicable Indian standards.
Step 6: Grant BIS Licence: If the product complies with the specified Indian standard, BIS will grant a BIS license to the manufacturer.
Note: The BIS Certificate is valid for two years. During these 2 two years, BIS may request random product inspections.
Cost for BIS Certification for Medical Textiles Products
Cost of BIS Certification includes:
- Application fee;
- Product sample testing fee;
- Audit fee;
- License fee;
- Marking fee.
Note: It also required investment in factory facilities, particularly installing testing machinery for in-house factory test labs.
The usage of textile materials for diverse medical purposes has increased due to recent discoveries and advancements in medicine and textiles. However, in light of the user’s health and safety, more attention should be put to their quality requirements. All medical textile manufacturers must get BIS certification for their medical textiles, such as Elastic Adhesive Dressing, Medicated Paraffin Gauze Dressing, Knitted, Viscose Primary Dressing, Knitted Dressing, and so on, to ensure textile quality and the use of the standard mark. Compliance, though, can be difficult. Obtaining BIS certification requires working with authorities, gathering samples for testing, and meeting BIS regulations, so it’s not as easy as it previously appears. Therefore, it is best to seek professional assistance so that they can manage the entire procedure and help you receive a BIS certificate.
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