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BIS Certification for Medical Textiles Products

Medical textiles play an essential protective function in the healthcare industry. Medical Textile is widely used to meet the diverse needs of the medical sector. These products range from high-volume disposables products for infant diapers, feminine hygiene, and adult incontinence to highly specialised and expensive textiles used in blood filtration, surgical sutures, prostheses, and, most recently, scaffolds for the growth of new tissue. So as to ensure the health and safety of the user, all manufacturer is required to obtain BIS certification for medical Textile.

It is critical to test the properties and performance of medical textiles with suitable methods as per Indian standards. The Indian standard specifies the performance requirements for medical textiles in medical applications, and all medical Textiles must comply with the applicable Indian standard. BIS-certified medical textile products assure you that the medical textile products meets all the requirements of Indian standards.

BIS certification is required for all medical textiles like baby diapers, eye pads, dressings, sanitary pads, napkins, shoe covers, surgical face masks, bandages, adhesive plasters, handloom cotton lint, caps, and other medical textiles to ensure that products meet Indian standards and are safe and reliable for customers.

Before moving forward, Let’s take a closer look at what is BIS certification?

What is BIS (Bureau of Indian standard)?

BIS is an Indian certification body responsible for the standard formulation, marking, and quality certification of goods. BIS operates various certification schemes to ensure that the public receives high-quality, risk-free products.

BIS license: BIS operates a product certification scheme, also known as the ISI Mark certification scheme, to grant a BIS licence to manufacturers to use the ISI mark on products and sell them into the Indian market. ISI Marked product guarantee that it meets the requirements of applicable Indian standards.

To use the standard mark and sell their product in the Indian market, manufacturers must obtain BIS certification for their product from BIS. BIS Certificate is issued only after confirming that the product meets all the requirements of applicable Indian standards. To obtain BIS Licence, all manufacturers must ensure that their product conforms to all applicable Indian standards. By obtaining BIS certification, companies can gain consumer trust, ensure consumer health and assure that their product is safe and out of physical harm.

In the above paragraph, you learned about what is BIS Licence. Now, you will be wondering about how to obtain BIS certification for your product? Let's go over the process of obtaining BIS certifications for the medical textile product.

What is the Process of BIS certification for Medical Textile?

The process of BIS certification for medical Textile is as follows:

  • Documentation: If you want to obtain BIS certification for your medical textile product, you must prepare all necessary documentation before submitting your application.
  • Application Submission: Once all relevant documents are prepared, the application form and supporting documentation will be submitted to the BIS Portal.
  • Scrutiny of application: BIS officials will carefully review each and every document and application submitted.
  • Audit of manufacturing premises: Following scrutiny, BIS will appoint an auditor to audit manufacturing premises. During the inspection of manufacturing premises, BIS officials will draw a sample and send it to a BIS-approved laboratory for testing.
  • Sample testing: All samples collected will be tested in a BIS-approved laboratory to ensure that the product meets the requirements of applicable Indian standards.
  • Grant of BIS Licence: If the product complies with the specified Indian standard, BIS will grant a BIS license to the manufacturer.

Documents Required to get BIS certification in India

Documents required for BIS Certification are very specific and generic, which include:

  • Laboratory Test Reports as per Product Standard
  • Factory Registration Documents
  • Manufacturing process flow chart
  • In-house Testing Facilities
  • Details of Authorised Signatory and other related documents

BIS covered medical Textile:

The standardisation of medical textiles is crucial because it affects the health and safety of the user. Various performance and functional requirements must be appropriately standardised according to the most recent technological advancements on a global scale. A medical textile of standard quality is required to ensure the user's health and safety.

However, the Bureau of Indian Standards has developed some standards for medical textiles, which are given below:

S.No. Indian Standard Title
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 Xray 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

What is the BIS certification cost for Medical Textile products?

BIS certification costs include:

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

It also required investment in factory facilities, particularly in installing testing machinery for in-house factory test labs.


With new discoveries/inventions in both textiles and medicines, textile material has become more important, and the use of textile materials for various medical applications has increased. However, greater emphasis should be placed on their quality standards in view of the health and safety of the user.

To assure medical textile quality and use of the standard mark, all medical textile manufacturers must obtain BIS certification for their medical textiles such as Elastic Adhesive Dressing, Medicated Paraffin Gauze Dressing, Knitted, Viscose Primary Dressing, Knitted Dressing, and so on. However, compliance can be challenging. Getting BIS certification is not as easy as it first seems because it necessitates cooperation with authorities, sample collection and testing, and fulfilling BIS requirements. That’s why It is best to seek expert help so that they can handle the entire process and assist you in obtaining a BIS certificate.

Aleph India is a one-stop solution for all your compliance requirements. Aleph India provides a single window to the manufacturer and importer for product testing, training, technical certification, Auditing, Laboratory setup and technical compliance services. Our Expert will assist you in getting your product tested and approved, providing useful insight and advice at every step of the process, from standard testing compliance to extensive documentation required for BIS certification.

Aleph India is the first choice for manufacturers, importers, and brand owners because we provide the best regulatory compliance services. Our conformity assessment vertical will meet your certification needs while ensuring a smooth certification process.