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.
Conclusion:
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.
