BIS Certification
BIS Registration

How to Obtain BIS Certification for Medical Textiles Products in India?

calendar15 Sep, 2022
timeReading Time: 5 Minutes
BIS Certification for Medical Textiles Products

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[1] 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:

  1. Application fee;
  2. Product sample testing fee;
  3. Audit fee;
  4. License fee;
  5. Marking fee.

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

Conclusion

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.

Read our Article:How to Obtain BIS Certification for Agro Textiles Products in India?

BIS Certification

Request a Call Back

Are you human? : 7 + 3 =

Easy Payment Options Available No Spam. No Sharing. 100% Confidentiality