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BIS CERTIFICATION FOR MEDICAL TEXTILE PRODUCTS

BIS CERTIFICATION FOR MEDICAL TEXTILE PRODUCTS
By Mohini Kishore

BIS CERTIFICATION FOR MEDICAL TEXTILE PRODUCTS

Introduction

Medical textiles are special fabrics made for things like hospitals and doctors. They have to be safe for our bodies, easy to keep clean, able to soak up liquids, and strong even after being cleaned a lot. We use them for things like covering wounds, keeping surgeries clean, and personal care products. They're really important in healthcare to keep us healthy and safe.

It is crucial to test the properties and performance of medical textiles using appropriate methods in accordance with Indian standards. These standards outline the performance requirements for medical textiles in medical applications, and it is mandatory for all medical textiles to adhere to the relevant Indian standard. BIS-certified medical textile products provide assurance that they meet all the requirements of Indian standards.

BIS certification is necessary for various medical textiles, including baby diapers, eye pads, dressings, sanitary pads, napkins, shoe covers, surgical face masks, bandages, adhesive plasters, handloom cotton lint, caps, and other medical textiles. This certification ensures that these products conform to Indian standards and are safe and reliable for customers.

The Bureau of Indian Standards (BIS)

The Bureau of Indian Standards (BIS) is like a quality checker in India. It makes sure that the things people buy are good and safe to use. BIS does this by checking products, making rules for how things should be made, and testing them. If a product meets the BIS standards, it gets a special mark called the ISI mark. This mark shows that the product is reliable and safe.

To sell products in India with this mark, manufacturers must get a BIS license. This means they have to follow all the Indian rules and specifications for making their products. If they don't follow these rules, their products can't have the ISI mark, and they can't be sold in India. So, the ISI mark is a sign that a product meets India's quality standards and is trusted by consumers.

What is the Process of BIS certification for Medical Textile?

Getting a BIS Certificate for Medical Textiles involves several steps:

1.     Documentation: First, you gather all the necessary paperwork and documents needed for the certification.

2.     Application Submission: You submit your application form and all supporting documents through the BIS Portal.

3.     Scrutiny of Application: BIS officials carefully review all the documents and your application to make sure everything is in order.

4.     Audit of Manufacturing Premises: After the initial review, BIS will send an auditor to visit your manufacturing facilities. They might also take a sample of your product for testing during this visit.

5.     Sample Testing: The product sample collected is tested in a BIS-approved laboratory to check if it meets the required Indian standards.

6.     Grant of BIS License: If your product passes all the tests and meets the standards, BIS will issue a BIS license for your manufacturing company.

This means your product is certified and can be sold in India with the BIS mark, showing it's of good quality and safe to use.

Documents Required to get BIS certification in India

The documents needed for BIS Certification are both specific and generic, encompassing:

1.     Laboratory Test Reports in accordance with the Product Standard.

2.     Factory Registration Documents.

3.     A Manufacturing Process Flow Chart.

4.     Information about In-house Testing Facilities.

5.     Details of the Authorized Signatory and other relevant documents.

Ensuring the completeness and accuracy of these documents is crucial for a successful BIS Certification process.

BIS covered medical Textile:

Making sure medical textiles are made the right way is very important because it affects the health and safety of the people who use them. These textiles need to meet specific standards to make sure they work well and keep people safe. The Bureau of Indian Standards has created rules that these textiles must follow. These rules help ensure that medical textiles in India are of high quality and safe to use.

Here are some of the standards they've made:

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?

The BIS certification cost for Medical Textile products includes various fees: application, audit, sample testing, license, and marking fees. To meet certification requirements, investment in factory facilities, particularly testing machinery for in-house factory test labs, is necessary.

These expenses make sure that the products meet very strict quality and safety rules established by the Bureau of Indian Standards.

Conclusion

BIS certification is essential to get for making sure medical textiles used in healthcare are safe and good quality. These special textiles have to follow certain rules to work well and keep people safe. The Bureau of Indian Standards (BIS) creates these rules and checks the products to ensure they meet them. If a product gets BIS certification, it means it's trustworthy and safe to use in India's healthcare, and people can rely on it.


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