BIS Certification for Medical Textile Products

•  28 Nov, 2023
•  ISI Certification (BIS)

What are Medical textile products?

 

Medical textiles are various fiber-based materials intended for medical purposes. Medical textile is a sector of technical textiles that focuses on fiber-based products used in health care applications such as prevention, care, and hygiene. It is a new field which is result of combination of textile technology and medical science.

 

From the hygienic materials and hospital bed sheets, curtains to surgical masks, gowns, etc. used in operation theaters, even surgical threads, bandages and artificial bones, ligaments, artificial kidneys, livers, there are touches of technological and smart textiles everywhere. Medical textiles have been playing an important role in medicine for centuries.

 

Keeping in view the protection and health human beings and to ensure optimum quality of product, the Bureau of Indian Standards has published, Medical Textiles Quality Control Order, 2022 to bring Medical textiles under mandatory BIS certification.

The Bureau of Indian Standards (BIS) is the National Standards Body of India that develops and publishes Indian Standards, Implement Conformity Assessment Schemes, recognize & run laboratories for Conformity Assessment, Implement Hallmarking, Works for Consumer empowerment, Conducts capacity-building programs on quality assurance and represent the country in ISO & IEC.

·       Under sections 16, 17, and 25 of the Bureau of Indian Standards Act, 2016 (11 of 2016), the Central Government is of the opinion that it is necessary so to do in the public interest, and after consulting the Bureau of Indian Standards, hereby makes the Order –

Medical Textiles (Quality Control) Order, 2022.

 

·       As per this (Quality control) order, all the manufacturers of Medical textiles are obligated to bear the Standard Mark under a license from the Bureau in accordance with Scheme-I of Schedule-II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018

 

·       Penalty for contravention. – Any person who contravenes the provisions of this Order shall be punishable in accordance with the provisions of the Bureau of Indian Standards Act, 2016 (11 of 2016).

 

For  the specification and performance requirements, the Bureau of Indian Standards has developed standards for the following Agro textiles :

 

Medical textile products :

 

·       Sanitary Napkins

·       Baby Diaper

·       Reusable Sanitary Pad, Sanitary Napkins, Period Panties

·       Shoe Covers

·       Dental Bib/ Napkins

·       Bedsheet and Pillow Cover

 

Indian Standard for the above Medical textile products and the corresponding Title :

 

·       IS 5405: 2019 – Sanitary Napkins – Specification (Second Revision)

 

·       IS 17509 : 2021 – Disposable Baby Diaper - Specification

 

 

·       IS 17349 : 2020 – Medical Textiles – Shoe Covers - Specification

 

·       IS 17354 : 2020 – Medical Textiles – Dental bib/ Napkins - Specification

 

·       IS 17630 : 2021 - Medical Textiles – Bed Sheet and Pillow Cover Specification

Timeline for the Implementation :

 

·       For MSMEs :1 Year from the date of Publication in Official Gazette

·       For Self-Help Groups : 2 Years from the date of Publication in Official Gazette

·       For Others : 6 months from the date of Publication in Official Gazette

Benefits of getting BIS Certification for Medical textiles to sell in Indian Market with our help

 

·       BIS Certification means, that a certain product conforms to the quality standards set up by the government.

·       It is compulsory for Medical Textiles to obtain the BIS License and the violators are penalized with the material seize and a significant sum as fine.

·       Getting certification improves the probability of your product to survive and compete in the market.

·       Customers tend to buy BIS-certified products as they ensure safety and standard quality. Hence, with certified products, you can win the confidence and trust of the buyer.

·       With the word of mouth of such a client list, you can establish your credibility in the market.

·       Hence with a renowned brand, you can raise the standard and benchmark the market value of the product.

 

Requisites to get the BIS license for Medical textiles

 

·       Conformity of Raw Materials as per above mentioned Indian Standards for Medical textiles

·       In-house testing laboratory for mandatory tests

·       Competent Quality Control Personnel

·       Adherence to the BIS guidelines for Medical textiles as per mentioned Indian standards

·       There are 4 major categories of document required to get the BIS license:

a.   Administrative Details

b.   Technical Details

c.    Quality Control Personnel Details

d.   Commercial Details

 

Expenses involved in obtaining BIS certificate for Medical textiles :

 

 

·       BIS Fee :

 

o   Application Fees

o   Audit Charges (Consolidated)

o   License Fee

o   Marking Fee

 

·       Testing Charges :

 

o   Sample test Fee

 

In the certification process, product testing is the most important stage as it determines whether the quality of the product meets Indian standards.

 

·       Consultancy and other charges :

 

Expenses will be different for Indian Manufacturers and Foreign Manufacturers accordingly.

 

Role of ERCS Private Limited in getting your product certified :

 

·       To get BIS certification and produce a standard quality product, the manufacturer must ensure that their product must follow the specified Indian Standard Specifications (ISS) which we directly interpret to you from the BIS officials as per the Indian Standards.

·       ECRS Private Limited will be your friend, philosopher and guide in the whole process of getting your product certified by the concerned authorities/ departments.

 

It is always better to consult with experience team such as ERCS Pvt. Ltd. for smooth certification process.

For more information, please feel free to contact us at info@elitasrcs.com or call at +91-9076611770 / +91-9076611766.