ISI Certification (BIS) for
DENTAL BIB / NAPKINS IS 17354 in India

BIS CERTIFICATION FOR DENTAL BIB/NAPKINS IS 17354

Introduction to Indian Standard IS 17354; Dental bib/Napkins

 

·       IS 17354 cover Dental bib/Napkins.

·       Raw material should confirm the following points :

a)   The dental bib/napkins shall be made from suitable material that is not prohibited for use for the purpose under any applicable law/regulation in force so that the product made out of this meets the requirements specified in this standard. Each consignment of material shall be accompanied by the supplier’s test certificate.

b)   Further, manufacturer of dental bib/napkins shall submit a declaration identifying the materials being used to make the product and stating that no material that is prohibited for use for the purpose under any applicable law/regulation has been used.

 

·       IS 17354 specifies the quality parameters or characteristics of the  Dental bib/Napkins as follows :

(i)           Waterproofness

(ii)         Cleanliness

(iii)        Tensile Strength (Dry and Wet)

(iv)        Absorption (Sinking time and water holding capacity)

 

1.   Mandate for ISI Mark Certification of Dental bib/Napkins (IS 17354)

 

·       In exercise of the powers conferred by sub-sections (1) and (2) of section 16 read with section 17 and sub-section (3) of section 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 following Order, namely

Medical Textiles (Quality Control) Order, 2023.

·       As per the Medical Textiles (Quality control) order, all the manufacturers of Dental bib/Napkins are obligated to obtain ISI Mark Certification.

 

2.   Types of Dental bib/Napkins covered under IS 17354                      

 

Licence is granted to use Standard Mark on Dental bib/Napkins as per IS 17354 : 2020 with the following scope:
Type/Grade/Variety	Type – Disposable and/or Reusable Size / Shapes – As declared by the manufacturer Material - As declared by the manufacturer for each type as applicable i.e. Material for Disposable Dental bib/Napkins – Material for Reusable Dental bib/Napkins –

 

 

3.   Procedure to obtain BIS Certification of  Dental bib/Napkins to use ISI mark as per IS 17354

 

·       For Indian Manufacturers (Standard Timeframe – 30 days)

·       For Foreign Manufacturers (Standard Timeframe – 180 days)

 

4.   Requisites to get the BIS license for Dental bib/Napkins

 

·       Conformity of Raw Material as per IS 17354

·       In-house testing laboratory for mandatory tests

·       Competent Quality Control Personnel

·       Adherence to the BIS guidelines for  Dental bib/Napkins as per Indian standard IS 17354

·       There are 3 major categories of document required to get the BIS license:

a.   Administrative Details

b.   Technical Details

c.    Quality Control Personnel Details

d.   Commercial Details

 

5.   Expenses involved in obtaining BIS certificate for  Dental bib/Napkins as per IS 17354 under the Product Certification (Scheme-I) of BIS :

 

For Indian Manufacturers
No.	Major Charges		Amount	Remark
1.	BIS Fee	Application Fees	INR 1000	To be paid in BIS A/c directly. 20% rebate on Marking Fee for MSME units.
		Audit Charges	INR 7000
		License Fee	INR 1000
		Marking Fee	As per Actual
2.	Testing Charges	Sample Test Fee	As Applicable	To be paid into BIS approved Lab A/c
3.	ERCS Service Fee	Consultancy & others	As per actual, (Depending upon the product and the region of factory)

 

For the Foreign Manufacturers
No.	Major Charges	Particulars	Amount	Remark
1.	BIS Fee	Application Fees	USD 30	To be paid into BIS A/c directly in USD (SWIFT). SAARC countries can pay in INR with GST@18%
		Audit Charges (consolidated)	USD 3200 to USD 5900
		License Fee	USD 30
		Marking Fee	As per Actual
2.	Testing Charges	Sample Test Fee	As applicable	To be paid into BIS approved Lab A/c
3.	ERCS Service Fee	Consultancy & other charges	As per actual, (Depending upon the product and the location of mfg.)

 

     

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

·       For the same purpose, investments in testing facilities are required to install test equipment for internal factory test laboratories.

·       Apart from charges mentioned above in the table, we may ask you to pay/reimbursement for a Pre-Visit at your Factory Premises to ensure the conformity of your product as per the relevant Indian Standard & BIS guidelines for its BIS certification.

 

 

 

 

6.   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.

 

·       Scope of work by ECRS Private Limited:

 

a.     Ensuring the conformity of your product as per IS 17354

ERCS Pvt. Ltd. has developed a vast network within the Medical

Textile Industry & various BIS departments to assist for ensuring conformity of the product Dental bib/Napkins according to according to IS 17354.

 

b.     Effective documentation with the awareness of the BIS guidelines:

In order to facilitate the manufacturing industry in obtaining BIS certifications, guidelines have been developed. Our team has the experience of completing over 450 projects and technically competent acquaintances in various Industries.

We are familiar with the Indian Standard Specifications & BIS guidelines and deliver the most suitable interpretation to the Quality Control Personnel so we can do a reliable and effective documentation of your product in accordance with the BIS guidelines.

 

c.      A pre-visit can be paid at your factory premises:

In the process of getting BIS certification, the officer from BIS authority visits the factory for inspection. In order to get good results, the BIS inspection should go smoothly without any Non-Conformity. By keeping this goal in mind, our team will organize a pre-visit to your factory premises so that required changes can be adapted so as to remove the elements of fallibility.

 

d.     Assistance for BIS audits:

We will explain the whole procedure of conducting a BIS inspection and make you aware of the things which need to be prepared and readily available at the time of inspection.

 

 

 

 

7.   Benefits of getting ISI Mark for  Dental bib/Napkins to sell in Indian Market with our help :

 

§  The term “ISI mark" means, that a certain product conforms to the quality standards set up by the government.

§  It is compulsory for Dental bib/Napkins to obtain the ISI Mark 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 have the tendency of buying ISI certified products as it ensured safety and standard quality. Hence, with the certified products you can win the confidence and trust of the buyer.

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

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