ISI Certification (BIS) for
REUSABLE SANITARY PAD / SANITARY NAPKIN / PERIOD PANTIES IS 17514 in India

BIS CERTIFICATION FOR REUSABLE SANITARY PAD / SANITARY NAPKIN / PERIOD PANTIESIS 17514 

Introduction to Indian Standard IS 17514; Reusable Sanitary Pad / Sanitary Napkin / Period Panties

·       IS 17514 cover Reusable Sanitary Pad / Sanitary Napkin / Period Panties.

·       Raw material should confirm the following points :

a)   The materials used for making Reusable Sanitary Pad / Sanitary Napkin / Period Panties shall be as per the requirements at Cl. 3 and Cl. 4 of IS 17514:2021.

b)   The raw material/fabric used for manufacturing the product shall meet the Colourfastness and Dimensional Stability Requirement of Raw Material/Fabric as per Table 1 of IS 17514:2021.

c)    If required by the buyer, the manufacturer shall ensure that raw material used for manufacturing the final product are safe for user based on its known toxicological characteristics at intended use (Biocompatibility Evaluation — Cytotoxicity, Irritation and Skin 97491/2022/CMD-II 68 Sensitization (Optional)).

d)   If agreed between the buyer and the seller, the raw material/fabric used for reusable sanitary pad/sanitary napkin/period panties shall have anti-bacterial activity value (initially and after declared cycle washes) greater than or equal to 2 (Anti-Bacterial Activity Value (Optional))

e)    Conformity of raw materials to the requirements may be established through supplier’s test certificate, test report of BIS recognized/empanelled lab or any other NABL accredited lab or through in house testing. 

·       IS 17514 specifies the quality parameters or characteristics of the  Reusable Sanitary Pad / Sanitary Napkin / Period Panties as follows :

(i)           Top Cover / Top Sheet

(ii)         Absorbent Core

(iii)        Bottom Layer 

(iv)        Outer Protective Barrier and Back sheet

(v)          Types and Shapes

(vi)        PH Value

(vii)       Ability to withstand Pressure after absorption 

(viii)     Fastening Mechanism

(ix)        Size  

(x)          Bacterial and Fungal Bioburden 

1.   Mandate for ISI Mark Certification of Reusable Sanitary Pad / Sanitary Napkin / Period Panties (IS 17514) 

·       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 Reusable Sanitary Pad / Sanitary Napkin / Period Panties are obligated to obtain ISI Mark Certification.

2.   Types of Reusable Sanitary Pad / Sanitary Napkin / Period Panties covered under IS 17514                    

 | Licence is granted to use Standard Mark on Reusable Sanitary Pad / Sanitary Napkin / Period Panties as per IS 17514 : 2021 with the following scope:
 | Type/Grade/Variety  | Size Class – Small/Medium/Large/Extra Large Optional requirements – With/Without Biocompatibility Evaluation With./Without Anti Bacterial Activity Value (if with anti bacterial activity value, the declared value, (initially and after declared cycle washes) shall be specified)

3.   Procedure to obtain BIS Certification of  Reusable Sanitary Pad / Sanitary Napkin / Period Panties to use ISI mark as per IS 17514 

·       For Indian Manufacturers (Standard Timeframe – 30 days) 

·       For Foreign Manufacturers (Standard Timeframe – 180 days) 

4.   Requisites to get the BIS license for Reusable Sanitary Pad / Sanitary Napkin / Period Panties

·       Conformity of Raw Material as per IS 17514 

·       In-house testing laboratory for mandatory tests

·       Competent Quality Control Personnel 

·       Adherence to the BIS guidelines for  Reusable Sanitary Pad / Sanitary Napkin / Period Panties as per Indian standard IS 17514 

·       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  Reusable Sanitary Pad / Sanitary Napkin / Period Panties as per IS 17514 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 17514

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

Textile Industry & various BIS departments to assist for ensuring conformity of the product Reusable Sanitary Pad / Sanitary Napkin / Period Panties according to according to IS 17514. 

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  Reusable Sanitary Pad / Sanitary Napkin / Period Panties 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 Reusable Sanitary Pad / Sanitary Napkin / Period Panties 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.