BIS CERTIFICATION FOR DENTAL BIBS/NAPKINS IS 17354:2020

As per IS 17354:2020, BIS certification is compulsory for Dental Bibs/Napkins. This standard defines requirements for both disposable and reusable dental bibs/napkins intended for medical use. Materials utilized must adhere to relevant laws and regulations to ensure compliance with specified standards. Dental Bibs/Napkins may be produced in diverse sizes and shapes based on customer preferences and must maintain cleanliness and freedom from spoilage substances during storage.

According to IS 17354:2020 guidelines, all dental bibs/napkins fall under the ISI certification scheme. It's vital to note that these products cannot be legally marketed, imported, or exported in the Indian consumer market without the ISI mark. IS 17354:2020 outlines precise quality parameters, covering water resistance, cleanliness evaluated through microbial content, tensile strength under dry and wet conditions, and absorption properties like sinking time and water holding capacity.

Adhering to these quality standards not only guarantees the effectiveness and safety of dental bibs/napkins but also demonstrates our dedication to upholding elevated standards of healthcare products in the market.

Key Highlights

Product Name	Medical Textiles - Dental Bib / Napkins - Specification
Applicable Indian Standard	IS 17354: 2020
Applicable Certification Scheme	Product Certification Scheme (ISI Mark Scheme) Scheme 1 - Schedule 2
Compliance Requirement	Mandatory
QCO Link	Quality Control Order
Scope as per Standard	This standard encompasses the criteria for single-use (non-reusable) baby diapers intended for external application.

TESTS

The following are the major tests for Dental Bibs/Napkins:

Workmanship and Finish
Waterproofness
Cleanliness - Microbia
Tensile Strength (dry and wet)
Absorption a) Sinking Time b) Water holding capacity

BIS Certification Process

Acquiring a BIS license entails a detailed evaluation of manufacturing infrastructure, quality control capabilities, testing facilities, and production processes. This thorough assessment guarantees that the products not only meet regulatory standards but also ensure safety and reliability for consumers.

NOTE:

For comprehensive guidance on the BIS ISI Certification process, please explore:

Timeline

Below is the approximate timeline for obtaining BIS Certification for Medical Textiles - Dental Bib / Napkins - Specification, to use the ISI mark in compliance with IS 17354:2020:

For Indian Manufacturers (Standard Timeframe – 30 days)
For Foreign Manufacturers (Standard Timeframe – 180 days)

WHY USE ABSOLUTE VERITAS?

Absolute Veritas is a prominent organisation from the private sector of India primarily dealing with the Inspection, Testing, Audits, Certification of products& consulting services to various industries in India and worldwide, ensuring compliance with regulatory standards and industry requirements. Offering a comprehensive range of services including product certification, testing, training, auditing, and compliance services, Absolute Veritas helps manufacturers and importers achieve higher production efficiency and quality standards.

Absolute Veritas (AV) will handle end to end pre-registration request, sample preparation, documentation, testing and application process for FMCS Certification

For any questions regarding the most recent update on FMCS registration licenses, please reach out to us via email at cs@absoluteveritas.com