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BIS certification is mandatory for Dental Bibs/Napkins as per IS 17354:2020. This standard outlines the requirements for both disposable and reusable dental bibs/napkins for medical use. The materials used must comply with applicable laws and regulations, ensuring that the product meets specified standards. Dental Bibs/Napkins can be manufactured in various sizes and shapes as per customer requirements and should remain clean and free from spoilage substances during storage.
Under the guidelines of IS 17354:2020, all dental bibs/napkins are included in the ISI certification scheme. Importantly, without ISI mark these products cannot be legally marketed, imported or exported in the Indian consumer market. IS 17354:2020 delineates specific quality parameters, which include water resistance, cleanliness as measured by microbial content, tensile strength in dry and wet conditions, absorption properties such as sinking time and water holding capacity.
Adherence to these quality standards not only ensures the effectiveness and safety of the dental bibs/napkins but also reflects our commitment to maintaining high standards of health care products in the market.
Tests
- Workmanship and Finish
- Waterproofness
- Cleanliness - Microbia
- Tensile Strength (dry and wet)
- Absorption a) Sinking Time b) Water holding capacity
Key Highlight
| 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 | View QCO |
| Scope as per Standard | This standard covers the requirements for disposable (non-reusable) baby diaper for external use. |
BIS Certification Process
Obtaining a BIS license involves a thorough assessment of manufacturing infrastructure, quality control capabilities, testing facilities, and production processes. This comprehensive evaluation ensures that the products not only comply with regulations but are also safe and reliable for consumers.
Process
Process for BIS ISI Mark Certification
A streamlined process designed to ensure compliance, quality, and efficiency at every step.
01
Documentation
Preparation and submission of required documents.
02
Application Submission
Filing the application with BIS along with applicable fees.
03
BIS Audit
Inspection and evaluation of manufacturing facility.
04
Sample Testing
Testing of product samples in BIS recognized laboratory.
05
Grant of License
Successful evaluation and grant of BIS ISI Mark license.
Learn the complete process
Watch our detailed video to understand each step involved in obtaining BIS ISI Mark Certification.
Timeline for BIS Certification
The estimated time frame for obtaining BIS certification under IS 17354:2020 is:
For Indian Manufacturers
(Standard Timeframe)30 Days
For Foreign Manufacturers
(Standard Timeframe)180 Days
Conclusion
The implementation of the Medical Textiles (Quality Control) Order, 2023, is ushering in a transformative era for the market of Dental Bib / Napkins - Specification in India. Manufacturers, by embracing these guidelines and securing BIS certification, are not merely complying with regulations; they are setting new benchmarks for excellence in the industry. Opting for BIS-certified Dental Bib / Napkins - Specification signifies more than a product purchase; it represents a commitment to dependability, superior quality, and safety.
BIS certification for Dental Bib / Napkins — Specification goes beyond meeting regulatory checkboxes, assuring the highest performance standards in these products. In an era where quality takes precedence, choosing BIS-certified Dental Bib / Napkins - Specification guarantees a product that is not only dependable but also of the finest quality.
In this landscape of evolving standards, Aleph INDIA stands as a leading BIS consultant in India, dedicated to assisting manufacturers and importers in obtaining BIS licenses for their products. With a commitment to excellence, Aleph INDIA ensures that your products not only meet but exceed the required quality benchmarks. Aleph INDIA has been serving the industry as a single-window operator for all product regulatory compliance. We can assist importers or manufacturers in meeting all criteria for importing or selling a product in the Indian market.
Partner with Aleph INDIA to simplify your BIS certification journey and ensure full compliance with IS 17354:2020 for robust and high-performance packaging solutions.
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