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Introduction 

BIS certification for Dental Bibs or Napkins is crucial to ensure that these products meet Indian standards for quality, safety, and hygiene. According to the Medical Textiles (Quality Control) Order, 2023, issued by the Ministry of Textiles, manufacturers must obtain BIS certification before selling these products in the Indian market. This certification, based on IS 17354: 2020, allows manufacturers to use the ISI Mark on their products, indicating compliance with the required standards. BIS certification ensures that Dental Bibs or Napkins provide effective protection and maintain hygiene in medical settings, helping to build consumer trust and ensuring regulatory compliance.

Why is BIS Certification Necessary for Dental Bibs or Napkins? 

BIS certification is essential for Dental Bibs or Napkins to ensure they meet quality, safety, and performance standards as per IS 17354: 2020. Poor-quality bibs could lead to contamination, posing risks in clinical environments. The Medical Textiles (Quality Control) Order, 2023 mandates BIS certification to ensure that only compliant products are sold in the Indian market. Non-compliance can lead to penalties under the Bureau of Indian Standards Act, 2016, emphasizing the importance of certification for product reliability and market entry.

BIS Quality Control Order for Dental Bib/Napkins

Overview of Indian Standard IS 17354: 2020 

IS 17354: 2020 defines the material specifications, absorbency, and durability requirements for Dental Bibs or Napkins. This standard ensures that the products are effective in preventing cross-contamination, are tear-resistant, and maintain their functionality during dental procedures. Adhering to this standard is mandatory for BIS certification under the Medical Textiles (Quality Control) Order, 2023, guaranteeing that only high-quality and safe bibs are made available to consumers in the Indian market.

Process for BIS Certification

The BIS certification process for Dental Bib or Napkins involves multiple steps, designed to thoroughly evaluate a product's compliance with the required standards. Here is a general overview of the certification process:

1. Application Submission: Manufacturers must submit an application form along with required documentation to BIS.

2. Documentation Review: BIS reviews the submitted documents to ensure completeness and correctness.

3. Factory Inspection: BIS officials conduct an on-site inspection of the manufacturing facility to assess the production process and quality control measures.

4. Sample Testing: Product samples are taken and tested in BIS-approved laboratories to verify compliance with Indian standards.

5. Certification Grant: Upon successful completion of the inspection and testing, BIS grants certification, allowing the manufacturer to use the BIS mark on their products.

Documents Required for BIS Certification

To apply for BIS certification, manufacturers need to submit the following documents:

●      Application form

●      Manufacturing process details

●      Quality control plan

●      Test reports from BIS-approved laboratories

●      Factory layout and equipment details

●      Proof of business registration

●      Product specifications and technical details

●      Declaration of conformity to Indian standards

Additionally, manufacturers may be required to provide proof of compliance with environmental and safety regulations, depending on the specific type of product being certified.

BIS Documents For Domenstic and Foreign Manufacturer Check

To Know The Process in Detail, Please Visit:

Conclusion
In conclusion, BIS certification for Dental Bib or Napkins ensures adherence to Indian standards for quality, safety, and performance, particularly as mandated by IS 17354:2020. The certification process, required under the Medical Textiles (Quality Control) Order, 2023, guarantees that only compliant products are sold in the Indian market, ensuring reliability and hygiene.

Navigating the BIS certification process can be challenging, especially for small and medium-sized enterprises. EVTL India is a leading consultancy firm dedicated to assisting manufacturers in obtaining BIS certification (ISI Mark) efficiently. With expertise in managing BIS portal submissions, documentation, and regulatory fees, EVTL India ensures a smooth and successful certification process. By choosing EVTL India, manufacturers can enhance their product's marketability both in India and internationally, securing a competitive edge. Additionally, EVTL India provides ongoing support post-certification, helping manufacturers maintain compliance with BIS standards and renew their licenses as needed.