UMSPCS-Compliance

BIS QCO for Dental Bib or Napkin

UMSPCS - BIS QCO for Dental Bib or Napkin

Indian Standard Compliance

BIS QCO for Medical Textiles - Dental Bib/Napkins

Conformity Assessment & Regulatory Compliance

IS 17354:2020

27 Sep 2023

30th July, 2025

Dental bibs and napkins are medical textiles that are used in dental procedures helping to prevent the spread of germs and liquids in the patient’s mouth. They can be made of different materials, and it is essential to consider the material used for such products along with their details, absorbance, and other specifications necessary for their application within the dental industry. The Indian Standard that regulates Medical Textiles - Dental Bib / Napkins is called IS 17354: 2020. The BIS gives the code for this standard, which is Medical Textiles - Dental Bib / Napkins - Specification.

The specifications given in the standard outline the details of the required materials use, construction of the product, performance, and testing of the products mentioned above. It is advisable for the manufacturers to follow the latest Indian Standard and the BIS publication in order to understand the requirements that are followed for the production of this type of product.

Following the Indian Standard means that the products will always meet high quality requirements, making it easy to pass through other regulations concerning the production of dental bibs and napkins.

Requirements of Quality Control Order

Dental Bibs and Napkins are listed in the Medical Textiles (Quality Control) Order, 2023, according to IS 17354:2020. In order for products falling within the scope of the QCO to comply with the relevant Indian Standard, they must display the BIS Standard Mark as part of the prescribed conformity assessment scheme. The BIS product manual states that certification for IS 17354:2020 is carried out under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018.

Anyone who is a manufacturer, importer or supplier of products that are the subject of the QCO should check the most up-to-date requirements before manufacturing, importing, supplying or selling them in India.

The Bureau of Indian Standards (BIS) acts as the certifying and enforcing body for the products that are the subject of the Medical Textiles QCO; violations of the relevant Order are subject to punishment under the Bureau of Indian Standards Act, 2016.

Key Requirements for Dental Bib/Napkins

Important product characteristics under IS 17354:2020 may include:

  • Suitable raw material and material composition
  • Product construction
  • Dimensions and specified physical characteristics
  • Absorbency and related performance requirements
  • Strength and other applicable physical properties
  • Workmanship and finish
  • Cleanliness and hygiene-related requirements
  • Packaging and marking requirements
  • Applicable testing requirements

The product manual from the BIS specifies that the dental bibs or napkins must be made from an appropriate material that is not forbidden for the given purpose under the relevant laws or regulations, and it is also necessary for the manufacturers to give a declaration stating the materials used in the product.

The specific requirements and criteria for acceptance must be determined in accordance with the relevant provisions of IS 17354:2020 and the most recent BIS requirements.

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Uses of Dental Bib/Napkins

Dental bibs and napkins are used in dental procedures and in other activities relating to oral healthcare in order to protect both the patient and the surrounding area against moisture, fluids, and other contaminants. Since hygienic practices are supported by using them, it is important to consider the appropriate performance and absorbency of the materials.

Conformity Assessment under BIS Certification

In cases where BIS certification is required, manufacturers have to carry out the relevant conformity assessment procedure, which includes product testing, documentation, and factory assessment where these are required.

The BIS certification for Dental Bibs and Napkins is carried out in accordance with Scheme-I of the BIS (Conformity Assessment) Regulations, 2018, and the BIS product manual acts as a reference document for the certification of IS 17354:2020.

Significance of Conformity

Adherence to the relevant Indian Standard and QCO enables manufacturers to keep their product quality steady and to comply with the regulatory requirements that apply to medical textile products.

Manufacturers should likewise keep accurate records relating to production, quality control, and testing and make sure that the product still meets the relevant requirements after it has been certified.

Timeline for BIS Certification

The time taken to get BIS Certification for Dental Bibs/Napkins in accordance with IS 17354:2020 will depend on the documentation, product testing, inspection, and the processing carried out by BIS.

As a general timeframe:

  • Indian Manufacturers: Approximately 30 days
  • Foreign Manufacturers: Approximately 180 days

The length of time actually taken will vary according to the complexity of the application, the laboratory testing timetable, the factory's assessment requirements, and any questions or further explanations raised during the certification process.

Conclusion

Dental bibs and napkins are important examples of medical textile products, and when used during dental procedures, it is essential that the materials have suitable quality, absorbency, strength, cleanliness, and performance. The document IS 17354:2020 specifies the applicable requirements for Medical Textiles - Dental Bibs/Napkins - Specification.

Before they manufacture, import, supply, or market regulated Dental Bib/Napkins in India, manufacturers, importers, and suppliers should keep in mind the relevant Indian Standard, Quality Control Order, and BIS conformity requirements.

If businesses want the latest information and professional help concerning BIS standards, Quality Control Orders, certification procedures, testing, and other requirements for product compliance, they can obtain regulatory and standards-related support from UMSPCS. Read more also about BIS QCO for Curtains and Drapes.

Frequently Asked Questions (FAQs)

The dental bibs and napkins known as Medical Textiles are covered by IS 17354:2020, this standard setting out the relevant requirements concerning their material, construction, performance, and testing.

The standard sets out the quality and performance requirements for dental bibs and napkins, enabling manufacturers to ensure that their products maintain a consistent level of quality for their intended purpose.

The standard includes the requirements that apply to raw materials, construction, physical and performance characteristics, workmanship, testing, packaging, and marking.

Where the applicable BIS conformity assessment scheme requires it, the Dental Bib/Napkins must be tested against the relevant provisions of IS 17354:2020 by means of the prescribed testing route.

Foreign manufacturers who are eligible can apply under the relevant BIS certification framework and may have to meet further requirements, including those relating to the Authorized Indian Representative (AIR) where this applies.

In cases where BIS certification is required, not complying with the relevant QCO and BIS requirements could impact the manufacturer's legal ability to manufacture, import, supply, or sell the regulated product in India. Breach of the QCO is governed by the provisions of the BIS Act, 2016.

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