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- Dental bibs and napkins are critical for patient hygiene in dental and medical practices.
- BIS certification ensures that these products meet national safety and quality standards.
- Dental bibs may be covered under relevant IS standards for medical textiles or disposable hygiene products.
- Certification improves market access, trust, and regulatory compliance.
- Manufacturers, importers, and suppliers must apply for BIS certification before sale.
- BIS process involves document submission, product testing, and factory audit.
- Diligence Certifications offers expert support to simplify your BIS approval process.
Introduction
Dental bibs and napkins may seem like simple disposable items, but in clinical and dental settings, they are essential for maintaining patient hygiene and infection control. With the rise in demand for safe, hygienic, and non-toxic medical disposables, the Bureau of Indian Standards (BIS) has taken a proactive step to ensure product quality through certification.
If you are a manufacturer, supplier, or importer of dental bibs and napkins in India, obtaining BIS Certification is more than just a regulatory it is a trust-building investment in your
In this blog, we’ll walk you through everything you need to know about BIS Certification for dental bibs and napkins including applicable standards, process, documents, cost, and how expert consultants Diligence Certificates like can help you get approved smoothly.
What Are Dental Bibs and Napkins?
Dental bibs are a protective covering that is placed on patients during dental treatment to protect clothing and skin from fluids, instruments, and aerosols. Dental napkins are used for similar reasons. They are soft, disposable, absorbent, with a tissue section and polyethylene backing that is designed to be fluid resistant.
Fluid resistant back (typically PE film), Multi-ply absorbent tissue, Single use and disposable, Latex free, and friendly to skin
Dental offices, Oral surgery centers Diagnostic laboratories Hospitals and mobile clinics
Why is BIS Certification Needed for Dental Bibs and Napkins?
BIS Certification verifies that your product follows Indian standards for: Hygiene Fluid absorbency Tear resistance
Compliance with national safety regulations Qualification for government tenders & hospital purchasing Credibility for exports and e-commerce Assurance for consumers in the healthcare market Ability to use the ISI mark on packaging
Is BIS Certification Mandatory for All Dental Bibs and Napkins?
No, as of now in 2025, BIS Certification is not universally mandatory for all dental bibs and napkins — but it can be required in certain cases, especially when:
When BIS Certification Becomes Mandatory:
Supplying to Govt Hospitals or Tenders Many public health authorities and procurement agencies require BIS certified biomedical materials for dental and medical use.
Bulk Supply to Health Organizations Many large dental chains, clinics, and hospitals might require only ISI marked or BIS certified disposables.
Selling on e-commerce platforms E-commerce platforms such as Amazon, Flipkart and B2B sites may require documentation demonstrating BIS compliant products for medical and hygiene supplies. Product falls in a notified standard If your dental bibs/napkins fall under a specified IS standard for hygiene/medical disposables then certified product may be mandated by the BIS.
BIS Certification Applicability Based on Manufacturer Type
| Manufacturer Type | BIS Certification | Remarks |
| Indian Manufacturer | Recommended / Often Required | Extremely important for hospital supply, tenders, and e-commerce |
| Foreign Manufacturer | Required via FMCS | Application must be submitted through an Indian Authorized Representative under the FMCS scheme |
| Indian Importer / distributor | Applicable for representation of foreign brand | Can apply on behalf of overseas manufacturers; the onus is on the Indian importer or distributor to ensure full compliance with BIS standards. |
| Small- scale Manufacturer | Not Mandatory (Voluntary) | Not required unless selling to hospitals or through any public procurement channels. |
Other Related Standards BIS May Refer’s To
| Standard Code | Standard Title | Applicability to Dental Bibs & Napkins |
| IS 17354:2020 | Disposable Face Masks & Healthcare Textiles | Principal standard for disposable clinical textile items. |
| IS 16289:2014 | Absorbent Hygiene Products | Applies to layered absorbent polyethylene backed napkins with hygiene application |
| IS/ISO 10993 | Biological Evaluation of Medical Devices | For skin-contact safety and biocompatibility |
| IS 5405 | Sanitary Napkins | Referenced for multilayer absorbent products to hygienic applications |
| IS/ISO 22610 | Resistance to Wet Bacterial Penetration | Applies when the bib is used in a surgical or sterile environment |
| IS 14767 | Guidelines for Disposable Plastic Medical Products | Refers to product having polyethylene film backing or when composed of plastic components |
Understanding IS 17354:2020: Diligence Certifications for Dental Bibs and Napkins
Very important in the field of dentistry are hygiene and patient comfort. One of the most important components of both these factors is the dental bib or napkin. The recently launched IS 17354:2020 specifications on dental bibs call for extra caution and due diligence for all the manufacturers in the manufacture or usage of their products. In this blog, we shall be discussing the very essential elements of IS 17354:2020 with respect to possible tests, documents to be maintained, equipment needed, and material considerations as very crucial for a Diligence certifications.
What is IS 17354:2020?
The Indian standard IS 17354:2020 specifies the design requirements for dental bibs and napkins with the intention of using them safely, efficiently, and comfortably from a patient’s view during dental procedures. Descriptive standards cover essentially those characteristics related to qualifying materials, dimensions, performance characteristics, and test protocols for certifying suitability for oral healthcare use.
The standard thereby ensures that dental bibs and napkins are hygienically as well as functionally suited for the purpose of providing protection against spillage and contamination during treatment. It also stipulates the testing standards according to the materials used, concerning the absorbent layers and waterproof barriers, for comfortable patient use as well as practitioner convenience. Dimension and structural characteristics are also described to develop easy handling and compatibility with various dental procedures.
Performance testing protocols therefore confirm that IS 17354:2020 maintains the integrity of these products under operating conditions while remaining true to rigorous safety and durable standards. It provides a special design for manufacturers in the course of making dental bibs and napkins in oral healthcare settings, where high quality and safety standards prevail.
BIS Certification Process for Dental Bibs and Napkins (IS 17354:2020)
Step-by-Step Certification Procedure
Here is the step-by-step BIS certification procedure for products under IS 17354:2020:
Step 1: Determine Applicable Standard
First, determine if your product is classified under IS 17354:2020:
“Textiles — Requirements for Disposable Face Masks and Other Healthcare Textile Products.”
IS 17354:2020 refers to disposable, single-use, medical textile products including dental bibs and dental napkins.
Step 2: Prepare Required Documentation
These will typically include:
Business registration certificate (for manufacturers or importers)
Product specifications (material, GSM, layer details)
Details of manufacturing process on flowchart
Details of raw materials and sources
Address proof for manufacturing plant address
Identity and authorization proof (director/owner)
History of product testing or laboratory reports (if available)
Trademark or brand certificate (if registered)
Step 3: Product Testing from BIS-Recognized Laboratory
You provide samples of your dental bib and napkin to a BIS-recognized laboratory for testing.
The laboratory will use parameters listed in IS 17354:2020, which will include:
Fluid resistance
Non-toxic
Skin compatibility
Physical integrity (tear strength, bond of layers, etc.)
Step 4: Apply Online at the BIS Portal
Register at manakonline.in.
Select the ISI mark (Scheme-I) certification scheme.
Upload all supporting documents, lab testing reports, and application fee.
Step 5: Factory Audit by BIS Officers.
BIS Officers will review your factory to confirm:
Production capabilities.
Quality control mechanisms.
Raw materials procurement and traceability.
Batch marking and formulation of labels.
Step 6: Grant of BIS Certification.
If your factory audit and sample testing both meet the BIS standard, the Bureau will issue:
The BIS license number.
Permission to use the ISI mark with the standard number (IS 17354:2020).
Importance of Diligence Certifications
Diligence certifications will secure compliance of standards across the industry in manufacturing. For dental professionals, it would earn patients’ trust and safety in using certified products. Through diligence certification, dental bibs and napkins are established to be compliant with certain safety and quality requirements, ensuring adherence to best practices in dentistry.
Documents Required for BIS Certification
General Checklist
- Factory registration certificate
- Production flow chart
- List of test equipment
- Raw material quality proofs
- Authorized signatory ID
- Previous third-party lab reports
- Sample product packaging design with ISI mark placement
BIS Certification for Dental Bibs and Napkins – Cost, Validity & Renewal
| Aspect | Details |
| Cost Structure | – Application Fee: Paid when you submit the application. – Processing Fee: Covers review of documents, product testing, and inspection. – Licence Fee: Required to keep your certification active every year. – Marking Fee: Based on your production or sales volume, for using the BIS mark. – Testing Charges: Product samples must be tested in BIS-recognized labs. |
| Validity | – Certification is usually granted for an initial period of 2 years. – It stays valid as long as you follow BIS guidelines and pay the required marking fee. |
| Renewal | – Renewal should be applied before the certification expires. – It can be renewed for a minimum of 1 year and up to 5 years. – You need to submit updated documents, production reports, and the renewal fee. – If renewal is delayed, penalties apply, and using the BIS mark becomes illegal after expiry. |
How Diligence Certification Can Help
Ways Diligence Certification Can Help Diligence Certification is a trusted consultancy that provides the necessary help to obtain a BIS (Bureau of Indian Standards) certification as smoothly and efficiently as possible.
Services include:
- Standard Mapping to IS 17354:2020
- Coordination of Product Testing
- Documentation management
- Movement of your application through the BIS portal
- Preparation for Factory Audit
- Help with an ongoing compliance process after you are certified
Diligence Certification guarantees that your BIS approval process will be faster, compliant, and less stressful
Conclusion
The standard IS 17354:2020 is vital for ensuring quality and safety in dental bibs and napkins. Importantly, achieving the Diligence certification under this standard is key to manufacturers and dentist professionals alike. In accordance with the requirements expressed in this standard, manufacturers will be able to produce quality products that assure the populace of its comfort and surroundings the hygienic aspect of the dental operations. Knowledge about tests, documents, equipment, and materials, with which the certification process deals, will inform dentists on how to choose the best among dental bibs for efficient patient care besides credibility as well as trust in their practices.
Keeping up with the IS 17354:2020 standard will then guarantee services that rank highest in quality and safety in dental care.
FAQs
Is BIS certification mandatory for all dental bibs?
It’s mandatory for government supply and highly recommended for quality-conscious buyers and e-commerce platforms.
Which BIS standard applies to dental bibs?
IS 17354:2020, which covers disposable medical textile products.
Can importers get BIS certification?
Yes, through proper authorization from the manufacturer.
Does the BIS cover biodegradable bibs?
Yes, and they will provide guidance provided the bib qualifies under the IS 17354 performance and hygiene standards.
How long does the BIS process take?
Typically 30-60 working days based on lab and audit schedules.
What if my product fails lab testing?
You can retest after implementing improvements or corrections.
Is the ISI mark mandatory after approval?
Yes, all certified products must carry an ISI logo, IS number, and license number.
Can Diligence assist foreign manufacturers?
Definitely, they assist with FMCS (Foreign Manufacturers Certification Scheme) too.
Can I use one license for bibs that have multiple variations?
Only for the same specification, all variations need a separate approval.
What is the validity of a BIS license?
Typically 1-2 years, and is renewable on conditions of compliance.
