Medical Textiles
Dental Bib/Napkins – IS 17354:2020
Strategic Recommendations for Dental Bib/Napkins
Engage Early with BIS & Labs
Partner with Compliance Experts
Consult ERA Compliance team to assist with BIS application, technical documentation, and lab testing coordination specific to dental bib/napkin manufacturing.
Contact ERA Support Team
📧 cs@eraglobal.co.in | 📞 +91 9599296331 | 💬 WhatsApp
Get help with license filing, ISI marking guidance, and inspection readiness.
Track Notifications & Circulars
Subscribe to ERA’s Newsletter to receive BIS circulars, QCO notifications, and enforcement reminders.
Do a Gap Assessment
Identify uncertified or untested products. Stop manufacturing/sale of non-ISI marked stock after 1 April 2024.
| Section | Details |
|---|---|
| Product Name | Dental Bib/Napkins |
| IS Standard | IS 17354:2020 |
| Title of IS | Medical Textiles — Dental Bib or Napkins — Specification |
| Quality Control Order | Medical Textiles (Quality Control) Order, 2024 |
| Notification & Amendments | Notified via S.O. 4634(E) dated 23 October 2024, Supersedes Medical Textiles QCO, 2023 [S.O. 4247(E)] Reaffirmed in Amendment Order 2025 [S.O. 04(E)] — no change for this item |
| Final Enforcement Date | 1 April 2024 – Applies uniformly to all manufacturers. |
| Objective & Scope | To regulate the quality of dental bibs/napkins used for patient protection in dental practices, ensuring adequate absorbency, hygiene, and safety. |
| Products Covered | Disposable dental bibs or napkins used to protect patients during oral healthcare procedures in dental clinics and hospitals. |
| Exemptions | Products meant exclusively for export. |
| Industries Impacted | Dental Clinics and Hospitals , Medical Textile Manufacturers, Disposable Hygiene Product Suppliers. |
| Mandatory Compliance | BIS certification under Scheme-I is mandatory , Product must conform to IS 17354:2020 , Must bear the ISI mark. |
| Next Steps for Stakeholders | Apply for BIS license, Get product tested at BIS-approved labs, Ensure ISI marking and BIS compliance before manufacturing or sale post 1 April 2024. |
| Legal Framework & Enforcement | Governed under the BIS Act, 2016, Sections 16, 17, and 25(3); enforcement by BIS and the Textiles Committee. |
| Penalties for Non-Compliance | Seizure of non-compliant goods, Suspension or cancellation of license, Fines and/or imprisonment up to 2 years. |
| Conclusion | From 1 April 2024, all dental bibs or napkins manufactured or sold in India must comply with IS 17354:2020 and be certified by BIS with ISI marking. |
Ready to start your certification journey?
Let us help you navigate regulatory challenges and achieve certification with ease. Leave us your details, and we’ll get back to you—or request a free consultation today.
Get in touch with us today
Notification
The product Dental Bib/Napkins is covered under the Medical Textiles (Quality Control) Order, 2024, issued by the Ministry of Textiles through S.O. 4634(E) dated 23 October 2024. This Order supersedes the earlier 2023 notification [S.O. 4247(E)]. The applicable standard is IS 17354:2020. The Amendment Order, 2025 [S.O. 04(E), dated 1 January 2025] reaffirmed this inclusion, with no change to the enforcement date.
Overview
Dental bibs or napkins are protective disposable materials used in dental clinics and hospitals to shield patients from contamination, fluids, and debris during procedures. These bibs are made from absorbent and fluid-resistant materials to ensure both hygiene and patient comfort.
Objective & Scope
IS 17354:2020 lays down the specifications for dental bibs/napkins in terms of construction, performance, and hygiene requirements. The aim is to ensure that dental accessories used across India meet minimum quality standards that support safe and hygienic dental practices.
Products Covered
This standard applies to disposable dental bibs or napkins typically used during dental treatments. The products are designed to be worn by patients to protect clothing and skin from splashes or spills, and are essential for maintaining sterile conditions.
Exemptions Provided
Only products manufactured exclusively for export are exempt from mandatory BIS certification.
Industries Impacted
- Dental Hospitals and Clinics,
- Manufacturers of Disposable Medical Supplies,
- Importers and Distributors of Medical Textiles,
- Hygiene and Patient Care Equipment Suppliers.
Mandatory Compliance Requirements
With effect from 1 April 2024, BIS certification is mandatory under Scheme-I (ISI Mark Scheme). All dental bibs or napkins manufactured, sold, or imported for domestic use in India must conform to IS 17354:2020 and must bear the ISI mark. Testing must be conducted through BIS-recognized laboratories, and factory assessment is required as part of the certification process.
Next Steps for Stakeholders
Manufacturers and importers should:
- Apply for BIS license under IS 17354:2020,
- Conduct product testing at BIS-recognized laboratories,
- Complete factory inspection and compliance documentation,
- Affix the ISI mark to all certified products before the enforcement deadline,
Ensure no uncertified stock is manufactured or sold after 1 April 2024.
Legal Provisions, Enforcement & Penalties
This regulation is enforced under the Bureau of Indian Standards Act, 2016, specifically Sections 16, 17, and 25(3). The BIS and Textiles Committee are the responsible enforcement bodies. Non-compliance may result in:
- Seizure of non-conforming goods,
- Suspension or cancellation of BIS license,
- Fines and/or imprisonment for up to two years.
Conclusion
Effective from 1 April 2024, all dental bibs or napkins intended for domestic sale or use in India must be certified by BIS under IS 17354:2020 and carry the ISI mark. Manufacturers, importers, and suppliers must take timely steps to obtain certification and align production processes to ensure uninterrupted market access.
Ready to start your certification journey?
Let us help you navigate regulatory challenges and achieve certification with ease. Leave us your details, and we’ll get back to you—or request a free consultation today.