Medical Textiles
Bedsheet and Pillow Cover – IS 17630:2021
Strategic Recommendations – Bedsheet and Pillow Cover
Engage Early with BIS & Labs
All manufacturers must comply with IS 17630:2021 under Scheme-I by 1 April 2024.
Partner with Compliance Experts
Consult ERA Compliance team for smooth coordination of BIS documentation, lab approvals, and packaging with ISI marking for bedsheet and pillow cover products.
Contact ERA Support Team
📧 cs@eraglobal.co.in | 📞 +91 9599296331 | 💬 WhatsApp Assistance available for license application, factory audit prep, and BIS label guidance.
Track Notifications & Circulars
Subscribe to ERA’s Newsletter to receive BIS circulars, QCO notifications, and enforcement reminders.
Do a Gap Assessment
Identify uncertified stock. Prepare for BIS audits and testing. Only ISI-marked bedsheets and pillow covers can be sold or manufactured after 1 April 2024.
| Section | Details |
|---|---|
| Product Name | Bedsheet and Pillow Cover |
| IS Standard | IS 17630:2021 |
| Title of IS | Medical Textiles — Bed Sheet and Pillow Cover — 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 ensure the quality, hygiene, and safety of bedsheets and pillow covers used in medical environments through standardized specifications and mandatory certification. |
| Products Covered | Disposable and reusable bed sheets and pillow covers intended for use in hospitals, clinics, and healthcare facilities. |
| Exemptions | Products meant exclusively for export. |
| Industries Impacted | Hospitals and Clinics, Medical Textile Manufacturers, Healthcare Supply Companies. |
| Mandatory Compliance | BIS certification under Scheme-I is mandatory, Product must conform to IS 17630:2021, 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 bed sheets and pillow covers manufactured or sold in India must be BIS certified as per IS 17630:2021 and carry the ISI mark. |
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Notification
The product Bedsheet and Pillow Cover is covered under the Medical Textiles (Quality Control) Order, 2024, notified by the Ministry of Textiles via S.O. 4634(E) dated 23 October 2024. This order supersedes the earlier 2023 QCO [S.O. 4247(E)]. The applicable Indian Standard is IS 17630:2021. The Amendment Order 2025 [S.O. 04(E)] reaffirmed coverage of this product without changing the enforcement timeline.
Overview
Bedsheets and pillow covers are widely used in healthcare facilities to maintain patient hygiene and prevent cross-contamination. These items are required to meet performance and safety standards suitable for hospital and clinical settings, especially in situations requiring infection control and patient care.
Objective & Scope
IS 17630:2021 defines the specifications for both disposable and reusable bed sheets and pillow covers used in medical environments. The objective is to ensure hygienic, durable, and safe textiles for use in hospitals, thereby establishing a uniform benchmark across the healthcare sector.
Products Covered
This standard covers bed sheets and pillow covers made of medical-grade textile materials intended for single-use or reusable applications in hospitals, clinics, diagnostic centers, and healthcare environments.
Exemptions Provided
Only products manufactured exclusively for export are exempt from BIS certification.
Industries Impacted
- Hospitals and Nursing Homes,
- Clinics and Healthcare Centers,
- Medical Textile Manufacturers,
- Healthcare Distributors and Procurement Agencies,
- Hospitality and Emergency Medical Services (EMS).
Mandatory Compliance Requirements
From 1 April 2024, BIS certification under Scheme-I (ISI Mark Scheme) is mandatory for all bedsheets and pillow covers intended for domestic sale or use. Products must conform to IS 17630:2021 and bear the ISI mark. Testing must be carried out in BIS-approved laboratories, and factory inspection is a requirement during the certification process.
Next Steps for Stakeholders
Stakeholders should:
- Apply for BIS certification under IS 17630:2021,
- Submit product samples for testing in BIS-recognized labs,
- Undergo factory assessment by BIS inspectors,
- Affix the ISI mark to each certified product,
Cease manufacture or sale of uncertified stock after 1 April 2024.
Legal Provisions, Enforcement & Penalties
This compliance is mandated under the BIS Act, 2016, enforced through Sections 16, 17, and 25(3). The Bureau of Indian Standards and the Textiles Committee are responsible for enforcement. Violations may result in:
- Seizure of non-compliant goods,
- Suspension or cancellation of BIS license,
- Fines and/or imprisonment up to two years.
Conclusion
From 1 April 2024, it is mandatory for all bedsheets and pillow covers intended for the Indian market to comply with IS 17630:2021 and be certified by BIS. Timely action is required by manufacturers and importers to meet compliance requirements and ensure continued market access without disruption.