Note
For detailed information about the Procedure for
BIS ISI Certification, visit:
BIS certification is essential for Shoe Covers as per IS 17349:2020. This standard ensures that shoe covers used in healthcare, pharmaceutical, food processing, and cleanroom environments meet strict quality and safety benchmarks. Certification guarantees that the shoe covers are manufactured using suitable materials, provide adequate coverage and protection, and maintain integrity under specified conditions. Adherence to IS 17349:2020 signifies a manufacturer’s commitment to producing hygienic and reliable protective gear that meets industry expectations for safety and contamination control.
This standard specifies the requirements and test methods for disposable and reusable shoe covers designed to protect clean environments from contamination. It outlines specifications related to material composition, tensile strength, water resistance, seam strength, and overall design to ensure proper fit and function. The standard also includes testing procedures for evaluating resistance to penetration by liquids and particulates, as well as durability under mechanical stress. Shoe covers compliant with IS 17349:2020 are intended to minimize the risk of contaminant transfer from footwear, making them critical in sterile and controlled settings.
| Product Name | Shoe Covers |
| Applicable Indian Standard | IS 17349:2020 |
| Applicable Certification Scheme | Product Certification Scheme (ISI Mark Scheme) Scheme 1 - Schedule 2 |
| Compliance Requirement | Mandatory |
| Quality Control Order | View QCO |
| Scope as per Standard | This standard specifies the requirements for disposable and reusable shoe covers intended for medical use during various procedures, aiming to protect patients and materials from the transfer of microorganisms, particulates, and other contaminants. |
BIS certification under IS 17349:2020 ensures compliance with recognized safety and hygiene standards, boosting the credibility and marketability of the product. For manufacturers, it serves as a mark of quality assurance, supporting regulatory approvals and competitive positioning in sectors with stringent cleanliness requirements. For end-users, certified shoe covers offer confidence in product performance, safety, and contamination control, essential for maintaining sterile and hygienic environments. Certification also simplifies procurement for institutions that prioritize compliance and reliability.
A streamlined process designed to ensure compliance, quality, and efficiency at every step.
Preparation and submission of required documents.
Filing the application with BIS along with applicable fees.
Inspection and evaluation of manufacturing facility.
Testing of product samples in BIS recognized laboratory.
Successful evaluation and grant of BIS ISI Mark license.
Watch our detailed video to understand each step involved in obtaining BIS ISI Mark Certification.
For detailed information about the Procedure for
BIS ISI Certification, visit:
The estimated time frame for obtaining BIS certification under IS 17349:2020 is:
BIS certification under IS 17349:2020 is critical for manufacturers of shoe covers aiming to meet the highest standards of hygiene, safety, and performance. Compliance ensures that products are suitable for demanding applications in sensitive environments.
Partner with Aleph INDIA for expert guidance in navigating the BIS certification process and ensuring full compliance with IS 17349:2020 for shoe covers.
Partner with Aleph INDIA to simplify your BIS certification journey and ensure full compliance with IS 17349:2020 for robust and high-performance packaging solutions.
BIS certification for shoe covers as per IS 17349:2020 is not currently under mandatory certification; however, voluntary certification enhances product credibility, assures quality, and is often preferred in institutional and government procurement.
IS 17349:2020 applies to both disposable and reusable shoe covers made from various materials such as non-woven fabrics, plastic, or other suitable materials, intended for use in clean environments like hospitals, laboratories, and food processing units.
The standard includes tests for tensile strength, water resistance, seam integrity, resistance to particulate and liquid penetration, and overall construction to ensure durability and effective protection.
For Indian manufacturers, the certification process typically takes about 30 days. For foreign manufacturers, it may take approximately 180 days, depending on the completion of documentation, product testing, and factory inspection.
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