Shoe Covers are
protective accessories designed to cover footwear, preventing contamination and
maintaining hygiene in various environments like hospitals, laboratories, and
cleanrooms. Made from non-woven fabric, plastic, or other durable materials,
these covers are lightweight, waterproof, and disposable, ensuring easy usage
and disposal. They provide a protective barrier, keeping surfaces clean and
reducing the risk of contamination in sensitive areas such as medical
facilities, food industries, and research labs.
Introduction
BIS certification
for Shoe Covers ensures that these protective products meet Indian quality and
safety standards as outlined in the Indian standard IS 17349: 2020. Following
the Medical Textiles (Quality Control)
Order, 2023, issued by the Ministry of Textiles, it is mandatory for
manufacturers to obtain BIS certification before selling Shoe Covers in the
Indian market. This certification allows manufacturers to use the ISI Mark on
their products, indicating compliance with the required standards. Ensuring
quality and safety through BIS certification is crucial for maintaining high
hygiene standards in industries like healthcare, where shoe covers play an
essential role in infection control.
Why is BIS Certification for Shoe Covers Necessary?
BIS certification is necessary for Shoe Covers to ensure they meet the prescribed quality, safety, and performance standards under IS 17349: 2020. Poor-quality shoe covers can result in contamination, which is particularly dangerous in medical and cleanroom environments. The Medical Textiles (Quality Control) Order, 2023 mandates BIS certification to ensure that only products adhering to regulated standards are sold in the Indian market. Non-compliance can result in penalties under the Bureau of Indian Standards Act, 2016, making certification vital for market access and product reliability.
Overview of Indian Standard IS 17349: 2020
IS 17349: 2020
specifies the requirements and testing methods for Shoe Covers used in medical,
industrial, and other sensitive environments. This standard outlines essential
characteristics like material strength, impermeability, resistance to tearing,
and proper fit. Compliance with IS 17349: 2020 ensures that Shoe Covers provide
effective protection against contamination and meet durability and safety
standards. Manufacturers must adhere to this standard to obtain BIS
certification, which is mandatory as per the Medical Textiles (Quality Control)
Order, 2023, for selling shoe covers in the Indian market.
The BIS
certification process for shoe covers involves multiple steps, designed to
thoroughly evaluate a product's compliance with the required standards. Here is
a general overview of the certification process:
1. Application Submission: Manufacturers
must submit an application form along with required documentation to BIS.
2. Documentation Review: BIS reviews the
submitted documents to ensure completeness and correctness.
3. Factory Inspection: BIS officials
conduct an on-site inspection of the manufacturing facility to assess the
production process and quality control measures.
4. Sample Testing: Product samples are
taken and tested in BIS-approved laboratories to verify compliance with Indian
standards.
5. Certification Grant: Upon successful
completion of the inspection and testing, BIS grants certification, allowing
the manufacturer to use the BIS mark on their products.
To apply for BIS
certification, manufacturers need to submit the following documents:
● Application form
● Manufacturing process details
● Quality control plan
● Test reports from BIS-approved
laboratories
● Factory layout and equipment
details
● Proof of business registration
● Product specifications and
technical details
● Declaration of conformity to
Indian standards
Additionally, manufacturers may be required to provide proof of compliance with environmental and safety regulations, depending on the specific type of product being certified.
Conclusion
In conclusion, BIS certification for Shoe Covers
ensures adherence to Indian standards for quality, safety, and performance,
particularly as mandated by IS 17349: 2020. The certification process, required
under the Medical Textiles (Quality Control) Order, 2023, guarantees that only
compliant products are sold in the Indian market, ensuring reliability and
hygiene.
Navigating the BIS certification
process can be challenging, especially for small and medium-sized enterprises.
EVTL India is a leading consultancy firm dedicated to assisting manufacturers
in obtaining BIS certification (ISI Mark) efficiently. With expertise in
managing BIS portal submissions, documentation, and regulatory fees, EVTL India
ensures a smooth and successful certification process. By choosing EVTL India,
manufacturers can enhance their product's marketability both in India and
internationally, securing a competitive edge. Additionally, EVTL India provides
ongoing support post-certification, helping manufacturers maintain compliance
with BIS standards and renew their licenses as needed.