BIS Certification for Shoe Covers, Dental Bibs/Napkins, Bed Sheet & Pollow Coves as per IS 17349, IS 17354 AND IS 17630

In a world driven by quality and standards, certification plays a pivotal role in ensuring that products meet the desired criteria for safety, performance, and reliability. The Bureau of Indian Standards (BIS) is India’s national standards body that sets benchmarks for various products to protect consumers and promote quality. In this article, we will delve into the BIS certifications for three essential products: Shoe Covers (IS 17349: 2020), Dental Bibs or Napkins (IS 17354: 2020), and Bed Sheets and Pillow Covers (IS 17630: 2021). We will also explore how Omega QMS Pvt Ltd can assist you in obtaining these crucial certifications.

INDIAN STANDARDS

IS 17349:2020 SHOE COVERS

This standard specifies the requirements for shoe covers (disposable and reusable) intended to be used for medical purpose during various procedures to protect patient/materials from transfer of microorganisms, particulates, contaminants etc. This standard does not cover the requirement of legging/boot legging used in operation theatre. Cleanliness – Microbial (CFU/100 cm2 ) , Tensile strength (Dry and wet) and  Bursting strength (Dry and wet)  are some of the requirements specified for shoe covers apart from requirement of elastic thread .

IS 17354:2020 DENTAL BIBS/NAPKINS

This standard specifies the requirements for dental bib/ napkins (disposable and reusable) intended for medical use. The dental bib/napkins shall be made from suitable material that is not prohibited for use for the purpose under any applicable law/regulation in force so that the product made out of this meets the requirements specified in this standard. These can be manufactured in various sizes and shapes as per the customer’s requirements. The dental bib/napkins shall be clean and free from substances liable to cause tendering during storage. The dental bib/napkins shall conform to the requirements of Waterproofness, Cleanliness – Microbial (CFU/100 cm), Tensile strength (dry and wet), Absorption, Sinking time, Water holding capacity

IS 17630:2021 BED SHEETS AND PILLOW COVERS

Bedsheets and pillow covers are useful in providing an aid to infection control in hospitals and nursing homes. This standard specifies the requirements for single use and reusable bedsheet and pillow cover set intended for medical use. The bedsheet and pillow cover set shall be clean and free from substances liable to cause tendering during storage. The manufacture and preparation of the bedsheet and pillow cover shall be conducted under proper hygienic conditions. The fabric selvedges of bedsheet and pillow cover when visually examined shall be straight and firm. Colour fastness to rubbing ( Dry and  Wet), Colour fastness to perspiration (acidic and alkaline), Colour fastness to washing , Colour fastness to light , Dimensional stability to washing, Pilling resistance and  Scouring loss are some of the requirements specified for bedsheeet and pillow covers.

QUALITY CONTROL ORDER (TECHNICAL REGULATION) ISSUED BY THE MINISTRY OF TEXTILES, GOVT. OF INDIA ON 27 SEPTEMBER 2023 FOR MANDATORY BIS CERTIFICATION

The Ministry of Textiles, Govt. of India, has issued an order, making it mandatory for all medical textiles as mentioned above to be used in India, whether manufactured in India or imported from foreign countries, shall mandatorily carry the Standard Mark of the Bureau of Indian Standards under a valid BIS licence.  In short, it has become obligatory for all the manufacturers of medical textiles products as mentioned above, whether in India or overseas, to immediately apply for BIS licence and obtain a valid BIS certification licence before that the last date of implementation of the order, i.e., 01 Oct  2024 for small and micro enterprises and 01 April 2024 for others. .

BIS CERTIFICATION SCHEME

The BIS Standards, IS 17349, IS 17354 and IS 17630, establish a comprehensive framework encompassing various quality parameters that medical textile products must adhere to. The Bureau of Indian Standards Certification Scheme is a vital framework established by the Indian government to ensure the quality, safety, and reliability of products available in the market. This scheme aims to safeguard consumer interests by setting stringent benchmarks and guidelines that products must meet before they can be deemed compliant. BIS certification covers a wide range of industries and products, encompassing the entire gamut of industrial and manufacturing activity.  Various steps involved in the BIS Certification process are enumerated below:

• Standard Identification: Manufacturers identify the relevant BIS standard that applies to their chosen product category. These standards outline the specific quality, safety, and performance requirements that the product must meet.
• Application Submission: Manufacturers submit an application for BIS certification to the Bureau of Indian Standards (BIS), providing details about the product, its specifications, and the desired certification mark.
• Factory Inspection: BIS conducts an inspection of the manufacturer’s production facility to assess the quality control processes, infrastructure, and adherence to relevant standards.
• Sample Testing: BIS collects samples of the product from the manufacturer for testing in authorized BIS laboratories or recognized testing centers. These tests evaluate various parameters specified by the BIS standard.
• Certification Decision: Based on the satisfactory test results and compliance with standards, BIS decides whether to grant certification to the product. If approved, the manufacturer is issued a BIS certification license.
• Regular Monitoring: BIS monitors the manufacturing process of certified products through periodic audits and market surveillance to ensure ongoing compliance with quality control processes and standards.

OMEGA QMS PVT. LTD. – PARTNERING FOR SUCCESS

In the pursuit of achieving BIS certification and maintaining the highest levels of product quality, Omega QMS Pvt. Ltd. emerges as an invaluable partner for manufacturers. Backed by a global presence and a stellar track record of successful collaborations with Fortune 500 companies, Omega QMS provides an extensive array of services designed to streamline the certification process and ensure compliance with industry standards.

• Expert Guidance: Omega brings together a team of seasoned experts who possess in-depth knowledge of regulatory requirements, industry best practices, and intricacies of certification process. These experts guide manufacturers through the complex landscape, offering insights and strategies to navigate the process efficiently.
• Testing and Validation: Omega assists manufacturers in planning and executing necessary tests and validations required for BIS certification.
• Documentation and Compliance: The journey toward BIS certification demands meticulous documentation of processes, materials, and testing procedures. Omega aids manufacturers in creating comprehensive and accurate documentation that aligns with BIS requirements, reducing the risk of errors and rejections.
• Audit Support: Omega prepares manufacturers for BIS audits, which are a crucial part of the certification process. With its expertise, the organization ensures that manufacturers are well-prepared for audits, addressing any issues that may arise and increasing the likelihood of a successful outcome.
• Customized Approach: Each manufacturer’s journey toward BIS certification is unique. Omega understands this and tailors its services to fit the specific needs, challenges, and goals of individual manufacturers, ensuring a personalized and effective approach.
• Global Experience: With presence in over 40 countries, Omega brings global experience to the table. This international exposure allows the organization to offer insights into varying regulatory environments and industry practices, enabling manufacturers to excel globally.

Omega QMS Pvt. Ltd. functions as a strategic partner for manufacturers aiming to achieve BIS Certification. Its multifaceted approach encompasses expert guidance, process control, testing and validation support, documentation assistance, audit preparation, training, and a global perspective. By collaborating with Omega, manufacturers gain a competitive edge in their pursuit of certification while upholding the highest standards of product quality and consumer satisfaction.

For more details you can reach out to Omega at info@globalomega.com.

BIS certification is a mark of quality and compliance that instills confidence in both manufacturers and consumers. For products like shoe covers, dental bibs and  bed sheets & pillow covers, obtaining BIS certification is not only a legal requirement but also a testament to your commitment to delivering high-quality, safe, and reliable products.

Omega QMS Pvt Ltd can be your trusted partner in this journey, simplifying the complex certification process and ensuring that your products meet the stringent BIS standards. With their expertise and support, you can streamline the certification process, save time and resources, and focus on delivering products that adhere to the highest quality and safety standards.