Medical Textile NonWoven Wipes refer to single-use dry or wet wipes used for baby care and personal hygiene. The non-woven fabric is used for the production of these wipes. These products are gentle on the skin and effectively clean and remove impurities. The demand for these wipes in India has been soaring owing to the growing awareness of hygiene & sanitation, especially in the wake of the COVID-19 outbreak. Additionally, the rise in disposable income and the hectic lifestyle of people have also been attributed to the soaring demand for these products. Let’s discover how to secure BIS certification for Medical Textile NonWoven Wipes.
Underlining the Significance of IS17787:2021
IS 17787:2021 encompasses the minimum performance norms for single-use nonwoven dry or wet wipes for baby care as well as personal hygiene. However, this standard doesn’t apply to wipes with a germicidal claim or wet wipes impregnated with alcohol. All guidelines in the standard pave the foundation for the BIS certification for Medical Textile NonWoven Wipes.
It also doesn’t address the need for chemicals, cleaning agents, moisturizing agents, aroma, preservatives, and other additives to be impregnated/coated on the product. The acceptable limits of these chemicals/ingredients must be within the norms underpinned by the FDA or another concerned authority.
To manufacture wipes, the non-woven fabric used must adhere to IS 17788: 2021. The wipes must be free of any compounds that could cause tendering during storage and must be clean. The length and width of the wipes should be mutually agreed upon by both the buyer and seller.
Manufacturing of wipes must take place in hygienic circumstances, as per the general guidance provided in Annex B of the standard. The wipes must meet all the specifications mentioned in the standard.
Tests concerning BIS certification for Medical TextileNonWoven Wipes
Products like medical textile nonwoven wipes must undergo the following test for quality for BIS certification:
- Length and width test
- Total viable count test
- pH test
- Pseudomonas aeruginosa test
- Candida albicans test
- Staphylococcus aureus test
- E. coli test
Packing norms concerning BIS certification for Medical Textile NonWoven Wipes
The packaging of wipes should be secure enough to withstand normal handling and transportation without tearing or exposing the contents. Additionally, each packet of wipes must be labeled legibly and indelibly with the information specified in the standard.
If the product(s) meet the requirements of this standard, they can be certified under the Bureau of Indian Standards Act, 2016, and the Rules and Regulations formulated thereunder. The product(s) can then be marked with the Standard Mark (ISI Mark).
The manufacturer should mandatorily secure a BIS license from the Bureau of Indian Standards to use the ISI Mark. The BIS grants a license only after a successful assessment of the manufacturing process, quality control, and testing capabilities.
Documents required for BIS certification for Medical Textile NonWoven Wipes
The common paperwork required for securing BIS certification for Medical Textile NonWoven Wipes is as follows:
- Application form for BIS certification
- Manufacturing license (if applicable)
- Test reports from a BIS-approved laboratory
- Technical documents such as product design and specifications
- ISO 9001 certificate (if applicable)
- Quality control manual
- List of manufacturing machinery and equipment
- Factory layout plan
- Details of raw materials
- Electrical safety reports (if applicable)
- Bill of materials (BOM) for the product(s)
- Declaration of conformity with the relevant Indian Standard(s)
- Undertaking for compliance with BIS norms.
It’s important to note that the exact paperwork needed may vary based on the type of product.
What is the process of securing BIS certification for Medical Textile NonWoven Wipes?
Obtaining a BIS registration for ISI marking is a crucial step for every business. The Bureau of Indian Standards (BIS) outlines what quality and labelling norms should be met by the manufacturers. Here’s how you can apply for this BIS certification for Medical Textile NonWoven Wipes:
1. Determine if your product falls under the ISI scheme: The first step in securing a BIS registration is to discover if your product requires it. The BIS ISI scheme covers a range of products, which are highlighted on the authority’s website.
2. Look out for relevant Indian Standards: Once you get assured that your product requires ISI marking, proceed to discover which standard applies to your products. You can do so by hopping onto the authority’s website.
3. Secure the test report: Before you apply for BIS registration, you will need to approach a BIS-recognized laboratory to perform test and generate the report. The lab report shall authenticate whether or not the product has met the underlying quality norms.
4. File the BIS application: After securing the lab report, visit the BIS portal to file an application concerning BIS certification for medical textile nonwoven wipes. The e-form should entail all the key information regarding the product, specs, production facility, standards in use, testing facility, etc.
5. Pay the fee: There is an applicable charge cum fee for obtaining a BIS license, and it is vital to pay the authority while submitting your application.
6. Wait for approval: Post application submission, wait for a while until the BIS approves your request for certification. The completion timeline of this process will differ based on product type and paperwork threshold.
7. Mark your product: After securing the BIS certification for Medical Textile NonWoven Wipes, the manufacturer can start using ISI marking on their product. The ISI logo indicates that the product is of utmost quality and hence is safe for the intended use.
In conclusion, securing a BIS registration requires careful attention to detail and compliance with all applicable guidelines. By following this above process, you can ensure that your product adheres to the necessary quality norms and is approved for sale in India.