Mandatory BIS Standard
ISI Mark for Medical Textiles
- Minimum marking fee per year
- ₹9,200 – ₹1,96,000
- Micro to large firms
- Testing cost
- ₹4,500 – ₹21,500
- Based on 9 lab prices
- HSN codes
- 96190010, 62101000, 94042190
- Check the code with customs
Medical textiles BIS certification guarantees that products satisfy Indian quality and safety requirements under the Bureau of Indian Standards. Key criteria include IS 17423, IS 15142, and related medical textile standards.
Applicable Indian Standards for ISI Mark for Medical Textiles
| IS number | Product | Testing cost |
|---|---|---|
| IS 5405 : 2019 | Sanitary napkins | ₹4,500 – ₹16,5009 labs |
| IS 17509 : 2021 | Disposable baby diaper | ₹16,000 – ₹21,5004 labs |
| IS 17514 : 2021 | Reusable Sanitary pad/ Sanitary Napkin/ Period Panties | ₹17,0001 lab |
| IS 17349 : 2020 | Shoe covers | ₹5,800 – ₹6,5003 labs |
| IS 17354 : 2020 | Dental Bib or Napkins | — |
| IS 17630 : 2021 | Bed sheet and Pillow Cover | ₹8,5501 lab |
Minimum marking fee by firm size
You pay BIS a minimum marking fee every year. Micro, small and medium firms (with Udyam registration) pay less. BIS also works out a fee from the unit rate and your production. You pay whichever amount is higher.
| IS number | Large | Medium | Small | Micro | Unit rate |
|---|---|---|---|---|---|
| IS 5405 : 2019 | ₹46,000 | ₹37,000 | ₹23,000 | ₹9,200 | ₹10 per 1,000 pieces |
| IS 17509 : 2021 | ₹1,11,000 | ₹89,000 | ₹55,500 | ₹22,200 | ₹0.10 per 100 pieces |
| IS 17514 : 2021 | ₹1,03,000 | ₹83,000 | ₹51,500 | ₹20,600 | ₹20 per 100 pieces |
| IS 17349 : 2020 | ₹67,000 | ₹54,000 | ₹33,500 | ₹13,400 | ₹0.40 per 100 pairs |
| IS 17630 : 2021 | ₹1,96,000 | ₹1,57,000 | ₹98,000 | ₹39,200 | ₹0.55 per 100 sq m |
- Other BIS charges
- ₹9,000 for every ISI mark product: application charge ₹1,000 · licence fee ₹1,000 · audit charges ₹7,000
- Foreign manufacturers
- Get a detailed quote
- Our consulting fee
- Best-value quote – let’s talk
All prices are a guide only and do not include GST. Rules and dates can change, so check the latest notice before you apply. Ask us for an up-to-date quote.
Common questions
What is BIS certification for medical textiles?
It ensures medical textile products meet Indian safety and quality standards, allowing manufacturers to use the ISI mark for compliance.
Which BIS standards apply to medical textiles?
Common standards include IS 16289:2014 (sanitary napkins), IS 4687:2021 (surgical gloves), and IS 17334:2020 (coveralls).
How to apply for BIS certification?
Apply via www.manakonline.in, submit documents, test the product in a BIS-approved lab, and undergo factory inspection if required.
Is BIS certification mandatory?
Yes, for certain medical textiles like surgical gloves and coveralls, ensuring regulatory compliance.
What is the validity of BIS certification?
Typically valid for one to two years, requiring renewal and compliance audits.
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