Why Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 39 peritoneal dialysis equipment needs BIS certification
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 39 peritoneal dialysis equipment falls under the Medical Devices & Textiles category and is covered by IS 13450: Part 2: Sec 39 (2019). Manufacturers and importers must obtain the ISI mark licence from the Bureau of Indian Standards before the product can be manufactured, imported, stored or sold in India. Selling a notified product without a valid BIS licence can lead to seizure of stock, marketplace delisting and penalties under the BIS Act, 2016.
Testing & costs
Sample testing for IS 13450: Part 2: Sec 39 (2019) is currently available at 1 BIS-recognised laboratory across India. Reported test charges range from ₹9.8L (excluding GST), depending on the laboratory, the number of models/varieties and the tests included in the scope. Certko can help you pick a lab that balances cost, turnaround time and location.
Typical process
- Standard & scope check – confirm your exact product variant maps to IS 13450: Part 2: Sec 39 (2019).
- Documentation – factory details, quality control records, test equipment list and trademark proof.
- Sample testing – testing at a BIS-recognised lab against every clause of the standard.
- Factory inspection – BIS officers audit the manufacturing site (for ISI mark licences).
- Grant of licence – on successful evaluation, the licence/registration is issued, typically within 10-18 weeks.
