IS 13450
IS 13450 — Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 47 ambulatory electrocardiographic systems
IS 13450 is an Indian Standard titled Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 47 ambulatory electrocardiographic systems.
- IS Number
- IS 13450
- Status
- 0
- Certification
- —
- Committee
- Electromedical, Diagnostic Imaging and Radiotherapy Equipment
Need ISI Mark certification for IS 13450? Fixed-fee, 6–12 week timeline.
Get a quoteWhat is IS 13450?
IS 13450 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 47 ambulatory electrocardiographic systems.. Certification under this standard is voluntary.
How to get certified for IS 13450
- 1Apply online — Submit the BIS portal application with product details, factory information, and test reports.
- 2Lab testing — Submit product samples to a BIS-recognised testing laboratory for evaluation against the standard.
- 3Factory inspection — A BIS officer visits your manufacturing facility to verify quality control systems.
- 4Licence grant — On approval, BIS issues the licence. You may then affix the ISI Mark on compliant products.
Amendments to IS 13450
| Amendment | Year |
|---|---|
| First Amendment | 2021 |
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Fixed fee. End-to-end handling. We manage the entire BIS certification process.