IS/IEC 62366 : Part 1 : 2015
IS/IEC 62366 : Part 1 : 2015 — Medical Devices Part 1 Application of Usability Engineering to Medical Devices
IS/IEC 62366 : Part 1 : 2015 is an Indian Standard titled Medical Devices Part 1 Application of Usability Engineering to Medical Devices, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.
- IS Number
- IS/IEC 62366 : Part 1 : 2015
- Status
- 1
- Certification
- Voluntary
- Ministry
- Ministry of Health and Family Welfare
- Committee
- Hospital Planning
- Type
- Code of Practice
Need ISI Mark certification for IS/IEC 62366 : Part 1 : 2015? Fixed-fee, 6–12 week timeline.
Get a quoteWhat is IS/IEC 62366 : Part 1 : 2015?
IS/IEC 62366 : Part 1 : 2015 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Medical Devices Part 1 Application of Usability Engineering to Medical Devices. It falls under the <strong>Medical and Hospital Equipments</strong> group and is administered by the Ministry of Health and Family Welfare. Certification under this standard is voluntary.
How to get certified for IS/IEC 62366 : Part 1 : 2015
- 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.
Complyris an independent compliance consultancy. We are not affiliated with, endorsed by, or representing the Bureau of Indian Standards or any government body. All Indian Standards are © Bureau of Indian Standards. Visit bis.gov.in for official standard documents.
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Fixed fee. End-to-end handling. We manage the entire BIS certification process.