IS/IEC 82304 : Part 1 : 2016
IS/IEC 82304 : Part 1 : 2016 — Health software: Part 1 general requirements for product safety
IS/IEC 82304 : Part 1 : 2016 is an Indian Standard titled Health software: Part 1 general requirements for product safety, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.
- IS Number
- IS/IEC 82304 : Part 1 : 2016
- Status
- 0
- Certification
- Voluntary
- Ministry
- Ministry of Health and Family Welfare
- Committee
- Health Informatics
- Type
- Others
Need ISI Mark certification for IS/IEC 82304 : Part 1 : 2016? Fixed-fee, 6–12 week timeline.
Get a quoteWhat is IS/IEC 82304 : Part 1 : 2016?
IS/IEC 82304 : Part 1 : 2016 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Health software: Part 1 general requirements for product safety. 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 82304 : Part 1 : 2016
- 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.