IS/ISO 14708 : Part 1 : 2014 — Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision)

What is IS/ISO 14708 : Part 1 : 2014?

IS/ISO 14708 : Part 1 : 2014 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision). It falls under the <strong>Medical and Hospital Equipments</strong> group. Certification under this standard is voluntary.

How to get certified for IS/ISO 14708 : Part 1 : 2014

1. 1
   Apply online — Submit the BIS portal application with product details, factory information, and test reports.
2. 2
   Lab testing — Submit product samples to a BIS-recognised testing laboratory for evaluation against the standard.
3. 3
   Factory inspection — A BIS officer visits your manufacturing facility to verify quality control systems.
4. 4
   Licence grant — On approval, BIS issues the licence. You may then affix the ISI Mark on compliant products.

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