IS 18644 : 2024 — Biotechnology Bioprocessing General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

What is IS 18644 : 2024?

IS 18644 : 2024 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Biotechnology Bioprocessing General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use. 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 18644 : 2024

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.