IS/ISO 11239 : 2023 — Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (First Revision)

What is IS/ISO 11239 : 2023?

IS/ISO 11239 : 2023 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (First Revision). 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/ISO 11239 : 2023

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.

Related Indian Standards

• IS 17764Health informatics Requirements for a record of a dispense of a medicinal product
• IS 17769Health informatics Requirements for Electronic prescriptions
• IS 4182Misch Metal — Specification (Second Revision)
• ISO 3166 (Part 1):2020ISO 3166 (Part 1):2020
• ISO 639 (Part 1)ISO 639 (Part 1)