All terms
ManufacturingManufacturing & Supply
Sterilization
Validated process used to render a device free from viable microorganisms.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Sterilization is a validated process used to render a product free from viable microorganisms. Common modalities include ethylene oxide (EO), gamma radiation, electron beam, and steam.What this means in practice
FDA has prioritized reducing EO use due to environmental concerns, accelerating adoption of alternative modalities under ISO 11135 and related standards.Mentioned in recent activity
5 entriesFlamingo Funnel Medium, Model Number SQ20012-02
Class II· 2026-03-16
Flamingo Funnel Large, Model Number SQ20012-03
Class II· 2026-03-16
Flamingo Funnel Small, Model Number SQ20012-01
Class II· 2026-03-16
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Class II· 2026-03-16
Primary references
3 sourcesLink health: 2 verified 1 bot-blocked· last checked 2026-05-09
FDA·1ISO·1IMDRF/GHTF·1
- 1
FDA SterilizationBot-blockedFDAfda.gov
- 2
ISO 13485 Standard PageVerifiedISOiso.org
- 3
GHTF/IMDRF Process Validation GuidanceVerifiedIMDRF/GHTFimdrf.org
Inline markers like [1] jump to the matching reference above.