PI-WIKI-BIO-01 · Biosecurity · reviewed 2026-10-26
Autoclave Sterilization for Body Jewellery | BioFlex
Critical numbers
B-Cycle Temperature134°C (273°F)
B-Cycle Pressure2.1 bar (30.4 PSI)
B-Cycle Exposure Time3.5 – 5 minutes (porous load)
Gravity Cycle121°C · 1.1 bar · 15 – 30 minutes
Sterility Assurance LevelSAL 10⁻⁶
Spore Test OrganismGeobacillus stearothermophilus (ATCC 7953)
Biological Indicator FrequencyWeekly minimum (ANSI/AAMI ST79)
Bowie-Dick TestDaily, B-cycle autoclaves only
Water Conductivity Limit≤ 5 µS/cm (distilled / deionised only)
Pouch Shelf LifeEvent-related (sealed, dry, intact); often capped at 12 months
Sterilization Log Retention5 years minimum
Primary Standard (EU)EN 13060 / EN ISO 17665-1 [1, 3]
Do not
- Overloading the chamber
- Using tap water
- Skipping pre-cleaning
- Using an N-cycle for pouched instruments
- Removing loads before the dry phase completes
- No biological indicator programme
Applicable standards
- European Union & UK — EN 13060
- United States — ANSI/AAMI ST79
- ASEAN & Asia-Pacific — Thailand