Standard
International Organization for Standardization
Published by ISO
Standards for cleanrooms, sterilisation and bioburden that supply the measurement methods behind GMP requirements.
Why it matters to you: Cleanroom classification and many sterilisation validations rely on ISO methods.
Key references for microbiology
| Reference | Topic | In short |
|---|---|---|
| ISO 14644-1 | Cleanroom classification | Number of locations, particle limits |
| ISO 14644-2 | Monitoring | Continued compliance |
| ISO 14644-3 | Test methods | Filter leak, airflow, recovery |
| ISO 11737-1 | Bioburden | Medical devices |
| ISO 11138 | Biological indicators | Specifications |
| ISO 17665 | Moist heat sterilisation | Development and validation |
Practical tips
- Classification (ISO 14644-1) is not the same as monitoring; justify monitoring by risk.
Learn and test yourself
Other standards
Summarised in our own words for learning. Always refer to the current official text for exact requirements. How we use references