EN ISO 11138-1:2017 pdf download.Sterilization of health care products — Biological indicators — General requirements
1 Scope
2 Normative references
Sterilization of health-care products — Ethylene oxide — Requirements for the development,validation and routine control of a sterilization process for medical devices
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products — Moist heat — Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices
Sterilization of health care products — Biological and chemical indicators — Test equipment
3 Terms and definitions
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp/
3.1 biological indicator
3.2 carrier
3.3 colony forming unit
CFU
3.4 culture collection number
3.5 culture conditions
EN ISO 11138-1:2017 pdf download
