Overview
EN ISO 11139:2018 (ISO 11139:2018) is a vocabulary standard for the sterilization of health care products. Published by ISO and adopted by CEN as EN ISO 11139:2018, it defines terms used across standards that address sterilization processes, related equipment, monitoring and validation, and aseptic processing. This first edition replaces ISO/TS 11139:2006 and provides a single, authoritative source of terminology to ensure consistent use of key concepts in standards, technical documents and regulatory texts.
Key topics
The standard contains alphabetically arranged, carefully reviewed terms and definitions relevant to sterilization and associated processes, including (examples from the document):
- Aseptic processing / Aseptic presentation / Aseptic technique
- Bioburden / Bioburden estimate / Bioburden correction factor
- Biological indicator
- Aeration, air detector, airlock
- Absorbed dose (radiation) and absolute pressure
- Calibration and automatic controller
- Process control levels such as alert level and action level
Additional features:
- Annex A maps each term to the standards in which it appears.
- The vocabulary supports standards on cleaning, disinfecting, sterilizing and aseptic processing of medical devices and ancillary equipment.
Practical applications
EN ISO 11139:2018 is used to:
- Harmonize terminology across international and European sterilization standards, reducing ambiguity in specifications and compliance documents.
- Support development and revision of standards by technical committees (e.g., ISO/TC 198).
- Inform quality managers, regulatory affairs professionals, and auditors drafting or evaluating sterilization policies, validation protocols and product dossiers.
- Guide manufacturers of medical devices, sterilizer and equipment designers, and test laboratories in consistent reporting and documentation.
- Serve as a reference in clinical sterile services departments (CSSD), contract sterilization providers, and training programs to ensure a common understanding of process terms.
Who should use this standard
- Medical device manufacturers and designers
- Sterilizer and process equipment manufacturers
- Regulatory bodies and conformity assessment organizations
- Hospital Sterile Services Departments (CSSD) and infection control teams
- Standards developers, test laboratories and validation specialists
Related standards
- EN ISO 11139:2018 is the vocabulary source for many process and equipment standards authored by ISO/TC 198 and referenced by CEN/TC 102. Annex A of the document lists specific standards where each term is used, helping users trace term usage across the relevant sterilization standards landscape.
Keywords: EN ISO 11139:2018, ISO 11139, sterilization vocabulary, sterilization of health care products, sterilization terminology, bioburden, biological indicator, aseptic processing, sterilization standards.
