Overview
ISO 11139:2018 is the International Organization for Standardization (ISO) vocabulary for the sterilization of health care products. This first edition (2018) replaces ISO/TS 11139:2006 and was prepared by ISO/TC 198. It defines terms used across standards addressing cleaning, disinfecting, sterilizing, and aseptic processing, and serves as the authoritative source for consistent terminology used in equipment, processes, and regulatory documentation.
The vocabulary is arranged alphabetically in English and includes terms that cover microbiological concepts (for example bioburden and biological indicator), equipment and process elements (such as chamber, sterilizing agent, access device), and operational practices (for example aseptic technique, aseptic processing, cleaning).
Key Topics
- Standardized terminology: Clear definitions to reduce ambiguity across sterilization and related standards.
- Scope coverage: Terms for products, equipment, processes, zones and controls used in sterilization and aseptic processing.
- Microbiological vocabulary: Definitions for bioburden, bacterial challenge test, colony forming unit (CFU), and assurance of sterility.
- Process and equipment terms: Definitions such as chamber pre-heating, airlock, automatic controller, and clean-in-place (CIP).
- Documentation and structure: Alphabetical arrangement, annex summarizing which standards include each term, and a bibliography to support cross-references.
Applications
ISO 11139:2018 is practical for a wide range of stakeholders involved in health care sterilization:
- Manufacturers of medical devices and sterilization equipment use the vocabulary to align product specifications and labeling.
- Quality and regulatory teams adopt consistent terms in policies, validation protocols, and submissions to regulators.
- Sterile processing departments, service engineers, and clinical personnel benefit from shared definitions that improve training, procedures, and incident investigation.
- Standards developers use ISO 11139 as the source vocabulary when drafting or revising related standards to ensure consistency across documents.
Key benefits include improved clarity in technical documentation, enhanced regulatory compliance through consistent terminology, and smoother cross-disciplinary communication during design, validation, and routine sterilization operations.
Related Standards
ISO 11139:2018 supports and is cross-referenced by other ISO/TC 198 standards covering sterilization processes, testing methods, and equipment requirements. Annex A in ISO 11139 provides a summary of the standards that include each term, and the Bibliography lists referenced standards. Users should consult ISO Online Browsing Platform and the relevant ISO/TC 198 documents for specific process or equipment requirements.
For implementation, reference ISO 11139:2018 alongside product-specific and process-specific standards to ensure both technical compliance and consistent use of terminology across teams and documentation.
Open preview (PDF)Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards
