SIST EN ISO 11139:2018/A1:2024 PDF

Overview

EN ISO 11139:2018/A1:2024 is the CEN-endorsed Amendment 1 to ISO 11139:2018 - a vocabulary standard for the sterilization of health care products. This amendment updates, clarifies and adds terms and definitions used across sterilization equipment and process standards (e.g., moist heat, irradiation, biological indicators). It harmonizes language for manufacturers, test labs, regulators and healthcare providers to reduce ambiguity in requirements, validation and reporting.

Key topics and changes

This amendment revises existing entries and introduces new vocabulary that is widely referenced in sterilization and processing standards:

• Exposure stage (replaces “exposure phase”) - clarifies the cycle stage where the sterilant exerts its microbicidal effect.
• F value (BIO and BIOLOGICAL) - distinguishes between resistance-related expressions and delivered lethality measured using biological indicators.
• Holding time and temperature band - refined definitions for process stability during sterilization cycles.
• Labelling and accompanying information - aligned with ISO 13485:2016 and ISO 20417:2021 for consistent device information and instructions.
• Medical device - updated wording (includes “in or on the human body”) and expanded notes covering sterilization-related products (pouches, wraps, disinfectants).
• New terms added for biologics and tissue-based products (e.g., processing, companion tissue, contained product sterilization).
• Definitions for quality, safety and test concepts: simulated product, terminally sterilized, end product testing, endotoxin limit/unit, acceptance range, critical medical device, and various endpoint definitions.

Practical applications

This vocabulary amendment supports:

• Clear communication in technical specifications, validation protocols, and conformity assessments for sterilization processes.
• Development and interpretation of validation reports, biological indicator testing, sterilizer performance specifications and sterilization cycle documentation.
• Harmonized regulatory submissions and standards-based procurement of sterilization equipment, consumables and packaging.

Who should use it

• Medical device manufacturers and contract sterilization providers
• Sterilizer and process equipment designers and test laboratories
• Quality assurance, regulatory affairs, and clinical engineering teams in hospitals
• Standards writers and auditors working on sterilization and infection-control procedures

Related standards

• ISO 11139:2018 (original vocabulary)
• ISO 13485:2016 (labelling source)
• ISO 20417:2021 (accompanying information)

This amendment (EN ISO 11139:2018/A1:2024) ensures consistent terminology across European and international sterilization standards, improving clarity for validation, safety and regulatory compliance.