Overview
ISO 11139:2018/Amd 1:2024 is an important international standard focusing on the sterilization of health care products. This amendment updates and expands the vocabulary of terms related to sterilization processes, equipment, and related standards. Maintaining clarity and consistency in terminology is essential for ensuring the safety, effectiveness, and regulatory compliance of sterilization practices in healthcare settings.
This amendment brings revised definitions and new terms that reflect the latest understandings and technological advances in sterilization. Developed by ISO Technical Committee ISO/TC 198 in collaboration with the European Committee for Standardization (CEN/TC 102), this document ensures harmonization across global medical device manufacturing and processing sectors.
Key Topics
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Exposure Stage: Revised term defining the critical phase in a sterilization cycle where the sterilizing or disinfecting agent is active and microbial lethality is claimed.
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F Value (Biological & Biological): Updated expressions for calculating resistance (F value BIO) and delivered lethality (F value BIOLOGICAL) based on microorganism kill rates on biological indicators.
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Holding Time: Clarification on maintaining process parameters within specified tolerances during sterilization, with specific definition for moist heat sterilization.
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Labelling and Accompanying Information: Updated and detailed definitions emphasizing labeling, instructions for use, and user information of medical devices excluding shipping documentation.
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Medical Device: Expanded definition including instruments, apparatus, implants, reagents, and software intended for human use that do not primarily function by pharmacological means.
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Simulated Product: Defined as items representing product characteristics for process performance validation.
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Temperature Band: Defined operating temperature range during sterile processing.
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Terminally Sterilized: Products successfully sterilized within their sterile barrier system.
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New Terms: Several added entries such as acceptance range, biologic products, companion tissue, contained product sterilization, critical medical device, donor identification, endotoxin concepts, health care facility, implantable health care products, and more.
Applications
ISO 11139:2018/Amd 1:2024 has broad application across medical device manufacturers, sterilization equipment suppliers, healthcare facilities, and regulatory bodies. It supports:
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Standardization of terminology used in sterilization validation, process control, and quality assurance.
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Improved communication and compliance between manufacturers, healthcare providers, and auditors.
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Enhanced safety by ensuring clear understanding of sterilization stages, product handling, and labeling for medical devices.
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Guidance for equipment design and process validation by defining concepts such as biological indicators, holding times, and sterilization efficacy measures.
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Facilitation of regulatory submissions and audits by adhering to internationally recognized definitions and vocabulary.
Related Standards
This amendment complements several other ISO standards related to healthcare product sterilization and quality management:
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ISO 13485: Medical devices - Quality management systems - Requirements.
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ISO 20417: Medical devices - Information to be supplied by the manufacturer.
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ISO/IEC Guide 63: Principles for medical device standards.
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ISO 11135: Sterilization of health care products - Ethylene oxide.
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ISO 17665: Sterilization of health care products - Moist heat.
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ISO 14937: General requirements for sterilization of health care products.
By aligning with these standards, ISO 11139:2018/Amd 1:2024 ensures a comprehensive framework for sterilization vocabulary that supports product safety, performance, and regulatory adherence on a global scale.
Keywords: ISO 11139:2018/Amd 1:2024, sterilization vocabulary, health care products, medical device sterilization, sterilization process standards, sterilization terminology, biological indicator, sterilization holding time, medical device labeling, healthcare sterilization standards, sterilization equipment definitions, ISO sterilization amendment.
Open preview (PDF)Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions