Overview
EN ISO 17665:2024 - Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices - specifies requirements and gives guidance for the development, validation and routine control of moist heat (steam) sterilization processes used on medical devices. The document combines normative requirements with explanatory guidance to promote good practice for moist heat sterilization in both industrial and healthβcare settings. It replaces earlier editions (EN ISO 17665-1:2006 and CEN ISO/TS 17665-2:2009) and is endorsed by CEN.
Key topics and requirements
- Process development: requirements for designing a moist heat sterilization cycle appropriate to the device and load configuration.
- Process validation: requirements for establishing and documenting that a sterilization process consistently achieves the intended microbial reduction (including use of biological and chemical indicators and process challenge devices).
- Routine control and monitoring: requirements for ongoing control, routine testing and records to ensure continuing process performance.
- Guidance and good practice: explanatory guidance intended to clarify normative clauses and support practical implementation.
- Regulatory alignment: informative annexes (ZA and ZB) detail the relationship to EU Regulations (MDR 2017/745 and IVDR 2017/746), noting scope limits and how conforming to the standard can provide a presumption of conformity when cited in the Official Journal of the EU.
- Scope limits: the standard focuses on achieving microbial states via moist heat; aspects such as package design for maintenance of sterility during transport/storage or unrelated manufacturing activities are not covered.
Practical applications
- Developing and qualifying steam sterilization cycles for packaged medical devices and reusable instruments.
- Validating new sterilizer models, load configurations and process challenge devices.
- Establishing routine monitoring programs using biological and chemical indicators and documenting ongoing compliance.
- Supporting regulatory submissions and demonstrating compliance with EU MDR/IVDR when the standard is applied as part of a quality and validation program.
Who should use this standard
- Medical device manufacturers and contract sterilization service providers
- Hospital sterilization/central sterile services departments (CSSD) and clinical engineering teams
- Sterilizer manufacturers, validation laboratories and quality assurance/regulatory affairs professionals
- Notified bodies and auditors assessing sterilization processes or conformity with MDR/IVDR
Related standards
Normatively referenced standards (examples important for implementation) include:
- ISO 11140 series (chemical indicators)
- ISO 11138 series (biological indicators)
- ISO 11607β1 / β2 (packaging for terminally sterilized medical devices)
- ISO 11737β1 / β2 (microbiological methods - population and sterility testing)
Using EN ISO 17665:2024 helps organizations implement robust steam sterilization validation, routine control and regulatoryβaligned practices for medical device sterilization.
