ISO 17665:2024
Moist Heat (Steam) Sterilization for Medical Devices
Last updated: March 2025 (ISO 17665:2024)
ISO 17665:2024 defines how to develop, validate, and routinely control moist heat (steam) sterilization processes for medical devices. The standard helps you justify your autoclave cycle scientifically, validate it, and keep it under control throughout production.
Takes about 60–90 seconds.
Typical response within 1 business day.
15-minute consult with a steam specialist.
Video Overview: ISO 17665 & Steam Sterilization
Watch this quick primer on steam (moist heat) sterilization — how saturated steam achieves lethality, what happens during pre-vacuum, exposure, and dry/cool, and how ISO 17665:2024 frames process development, validation, and routine control.
ISO 17665 is the global standard that governs moist heat sterilization for medical devices. It ensures that every sterilization process delivers consistent, reliable microbial inactivation—protecting both patient safety and product performance. —
ISO 17665 outlines requirements for the development, validation, and routine control of steam-based sterilization processes. It applies to saturated steam, air removal systems, and other moist heat methods. —
Following ISO 17665 helps safeguard patient health, ensures sterility assurance levels, and meets regulatory expectations from the FDA and international bodies.–
This standard applies to OEMs, contract manufacturers, and reprocessors using steam sterilization for terminally sterilized or reusable devices. —
Compliance requires process validation—defining and confirming critical parameters like temperature, exposure time, and drying time. Testing includes biological indicators, Bowie-Dick tests, and performance qualification. —
Life Science Outsourcing provides end-to-end steam sterilization validation per ISO 17665. With in-house BI testing, GMP-compliant autoclaves, and custom cycle development, we help you stay audit-ready and on schedule. —
Need to validate your steam sterilization process or meet ISO 17665 requirements? Contact Life Science Outsourcing for expert guidance and rapid turnaround.
What Is ISO 17665?
ISO 17665 is the global standard for steam (moist-heat) sterilization of health care products. It requires documented evidence that a defined autoclave cycle consistently achieves the intended sterility assurance level (SAL) when operated within specified limits, covering:
Process development
Validation (IQ/OQ/PQ)
Routine control
Typical users include medical device OEMs, contract manufacturers, and sterilization providers operating validated autoclaves.
What Changed in ISO 17665:2024?
- Single current edition: ISO 17665:2024 replaces earlier editions (e.g., 2006-era references).
- Lifecycle clarity: tighter expectations around development → validation → routine control, monitoring, and requalification.
- Action item: if your protocol/report still cites 2006 content, plan a gap review.
Scope & Core Requirements
To comply with ISO 17665, your documentation should address:
- Process development: cycle parameters, load configuration, PCD/BI strategy, and acceptance criteria grounded in microbiology.
- Validation: IQ/OQ/PQ, worst-case load studies, BI placement/results, and documented acceptance decisions.
- Routine control: load release criteria; monitoring/recording of pressure, temperature, and time; change control; periodic requalification.
When Steam Is the Right Modality
Steam Sterilization is a simple yet very effective decontamination method. Sterilization is achieved by exposing products to saturated steam at high temperatures (121°C to 134°C). Product(s) are placed in a device called the autoclave and heated through pressurized steam to kill all microorganisms including spores. The device’s exposure time to steam would be anywhere between 3 to 15 minutes, depending on the generated heat.
Steam sterilization process is not appropriate for many materials due to the high temperatures involved. Some quarantine/down time is required once products have been sterilized. Sterilized packages need to be allowed to dry before being removed from the autoclave to prevent contamination. Once removed, they must be allowed to cool to ambient temperatures, which may take several hours.
For effective sterilization it is critical that the steam covers all surfaces of the device. To ensure optimal conditions, many autoclaves have built in meters that display temperature and pressure conditions with respect to time. Biological indicator devices and Indicator tape which changes color are also used to gauge the performance of the autoclave. The chemical tape is placed both inside and outside the sterilized packages, whereas bioindicator devices release spores inside the autoclave. The spores are incubated for 24 hours at the end of which time their growth rate is measured. If the spores have been destroyed it indicates that the sterilization process was effective.
What We Provide
LSO provides Contract Steam Sterilization services for any product capable of withstanding high-temperature sterilization. Our sterilizer features a high capacity 19 cubic foot chamber size. We can program any desired cycle parameters and duplicate an existing sterilization cycle or develop a cycle for specialized requirements.
Sterilization validations are performed according to ANSI/AAMI/ISO guidelines. Our staff will prepare the protocol, perform all required sterilization cycles, conduct all testing and generate a complete final report. Customers review and approve the protocol before the validation process begins.
ISO 17665 vs. AAMI ST79 — and Where ISO 17664 Fits
ISO 17665: manufacturing context; lifecycle requirements for steam sterilization (development, validation, routine control).
AAMI ST79: practical guidance widely used in health-care facilities (reprocessing, QA/monitoring, documentation).
ISO 17664: what manufacturers must include in the IFU for reusable devices (cleaning, disinfection, sterilization).
Documentation You’ll Need
- Sterilization protocol(s) with defined acceptance criteria
- IQ/OQ/PQ records, BI results, worst-case load studies
- Routine monitoring procedures and load release criteria
- Change control and requalification plan
ISO 17665 FAQs
Is there a new version of ISO 17665?
Yes—ISO 17665:2024 is the current edition. If your validation cites older documents, plan a gap review and update.
What does ISO 17665 cover?
Requirements to develop, validate, and routinely control moist-heat (steam) sterilization processes for medical devices.
How does ISO 17665 relate to AAMI ST79?
ST79 provides practical guidance for health-care facilities; ISO 17665 frames the device manufacturing lifecycle. Both are commonly referenced.
What should the IFU include?
Use ISO 17664 to define the required processing information (cleaning, disinfection, sterilization) for reusable devices.
Takes about 60–90 seconds.
Typical response within 1 business day.
15-minute consult with a steam specialist.