Sterilization, Cleanrooms and Packaging
ISO 17665: Moist Heat Sterilization
ISO 17665 covers moist heat sterilization, the steam processes used both by manufacturers sterilizing product and by health care facilities reprocessing devices. It sets out how to develop, validate and routinely control a steam process so it reliably delivers the intended lethality.
At a Glance
- Standard
- ISO 17665
- Subject
- Moist Heat Sterilization
- Group
- Sterilization, Cleanrooms and Packaging
- Industries
- 5 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The standard addresses the sterilizing agent, the process and equipment, product definition, process definition, validation, and routine monitoring and control. Moist heat can be applied in different ways, for example saturated steam processes for wrapped and porous loads and other processes for liquids in sealed containers, and the validation approach has to fit the process chosen.
Validation combines physical measurements, such as temperature and pressure across the chamber and load, with microbiological evidence where appropriate, plus confirmation that product and packaging withstand the process. Load configuration matters, so validated loads are defined precisely and reproduced in routine use.
Moist heat also reaches into labeling. Manufacturers of reusable devices provide reprocessing instructions that often include a steam sterilization step, and those instructions need validation evidence behind them.
Who It Applies To
- Manufacturers that steam sterilize product in house or through a contractor
- Makers of reusable devices whose instructions specify steam sterilization
- Combination product sites using steam for components or equipment
- Health care facilities and reprocessors running steam sterilizers
What Auditors Check
Equipment Qualification
Installation and operational qualification of the sterilizer, with calibrated instruments and maintenance records.
Defined Loads
Validated load configurations documented clearly enough that production staff reproduce them every time.
Performance Qualification
Temperature mapping and, where used, biological indicator results showing process conditions reach the hardest-to-sterilize locations.
Routine Cycle Records
Each cycle's physical parameters reviewed against specification before release, with deviations investigated.
Support for Reprocessing Instructions
For reusable devices, validation data that supports the sterilization parameters given to users.
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Industry Guides That Reference ISO 17665
ISO 17665
Check Your Quality System Against ISO 17665
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