Sterilization, Cleanrooms and Packaging
ISO 11137: Radiation Sterilization
ISO 11137 is a multi-part standard for radiation sterilization of health care products using gamma rays, electron beams or X-rays. It covers developing, validating and routinely controlling the process, and establishing and maintaining the sterilization dose.
At a Glance
- Standard
- ISO 11137
- Subject
- Radiation Sterilization
- Group
- Sterilization, Cleanrooms and Packaging
- Industries
- 1 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
One part sets requirements for developing, validating and routinely controlling the process. Another describes methods for establishing the sterilization dose from the product's bioburden and the intended sterility assurance, or for substantiating a selected dose. A further part gives guidance on dosimetry, including dose mapping and measurement.
Two doses frame a radiation process: the minimum dose needed to reach sterility and the maximum dose the product and packaging can tolerate while still performing. Validation shows, through dose mapping, that the irradiator delivers a dose range inside those limits for the specified loading pattern. Material compatibility is a design question too, since radiation can degrade some polymers.
An established dose isn't set and forgotten. Periodic dose audits test whether the bioburden still supports it, and changes in product, raw materials, manufacturing environment or irradiation facility can require reassessment.
Who It Applies To
- Manufacturers of radiation-sterilized devices, often working with contract irradiators
- Gamma, electron beam and X-ray sterilization service providers
- Firms changing irradiation sites or modalities
- Design teams selecting materials that must tolerate a radiation dose
What Auditors Check
Dose Establishment
The method used to set or substantiate the sterilization dose, with the supporting bioburden data and verification dose results.
Maximum Acceptable Dose
Evidence that product and packaging still meet specifications at the maximum dose, including aging effects where relevant.
Dose Mapping
Performance qualification dose maps for the actual loading pattern and process at the facility in use.
Dose Audits
Periodic dose audit records, and defined actions taken when an audit fails.
Routine Release
Dosimetry records for each run showing delivered dose within the specified range before product is released.
Irradiator Agreement
A quality agreement and supplier controls for the contract irradiator, including notification of changes to the facility or process.
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Industry Guides That Reference ISO 11137
ISO 11137
Check Your Quality System Against ISO 11137
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