BS EN ISO 11137-3:2006
Sterilization of health care products. Radiation. Guidance on dosimetric aspects
This part of BS EN ISO 11137 gives guidance on the requirements in BS EN ISO 11137 parts 1 and 2 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described.
An integral part of radiation sterilization is the ability to measure dose. Dose is measured during all stages of development, validation and routine monitoring of the sterilization process. It has to be demonstrated that dose measurement is traceable to a national or International Standard, that the uncertainty of measurement is known, and that the influence of temperature, humidity and other environmental considerations on dosimeter response is known and taken into account. Process parameters are established and applied based on dose measurements. This part of BS EN ISO 11137 provides guidance on the application of dose measurements (dosimetry) during all stages of the sterilization process.
This standard describes requirements that, if met, will provide a radiation sterilization process, intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore, compliance with the requirements helps ensure that this activity is both reliable and reproducible so that predictions can be made, with reasonable confidence, that there is a low level of probability of there being a viable microorganism present on product after sterilization.
Generic requirements of the quality management system for design and development, production, installation and servicing are given in ISO 9001 and particular requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality management systems recognize that, for certain processes used in manufacturing or reprocessing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process monitored routinely and the equipment maintained.
Requirements in regard to dosimetry are given in BS EN ISO 11137-1 and BS EN ISO 11137-2. This part of BS EN ISO 11137 gives guidance to these requirements. The guidance given is not normative and is not provided as a checklist for auditors. The guidance provides explanations and methods that are regarded as being suitable means for complying with the requirements. Methods other than those given in the guidance may be used, if they are effective in achieving compliance with the requirements of BS EN ISO 11137-1.
Contents include:- Scope
- Normative references
- Terms and definitions
- Measurement of dose
- Selection and calibration of dosimetry systems
- Selection of dosimetry systems
- Calibration of dosimetry system
- Establishing the maximum acceptable dose
- Establishing the sterilization dose
- Installation qualification
- Operational qualification
- Gamma irradiators
- Electron beam irradiators
- X-ray irradiators
- Performance qualification
- Gamma and X-ray
- Electron beam
- Routine monitoring and control
- Frequency of dose measurements
- Mathematical modelling
- Bibliography
- Relationship between this European Standard and the Essential Requirements of EU Directives 90/385/EEC concerning active implantable medical devices, 93/42/EEC concerning medical devices and 98/79/EEC concerning in vitro diagnostic medical devices
