If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:
A sterile product is one which is free of viable microorganisms. The International Standards for sterilization of medical devices require, when it is necessary to supply a sterile product item, that adventitious microbiological contamination of a medical device from all sources be minimized by all practical means. Even so, product items produced under standard manufacturing conditions in accordance with the requirements for quality management systems for medical devices (see, for example, BS EN ISO 13485) may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such products are non-sterile. The purpose of sterilization processing is to inactivate the microbiological contaminants and thereby transform the non-sterile items into sterile ones.
The inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices often approximates an exponential relationship; inevitably this means that there is always a finite probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of micro-organisms and by the environment in which the organisms exist during treatment. Therefore the sterility of any one item in a batch of items subjected to sterilization processing cannot be guaranteed. So, in a batch of processed items, the sterility has to be defined in terms of the probability of the existence of a non-sterile item being included.
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BS EN ISO 17665 describes the requirements for ensuring that the activities associated with the process of moist heat sterilization are performed properly. These activities are described in documented work programmes designed to demonstrate that the moist heat sterilization process will consistently yield sterile products on treatment with process variables falling within the predetermined limits.
 BS EN ISO 11137-3:2006
Sterilization of health care products - Radiation Part 3: Guidance on dosimetric aspects |
BS EN ISO 11137-1:2006
Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices |
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BS EN ISO 11607-1:2006
Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems |
BS EN ISO 11607-2:2006
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes |
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