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BS EN 556-1:2001 specifies the requirements for a terminally-sterilized medical device to be designated "STERILE". Part 2 of BS EN 556-1:2001 specifies the requirements for an aseptically processed medical device to be designated "STERILE".

NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as "STERILE" is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.

A sterile product item is one which is free of viable micro-organisms. European Standards for medical devices require, when it is necessary to supply a sterile product item, that adventitious microbiological contamination of a medical device from all sources is minimized by all practical means. Even so, product items produced under standard manufacturing conditions in accordance with their requirements for quality systems for medical devices (see EN ISO 13485:2000 or EN ISO 13488:2000) may, prior to sterilization, have micro-organisms on them, albeit in low numbers. Such product items 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 micro-organisms by physical and/or chemical agents used to sterilize medical devices often approximates to an exponential relationship; inevitably this means that, regardless of the extent of treatment applied, there is always a finite probability that a micro-organism will survive. 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. It follows that the sterility of any one item subjected to sterilization processing cannot be guaranteed and the sterility of the processed items has to be defined in terms of the probability of the existence of a surviving micro-organism on/in an item. The standards for quality management systems recognize that there are processes used which cannot be fully verified by subsequent inspection and testing of product. Sterilization is an example of such a process. Sterilization processes have to be validated before use, the performance of the process monitored routinely and the equipment maintained.

It is important to be aware that exposure to a properly validated and accurately controlled sterilization process is not the only factor associated with the provision of assurance that the product item is sterile and, in this respect, suitable for its intended use. Attention has also to be given to a number of factors including the microbiological status (bioburden) of incoming raw materials and/or components, their subsequent storage and to the control of the environment in which the product is manufactured, assembled and packaged.

Cross References:
EN ISO 13485:2000
EN ISO 9001
EN ISO 13488:2000
ISO 13485:1996
ISO 13488:1996
EN ISO 9001:1994
ISO 9001
EN ISO 9002:1994
ISO 9002:1994
EN 550
EN 552
EN 554
EN 980
EN ISO 14971:2000
ISO 14971:2000
EN ISO 14160:1998
EN ISO 14937:2000
ISO 14937:2000
90/385/EC
93/42/EC
98/79/EC
 

Document History

  1. BS EN 556-1:2001

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    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE"-Part 1. Requirements for terminally sterilized medical devices

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  2. BS EN 556:1995


    Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'

    • Historical Version