BS EN 550:1994,Sterilization of medical devices – Validation and routine control of ethylene oxide sterilization.BS EN 550:1994 pdf free download.
A sterile product item is one which is free of viable micro-organisms. The 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 the requirements for quality systems for medical devices (see EN 46001 or EN 46002) 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.
This standard contains requirements for the
validation and routine monitoring of sterilization by gaseous ethylene oxide; guidance on the application of this standard is offered in informative annex B.
NOTE: The requirements are the obligatory parts of this standard in that these are to be observed if compliance is to be achieved. The guidance given in annex B is not obligatory and it is not provided as a check list for auditors.
1 Scope
1. This European Standard specifies requirements for the development, validation, process control and monitoring of the sterilization of medical devices using ethylene oxide.
2. This European Standard does not describe a quality assurance system for the control of all stages of manufacture.