Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods

1.1 This European Standard specifies the requirements and test methods for packaging materials and systems: - which are used for packaging of medical devices which are to be terminally sterilized; and - which are intended to maintain sterility of the device. NOTE 1: This standard has been developed as a means to show compliance with relevant European Directives. If health care facilities e. g. hospitals do not place medical devices on the market, they are not covered by these Directives. Nevertheless, such health care facilities can fulfil the same requirements as manufacturers but can use alternative means to demonstrate conformity to this standard. NOTE 2: Compliance with other Parts of prEN 868 series can be used to demonstrate compliance with one or more of the requirements of this standard. 1.2 This standard does not apply to packaging materials and systems used for packaging aseptically manufactured products. 1.3 This European Standard does not describe a quality assurance system for control of all stages of manufacture. NOTE: Attention is drawn to the standards for quality systems (see e. g. EN ISO 9001, EN ISO 9002, EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system can be applied.