This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i. e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e. g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for large steam sterilizers intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e. g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.
EN 285:2015 Referenced Document
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-20 Update
EN 764-1:2004 Pressure equipment - Part 1: Terminology - Pressure, temperature, volume, nominal size Supersedes EN 764:1994
EN 764-7:2002 Pressure equipment - Part 7: Safety systems for unfired pressure equipment
EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers type B and type S
EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2009 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN 868-7:2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 285:2015 history
2021EN 285:2015+A1:2021 Sterilization - Steam sterilizers - Large sterilizers