This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e. g. EN ISO 13485, EN ISO 14971). This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e. g. flammable gases). This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1. This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
EN 13060:2014 Referenced Document
EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
EN 13445 Unfired pressure vessels - Part 8: Additional requirements for pressure vessels of aluminium and aluminium alloys*， 2021-05-12 Update
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 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 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
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 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods