灭菌相关所有标准列表.doc

灭菌相关所有标准列表EN285Sterilization - Steam sterilizers - Large sterilizersEN550Sterilization of medical devices - Validation and routine control of ethylene oxide sterilizationEN552Sterilization of medical devices - Validation and routine control of sterilization by irradiationEN554Sterilization of medical devices - Validation and routine control of sterilization by moist heatEN556Sterilization of medical devices - Requirements for medical devices to be labelled SterileEN866-1Biological systems for testing sterilizers and sterilization pro-cents - Part 1: General requirementsEN866-2Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizersEN866-3Biological systems for testing sterilizers and sterilization processes - Part 3: Particular systems for use in moist heat sterilizersEN866-4Biological systems for testing sterilizers - Part 4: Particular systems for use in irradiation sterilizersEN866-5Biological systems for testing sterilizers - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizersEN866-6Biological systems for testing sterilizers - Part 6: Particular systems for use in dry heat sterilizersEN866-7Biological systems for testing sterilizers - Part 7: Particular requirements for self-contained biological indicator systems for use in moist heat sterilizersEN866-8Biological systems for testing sterilizers - Part 8: Particular requirements for self-contained biological indicator systems tot use in ethylene oxide sterilizersEN867-1Non-biological systems for use in sterilizers - Part 1: General requirementsEN867-2Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)EN867-3Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick testEN867-4 Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetrationEN867-5 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance for small sterilizers Type 3 and Type SEN868-1Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methodsEN868-2Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and Test methodsEN868-3Packaging materials and systems for medical devices which are to be sterilized - Part 3: Paper for use in the manufacture of paper Bags (specified in EN868-4) and in the manufacture of pouches and reels (specified in EN868-5) - Requirements and test methodsEN868-4Packaging materials and systems for medical devices which are to be sterilized - Part 4: Paper bags - Requirements and test methodsEN868-5Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of Paper and plastic film construction - Requirements and test methodsEN868-6Packaging materials and systems for medical devices which are to be sterilized - Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methodsEN868-7Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilisation of ethylene oxide or radiation - Requirements and test methodsEN868-8Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methodsEN868-9Packaging materials and systems for medical devices which are to be sterilized - Part 9: Uncoated nonwoven materials of polyolefines for use in manufacture of beat sealable pouches, reels and lids - Requirements and test methodsEN868-10Packaging materials and systems for medical devices which are to be sterilized - Part 10: Adhesive coated nowoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methodsEN980Graphical symbols for use in the labelling of medical devicesEN/ISO11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO11737-2: 1998)EN1174-1Sterilization of medical devices - Estimation of the population of microorganisms on product - Part 1: RequirementsEN1174-2Sterilization of medical devices - Estimation of the population of microorganisms on product - Part 2: GuidanceEN1174-3Sterilization of medical devices - Estimation of the population of microorganisms on product - Part 3: Guide to the methods for validation of microbiological techniquesEN1422Sterilizers for medical purposes - Ethylene sterilizers - Requirements and test methodsEN13060 Small steam sterilizersEN13795-1 Single-use and reusable surgical coverings, used as medical devices in healthcare facilities, for patients, clinical staff and equipment - Part 1: Information to be supplied, manufacturing and processing requirements and general guidanceprEN13795-2 Single use and reusable surgical coverings, used as medical devices in healthcare facilities, for patients, clinical staff and equipment - Part 2: Test methodsprEN13795-3 Single use and reusable surgical coverings, used as medical devices in healthcare facilities, for patients, clinical staff and equipment - Part 3: Minimal requirementsISO14160Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of Sterilization by liquid sterilantsEN/ISO14161Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of resultsEN14180 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testingISO14937 Sterilization of medical devices - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization processprEN ISO 15883-1 Washer-disinfectors - Part 1: General requirements, definitions and tests (ISO/DIS 15883-1:2003)prEN ISO