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Aseptic processing of health care products — Part 5: Sterilization in place
90.93 Standard confirmed
Aseptic processing of health care products — Part 6: Isolator systems
60.60 Standard published
Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
90.93 Standard confirmed
Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
60.60 Standard published
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
90.93 Standard confirmed
Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
90.93 Standard confirmed
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
90.92 Standard to be revised
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests — Amendment 1
60.60 Standard published
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
90.92 Standard to be revised
Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
90.92 Standard to be revised
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
90.60 Close of review
Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
60.60 Standard published
Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
90.92 Standard to be revised
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
90.92 Standard to be revised
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
60.60 Standard published
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
60.60 Standard published
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
60.60 Standard published
Manufacture of cell-based health care products — Control of microbial risks during processing
90.93 Standard confirmed