Wednesday, June 28, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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SECTION B: SPECIFIC OCULAR REQUIREMENTS

  • B.1 DONOR SCREENING
    • B.1.1. ACTIVITIES
      • B.1.1.1.Donor detection
      • B.1.1.2.Donor consent
      • B.1.1.3. Donor evaluation
        • B.1.1.3.1.General
        • B.1.1.3.2. Medical evaluation
          • B.1.1.3.2.1.Anamnesis
          • B.1.1.3.2.2.Social evaluation
          • B.1.1.3.2.3. Physical evaluation
          • B.1.1.3.2.4.Exclusion criteria
          • B.1.1.3.2.5. Exclusion criteria for scleral tissue donors
  • B.2. RECOVERY
    • B.2.1. ACTIVITIES
      • B.2.1.1. Access to the operating room or other recovery room
      • B.2.1.2. Recovery
        • B.2.1.2.1. General
        • B.2.1.2.2. Deceased donors
          • B.2.1.2.2.1. Donor identification
          • B.2.1.2.2.2. Gowning
          • B.2.1.2.2.3. Donor preparation
          • B.2.1.2.2.4. Whole eye retrieval by enucleation
          • B.2.1.2.2.5. Corneoscleral disc retrieval by in situ excision
          • B.2.1.2.2.6. Scleral tissue recovery
        • B.2.1.3. Processing during recovery
        • B.2.1.4. Quality control
        • B.2.1.5. Packaging and labelling
          • B.2.1.5.1. Primary packaging and labelling
            • B.2.1.5.1.1. Packaging for organ culture
            • B.2.1.5.1.2. Packaging for hypothermic storage
            • B.2.1.5.1.3. Whole eye packaging / Moist Chamber Storage
            • B.2.1.5.1.4. Scleral tissue packaging
          • B.2.1.5.2. Packaging for cryopreservation
        • B.2.1.6. Storage and transport after recovery
          • B.2.1.6.1. Storage after tissue recovery
            • B.2.1.6.1.1. Storage temperatures
            • B.2.1.6.1.2. Storage time
          • B.2.1.6.2.Transport after tissue recovery
        • B.2.1.7. Documentation and release for processing
  • B.3. PROCESSING
    • B.3.1. ACTIVITIES
      • B.3.1.1. Reception
      • B.3.1.2. Access to the processing facilities
      • B.3.1.3. Processing
        • B.3.1.3.1.General
        • B.3.1.3.2. Processing methods
          • B.3.1.3.2.1. Processing of tissues and cells
          • B.3.1.3.2.2. Decontamination of tissues and cells
      • B.3.1.4. Quality control
        • B.3.1.4.1. Microbiological control
          • B.3.1.4.1.1. General Principle
          • B.3.1.4.1.2. Methods
        • B.3.1.4.2.Other controls
          • B.3.1.4.2.1.Other controls for cornea
          • B.3.1.4.2.2. Evaluation of scleral quality
      • B.3.1.5. Packaging and labelling
      • B.3.1.6. Storage/ preservation
        • B.3.1.6.1. General
        • B.3.1.6.2. Methods of preservation and storage
          • B.3.1.6.2.1. Preservation and storage of corneal tissue
          • B.3.1.6.2.2. Preservation and storage of scleral tissue
        • B.3.1.6.3. Storage area
      • B.3.1.7. Documentation and release
        • B.3.1.7.1. General
        • B.3.1.7.2. Release
          • B.3.1.7.2.1. Release of cornea
          • B.3.1.7.2.2. Release of sclera
        • B.3.1.7.3. Processing file contents
        • B.3.1.7.4. Availability for inspection
        • B.3.1.7.5. Traceability
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