Friday, May 26, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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SECTION C: SPECIFIC AMNIOTIC MEMBRANE REQUIREMENTS

 

  • C.1.DONOR SCREENING
    • C.1.1. ACTIVITIES
      • C.1.1.1.Donor detection
      • C.1.1.2.Donor consent
      • C.1.1.3. Donor evaluation
        • C.1.1.3.1. General
        • C.1.1.3.2. Medical evaluation
          • C.1.1.3.2.1. Exclusion criteria
  • C.2.RECOVERY
    • C.2.1. ACTIVITIES
      • C.2.1.1.Access to the operating room
      • C.2.1.2. Recovery
        • C.2.1.2.1. General
        • C.2.1.2.2. Deceased donors
        • C.2.1.2.3. Living donors
      • C.2.1.3. Processing during recovery
      • C.2.1.4. Quality control
      • C.2.1.5. Packaging and labelling
        • C.2.1.5.1. Primary packaging and labelling operations
        • C.2.1.5.2. Secondary packaging and labelling operations
      • C.2.1.6. Storage and transport after recovery
        • C.2.1.6.1. Storage
        • C.2.1.6.2. Transport
      • C.2.1.7. Documentation and release for processing
  • C.3.PROCESSING
    • C.3.1. ACTIVITIES
      • C.3.1.1. Reception
      • C.3.1.2. Access to the processing facilities
      • C.3.1.3. Processing
        • C.3.1.3.1. General
        • C.3.1.3.2. Processing methods
          • C.3.1.3.2.1. Organ culture and cell culture
          • C.3.1.3.2.2. Decontamination of tissues and cells
          • C.3.1.3.2.3. Sterilization/disinfection of tissue
          • C.3.1.3.2.4. Viral inactivation
          • C.3.1.3.2.5. Prion inactivation
          • C.3.1.3.2.6. Other processes
        • C.3.1.3.3. Cross contamination
        • C.3.1.4. Quality control
          • C.3.1.4.1. Microbiological control
          • C.3.1.4.2. Other controls
        • C.3.1.5. Packaging and labelling
        • C.3.1.6. Storage / preservation
          • C.3.1.6.1. General
          • C.3.1.6.2. Methods of preservation and storage
            • C.3.1.6.2.1. Preservation and storage at +37C.
            • C.3.1.6.2.2. Preservation and storage at +4C.
            • C.3.1.6.2.3. Cryopreservation
            • C.3.1.6.2.4. Glycerolization
            • C.3.1.6.2.5. Freeze drying and dehydration
            • C.3.1.6.2.6. Other methods of preservation and storage
          • C.3.1.6.3. Storage area
        • C.3.1.7. Documentation and release
          • C.3.1.7.1. General
          • C.3.1.7.2. Release
          • C.3.1.7.3. Processing file contents
          • C.3.1.7.4. Availability for inspection
          • C.3.1.7.5. Traceability
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