Musculoskeletal tissue banking in Europe--regulations and quality assurance.
This paper is confined to the use of human musculoskeletal tissue in the treatment of patients. Its focus is on the safety and quality dimension of human tissue transplantation, including the ethical and legal aspects, the regulations and standards from the European perspective, quality assurance and quality management in tissue banking and as a special subject, tissue sterilisation and the validation of sterilisation methods.
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DIZG German Institute for Cell and Tissue Replacement, Berlin. dizg@mdc-berlin.de
D016025:Bone Transplantation / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D004992:Ethics, Medical; D005060:Europe; D006801:Humans; D009132:Muscles / Q000637:transplantation*; D016133:Polymerase Chain Reaction; D011785:Quality Assurance, Health Care; D013242:Sterilization / Q000379:methods; D014015:Tissue Banks / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards*; D016378:Tissue Transplantation / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards