Musculoskeletal tissue banking in Europe regulations and quality assurance

Annales Chirurgiae et Gynaecologiae

Volumn 88, Issue 3, 1999, Pages 215-220

  Von Versen, R ^a  

^a Haus 42   (Germany)

Author keywords

Bone banking; Ethics; Quality assurance; Regulations; Sterilization; Tissue banking; Validation

Indexed keywords

EUROPE; HEALTH CARE FACILITY; MEDICAL ETHICS; QUALITY CONTROL; REVIEW; TISSUE TRANSPLANTATION; VALIDATION PROCESS;

EID: 0032845071     PISSN: 03559521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (16)

1. Jerosch J, Castro WHM, Granrath M, Rosin H: Knochenbanken in der BRD - Ergebnisse einer Befragung- Unfallchirurg 61: 334-338, 1990
2. Wissenschaftlicher Beirat der Bundesärztekammer: Guidlines for Bone Banking. Dt. Ärzteblatt 87: 41, 1990
3. von Versen R, Starke R: The peracetic acid/low pressure cold sterilization - A new method to sterilize corticocancellous bone and soft tissue. Z. exp. Chir, Transplant. Künstl. Organe 22: 18-21, 1989
4. von Versen R, Haider H, Kleemann I, Starke R: Chemische Sterilisation biologischer Implantate mit einer Kombinationsmethode. In: Osteologie aktuell VII. Eds H.-J. Pesch, H. Stöss and B. Kummer. Springer Verlag Berlin, Heidelberg, New York, 1993, pp 380-386
5. Pruss A, Kao M, Kiesewetter H, von Versen R, Pauli G: Virus safety of avital bone tissue transplants: Evaluation of sterilisation steps of spongiosa cuboids using peracetic acid - methanol mixture. Biologicals 27 (2) 7-14, 1999
6. Congress of the Society of Organ Sharing, Rome, Italy, June 20, 1991
7. European Association of Tissue Banks (EATB), Ethical Code, 1994
8. Council of Transplantation Society, 1985
9. Human Organ Transplant Act, §7, Great Britain, 1989.
10. Recommendation No. R (94) 1 of the Committee of Ministers of the Council of Europe to Member States on Human Tissue Banks (adopted by the Committee of Ministers on 14 March 1994 at the 509th meeting of the Ministers' Deputies)
11. Recommendation No. R (79) 5 of the Committee of Ministers to Member States concerning "International Exchange and Transportation of Human Substances" (Adopted by the Committee of Ministers on 14 March 1979 at the 301st meeting of the Ministers' Deputies)
12. European Association of Tissue Banks (EATB) and European Association of Musculoskeletal Transplantation (EAMST) Common Standards for Musculoskeletal Tissue Banking, 1997
13. Quality systems - Model for quality assurance in design/development, production, installation and servicing (ISO 9001: 1994), issued by CEN European Committee for Standardisation, Brussels 1994
14. CEN (European Committee for Standardization) TC:316 WG3 Part 3: Validation of the elimination and/or inactivation of viruses and other transmissible agents. 1997
15. Anforderungen an Validierungsstudien zum Nachweis der Virussicherheit von Arzneimitteln aus menschlichem Blut oder Plasma, Paul-Ehrlich-Institut - Bundesamt für Sera und Impfstoffe, 21 January 1994
16. The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses, Committee for Proprietary Medicinal Products, London, 29 February 1996