Biomaterial regulations for tissue engineering

Desalination

Volumn 199, Issue 1-3, 2006, Pages 265-267

  Grosskinsky, Ulrich ^a  

^a TOTAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL CONTROL;

EID: 33746674345     PISSN: 00119164     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.desal.2006.03.172     Document Type: Article

References (24)

1. EU directive 2003/94/EC on good manufacturing practice, 8 October 2003.
2. US FDA; Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs, 21CFR Part 210.
3. US FDA; cGMP for finished pharmaceuticals, 21 CFR Part 211.
4. US FDA; Regulations for biological products, 21 CFR, Part 600-680.
5. US FDA. 21 CFR Parts 16, 1270 and 1271 Current good tissue practice for manufacturers of human cellular and tissue-based products, 2004.
6. EU Directive 2004/23/EC on quality and safety for the donation, procurement, testing, processing, preservation, storage, distribution of human tissues and cells, 31 March 2004.
7. EU Proposal for a Regulation of the European parliament and of the council on advanced therapy medicinal products, 16.Nov. 2005.
8. EU Directive 93/42/EEC of 14 June 1993 concerning medical devices.
9. ISO EN DIN 9001 Standard, Quality management systems, 2000.
10. ISO EN DIN 13485 Standard, Medical devices quality management systems, 2003.
11. US FDA, Quality system regulation. 21 CFR Part 820.
12. Griffith G.L. Emerging design principles in biomaterials and scaffolds for tissue engineering. Ann. N.Y. Acad. Sci. 961 (2002) 83-95
13. Chapter 1031, The biocompatibility of materials used in drug containers, medical devices and implants, United States Pharmacopoeia, USP 28, 2005.
14. Chapter 87, Biological reactivity tests in vitro; USP 28; 2005.
15. Chapter 88: Biological reactivity tests in vivo; USP 28; 2005.
16. Chapter 3: Materials for Containers, and Containers; E.P., 4th edition, 2002.
17. ISO EN AAMI DIN 10993 Standard: Biological evaluation of medical devices.
18. ASTM D1239-98, Test method for resistance of plastics films to extract by chemicals.
19. ASTM F2150-02e1, Guide for characterization and testing of biomaterial scaffolds used in tissue-engineered medical products.
20. National Institute of Standards and Technology(NIST), Polymers Division; Biomaterials Group; http://polymers.msel.nist.gov/researcharea/biomaterials/index.html
21. US FDA. Indirect food additives: Polymers. 21 CFR, Part 177.
22. Part PM- Polymer based materials, PM-2.6 Materials of construction; Standard ASME BPE-a-2004 Add. to ASME BPE-2002 Bioprocessing Equipment (2005), ASME 84.2
23. Part SD- Design for sterility and cleanability, SD-3.4 Materials of Construction, Standard ASME BPE-2002 Bioprocessing Equipment (2002), ASME 10
24. EN DIN 10088 Standard: Stainless steel, 1995.