YY/T 0606.5-2007Tissue Engineered Medical Products - Part 5: Characterization and Testing of Substrates and Scaffolds (English PDF)
组织工程医疗产品 第5部分：基质及支架的性能和测试
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 31, 2007
Implementation date
January 1, 2008
Scope
YY/T 0606.5-2007 is the English-translated version of 组织工程医疗产品 第5部分：基质及支架的性能和测试.
Part 5 of the YY/T 0606 series, YY/T 0606.5-2007 is a recommended standard of the Chinese medical device and pharmaceutical industry given over to tissue engineered medical products.
It covers the performance of the substrates and scaffolds used in those products and the guidelines for characterizing and testing them. The guidance is meant to be followed when the raw materials are produced, when suitable test methods are chosen and when the finished scaffold is characterized.
Its list of cited documents is unusually long and takes in the GB/T 16886 parts on biological evaluation of medical devices, the GB/T 1040 parts, GB/T 19466 and GB/T 19633, among many others. Issued on 31 January 2007, it has applied since 1 January 2008.
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Document preview — YY/T 0606.5-2007
National Standard of the People's Republic of China
- ICS
- 11.040.10
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY/T 0606.5-2007 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 528-1998
GB/T 1034-1998
GB/T 1040.1-2006
GB/T 1040.2-2006
GB/T 1040.3-2006
GB/T 1040.4-2006
GB/T 1041-1992
GB/T 1630-1989
GB/T 1632-1993
GB/T 1634.1-2004
GB/T 1634.2-2004
GB/T 2547-1981
GB/T 3358.1-1993
GB/T 3358.2-1993
GB/T 3358.3-1993
GB/T 3682-2000
GB 4234-2003
GB/T 6379.1-2004
GB/T 6379.2-2004
GB/T 6425-1986
GB/T 9341-2000
GB 11415-1989
GB/T 12909-1991
GB/T 13022-1991
GB/T 13810-1997
GB 15593-1995
GB 16352-1996
GB/T 16421-1996
GB/T 16886.1-2001
GB/T 16886.3-1997
GB/T 16886.4-2003
GB/T 16886.5-2003
GB/T 16886.6-1997
GB/T 16886.9-2001
GB/T 16886.10-2005
GB/T 16886.11-1997
GB/T 16886.12-2005
GB/T 16886.13-2001
GB/T 16886.14-2003
GB/T 16886.15-2003
GB/T 16886.16-2003
GB/T 16886.17-2005
GB 17100-1997
GB 18278-2000
GB 18279-2000
GB 18280-2000
GB 18281.1-2000
GB 18281.2-2000
GB 18281.3-2000
GB/T 19000-2000
GB/T 19001-2000
GB/T 19466.1-2004
GB/T 19466.2-2004
GB/T 19466.3-2004
GB/T 19500-2004
GB/T 19633-2005
YY 0117.2-2005
YY/T 0287-2003
YY 0303-1998
YY 0305-1998
YY 0334-2002
YY 0459-2003
YY/T 0473-2004
YY/T 0474-2004
ISO 844-2004
ISO 6474-1994
ISO 10993.18-2005
EN 12442.1-2000
EN 12442.2-2000
EN 12442.3-2000
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 528-1998Rubber, vulcanized or thermoplastic -- Determination of tensile stress-strain properties
- GB/T 1034-1998Plastics -- Determination of water absorption
- GB/T 1040.1-2006Plastics - Determination of tensile properties - Part 1: General principles
- GB/T 1040.2-2006Plastics – Determination of Tensile Properties – Part 2: Test Conditions for Moulding and Extrusion Plastics
- GB/T 1040.3-2006Plastics—Determination of tensile properties—Part 3:Test conditions for films and sheets
- GB/T 1040.4-2006Plastics - Determination of tensile properties - Part 4: Test conditions for isotropic and orthotropic fibre-reinforced plastic composites
GB 4234-2003 · GB 11415-1989 · GB/T 12909-1991 · GB/T 13022-1991 · GB 15593-1995 · GB 16352-1996 · GB/T 16421-1996 · GB 17100-1997 · GB 18278-2000 · GB 18280-2000 · GB 18281.1-2000 · GB 18281.2-2000 · GB 18281.3-2000 · GB/T 19633-2005 · ISO 844-2004 · ISO 6474-1994 · ISO 10993.18-2005 · EN 12442.1-2000 · EN 12442.2-2000 · EN 12442.3-2000
Cited by
- YY/T 1577-2017Tissue engineering medical device products - Standard guide for microstructure of polymeric scaffolds
- YY/T 0606.14-2014Tissue engineered medical products - Part 14: Standard practice for evaluating the immune response of matrices and scaffolds - ELISA method
- YY/T 0606.20-2014Tissue engineered medical products - Part 20: Standard practice for evaluation of immune responses of substrate and scaffold products:Cell migration tests
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Related Standards
GB/T 1040.3-2006 — Plastics -- Determination of tensile properties -- Part 3: Test conditions for films and sheets
GB/T 1040.4-2006 — Plastics - Determination of tensile properties - Part 4: Test conditions for isotropic and orthotropic fibre-reinforced plastic composites
GB/T 1630-1989 — Plastics -- Epoxy resins -- Part 1: Designation
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