YY/T 0513.2-2009
Allogeneic bone grafts.Part 2:Deep-frozen allogeneic bone grafts and freeze-dried allogeneic bone grafts (English Version)
- Standard No.
- YY/T 0513.2-2009
- Language
- Chinese, Available in English version
- Release Date
- 2009
- Published By
- Professional Standard - Medicine
- Status
- 2021-06
- Replace By
- YY/T 0513.2-2020
- Latest
- YY/T 0513.2-2020
- Scope
- This standard specifies the definitions of cryogenic frozen bones and freeze-dried bones, product classification, models and specifications, requirements, test methods, inspection rules, marking, instructions, packaging, transportation and storage requirements. This standard applies to product requirements for cryogenic frozen bone and freeze-dried bone prepared from human bone tissue. This product is suitable for surgical treatment of human bone repair.
YY/T 0513.2-2009 Referenced Document
- GB 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
- GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
- GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
- GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
- GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation
- YY 0236-1996 Composite Films for Pharmaceutical Packaging (General Rules)
YY/T 0513.2-2009 history
- 2020 YY/T 0513.2-2020 Allograft Restorative Materials Part 2: Cryogenic and Freeze-Dried Bone
- 2009 YY/T 0513.2-2009 Allogeneic bone grafts.Part 2:Deep-frozen allogeneic bone grafts and freeze-dried allogeneic bone grafts
YY/T 0513.2-2009 Allogeneic bone grafts.Part 2:Deep-frozen allogeneic bone grafts and freeze-dried allogeneic bone grafts was changed to ATIS 0300253-2011 Identification of Location Entities for Information Exchange.
