This Standard specifies the basic requirements that cryosurgical medical instrument in refrigeration system shall meet in the performance, reproducibility, publication, labelling, documentation, and safety aspects. The cryosurgical medical instrument referred in this Standard adopts the principle of Latent Heat of Vaporization or the Joule-Thompson Effect, produces low temperature in cryotip rod or directly to the target tissue, so as to produce cryonecrosis, inflammatory response or cryoadhesion. If, during the application, cryosurgical medical instrument utilizes displayable cryotip or accessories at cryogen area temperature to monitor the treatment process, the requirements of this Standard are applicable to these accessories.
Basic Data
Standard ID
YY 0678-2008 (YY0678-2008)
Description (Translated English)
Standard performance and safety specification for cryosurgical medical instruments
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C37
Classification of International Standard
11.040.60
Word Count Estimation
8,862
Date of Issue
2008-10-17
Date of Implementation
2010-06-01
Quoted Standard
GB/T 1226-2001; GB 9706.1; GB 15382-1994
Adopted Standard
ASTM F882-1984 (2002), MOD
Regulation (derived from)
SFDA [2008] No. 605
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the surgical treatment of medical refrigeration equipment refrigeration system performance and reproducibility, publish, marking, documentation and safety should follow the basic requirements. This standard requires surgical treatment for medical refrigeration equipment using phase change latent heat of vaporization or Joule Thomson effect principle, in the freezing probe or directly in the target tissue temperature, is used to produce frozen necrosis, inflammatory reaction or frozen adhesions. Cryosurgery is used medical equipment can be displayed by freezing or frozen zone temperature probe attachment to monitor the treatment process, the requirements of this standard apply to these attachments.
