1 Scope
This Standard specifies the basic requirements for medical cryosurgery treatment equipment in refrigeration system performance and reproducibility, publication, mark, document and safety aspects.
The medical cryosurgery treatment equipment referred in this Standard adopts phase change vaporization latent heat or joule Thomson effect principle, generates low temperature in cryotip rod or directly at target tissue so as to generate cryonecroses, inflammatory response or cryoadhesion.
If during the application, medical cryosurgery equipment utilizes displayable cryotip or accessories at cryogen area temperature to monitor the treatment process, the requirements of this Standard are applicable to these accessories.
Foreword
1 Scope
2 Normative References
3 Terms and Definitions
4 Cryosystem Performance and Reproducility Requirements
5 Disclosure, Labeling, and Documentation Requirements
6 Cryosystem Safety Requirements
