YY/T 0678-2008 Active Industry standards-Medicine

YY/T 0678-2008 Standard performance and safety specification for cryosurgical medical instruments

Publish Date: 2008-10-17 Implement Date: 2010-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0678-2008

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: General requirements for medical equipment

ICS Name: Treatment equipment

Publish Date: 2008-10-17

Implement Date: 2010-06-01

Pages: 16 pages

Scope

This standard specifies the basic requirements for medical cryosurgical treatment equipment in terms of the performance and reproducibility of the cryogenic system, disclosure, marking, documentation, and safety.
The medical cryosurgical treatment equipment referred to in this standard uses the principle of phase-change vaporization latent heat or the Joule–Thomson effect to generate low temperatures within the cryogenic probe or directly in the target tissue, which is used to induce cryogenic necrosis, inflammatory reactions, or cryogenic adhesions.
When using medical cryosurgical equipment, the treatment process is monitored by accessories that can display the temperature of the cryogenic probe or the cryogenic area. The requirements of this standard apply to these accessories.