YY/T 0644-2008 Active Industry standards-Medicine

YY/T 0644-2008 Ultrasonics-surgical systems—Measurement and declaration of the basic output characteristics

Publish Date: 2008-04-25 Implement Date: 2009-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0644-2008

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical ultrasound, laser, and high-frequency instruments and equipment

ICS Name: Integrated medical equipment

Publish Date: 2008-04-25

Implement Date: 2009-06-01

Pages: 23 pages

Scope

This standard specifies: — The main non-thermal output characteristics of ultrasonic surgical systems; Note 1: One specific parameter involved is output acoustic power. This standard only considers the low-frequency component (below 100 kHz) of the total released energy, and does not take into account the high-frequency component possibly related to cavitation generated by the tip. — The measurement methods for output characteristics; — The characteristic parameters that equipment manufacturers should disclose. Note 2: For simplicity, this standard does not consider all possible complex appearances and shapes of the treatment head tip. The interpretation of parameters and measurements is illustrated using a straight-tube-shaped tip as an example. If necessary, users of this standard can apply the basic methods described in the standard to more complex designs.

Development Information

Word Count: 40 Thousand words Pages: 23 pages

Referenced Standards

IEC 60500:1974 IEC 61205:1993

Adopt standards

IEC 61847:1998

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24