GB/T 16846-2008

Active

Requirement for the declaration of the acoustic output of medical diagnostic ultrasonic equipment

医用超声诊断设备声输出公布要求

Standard Type
GBT
ICS
11.040.50
CCS
C41
Status
Active
Issue Date
2008-03-24
Implementation
2009-01-01
Centralized Committee
国家药监局
Issuing Authority
国家药监局

Application Summary AI generated

This standard specifies the requirements for manufacturers to declare the acoustic output parameters of medical diagnostic ultrasonic equipment, including measurement methods and reporting formats. It is applied in the healthcare industry for the production, quality control, and regulatory approval of ultrasound imaging devices used in clinical diagnostics. The standard ensures that acoustic output data is consistently and accurately communicated to users and regulators, facilitating safe operation and risk assessment.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.