GB 10035-2006
AbolishedThe air-bag type sequential external counter-pulsation device
气囊式体外反搏装置
Application Summary AI generated
GB 10035-2006 specifies safety, performance, and testing requirements for air-bag type sequential external counter-pulsation devices used in non-invasive cardiac assist therapy. It applies to medical devices that inflate and deflate cuffs around the lower limbs in sequence with the patient's cardiac cycle to improve coronary perfusion and reduce cardiac workload. This standard is used by manufacturers, healthcare facilities, and regulatory bodies in China to ensure device reliability and patient safety during treatment for ischemic heart disease and related circulatory conditions.
Related Standards
GB/T 19381-2003
General methods of test for medical closures of butyl rubber
GB/T 14214-2003
Spectacle frames--General requirements and test methods
GB/T 18375.6-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 6:Loading parameters of supplementary structural tests
GB/T 18375.5-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 5:Supplementary structural tests
GB/T 18375.7-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 7:Test submission document
GB/T 19543-2004
Prostheses--Structural testing of hip units
GB/T 18375.8-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 8:Test report
GB/T 19629-2005
Medical Electrical Equipment-Dosimeters with ionization chambers and/or semi-conductors as used in X-ray diagnostic imaging
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.