Standards
Current Category: CN-YY - Medicine
YY/T 0684-2008 Neurosurgical implants—Marking and packaging of implantable neural stimulators
This standard specifies the requirements for the marking, labeling, packaging, and accompanying documents of implantable neurostimulators used to stimulate the nervous system (brain, spinal cord, peripheral nerves, and adjacent tissues).
This standard also covers implantable or externally accessible auxiliary components, including external controllers and programmers used to start or adjust neurostimulators.
This standard does not specify the indications or contraindications for the application of implantable neurostimulators; nor does it specify the range of test or routine operation variable parameters. However, this standard requires that such relevant information be included in the accompanying documents of each implantable pulse generator, implantable RF receiver, or RF transmitter used by clinicians in treating patients.
YY 0633-2008 Ophthalmic instrument, indirect ophthalmoscope
YY 1079-2008 Electrocardiographic monitors
This standard establishes the minimum performance requirements for monitors that use the electrocardiogram method to obtain heart rate and waveforms, intended for use under the working conditions specified in this standard.