Certification and Registration
Testing Standards for Surgical Medical Devices
Category:
Surgical Equipment
GB 9706.202-2021 Medical electrical equipment — Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high-frequency accessories
GB 9706.202 specifies the basic safety and essential performance requirements for high-frequency surgical equipment and high-frequency accessories.
GB 9706.204-2022 Medical electrical equipment — Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
YY 9706.210-2021 Medical electrical equipment—Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
YY 9706.210 specifies safety requirements for nerve and muscle stimulators used in physical medicine, including transcutaneous electrical nerve stimulators and electrical muscle stimulators.
Note: Muscle stimulators may also be considered neuromuscular stimulators.
YY 9706.210 does not apply to the following devices: devices intended for implantation or connection to implanted electrodes; brain stimulation devices (such as electroconvulsive therapy equipment); equipment used for neurological research; external cardiac pacemakers; evoked response diagnostic equipment; electromyography equipment; and cardiac defibrillation devices.
GB 9706.212-2020 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
GB 9706.212 specifies requirements for the design and manufacture of ventilators intended for therapeutic use, including requirements related to structure, operating modes, gas connections, signal waveforms, alarms, accompanying documentation, accessories, labeling, and packaging.
The fundamental requirement is that, when used correctly according to the manufacturer’s intended purpose and under specified environmental conditions, the ventilator shall not cause unacceptable risks or harm to the user, patient, or surrounding environment.
GB 9706.212 does not apply to other specialized ventilators, such as sleep apnea devices or emergency transport ventilators.
GB 9706.213-2021 Medical electrical equipment — Part 2-13: Particular requirements for the basics safety and essential performance of an anesthetic workstation
GB 9706.213 specifies particular requirements for complete anesthesia workstations and their components.
GB 9706.213 specifies the basic safety and essential performance requirements for anesthesia workstations used to administer inhaled anesthetics, which require continuous supervision by qualified operators.
GB 9706.218-2021 Medical electrical equipment — Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
SATISFY provides one-stop surgical medical device testing services, including preliminary assessment, preparation and submission of technical documentation, complete test monitoring, report interpretation, data analysis, and corrective action recommendations.
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