Certification and Registration
Category:
Electrical Safety Of Medical Devices
GB 4793.1-2007 Safety requirements for electrical equipment for measurement ， control ， and laboratory use - Part 1: General requirements
GB 4793.1 specifies the general safety requirements for electrical equipment intended for professional, industrial process, and educational applications.This part applies only to components that are part of equipment within the scope of this standard, or to computers, processors, and similar devices specifically designed for use with such equipment.This standard also specifies methods for verifying compliance with the requirements through inspection and type testing.
GB 4793.4-2019 Safety requirements for electrical equipment for measurement, control and laboratory use — Part 4: Particular requirements for sterilizers and cleaning disinfectors for handling medical materials
GB 4793.4 applies to electrical equipment used for sterilizing, cleaning, and disinfecting medical materials in healthcare facilities, veterinary facilities, pharmaceutical industries, and laboratories under specified environmental conditions.Applicable equipment includes steam sterilizers and disinfectors, chemical sterilizers and disinfectors using toxic gases, toxic aerosols, or toxic vapors, sterilizers and disinfectors using hot air or hot inert gases, and washer-disinfectors.
GB 4793.6-2008 Safety requirements for electrical for measurement, control, and laboratory use - Part 6: Particular requirements for laboratory equipment
GB 4793.9-2013 Safety requirements for electrical equipment for measurement, control and laboratory use ― Part 9: Particular requirements for automatic and semi-automatic equipment for laboratory use for analysis and other purposes
GB 4793.9 applies only to laboratory electrical equipment used for heating materials, where material heating is the sole function or one of several functions of the equipment.
YY 0648-2008 Safety requirements for electrical equipment for measurement, control and laboratory use -Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
GB/T 18268.1-2070 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
GB/T 18268.1 specifies electromagnetic compatibility (EMC) immunity and emission requirements for electrical equipment used in professional applications, industrial processes, industrial manufacturing, and educational environments.These requirements apply to electrical equipment powered by AC supplies below 1000 V, DC supplies below 1500 V, batteries, or equipment powered by the circuit under test, including equipment and computing devices used in both industrial and non-industrial environments.
SATISFY provides one-stop testing services for electrical equipment used in measurement, control, and laboratory applications, as well as medical device testing services. Our services include preliminary assessment, preparation and submission of technical documentation, complete test monitoring, report interpretation, data analysis, and corrective action recommendations.
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SATISFY TECH AND SERVICE LLC
SATISFY TECH AND SERVICE LLC delivers full-lifecycle technical solutions for children’s products, hygiene care, protective equipment, furniture, and building materials. Our framework spans compliance pre-assessment, standard upgrading, and risk control. We empower manufacturers and exporters through expert testing, certification, consulting, and standards interpretation.
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