Electrical safety inspection includes checking the insulation of electrical equipment with or without breakage, whether the insulation resistance is qualified, whether the exposed charged part of the equipment is protected, whether the screen protection device meets the safety requirements, and whether the safety spacing is sufficient.
Testing equipment testing equipment is a lot of different kinds of equipment, basically involves a variety of disciplines. Our country is accustomed to the measurement is divided into ten categories, in the major categories of measurement, but also includes several or even a dozen specific measurement projects.
Testing personnel medical equipment testing personnel should have received relevant training to understand the test equipment testing indicators and national laws and regulations on medical equipment testing. Such as 〈Medical Equipment Supervision and Administration Regulations〉〉, 〈Medical Equipment Manufacturer License Management Measures〉〉, 〈National Measurement Law〉, etc..
Testing standards:
Medical equipment testing standards are divided into national standards, industry standards and registered product standards.
(1) national standards or industry standards are standards that need to be standardized across the country in terms of technical requirements.
(2) registered product standards are developed by the manufacturer, should be able to ensure that the product is safe and effective, and in the product application for registration, by the municipal-level drug supervision and management department above the district based on the national standards and industry standards for the relevant requirements of the product standard review.
China has 167 national standards for medical devices and 585 industry standards. For example: YY 0068-1992 "General Technical Conditions for Medical Rigid Tube Endoscopes", GB 19517-2009 "National Safety Technical Code for Electrical Equipment", JJF1234-2010 "Ventilator Calibration Specification" and so on.