T/SAMD 0009-2024 Testing Application Guide for Production Inspection and Testing of Medical Electronic Instruments: Voltage Withstand Test

Scope

Scope: This document specifies the terms and definitions, requirements, test methods, and inspection rules for pressure resistance tests in the inspection and detection process of medical electronic instruments during production. This document defines medical electronic instruments as a general term for a series of medical electrical equipment, applicable to monitors, electrocardiographs, defibrillators, anesthesia machines, ventilators, etc. The pressure resistance tests for other medical electrical equipment can be carried out with reference to this document. This document aims to provide manufacturers with a reference for pressure resistance tests in the inspection and detection process of medical electronic instruments during production. Enterprises should make appropriate adjustments and applications to this document based on specific products and applicable scopes. Main technical content: This document specifies the terms and definitions, requirements, test methods, and inspection rules for pressure resistance tests in the inspection and detection process of medical electronic instruments during production. This document defines medical electronic instruments as a general term for a series of medical electrical equipment, applicable to monitors, electrocardiographs, defibrillators, anesthesia machines, ventilators, etc. The pressure resistance tests for other medical electrical equipment can be carried out with reference to this document. This document aims to provide manufacturers with a reference for pressure resistance tests in the inspection and detection process of medical electronic instruments during production. Enterprises should make appropriate adjustments and applications to this document based on specific products and applicable scopes.

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