Topic

functional-testing

Post-service functional and performance verification.

Diagnostic TestingAug 27, 20268 min read

Electrical Safety Testing After Repair: IEC 62353, NFPA 99, and What to Document

A technical guide for biomedical engineers on selecting in-service electrical safety testing standards after medical device repairs, navigating IEC 62353 vs IEC 60601-1 type tests, NFPA 99 (2012 edition) CoP requirements, and audit-ready test documentation.

By Ran Chen

A medical electrical device on a service bench beside an unenergized electrical-safety analyzer with coiled test leads.

Diagnostic TestingAug 27, 20268 min read

Infusion Pump Return-to-Service Verification: Performance, Alarms, and Evidence

A comprehensive return-to-service testing and verification framework for repaired infusion pumps, incorporating FDA Total Product Life Cycle safety principles, IEC 60601-2-24 essential performance, and CMS post-repair compliance.

By Ran Chen

A volumetric infusion pump on a clinical engineering workbench beside a flow analyzer and clamped administration tubing.