IEC 60601-1:2005 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

IEC 60601-1:2005 is a standard that specifies the general requirements for the basic safety and essential performance of medical electrical equipment. It applies to various types of medical electrical equipment during the design, manufacturing, and use processes. The standard covers multiple aspects such as electrical safety, mechanical protection, electromagnetic compatibility, marking, and usage information, aiming to ensure the safety and reliability of the equipment in clinical applications.

This standard is applicable to all relevant medical equipment manufacturers, medical institutions, and regulatory authorities, providing a basis for product compliance assessment. It includes detailed regulations on the test methods, performance indicators, and risk control measures of the equipment. The implementation of the standard helps improve the overall quality of medical equipment and protect the safety of patients and medical staff.

LISUN supplies the fully test solutions for the following IEC 60601-1:2005, please see the below excel table:

IEC 60601-1:2020 Clause and Subject	LISUN MODEL
5.3 Ambient temperature,humidity,atmospheric pressure	GDJS-015B
5.7 Humidity preconditioning treatment
8.9.3.4 Thermal cycling
11 Protection against excessive temperatures and other HAZARDS
5.9.2.1 30N Test Finger(Figure 6)	SMT-02T30
5.9.2.2 20N Test Hook(Figure 7)	SMT-S15
6.3 Protection against harmful ingress of water or particulate matter	JL-X
7.2.9 IP classification
11.6.5 Ingress of water or particulate matter
15.4.7.3 Entry of liquids
7.1.2 Illuminance meter	LMS-6000
8.4.2 Leakage Current	WB2675A
8.7 Leakage currents and patient auxiliary currents
8.4.2 10N Test Pin	SMT-1213
8.4.2 Oscilloscope	OSP1102
8.6.4 Current source	LSP-500VARC
8.8.3 Dielectric strength	HIPOT10-100KV
8.8.4.1 Ball pressure test(figure 21)	ZBP-T
8.8.4.2 Resistance to environmental stress	HLST-500D
8.9 Creepage distances and air clearances	CK-1
8.11.3.5 Force gauge (at least 100 N)	SMT-368T4
10.7 Ultraviolet radiation	UV-263LS
11.3 FV tests specified in IEC 60695-11-10	HVR-LS

Tags：CK-1 , GDJS-015B , HIPOT10-100KV , HLST-500D , HVR-LS , JL-X , LMS-6000 , LSP-500VARC , OSP1102 , SMT-02T30 , SMT-1213 , SMT-368T4 , SMT-S15 , UV-263LS , WB2675A , ZBP-T