IEC 60601-1-2, IEC 60035 & IEC 61010-1

IEC 60601-1-2:

FOURTH EDITION EMC STANDARDS

Introduced on December 31^st 2018, the latest edition (IEC 60601-1-2: 4^{th Edition)}  was established to address the reciprocal concern regarding electromagnetic compatibility (EMC) affecting both the medical device in question and other devices within the area.  Equipment must now be immune to HF fields up to 2.7GHz, an increase by 0.2GHz. In addition, the standard wants to prevent damage caused by electrostatic discharge, and the relevant limits have been increased accordingly. For contact discharge, the threshold went up from 6 to 8kV. For air discharge, it has been increased from 8 to 15kV.

IEC 60035

SAFETY OF ELECTRICAL/ELECTRONIC HOUSEHOLD APPLIANCES AND SIMILAR APPLICATIONS

IEC 60335-1:2020 deals with the safety of electrical appliances for household and similar purposes, with rated voltage being no more than 250 V for single-phase appliances and 480 V for other appliances including electrical, mechanical, and thermal hazards and fire and radiation hazards.

The standard applies to battery-operated and direct current (DC) supplied appliances as well as appliances not intended for common household use, but could potentially be a source of danger to the public, such as appliances used by workers in the light industry and on farms. Examples include appliances for cleaning, hairdressing, and catering equipment for commercial use.

IEC 61010-1

SAFETY OF MEASUREMENT, CONTROL AND LABORATORY EQUIPMENT

IEC 61010-1 is a safety standard for laboratory, process control and test measurement equipment. The standard was first established in 1990 and has had a number of revisions and changes since then. The standard looks at power supply applications for meters and oscilloscopes and even dips into the medical industry by looking at X-ray equipment.

The purpose of IEC 61010-1:2010 Edition 3 is to ensure that hazards to the operator and surrounding area are reduced to a tolerable level.  The standard looks to protect against electric shock, fire (mechanical & burn injuries), fluid pressure and radiation; spread of fire from the equipment; excessive temperatures; and liberated gases, explosion, and implosion. Compliance is verified by inspection, type tests, routine tests and risk assessment.

The third edition also defines more stringent requirements in respect to shock and fire hazards: