60601-1 125s

60601-1, Electrical Equipment


ANSI/AAMI ES60601-1:2005, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance is the third edition of the standard that covers any medical device that requires an electrical outlet or a battery. It has come to be known throughout the industry as the “bible” of medical electrical equipment standards. The standard covers many safety and fundamental application topics such as signage, leakage current, creepage, alarms, risk management plans, methods of sterilization as described below and more.

Methods of sterilization[]

Sterilization is necessary for the complete destruction or removal of all microorganisms (including spore-forming and non-spore-forming bacteria, viruses, fungi, and protozoa) that could contaminate pharmaceuticals or other materials and thereby constitute a health hazard. Since the achievement of the absolute state of sterility cannot be demonstrated, the sterility of a pharmaceutical preparation can be defined only in terms of probability. The efficacy of any sterilization process will depend on the nature of the product, the extent and type of any contamination, and the conditions under which the final product has been prepared. The requirements for Good Manufacturing Practice should be observed throughout all stages of manufacture and sterilization.

Classical sterilization techniques using saturated steam under pressure or hot air are the most reliable and should be used whenever possible. Other sterilization methods include filtration, ionizing radiation (gamma and electron-beam radiation), and gas (ethylene oxide, formaldehyde).[1]


  1. WHO. "Methods of Analysis: 5. Pharmaceutical technical procedures: 5.8 Methods of sterilization." accessdate 1/16/2015.