The Principles of Medical Device Decontamination

Terminology and Definitions

Label, instructions for use and any other information related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents.

Labelling

Lumen device

Item that consists of tube(s) or pipe(s).

Removal of contaminants from an item to the extent necessary for further processing or for the intended use without the use of an automated process. A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose. Natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his/her name; whether or not such a medical device is designed and/or manufactured by that person themselves or on their behalf by another person(s).

Manual cleaning

Medical Device

Medical Device manufacturer

Presence of unintended bacteria, fungi, protozoa, or viruses.

Microbial contamination

Loss of ability of microorganisms to grow and/or multiply.

Microbial inactivation

174

@ 2025 Central Sterilising Club. All rights reserved. Do Not duplicate