ANSIAAMIISO 11737-1 | 合法醫療器材資訊網

2018年4月30日—TheANSI/AAMI/ISO11737-1Standard...ANSI/AAMI/ISO11737-1:2018providesguidanceontheenumerationandmicrobialcharacterizationof ...

ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microrganisms on products[1] has been released.

Bacteria and other microorganisms are plentiful, more so than many of us like to think. While estimates have varied, there are at least several tens of thousands of species of bacteria[2] living on Earth, and there could potentially be hundreds of thousands or even millions. The natural ubiquity of these microbes means that microorganisms form colonies all over an animal’s surface tissues, such as its skin and mucous membranes. The normal flora of humans[3] consists of mostly bacteria, with some eukaryotic fungi and protists.

However, the internal tissues of a healthy animal are normally free of microorganisms. In the ...