AAMI ISO 11737-1 : 2006 : R2011

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 11737-1:2006
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality management system elements
  4.1 Documentation
  4.2 Management responsibility
  4.3 Product realization
  4.4 Measurement, analysis, and improvement - Control of
      nonconforming product
5 Selection of product
  5.1 General
  5.2 Sample item portion (SIP)
6 Methods of determination and microbial characterization
  of bioburden
  6.1 Determination of bioburden
      6.1.1 Selection of an appropriate method
      6.1.2 Removal of microorganisms
      6.1.3 Culturing of microorganisms
      6.1.4 Enumeration of microorganisms
  6.2 Microbial characterization of bioburden
7 Validation of method of determination of bioburden
8 Routine determination of bioburden and interpretation of
  data
9 Maintenance of the method of determination of bioburden
  9.1 Changes to the product and/or manufacturing process
  9.2 Changes to the method of determination of bioburden
  9.3 Revalidation of the method of determination of
      bioburden
Annexes
A - Guidance on determination of a population of
    microorganisms on product
B - Guidance on methods of determination of bioburden
C - Validation of bioburden methods
Bibliography

Describes requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material, or package.