ONORM EN ISO 11737-1 : 2011

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and 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
  6.2 Microbial characterization of bioburden
7 Validation of method for determining 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
Annex A (informative) Guidance on determination of a population
                       of microorganisms on product
Annex B (informative) Guidance on methods of determination of
                       bioburden
Annex C (informative) Validation of bioburden methods
Annex ZA (informative) Relationship between this European
                       Standard and the Essential Requirements
                       of EU Directives 90/385/EEC concerning
                       active implantable medical devices,
                       93/42/EEC concerning medical devices and
                       98/79/EC concerning in vitro diagnostic
                       medical devices
Bibliography

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