I.S. EN ISO 11737-1:2018&LC:2018

National Foreword
European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Selection of products
6 Methods of determination and microbial characterization of
  bioburden
7 Validation of the method for determining bioburden
8 Routine determination of bioburden and interpretation of
  data
9 Maintenance of the method for determining bioburden
Annex A (informative) - Guidance on the determination of
        a population of microorganisms on products
Annex B (informative) - Guidance on methods to determine
        bioburden
Annex C (informative) - Validation of bioburden recovery efficiency
Annex D (informative) - Typical assignment of responsibilities
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 90/385/EEC on active implantable
         medical devices
Annex ZB (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 98/79/EC on in vitro
         diagnostic medical devices

Gives 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.