04/30048118 DC : DRAFT MAY 2004

Foreword
Introduction
1 Scope
   1.1 Inclusions
   1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality management systems
   4.1 Documentation
   4.2 Management responsibility
   4.3 Product realization
   4.4 Measurement, analysis and improvement - Control of
       non-conforming product
5 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Material effects
   5.4 Environmental considerations
6 Process and equipment characterization
   6.1 Process
   6.2 Equipment
7 Product definition
   7.1 General
   7.2 Product safety and performance
   7.3 Microbiological quality
8 Process definition
9 Validation
   9.1 Installation qualification
   9.2 Operational qualification
   9.3 Performance qualification
   9.4 Varying load configurations
   9.5 Review and approval of validation
10 Routine monitoring and control
   10.1 General
   10.2 Data to be monitored
11 Product release from sterilization
   11.1 General
   11.2 Product release using biological indicators
   11.3 Parametric release
12 Maintaining process effectiveness
   12.1 General
   12.2 Maintenance of equipment
   12.3 Requalification
   12.4 Assessment of change
Annex A (normative) Bioburden Method
      A.1 General- Bioburden-Approach Method
      A.2 Bioburden evaluations
      A.3 Sampling
      A.4 Procedure
Annex B (normative) Biological Indicator/Bioburden Method
      B.1 General
      B.2 Procedure
      B.3 Enumeration
Annex C (normative) Overkill
      C.1 Conservative process definitions based on the
           inactivation of reference microorganisms
      C.2 Procedure
Annex D (informative) - General guidance
      D.1 Scope
      D.2 Normative references
      D.3 Terms and definitions
      D.4 Quality management systems
      D.5 Sterilizing agent characterization
      D.6 Process and equipment characterization
      D.7 Product definition
      D.8 Process definition
      D.9 Validation
      D.10 Routine monitoring and control
      D.11 Product release from sterilization
      D.12 Maintaining process effectiveness
Annex E (informative) Microbiological performance
        qualification - method for calculating D
        values using the BI/Biodurden approach
Bibliography
Annex ZA (normative) Normative references to international
         publications with their relevant European publications
Annex ZB (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directives 90/385/EEC
         of 20 June 1990 concerning active implantable medical
         devices, 93/42/EEC of 14 June 1993 concerning medical
         devices and 98/78/EC of 7 December 1988 concerning in vitro
         diagnostic medical devices

BS EN ISO 11135