04/30048301 DC : DRAFT MAY 2004

Introduction
1 Scope
   1.1 Inclusions
   1.2 Exclusions
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 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Material effects
6 Process and equipment characterization
   6.1 Process
   6.2 Equipment
7 Product definition
8 Process definition
   8.1 Establishing the maximum acceptable dose
   8.2 Establishing the sterilization dose
   8.3 Specifying the sterilization dose and the maximum
        acceptable dose
   8.4 Transference of maximum acceptable, verification or
        sterilization dose between radiation sources
9 Validation
   9.1 Installation qualification
   9.2 Operational qualification
   9.3 Performance qualification
   9.4 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
   12.1 Demonstration of continued effectiveness
   12.2 Recalibration
   12.3 Maintenance of equipment
   12.4 Requalification of equipment
   12.5 Assessment of change
Annex A (informative) Guidance
      A.1 Scope
      A.2 Normative references
      A.3 Terms and definitions
      A.4 Quality management system elements
      A.5 Sterilizing agent characterization
      A.6 Process and equipment characterization
      A.7 Product definition
      A.8 Process definition
      A.9 Validation
      A.10 Routine monitoring and control
      A.11 Product release from sterilization
      A.12 Maintaining process effectiveness
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 90/358/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 1137-1