04/30048118 DC : DRAFT MAY 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
06-29-2007
11-23-2012
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
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