DIN EN 15424:2007-08
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
01-09-2011
English
12-01-2013
Foreword
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 Control of non-conforming product
5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness
5.4 Material effects
5.5 Environmental considerations
6 Process and equipment characterization
6.1 General
6.2 Process
6.3 Equipment
7 Product definition
8 Process definition
9 Validation
9.1 General
9.2 Installation qualification
9.2.1 General
9.2.2 Installation
9.2.3 Equipment
9.3 Operational qualification
9.4 Performance
9.4.1 General
9.4.2 Performance qualification - physical
9.4.3 Performance qualification - microbiological
9.4.4 Performance qualification - desorption and drying
9.5 Review and approval of validation
10 Routine monitoring and control
10.1 General
10.2 Biological indicators
10.3 Chemical indicators
10.4 Records
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
Annex A (normative) Process definition based on inactivation
of reference microorganisms and knowledge
of bioburden on product items to be sterilized
A.1 General
A.2 Procedure
Annex B (normative) Process definition based on inactivation
of reference microorganisms
B.1 General
B.1.1 Overkill approach
B.1.2 Penetration characteristics into medical devices
B.2 Test procedure
B.2.1 General
B.2.2 Biological indicators
B.2.3 Test systems
B.2.4 Load configuration
B.2.5 Testing
Annex C (informative) Guidance on application of this European
Standard
C.1 Scope
C.2 Normative references
C.3 Terms and definitions
C.4 Quality management system elements
C.5 Sterilizing agent characterization
C.5.1 Neutralization
C.5.2 Studies of microbial inactivation
C.6 Process and equipment characterization
C.7 Product definition
C.7.1 General
C.7.2 Design considerations for medical devices
intended for sterilization
C.7.3 Packaging
C.8 Process definition
C.8.1 General
C.8.2 Influence on product and packaging
C.8.3 Determination of process effectiveness
C.9 Validation
C.9.1 General
C.9.2 Installation qualification (IQ)
C.9.3 Operational qualification (OQ)
C.9.4 Performance qualification (PQ)
C.9.5 Documentation and approval of validation
C.10 Routine monitoring and control
C.11 Product release from sterilization
C.11.1 General
C.11.2 Product release using biological indicators
C.11.3 Parametric release
C.12 Maintaining process effectiveness
C.12.1 Change control
C.12.2 Requalification
Annex D (informative) Environmental aspects regarding
development, validation and routine
control of Low Temperature Steam and
Formaldehyde processes
D.1 General
D.2 Formaldehyde (brief description)
D.3 Environmental impact of formaldehyde
D.4 Other environmental burdens
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC Medical devices
Bibliography
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