Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
German title
Sterilisation von Produkten für die Gesundheitsfürsorge - Trockene Hitze - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte
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Content
Content (en)
Foreword
Introduction
Scope
Inclusions
Exclusions
Normative references
Terms and definitions
Quality management system elements
Documentation
Management responsibility
Product realization
Measurement, analysis and improvement — Control of nonconforming product
Sterilizing agent characterization
Sterilizing agent
Microbicidal effectiveness
Material effects
Environmental considerations
Process and equipment characterization
Process characterization
Equipment characterization
Equipment specification
Identification
Safety
Manuals and instructions
Utilities
Components
Accessories
Control and recording systems
Control programs
Product definition
General
Product safety and performance
Packaging considerations
Microbiological quality
Product family
Biological safety
Process definition
Validation
General
Installation qualification
Operational qualification
Performance qualification
General
Performance qualification — Physical
Performance qualification — Microbiological
Performance qualification — Depyrogenation
Additional sterilization systems
Review and approval of validation
Routine monitoring and control
Routine control
Routine monitoring
Process monitoring locations
Product release from sterilization/depyrogenation
Maintaining process effectiveness
General
Recalibration
Maintenance of equipment
Requalification
Assessment of change
Guidance on the application of this International Standard (informative)
Scope
Inclusions
Exclusions
Normative references
Terms and definitions
Quality management system elements
Documentation
Management responsibility
Product realization
Measurement, analysis and improvement — Control of nonconforming product
Sterilizing agent characterization
Sterilizing agent
Microbicidal effectiveness
Material effects
Process and equipment characterization
Process characterization
Equipment characterization
Equipment specification
Identification
Safety
Manuals and instructions
Utilities
Components
Accessories
Control and recording systems
Control programs
Product definition
General
Product safety and performance
Packaging considerations
Microbiological quality
Product family
Biological safety
Process definition
Validation
General
Installation qualification
Operational qualification
Performance qualification
General
Performance qualification — Physical
Performance qualification — Microbiological
Performance qualification — Depyrogenation
Additional sterilization systems
Review and approval of validation
Routine monitoring and control
Routine control
Routine monitoring
Process monitoring locations
Product release from sterilization/depyrogenation
Maintaining process effectiveness
General
Recalibration
Maintenance of equipment
Requalification
Assessment of change
Process definition based on inactivation of the microbial population in its natural state (bioburden-based approach) (informative)
General
Product selection
Procedure
Maintaining process effectiveness
Process definition based on the inactivation of reference microorganisms and knowledge of bioburden (combined bioburden/biological indicator approach) (informative)
General
Procedure
Process lethality determination
Direct enumeration
Fraction-negative method using Holcomb-Spearman-Karber procedure (HSKP)
Fraction-negative method using Stumbo Murphy Cochran Procedure (SMCP)
Conservative process definition based on inactivation of reference microorganisms (overkill method) (informative)
General
Product selection
Procedure
Partial cycle approach
Full cycle approach
Process development (informative)
Process development — Biological methods
Process development — Physical methods
Bibliography
ICS
11.080.01
Cooperation at DIN
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