09/30157765 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 14160 REV - STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
31-07-2011
English
Foreword
Introduction
1 Scope
2 Normative references
3 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 non-conforming product
5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness
5.4 Effects on materials
5.5 Safety and the environment
6 Process and equipment characterization
6.1 General
6.2 Process characterization
6.3 Equipment characterization
7 Product definition
8 Process definition
9 Validation
9.1 General
9.2 Installation qualification
9.2.1 Equipment
9.2.2 Installation
9.3 Operational qualification
9.4 Performance qualification
9.4.1 General
9.4.2 Microbiological performance qualification
9.4.3 Physical performance qualification
9.4.4 Aseptic processing qualification
9.5 Review and approval of validation
10 Routine monitoring and control
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 (informative) - Guidance on the application of this
International Standard
A.1 Scope
A.2 Normative references
A.3 Definitions
A.4 Quality management system elements
A.4.1 Documentation
A.4.2 Management responsibility
A.4.3 Product realization
A.4.4 Measurement, analysis and improvement - Control
of non-conforming product
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
Annex B (normative) - Determination of lethal rate of
the sterilization process (Combined Reference
Organism/bioburden approach)
B.1 General
B.2 Procedure
B.3 Process lethality determination
B.3.1 Direct enumeration (Survivor Curve)
B.3.2 Fraction-negative method using Holcomb-Spearman
Karber procedure (HSKP)
B.3.3 Fraction-negative method using Stumbo Murphy
Cochran procedure (SMCP)
Annex C (normative) - Conservative determination of lethal
rate of the sterilization process (Halfcycle approach)
C.1 General
C.2 Procedure
Annex D (informative) - Flowahart for process definition
(Clause 8) and Microbiological Performance Qualification
(9.4.2)
Annex ZA (informative) - Clauses of this International
Standard addressing essential requirements
or other provisions of EU Directives
Bibliography
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