PREN ISO 14160 : DRAFT 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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
01-07-2011
12-01-2013
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
Defines requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilizing agents, of single-use medical devices comprising, in whole or in part, materials of animal origin.
| Committee |
TC 204
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| 09/30157765 DC : 0 | Identical |
| ISO 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 13408-2:2003 | Aseptic processing of health care products Part 2: Filtration |
| ISO 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 13408-3:2006 | Aseptic processing of health care products Part 3: Lyophilization |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 13408-6:2005 | Aseptic processing of health care products Part 6: Isolator systems |
| ISO 10012-1:1992 | Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 13408-5:2006 | Aseptic processing of health care products Part 5: Sterilization in place |
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