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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
29-06-2007
23-11-2012
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
BS EN ISO 11135
| Committee |
CH/198
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| EN 12442-3 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| 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 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 14040:2006 | Environmental management Life cycle assessment Principles and framework |
| ISO 10012-1:1992 | Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| IEC 61010-2-042:1997 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes |
| EN 12442-2 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
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