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04/30048118 DC : DRAFT MAY 2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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
Superseded date

06-29-2007

Published date

11-23-2012

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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