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EN 15424:2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
Superseded date

06-01-2011

Published date

04-04-2007

Foreword
Introduction
1 Scope
   1.1 Inclusions
   1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality Management System Elements
   4.1 Documentation
   4.2 Management responsibility
   4.3 Product realization
   4.4 Control of non-conforming product
5 Sterilizing agent characterization
   5.1 General
   5.2 Sterilizing agent
   5.3 Microbicidal effectiveness
   5.4 Material effects
   5.5 Environmental considerations
6 Process and equipment characterization
   6.1 General
   6.2 Process
   6.3 Equipment
7 Product definition
8 Process definition
9 Validation
   9.1 General
   9.2 Installation qualification
        9.2.1 General
        9.2.2 Installation
        9.2.3 Equipment
   9.3 Operational qualification
   9.4 Performance qualification
        9.4.1 General
        9.4.2 Performance qualification - physical
        9.4.3 Performance qualification - microbiological
        9.4.4 Performance qualification - desorption and drying
   9.5 Review and approval of validation
10 Routine monitoring and control
   10.1 General
   10.2 Biological indicators
   10.3 Chemical indicators
   10.4 Records
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 (normative) Process definition based on inactivation of
        reference microorganisms and knowledge of bioburden on
        product items to be sterilized
      A.1 General
      A.2 Procedure
Annex B (normative) Process definition based on inactivation of
        reference microorganisms
      B.1 General
          B.1.1 Overkill approach
          B.1.2 Penetration characteristics into medical devices
      B.2 Test procedure
          B.2.1 General
          B.2.2 Biological indicators
          B.2.3 Test systems
          B.2.4 Load configuration
          B.2.5 Testing
Annex C (informative) Guidance on application of this European
        Standard
      C.1 Scope
      C.2 Normative references
      C.3 Terms and definitions
      C.4 Quality management system elements
      C.5 Sterilizing agent characterization
          C.5.1 Neutralization
          C.5.2 Studies of microbial inactivation
      C.6 Process and equipment characterization
      C.7 Product definition
          C.7.1 General
          C.7.2 Design considerations for medical devices intended
                for sterilization
          C.7.3 Packaging considerations
      C.8 Process definition
          C.8.1 General
          C.8.2 Influence on product and packaging
          C.8.3 Determination of process effectiveness
      C.9 Validation
          C.9.1 General
          C.9.2 Installation qualification (IQ)
          C.9.3 Operational qualification (OQ)
          C.9.4 Performance qualification (PQ)
          C.9.5 Documentation and approval of validation
      C.10 Routine monitoring and control
      C.11 Product release from sterilization
           C.11.1 General
           C.11.2 Product release using biological indicators
           C.11.3 Parametric release
      C.12 Maintaining process effectiveness
           C.12.1 Change control
           C.12.2 Requalification
Annex D (informative) Environmental aspects regarding development,
        validation and control of Low Temperature Steam and
        Formaldehyde processes
      D.1 General
      D.2 Formaldehyde (brief description)
      D.3 Environmental impact of formaldehyde
      D.4 Other environmental burdens
Annex ZA (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 93/42/EEC
         Medical devices
Bibliography

1.1Inclusions1.1.1This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.NOTEAlthough the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. 1.1.2This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1)1.1.3This European Standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.1.2Exclusions1.2.1Sterilization processes validated and controlled in accordance with the requirements of this standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.1.2.2This standard does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556-1. 1.2.3This standard does not specify a quality management system for the control of all stages of production of medical devices. NOTEAttention is drawn to the standards for quality management systems (see EN ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. It is not a requirement of this standard to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appro

Committee
CEN/TC 204
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
SN EN 15424 : 2007 Identical
UNE-EN 15424:2007 Identical
NEN EN 15424 : 2007 Identical
NBN EN 15424 : 2007 Identical
I.S. EN 15424:2007 Identical
NF EN 15424 : 2007 Identical
PN EN 15424 : 2009 Identical
NS EN 15424 : 1ED 2007 Identical
UNI EN 15424 : 2007 Identical
BS EN 15424:2007 Identical
DIN EN 15424 E : 2007 Identical
DIN EN 15424:2007-08 Identical

DIN EN ISO 15882:2008-12 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
PREN 12182 : 2009-06 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
I.S. EN ISO 15882:2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
CSA Z15882 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
09/30201992 DC : 0 BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
AAMI ISO 15882 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
CSA Z15882:09 (R2019) Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01)
UNI EN ISO 15882 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
ANSI/AAMI/ISO 15882:2008(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
BS EN ISO 15882:2008 Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
EN ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
CSA Z15882 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results

EN 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 11737-2:2009)
IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
EN 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 14937:2009)
EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
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
EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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
EN ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
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 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
EN ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
CEN Guide 4:2008 GUIDE FOR ADDRESSING ENVIRONMENTAL ISSUES IN PRODUCT STANDARDS
EN ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003)
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
1997/23/EC : 1997 DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT

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