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EN ISO 11140-1:2014

Current
Current

The latest, up-to-date edition.

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
Published date

12-11-2014

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Categorization
5 General requirements
6 Performance requirements
7 Test methods
8 Additional requirements for process (Type 1)
   indicators
9 Additional requirements for single critical process
   variable (Type 3) indicators
10 Additional requirements for multicritical process
   variable (Type 4) indicators
11 Additional requirements for steam integrating
   (Type 5) indicators
12 Additional requirements for ethylene oxide
   integrating (Type 5) indicators
13 Additional requirements for emulating (Type 6)
   indicators
Annex A (normative) - Method for demonstrating
        shelf-life of the product
Annex B (informative) - Examples of testing indicators
Annex C (informative) - Rationale for the requirements
        for integrating indicators and the link to the
        requirements for biological indicators specified
        in ISO 11138 (all parts) and microbial inactivation
Annex D (informative) - Rationale for the liquid-phase
        test method for low temperature steam and
        formaldehyde indicators
Annex E (informative) - Relationship of indicator and
        indicator system components
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EC on medical devices

ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

Committee
CEN/TC 102
DevelopmentNote
Supersedes EN 867-1 and EN 867-2 (09/2005) Supersedes PREN ISO 11140-1. (11/2014)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

UNI EN 868-5 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
BS EN 868-5:2009 Packaging for terminally sterilized medical devices Sealable pouches and reels of porous and plastic film construction. Requirements and test methods
I.S. EN 15424:2007 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
12/30261215 DC : 0 BS EN 13060 - SMALL STEAM STERILIZERS
PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
05/30066638 DC : DRAFT OCT 2005 EN 15424 - STERILIZATION OF MEDICAL DEVICES - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF STERILIZATION PROCESSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE
PREN 13060 : DRAFT 2012 SMALL STEAM STERILIZERS
I.S. EN 868-5:2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
DIN EN 868-4:2017-05 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
DIN EN 868-5:2009-09 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
NF EN 868-5 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
UNE-EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
I.S. EN 868-4:2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
VDI 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
07/30166933 DC : DRAFT AUG 2007 BS EN 868-5 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
EN 13060:2014 Small steam sterilizers
DIN EN 13060:2015-03 SMALL STEAM STERILIZERS
DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
PREN 17180 : DRAFT 2017 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
07/30166930 DC : DRAFT AUG 2007 BS EN 868-4 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
17/30360908 DC : 0 BS EN 868-5 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
PREN 868-4 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
STANAG 2906 : 2015 ESSENTIAL PHYSICAL REQUIREMENTS AND PERFORMANCE CHARACTERISTICS OF FIELD TYPE HIGH PRESSURE STEAM STERILIZERS
UNE-EN 13060:2015 Small steam sterilizers
BS EN 13060 : 2014 SMALL STEAM STERILIZERS
BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
BS EN 868-4:2017 Packaging for terminally sterilized medical devices Paper bags. Requirements and test methods
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
15/30325861 DC : 0 BS EN 868-4 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
I.S. EN 13060:2014 SMALL STEAM STERILIZERS
PREN 868-5 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
17/30362728 DC : 0 BS EN 17169 - TATTOOING - SAFE AND HYGIENIC PRACTICE
DIN EN 868-4:2015-08 (Draft) PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
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/TS 17665-3:2013 Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO/IEC 17050-1:2004 Conformity assessment Supplier's declaration of conformity Part 1: General requirements
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
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
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 9001:2015 Quality management systems — Requirements
ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
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
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ISO 11138-4:2017 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 13060:2014 Small steam sterilizers
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

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