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I.S. 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)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Provides 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.

DevelopmentNote
Supersedes I.S. EN 867-1 and I.S. EN 867-2 (09/2005)
DocumentType
Standard
Pages
50
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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 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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