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PREN ISO 11140-1 : DRAFT 2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012)
Superseded date

11-01-2014

Published date

01-12-2013

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
   process variable (Type 3) indicators
10 Additional requirements for multi
   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 and microbial
        inactivation
Annex D (informative) - Rationale for the liquid-phase
        test method for steam-formaldehyde
        indicators
Annex E (informative) - Relationship of indicator
        and indicator system components
Bibliography

Defines 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.

Committee
TC 102
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
12/30238553 DC : 0 Identical
03/108542 DC : DRAFT MAY 2003 Identical

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN 45014 : 1998 GENERAL CRITERIA FOR SUPPLIER'S DECLARATION OF CONFORMITY
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
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 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/TS 11139:2006 Sterilization of health care products Vocabulary
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 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
ISO/IEC Guide 22:1996 General criteria for supplier's declaration of conformity

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