CSA Z11140.1 : 2007 : R2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
01-07-2016
English
01-01-2012
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 General requirements
6 Performance requirements
7 Test methods
8 Additional requirements for process (Class 1) indicators
9 Additional requirements for single variable (Class 3)
indicators
10 Additional requirements for multi-variable (Class 4)
indicators
11 Additional requirements for steam integrating (Class 5)
indicators
12 Additional requirements for dry heat integrating
(Class 5) indicators
13 Additional requirements for ethylene oxide integrating
(Class 5) indicators
14 Additional requirements for emulating (Class 6) indicators
Annex A - (informative) 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 (BIs) 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 components
Bibliography
Describes 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 variables required for a sterilization process.
| DocumentType |
Standard
|
| Pages |
46
|
| ProductNote |
Reconfirmed EN
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11140-1:2014 | 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 |
| 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 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| 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 9001:2015 | Quality management systems — Requirements |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| 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 |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
| 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 |
| ISO/IEC Guide 22:1996 | General criteria for supplier's declaration of conformity |
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