AAMI ISO 11140-5 : 2007 : R2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
Hardcopy , PDF
05-09-2020
English
01-01-2012
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Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 11140-5:2007
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Indicator system
5.1 Format
5.2 Performance
6 Indicator
6.1 Format
6.2 Performance
7 Packaging and labeling
8 Quality assurance
9 Sampling conditioning
Annex A (normative) Determination of the degree of
contrast between the color of the substrate
and the indicator agent
Annex B (normative) Method of determining uniform
color change on exposure to saturated steam
Annex C (normative) Method for determining indicator
color change on exposure to dry heat
Annex D (normative) Method for determining transfer of
indicator agent to standard test pack
Annex E (normative) Standard test pack
Annex F (normative) Method of determining non-uniform
color change on exposure to a standard fault
condition
Annex G (normative) Steam exposure apparatus
Bibliography
Describes the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.
| Committee |
WG 06
|
| DevelopmentNote |
Supersedes AAMI ST66. (06/2007)
|
| DocumentType |
Standard
|
| Pages |
26
|
| ProductNote |
Reconfirmed 2012
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11140-5:2007 | Identical |
| ISO 5636-3:2013 | Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| ISO 187:1990 | Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO 5-4:2009 | Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density |
| IEC 60751:2008 | Industrial platinum resistance thermometers and platinum temperature sensors |
| 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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