PREN ISO 11140-1 : DRAFT 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)
01-11-2014
12-01-2013
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
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