I.S. EN ISO 11140-1:2014
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014)
Hardcopy , PDF
English
01-01-2014
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
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
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