NEN EN ISO 11140-1 : 2014
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
01-12-2013
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
Annex ZA (informative) Relationship between this European
Standard and the Essential
Requirements of EU Directive
93/42 EEC
Annex ZA (normative) Normative references to international
publications with their relevant
European publications
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