ISO 11140-1:2014
Sterilization of health care products — Chemical indicators — Part 1: General requirements
ISO 11140-1:2014 specifies 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 process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_4
Section sec_4.1
Table tab_1
Section sec_4.2
Section sec_4.3
Section sec_4.4
Section sec_4.5
Section sec_4.6
Section sec_4.7
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Section sec_5.4
Section sec_5.5
Section sec_5.6
Section sec_5.7
Section sec_5.8
Section sec_5.9
Section sec_5.10
Figure fig_1
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.1.3
Section sec_6.1.4
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.3
Section sec_6.4
Section sec_6.4.1
Section sec_6.4.2
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_7.3.1
Section sec_7.3.2
Section sec_7.3.3
Section sec_7.3.4
Section sec_7.4
Section sec_7.4.1
Section sec_7.4.2
Section sec_7.4.3
Section sec_7.4.4
Section sec_7.4.5
Section sec_7.4.6
Section sec_7.5
Section sec_7.5.1
Section sec_7.5.2
Section sec_7.5.3
Section sec_7.5.4
Section sec_7.6
Section sec_7.6.1
Section sec_7.6.2
Section sec_7.6.3
Section sec_7.6.4
Section sec_7.6.5
Section sec_7.6.6
Section sec_7.6.7
Section sec_7.7
Section sec_7.7.1
Section sec_7.7.2
Section sec_7.7.3
Section sec_7.7.4
Section sec_8
Section sec_8.1
Section sec_8.2
Table tab_2
Section sec_8.3
Table tab_3
Section sec_8.4
Table tab_4
Section sec_8.5
Table tab_5
Section sec_8.6
Section sec_8.6.1
Table tab_6
Section sec_8.6.2
Section sec_8.7
Table tab_7
Section sec_9
Section sec_9.1
Section sec_9.2
Section sec_9.3
Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.3
Section sec_10.4
Table tab_8
Section sec_11
Section sec_11.1
Section sec_11.2
Section sec_11.3
Section sec_11.4
Section sec_11.5
Section sec_11.6
Section sec_11.7
Section sec_11.8
Section sec_12
Section sec_12.1
Section sec_12.2
Section sec_12.3
Section sec_12.4
Table tab_9
Section sec_13
Section sec_13.1
Section sec_13.2
Section sec_13.3
Section sec_13.4
Section sec_13.5
Table tab_10
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.3
Annex sec_A.4
Annex sec_B
Annex sec_B.1
Annex sec_B.2
Annex sec_B.3
Annex sec_C
Annex sec_C.1
Annex sec_C.1.1
Annex sec_C.1.2
Figure fig_C.1
Annex sec_C.2
Annex sec_C.2.1
Annex sec_C.2.2
Annex sec_C.3
Annex sec_C.4
Annex sec_D
Annex sec_D.1
Annex sec_D.2
Annex sec_D.3
Annex sec_E
Table tab_e
Figure fig_E.1
Reference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Reference ref_12
Reference ref_13
Reference ref_14
Reference ref_15
Reference ref_16
Reference ref_17
Reference ref_18
Reference ref_19
Reference ref_20
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Categorization
4.1 General
4.2 Type 1: process indicators
4.3 Type 2: indicators for use in specific tests
4.4 Type 3: single critical process variable indicators
4.5 Type 4: multicritical process variable indicators
4.6 Type 5: integrating indicators
4.7 Type 6: emulating indicators
5 General requirements
6 Performance requirements
6.1 General
6.2 Type 1 indicators
6.3 Type 2 indicators
6.4 Types 3, 4, 5 and 6 indicators
7 Test methods
7.1 General
7.2 Off-set (transference)
7.3 Procedure — Steam indicators
7.4 Procedure — Dry heat indicators
7.5 Procedure — EO indicators
7.6 Procedure — Low temperature steam and formaldehyde indicators
7.7 Procedure — Vaporized hydrogen peroxide indicators
8 Additional requirements for process (Type 1) indicators
8.1 Process indicators printed or applied on to packaging material
8.2 Process indicators for steam sterilization processes
8.3 Process indicators for dry heat sterilization processes
8.4 Process indicators for ethylene oxide sterilization processes
8.5 Process indicators for radiation sterilization processes
8.6 Process indicators for low temperature steam and formaldehyde sterilization processes
8.7 Process indicators for vaporized hydrogen peroxide sterilization processes
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
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_4
Section sec_4.1
Table tab_1
Section sec_4.2
Section sec_4.3
Section sec_4.4
Section sec_4.5
Section sec_4.6
Section sec_4.7
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Section sec_5.4
Section sec_5.5
Section sec_5.6
Section sec_5.7
Section sec_5.8
Section sec_5.9
Section sec_5.10
Figure fig_1
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.1.3
Section sec_6.1.4
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.3
Section sec_6.4
Section sec_6.4.1
Section sec_6.4.2
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_7.3.1
Section sec_7.3.2
Section sec_7.3.3
Section sec_7.3.4
Section sec_7.4
Section sec_7.4.1
Section sec_7.4.2
Section sec_7.4.3
Section sec_7.4.4
Section sec_7.4.5
Section sec_7.4.6
Section sec_7.5
Section sec_7.5.1
Section sec_7.5.2
Section sec_7.5.3
Section sec_7.5.4
Section sec_7.6
Section sec_7.6.1
Section sec_7.6.2
Section sec_7.6.3
Section sec_7.6.4
Section sec_7.6.5
Section sec_7.6.6
Section sec_7.6.7
Section sec_7.7
Section sec_7.7.1
Section sec_7.7.2
Section sec_7.7.3
Section sec_7.7.4
Section sec_8
Section sec_8.1
Section sec_8.2
Table tab_2
Section sec_8.3
Table tab_3
Section sec_8.4
Table tab_4
Section sec_8.5
Table tab_5
Section sec_8.6
Section sec_8.6.1
Table tab_6
Section sec_8.6.2
Section sec_8.7
Table tab_7
Section sec_9
Section sec_9.1
Section sec_9.2
Section sec_9.3
Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.3
Section sec_10.4
Table tab_8
Section sec_11
Section sec_11.1
Section sec_11.2
Section sec_11.3
Section sec_11.4
Section sec_11.5
Section sec_11.6
Section sec_11.7
Section sec_11.8
Section sec_12
Section sec_12.1
Section sec_12.2
Section sec_12.3
Section sec_12.4
Table tab_9
Section sec_13
Section sec_13.1
Section sec_13.2
Section sec_13.3
Section sec_13.4
Section sec_13.5
Table tab_10
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.3
Annex sec_A.4
Annex sec_B
Annex sec_B.1
Annex sec_B.2
Annex sec_B.3
Annex sec_C
Annex sec_C.1
Annex sec_C.1.1
Annex sec_C.1.2
Figure fig_C.1
Annex sec_C.2
Annex sec_C.2.1
Annex sec_C.2.2
Annex sec_C.3
Annex sec_C.4
Annex sec_D
Annex sec_D.1
Annex sec_D.2
Annex sec_D.3
Annex sec_E
Table tab_e
Figure fig_E.1
Reference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Reference ref_12
Reference ref_13
Reference ref_14
Reference ref_15
Reference ref_16
Reference ref_17
Reference ref_18
Reference ref_19
Reference ref_20
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Categorization
4.1 General
4.2 Type 1: process indicators
4.3 Type 2: indicators for use in specific tests
4.4 Type 3: single critical process variable indicators
4.5 Type 4: multicritical process variable indicators
4.6 Type 5: integrating indicators
4.7 Type 6: emulating indicators
5 General requirements
6 Performance requirements
6.1 General
6.2 Type 1 indicators
6.3 Type 2 indicators
6.4 Types 3, 4, 5 and 6 indicators
7 Test methods
7.1 General
7.2 Off-set (transference)
7.3 Procedure — Steam indicators
7.4 Procedure — Dry heat indicators
7.5 Procedure — EO indicators
7.6 Procedure — Low temperature steam and formaldehyde indicators
7.7 Procedure — Vaporized hydrogen peroxide indicators
8 Additional requirements for process (Type 1) indicators
8.1 Process indicators printed or applied on to packaging material
8.2 Process indicators for steam sterilization processes
8.3 Process indicators for dry heat sterilization processes
8.4 Process indicators for ethylene oxide sterilization processes
8.5 Process indicators for radiation sterilization processes
8.6 Process indicators for low temperature steam and formaldehyde sterilization processes
8.7 Process indicators for vaporized hydrogen peroxide sterilization processes
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