ISO/TS 17665-3:2013
Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
ISO/TS 17665-3:2013 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process.
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Section sec_1
Section sec_2
Section sec_3
Section sec_4
Section sec_4.1
Table tab_1
Section sec_4.2
Section sec_4.2.1
Table tab_2
Section sec_4.2.2
Table tab_3
Section sec_4.2.3
Table tab_4
Section sec_4.2.4
Table tab_5
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Table tab_6
Section sec_6
Section sec_7
Section sec_8
Section sec_8.1
Section sec_8.2
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.3
Annex sec_A.4
Table tab_a
Figure fig_A.1
Annex sec_A.5
Annex sec_A.6
Annex sec_B
Annex sec_B.1
Annex sec_B.1.1
Figure fig_B.1
Table tab_B.2
Table tab_B.3
Annex sec_B.1.2
Table tab_B.4
Annex sec_B.2
Annex sec_B.2.1
Figure fig_B.2
Table tab_B.5
Table tab_B.6
Annex sec_B.2.2
Table tab_B.7
Annex sec_B.3
Annex sec_B.3.1
Figure fig_B.3
Table tab_B.8
Table tab_B.9
Annex sec_B.3.2
Table tab_B.10
Annex sec_B.4
Annex sec_B.4.1
Figure fig_B.4
Table tab_B.11
Table tab_B.12
Annex sec_B.4.2
Table tab_B.13
Annex sec_B.5
Annex sec_B.5.1
Figure fig_B.5
Table tab_B.14
Table tab_B.15
Annex sec_B.5.2
Table tab_B.16
Annex sec_B.6
Annex sec_B.6.1
Figure fig_B.6
Table tab_B.17
Table tab_B.18
Annex sec_B.6.2
Table tab_B.19
Annex sec_B.7
Annex sec_B.7.1
Figure fig_B.7
Table tab_B.20
Table tab_B.21
Annex sec_B.7.2
Table tab_B.22
Annex sec_C
Annex sec_D
Annex sec_D.1
Table tab_b
Figure fig_D.1
Annex sec_D.1.1
Table tab_D.1
Table tab_D.2
Annex sec_D.1.2
Table tab_D.3
Annex sec_D.1.3
Table tab_D.4
Table tab_D.5
Annex sec_D.1.4
Table tab_D.6
Annex sec_D.1.5
Table tab_D.7
Table tab_D.8
Annex sec_D.1.6
Table tab_D.9
Annex sec_D.1.7
Table tab_D.10
Table tab_D.11
Annex sec_D.1.8
Table tab_D.12
Annex sec_D.1.9
Table tab_D.13
Table tab_D.14
Annex sec_D.1.10
Table tab_D.15
Annex sec_D.1.11
Table tab_D.16
Table tab_D.17
Annex sec_D.1.12
Table tab_D.18
Annex sec_D.2
Table tab_c
Figure fig_D.2
Table tab_D.19
Table tab_D.20
Table tab_D.21
Table tab_D.22
Table tab_d
Figure fig_D.3
Table tab_D.23
Table tab_D.24
Table tab_D.25
Table tab_D.26
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 General attributes
4.2 Detailed attributes
5 Product family (pf)
5.1 Example 1 — pf 1
5.2 Example 2 — pf 24
5.3 Example 3 — pf 27
6 Processing category
7 Sterilization process parameters
8 Additional considerations
8.1 Services
8.2 Process selection
Annex A (informative) Process parameters
Annex B (informative) Characterization of a procedure set — Examples
Annex C (informative) Designating a processing category
Annex D (informative) Processing categories — Examples
Bibliography
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Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices
Section sec_1
Section sec_2
Section sec_3
Section sec_4
Section sec_4.1
Table tab_1
Section sec_4.2
Section sec_4.2.1
Table tab_2
Section sec_4.2.2
Table tab_3
Section sec_4.2.3
Table tab_4
Section sec_4.2.4
Table tab_5
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Table tab_6
Section sec_6
Section sec_7
Section sec_8
Section sec_8.1
Section sec_8.2
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.3
Annex sec_A.4
Table tab_a
Figure fig_A.1
Annex sec_A.5
Annex sec_A.6
Annex sec_B
Annex sec_B.1
Annex sec_B.1.1
Figure fig_B.1
Table tab_B.2
Table tab_B.3
Annex sec_B.1.2
Table tab_B.4
Annex sec_B.2
Annex sec_B.2.1
Figure fig_B.2
Table tab_B.5
Table tab_B.6
Annex sec_B.2.2
Table tab_B.7
Annex sec_B.3
Annex sec_B.3.1
Figure fig_B.3
Table tab_B.8
Table tab_B.9
Annex sec_B.3.2
Table tab_B.10
Annex sec_B.4
Annex sec_B.4.1
Figure fig_B.4
Table tab_B.11
Table tab_B.12
Annex sec_B.4.2
Table tab_B.13
Annex sec_B.5
Annex sec_B.5.1
Figure fig_B.5
Table tab_B.14
Table tab_B.15
Annex sec_B.5.2
Table tab_B.16
Annex sec_B.6
Annex sec_B.6.1
Figure fig_B.6
Table tab_B.17
Table tab_B.18
Annex sec_B.6.2
Table tab_B.19
Annex sec_B.7
Annex sec_B.7.1
Figure fig_B.7
Table tab_B.20
Table tab_B.21
Annex sec_B.7.2
Table tab_B.22
Annex sec_C
Annex sec_D
Annex sec_D.1
Table tab_b
Figure fig_D.1
Annex sec_D.1.1
Table tab_D.1
Table tab_D.2
Annex sec_D.1.2
Table tab_D.3
Annex sec_D.1.3
Table tab_D.4
Table tab_D.5
Annex sec_D.1.4
Table tab_D.6
Annex sec_D.1.5
Table tab_D.7
Table tab_D.8
Annex sec_D.1.6
Table tab_D.9
Annex sec_D.1.7
Table tab_D.10
Table tab_D.11
Annex sec_D.1.8
Table tab_D.12
Annex sec_D.1.9
Table tab_D.13
Table tab_D.14
Annex sec_D.1.10
Table tab_D.15
Annex sec_D.1.11
Table tab_D.16
Table tab_D.17
Annex sec_D.1.12
Table tab_D.18
Annex sec_D.2
Table tab_c
Figure fig_D.2
Table tab_D.19
Table tab_D.20
Table tab_D.21
Table tab_D.22
Table tab_d
Figure fig_D.3
Table tab_D.23
Table tab_D.24
Table tab_D.25
Table tab_D.26
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 General attributes
4.2 Detailed attributes
5 Product family (pf)
5.1 Example 1 — pf 1
5.2 Example 2 — pf 24
5.3 Example 3 — pf 27
6 Processing category
7 Sterilization process parameters
8 Additional considerations
8.1 Services
8.2 Process selection
Annex A (informative) Process parameters
Annex B (informative) Characterization of a procedure set — Examples
Annex C (informative) Designating a processing category
Annex D (informative) Processing categories — Examples
Bibliography