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BS EN ISO 11140-6:2022 – TC:2023 Edition

BS EN ISO 11140-6:2022 – TC:2023 Edition

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Tracked Changes. Sterilization of health care products. Chemical indicators – Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

Published By Publication Date Number of Pages
BSI 2023 124
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This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060. NOTE      The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities. a)    Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). This document specifies the requirements for: ā€”    a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means; ā€”    an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design. b)    Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060). This document specifies the requirements for: ā€”    a reference hollow device (RHD) used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator; ā€”    an alternative hollow device: ā€”    employing the same specific test load as defined for the RHD and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator; ā€”    equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.

PDF Catalog

PDF Pages PDF Title
1 30466659
73 A-30327621
74 undefined
76 European foreword
Endorsement notice
78 Foreword
79 Introduction
81 1 Scope
82 2 Normative references
3 Terms and definitions
83 4 Requirements
4.1 General
4.2 Porous devices
4.2.1 Reference porous device (RPD)
84 4.2.2 Detector for reference porous device (RPD)
85 4.2.3 Alternative porous indicator system (APIS)
86 4.2.4 Reference porous device (RPD) response
4.3 Hollow devices
4.3.1 Reference hollow device (RHD)
87 4.3.2 Detector for reference hollow device (RHD)
88 4.3.3 Reference hollow indicator system (RHIS)
4.3.4 Reference hollow indicator system (RHIS) performance determination
89 4.3.5 Leakage test
4.4 Alternative hollow indicator system (AHIS)
4.4.1 General
90 4.5 Alternative hollow devices intended for multiple use
92 4.6 Test procedure for validation of conformance of the alternative hollow device to the reference hollow device (RHD)
93 5 Chemical indicator dry heat performance
5.1 General
5.2 Test 1
94 5.3 Test 2
6 Marking and labelling
6.1 Device labelling
6.2 Additional labelling requirements for hollow devices
95 6.3 Chemical indicators for use in hollow devices
96 Annex A (normative) Test method for performance of reference hollow indicator system (RHIS)
104 Annex B (normative) Test method for performance of alternative porous indicator system (APIS)
107 Annex C (normative) Test method for performance of alternative hollow indicator system (AHIS)
108 Annex D (informative) Relationship between chemical indicator components
110 Annex E (normative) Reference hollow device (RHD)
112 Annex F (informative) Accelerated ageing of test samples
113 Annex G (informative) Evaluation of reference hollow devices (RHDs) ā€” Interlaboratory results
120 Bibliography

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BS EN ISO 11140-6:2022 - TC
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