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1.1 This Standard defines essential elements for using containers (rigid sterilization containers) that are designed fo r use in gravity, prevacuum, and ethylene oxide sterilizers.
1.2 This Standard addresses instrument sets used in rigid sterilization containers.
1.3 Inclusions This Standard addresses requirements for
(a) general characteristics of containers; (b) testing prior to use; (c) reprocessing of containers; (d) preparation and assembly; (e) sterilizer loading and unloading; (f) sterile storage; (g) aseptic use and presentation; (h) transport of containers; and (i) quality assurance
1.4 This Standard does not address
(a) protective organization cases; (b) containers designed specifically for emergency (ie, flash) s terilization; and (c) noninstrument sets (eg, linen packs).
1.5 In this Standard, the word shall indicates a mandatory requiremen t; should indicates a recommendation, but is not mandatory. Notes accompanying clauses provide explanatory or informative material that is not properly a part of this Standard.
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