ANSI AAMI ISO 11140-1:2014 pdf download – Sterilization of health care products – Chemical indicators

03-12-2022 comment

ANSI AAMI ISO 11140-1:2014 pdf download – Sterilization of health care products – Chemical indicators
5.9 The manufacturer shall retain documentary evidence that the indicator, when used as intended by the manufacturer, does not release any substance known to be toxic in sufficient quantities to cause either a health hazard, or a hazard to the intended properties of the product being sterilized before, during or after the sterilization process for which it is designated.
5.10 If the indicator is designed for use with a specific test load only, this information shall be stated or coded on the indicator, the package of indicators and the technical information leaflet supplied with the package, together with the symbol (see Figure 1). If the size or format of the indicator does not permit affixing of the symbol at a size 5 mm or greater, it is permissible to provide this information only on the package of indicators and the technical leaflet.
6.1.1 Resistometers (see ISO 18472) are used to characterize the performance of the chemical indicators described in this part of ISO 11140 with the exception of Type 2 indicators (see 4.3). Resistometers allow for precise specification and control of the specific test conditions and cycle sequences in order to produce controlled, repeatable studies of the effect of process parameters on indicators. Resistometers differ from conventional sterilizers; therefore, if conventional sterilizers are used to attempt to duplicate resistometer conditions, erroneous and/or misleading results can occur.
6.1.2 The condition of the indicator after exposure to a sterilization process, during which all the critical process variables met or exceeded the specified level to produce a visible change, graduated response or end point, shall remain unchanged for a period of not less than six months from the date of use, when stored under the conditions specified by the indicator manufacturer.
6.1.3 If incompletely changed indicators deteriorate on storage, either returning to the unchanged condition or slowly completing the change reaction, this information shall be stated in the technical information supplied by the manufacturer [see 5.8 f)].
6.1.4 Indicators for steam processes shall be tested according to the method in 7.4 and the specified values in 11.7. The visible change or end point shall not be reached. NOTE The dry heat test is designed to ensure that indicators for steam require the presence of steam in order to respond.
7.1 General
Where appropriate, tests for compliance with the requirements for specific indicator types cited in Clauses 6 to 13 shall be carried out by exposing the indicators to the conditions specified and using equipment complying with ISO 18472, then examining the indicator for compliance. Specific test methods for radiation indicators are not given here. Performance requirements for radiation indicators are given in 8.5. NOTE Test equipment and methods for Type 2 indicators are contained in ISO 11140-3, ISO 11140-4 and ISO 11140-5.
7.3.1 Load the indicator on to a suitable sample holder. The sample holder shall not affect the performance of the indicator or impede exposure to critical process variables. The sample holder shall allow the indicator or indicator system to be directly exposed to the test conditions. Different indicators might require different sample holder designs. Third parties should consult the indicator manufacturer for guidance.

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