ANSI AAMI ISO 11140-1 pdf free download – Part 1: General requirements

ANSI AAMI ISO 11140-1 pdf free download.Sterilization of health care products – Chemical indicators – Part 1: General requirements.
4.2 Type 1: process indicators
Process indicators shall be designed for use with individual items (e.g. packs, containers) to show that the unit has been directly exposed to the sterilization process and to distinguish between processed and unprocessed items.
4.3 Type 2: indicators for use in specific tests
Type 2 indicators are intended for use in specific test procedures as defined in relevant sterilizer/sterilization standards. The requirements for specific test indicators and indicator systems (Type 2 indicators) are provided in ISO
11140-3, ISO 11140-4, and ISO 11140-5.
4.4 Type 3: single critical process variable indicators
A single critical process variable indicator shall be designed to react to one of the critical process variables (see 5.2) and is intended to indicate exposure to a sterilization process at a stated value (SV) of the chosen critical process variable (see 5.7 and 5.8).
4.5 Type 4: multicritical process variable indicators
A multicritical process variable indicator shall be designed to react to two or more of the critical process variables
(see 5.2) and is intended to indicate exposure to a sterilization process at SVs of the chosen critical process variables
(see 5.7 and 5.8).
4.6 Type 5: integrating indicators
An integrating indicator shall be designed to react to all critical process variables (see 5.2). The SVs are generated to be equivalent to, or exceed, the performance requirements given in the ISO 11138- series for BIs. The minimum SV shall be related to the minimum values required to achieve sterilization as specified in International Standards ISO 11135, ISO 11137 (all parts), ISO 17665 (all parts), or by local regulatory agencies (see Clauses 11 and 12).
NOTE The SVs demonstrate how the indicator integrates over the temperature range.
4.7 Type 6: emulating indicators
An emulating indicator shall be designed to react to all critical process variables for specified sterilization processes.
The SVs are generated from process variables of sterilization processes as specified in International Standards ISO
11135, ISO 11137 (all parts) and ISO 17665 (all parts), or by regulatory agencies (see Clause 13).
5 General requirements
5.1 The requirements given in this clause shall apply to all chemical indicators (CI) unless specifically excluded or amended in a subsequent clause or part of ISO 11140.
NOTE For ease of reading, only the term “indicator” is used hereinafter, although requirements do also apply to indicator systems.
6 Performance requirements
6.1 General
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.ANSI AAMI ISO 11140-1 pdf download.