ANSI/AAMI/ISO 11140-1-2014 pdf download.Sterilization of health care products—Chemical indicators—Part 1: General requirements.
This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
NOTE 1 Biological test systems are regarded as those test systems which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138- series for biological indicators (BIs).
The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of
ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.
Relevant test equipment is described in ISO 18472.
NOTE 2 Additional requirements for specific test indicators/indicator systems (Type 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 8601:2004, Data elements and interchange formats — Information interchange — Representation of dates and times
ISO 11135:2014, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-3:2006, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
ISO 11138-1:2006, Sterilization of health care products — Biological indicators — Part 1: General requirements.ANSI/AAMI/ISO 11140-1 pdf download.