AAMI ST81 pdf free download

AAMI ST81 pdf free download.Sterilization of medical devices- Information to be provided by the manufacturer for the processing of resterilizable medical devices.
2.5 manufacturer: Organization with responsibility for the design, manufacture, packaging, and labeling of a device before it is placed on the market under its own or another name, regardless of whether these operations are carried out by the manufacturer itself or on its behalf by a third party.
2.6 processing: Activity including cleaning, disinfection, and sterilization necessary to prepare a new or used medical device for its intended use.
2.7 processor: Organization with the responsibility for carrying Out the actions necessary to prepare a new or used device for its intended use.
2.8 sterilant: Chemical which has properties to destroy microorganisms, including viruses, when used at correct
dilution/dose and applied for recommended exposure time.
2.9 sterile: Free from all viable microorganisms.
2.10 sterilization: Validated process used to render a device free from all forms of viable microorganisms. NOTE—In a sterilization process, the nature of microbiological death is described by an exponential function. Therefore, the presence of microorganisms on any individual item may be expressed in terms of probability. While this probability may be reduced to a very low number, it can never be reduced to zero. (See ISO 11134.) This probability can only be assured for validated processes.
2.11 validation: Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.
2.12 verification: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
2.13 washer-disinfector: Machine intended to clean and disinfect medical devices and other articles used in the
context of medical, dental, pharmaceutical, and veterinary practice.
3 Information to be provided by the medical device manufacturer
3.1 Reprocessing instructions
At least one validated method for reprocessing the medical device shall be specified.
The following information shall be stated where it is critical to the maintenance of the intended function of the medical device and the safety of the user(s) and the patient:
— details of process steps;
— a description of special equipment and/or accessories;
— specification of process parameters and their tolerances.
NOTE—Further information is provided in Annex A.
3.2 Limitations and restrictions on reprocessing
The manufacturer shall determine it processing in accordance with the provided instructions leads to a degree of degradation that will limit the useful life of the medical device. Where such degradation is established, the manufacturer shall provide an indication of the end of the medical device’s ability to safely fulfill its intended use.
3.3 PreparatIon at the point of use prior to processing
Requirements for preparation at the point of use to ensure satisfactory reprocessing of the medical device shall be specified, if applicable.
Where appropriate, at least the following information shall be included:
— the containers for transportation;
— a description of the support systems (for instance, accessories to hold and protect the instrumentation within the container for transportation, if applicable);
— the maximum period of time that may elapse between use and cleaning;
— a description of the precleaning techniques critical to further processing;
— the requirements for wet or dry transportation of items to the decontamination area.AAMI ST81  pdf download.