EN ISO 17664 pdf download Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices
process used to reduce the number of viable microorganisms on a product to a level previouslyspecified as appropriate for its further handling or use
cleaning without the use of a washer-disinfector
organization with responsibility for the design，manufacture，packaging and labelling of a devicebefore it is placed on the market under its own name, regardless of whether these operations are
carried out by that person himself or on its behalf by a third party
activity including cleaning, disinfection and sterilization, necessary to prepare a new or used medicaldevice for its intended use
organization with the responsibility for carrying out the actions necessary to prepare a new or useddevice for its intended use
chemical which has properties to destroy micro-organisms including viruses,when used at correctdilution/dose and applied for recommended exposure time
free from all viable microorganisms
process used to render a device free from all forms of viable microorganisms
NOTE ln 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.Whist 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.
documented procedure for obtaining, recording and interpreting the results required to establish that aprocess will consistently yield product complying with predetermined specifications
confirmation by examination and provision of objective evidence that specified requirements havebeen fulfilled
machine intended to clean and disinfect medical devices and other articles used in the context ofmedical, dental,pharmaceutical and veterinary practice
NOTE 1 This type of machine does not include those designed specifically to wash linen or clothing.Machinesintended to sterilize, or designated as sterilizers, are specified in other standards e.g.EN 285.
NOTE2 Preliminary standards for washer-disinfectors (prEN 15883) are being prepared in an lSO-CEN project.
3Information 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 intendedfunction 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.
3.2Limitations and restrictions on reprocessing
The manufacturer shall determine if processing in accordance with the provided instructions leads to adegree of degradation that will limit the useful life of the medical device. Where such degradation isestablished, the manufacturer shall provide an indication of the number of reprocessing cycles thatcan normally be tolerated, or some other indication of the end of the medical device’s ability to safelyfulfil 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 medicaldevice, 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;
the maximum period of time that may elapse between use and cleaning;
a description of the pre-cleaning techniques critical to further processing;the requirements for transportation.