ANSI AAMI ISO 17664 pdf free download

ANSI AAMI ISO 17664 pdf free download.Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices.
4 Validation of the processes identified in the information provided by the medical device manufacturer 4.1 The medical device manufacturer shall validate each process that is identified in the information supplied with the medical device. Validation shall demonstrate that each process is suitable for processing of the medical device. 4.2 The medical device manufacturer shall have objective evidence available that validation of the processing procedures has been undertaken to confirm that the specific medical device will be clean, disinfected and/or sterilized when processed as directed. NOTE 1 In addition to the duty of a manufacturer to demonstrate the validity of provided information, national authorities can require the final effectiveness of the process to be verified by the processor. NOTE 2 National authorities can allow or require the use of an alternative process. In such cases they usually require validation of those processes by the processor. 4.3 If a manufacturer supplies a number of different medical devices that share common attributes, then validation studies may be performed as a product family. If this approach is taken, the medical device manufacturer shall demonstrate commonality between the different medical devices and the validation studies shall address the worst case attribute(s) of the product family.6 Information to be provided by the medical device manufacturer General 6.1 6.1.1 The information specified in this clause shall take into account the nature of the medical device and its intended use. 6.1.2 Where disinfection is the terminal process, the medical device manufacturer shall specify validated method(s) to reduce the risk of transmission of infectious agents to a level appropriate for the intended use of the medical device. Medical device manufacturers shall specify in their processing instructions any special techniques and accessories that will enable the processor to provide a medical device that is suitable for its intended use. 6.1.3 Where sterilization is the terminal process, the medical device manufacturer shall specify validated method(s) to achieve the required sterility assurance level. Medical device manufacturers shall specify in their processing instructions any specific requirements that will enable the processor to provide a medical device that is suitable for its intended use. 6.1.4 When providing processing instructions, medical device manufacturers shall be aware of — available national and international standards and guidelines,— the need for specific training, and — the processing equipment commonly available to the processor. NOTE Annex A and Annex C provide information on classification of medical devices which can assist with identifying the information required. 6.1.5 The equipment or materials required in the specified processes shall be identified by their generic names or specification. Trade names may be added in cases where generic names do not provide sufficient information (see D.2). Processing instructions 6.2 6.2.1 At least one validated method shall be specified for each applicable stage of processing of the medical device. The method shall be relevant to the market in which the medical device is to be supplied. NOTE Annex A provides information on the commonly used processes available.ANSI AAMI ISO 17664  pdf download.