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ISO 17664

September 15, 2021

Under what quality system should your reprocessing validation be performed?

ISO 17664[1] and ISO17664-2[2] clearly state that all reprocessing instructions provided in the Instructions For Use (IFU) document must be validated; and FDA[3] as well as other guidance documents provide information on how these validations should be performed. However, that...

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August 25, 2021

Can manual cleaning and disinfection be combined into a one-step process?

ISO17664:2017[1] notes that disinfection can be carried out concurrently with manual cleaning of a medical device but does not provide any additional guidance. On the other hand, FDA specifies that cleaning steps should be validated separately and independently from disinfection...

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July 28, 2021

When do you need a drying step?

ISO 17664[1] specifies that ”where drying is necessary, at least one verified drying method shall be specified.” FDA provides more detailed information on the importance of drying steps following different stages of processing[2] as outlined below. One important merit of...

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June 1, 2021

Should you name a detergent brand in the instructions for use (IFU) document?

ISO17664:2017[1] states that, where applicable, the following information with regards to the cleaning agent(s) should be included in the IFU; the “identification and concentration of chemicals required” and the “contact time of any cleaning agent used.” It also states that...

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