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Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices - Guidance on the designation of a reusable medical device to a cleaning classification

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1 Scope

This document gives guidance on designating medical devices to cleaning classification categories, attributes used for medical device cleaning classification category, and designation of a cleaning process.

The cleaning classification category is comprised of two parts:

  1. designate medical devices to a product family;

  2. designate product families to cleaning processes.

NOTE 1    This allows grouping of medical devices into cleaning classification categories during cleaning and identification of master products during cleaning validation.

This document is applicable to manufacturers devising cleaning methods and instructions for processing. It also applies to any processing facility where medical devices are cleaned.

This document does not cover processing of single-use medical devices provided as sterile before use and textile devices.

NOTE 2    Manual cleaning steps before automated cleaning do not include steps that are considered point of use treatment that can be specified.

NOTE 3    Microbiocidal processes (sanitization, disinfection, sterilization) are not in the scope of the medical device cleaning classification categories.