ČSN EN ISO 17664-2 - Zpracování výrobků pro zdravotní péči - Informace, které mají být poskytnuty výrobcem zdravotnických prostředků pro zpracování zdravotnických prostředků - Část 2: Nekritické zdravotnické prostředky

3.17 washer-disinfector

WD

equipment designed to clean and disinfect product

Note 1 to entry: See the ISO 15883 series.

[SOURCE: ISO 11139:2018, 3.319, modified — Note 1 to entry has been added.]

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Risk analysis

The medical device manufacturer shall undertake risk analysis to determine the content and detail of the information to be provided. The risk management undertaken by the manufacturer of the medical device shall conform with ISO 14971.

NOTE 1 Some of the points relevant to processing that any risk analysis can require (but not limited to) include:

— the likely points of contact with the user and/or the patient that might allow cross-contamination;

— nature and design of the medical device;

— nature of the contamination on the medical device;

— intended use;

— foreseeable user error and misuse;

— user training;

— equipment required for processing;

— accessories and consumables required for processing;

— necessary maintenance of the medical device;

— post-market information;

— service life;

— necessary warnings.

The points above can also be of benefit to those validating alternative processes in accordance with the NOTE 2 to 5.2.

NOTE 2 Annex C provides information on classification of medical devices, which can assist with any risk analysis process.

Validation of the processes identified in the information provided by the medical device manufacturer