ISO 20695-2020 pdf download.Enteral feeding systems一Design and testing. 4.6 Cleaning and disinfection If not labelled for single use, the medical device shall be capable of being cleaned, disinfected, or sterilized, according to the manufacturer’s instructions, without affecting the ability of the medical device to meet the requirements of this document throughout its claimed use life. NOTE ISO 17664 provides requirements and guidance for information provided by the supplier for the processing of reusable medical devices. Check conformity by inspection of the technical file. 4.7 Sterility All devices supplied as “STERILE” shall be sterilized using a sterilization process that has been validated and is routinely controlled in accordance with an International Standard for the applicable method of sterilization to demonstrate achievement of a maximal sterility assurance level (SAL) of 10-6, i.e. applicable parts of ISO 17665-1, ISO 11135, ISO 11137-1, ISO 25424 or ISO 14937. Check conformity by inspection of the technical file. 4.8 Packaging All medical devices supplied and marked as ‘STERILE shall be contained in a packaging system conforming to ISO 11607-1 and ISO 11607-2. Check conformity by inspection of the technical file. 4.9 Biological safety Enteral feeding systems shall be evaluated for biological safety in accordance with ISO 10993-1. Check conformity by inspection of the technical file. 4.10 Corrosion resistance Any metallic component exposed to the patient or in contact with enteral fluids or substances shall be manufactured from corrosion resistant materials. Check conformity by the test given in Annex B. 4.11 Surface finish External surfaces of the parts of the enteral devices that are inserted into the body shall be free from- extraneous matter and process and surface defects that can present an unacceptable risk of patient harm. Check conformity by visual inspection by normal or corrected vision under a minimum 2,5 x magnification under an illuminance of215 ± S Ix. 4.12 Information supplied by the manufacturer 4.12.1 Marking If present, markings on the devices shall be clearly legible and durable. Check conformity by rubbing the markings, without undue pressure, with a cloth soaked in either ethanol or isopropanol.ISO 20695 pdf download.
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