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ISO 20695 pdf free download

ISO 20695-2020 pdf free download.Enteral feeding systems一Design and testing.
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 of 215 ± 5 lx.
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 soakea in either ethanol or isopropanol.
Verify that the markings can be viewed from a distance of 50 cm ± 10 cm by an operator having a normal or corrected-to-normal vision.
4.12.2 Symbols
Symbols should be used where appropriate and shall be in accordance with ISO 15223-1 or ISO 7000.
If symbols that are used are not defined in either of these International Standards, national or regional standards may be used or the symbols shall be described in the instructions for use (see 4.12.4 g).
Check conformity by inspection.
4.12.3 Labelling
The information provided on enteral feeding system labelling shall conform to relevant international and national requirements for those medical devices. The packaging (sterile barrier system and/or packaging system) shall be labelled with the following information as a minimum:
a) the name or trade name of the enteral feeding device;
h) the name and address of the manufacturer and, where appropriate, the name and address of the manu facturers’ authorized representative;
c) the details necessary for the user to identify the enteral feeding device or contents of the packaging;
d) where appropriate, the word ‘STERILE’ and the method used to sterilize the enteral feeding device;
e) the batch code, preceded by the word “LOT”;
f) an indication of the date by which the enteral feeding device should be used, expressed at least as the year and month;
g) any special storage or handling conditions;
h) if appropriate, an indication that the device is for single patient use (a manufacturer’s indication of single use shall be consistent across its range).
NOTE Applicable regulatory requirements for Unique Device Identifier (LJDI) can apply.
4.12.4 Instructions for use
If present, the instructions for use shall include at least the following information:
a) where appropriate, an indication that the device is for single use or single patient use (a manufacturer’s indication of single use shall be consistent across its range);
b) any special operating instructions required for safe and effective use of the device;
c) any specific warnings or precautions;
d) where applicable, the method of cleaning, disinfecting or sterilization necessary prior to use;
e) where applicable, Magnetic Resonance Imaging (MRI) compatibility information;
f) the date of issue or the revision level of the instructions for use;
g) where applicable, a description of any symbols used on the device or labelling (see 4.12.2 and 4.12.3).ISO 20695 pdf download.

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