ISO 20695:2020 pdf download.Enteral feeding systems – Design and testing (ISO 20695:2020)
4 General requirements
4.1 General
The following requirements apply to all components of the enteral feeding system unless superseded in the specific requirements in Clauses 5, 6, 7 and 8.
4.2 Risk management
An established risk management process shall be applied to the design and development of the enteral feeding system.
NOTE ISO 14971 provides requirements and guidance for risk management of medical devices.
Check conformity by inspection of the risk management file.
4.3 Usability
An established usability engineering process shall be applied to the design of the enteral feeding system to assess and mitigate risks caused by usability problems associated with correct use and use errors.
NOTE IEC 62366-1 provides requirements and guidance on the application of usability of medical devices.
Check conformity by inspection of the usability-engineering file.
4.4 Test methods
The medical device shall be tested in accordance with the test methods specified in Annexes B to J.
Alternative test methods may be used if an equivalent degree of safety is obtained and the results of those alternative test methods can be related to the results obtained using the test methods specified in this document.
Check conformity by inspection of the technical file.
4.5 Materials
For certain materials, specific labelling and risk assessment requirements might apply, depending on national or regional regulations.
EXAMPLE Natural rubber latex, certain plasticizers used in polyvinyl chloride (PVC).
Check conformity by inspection of the technical file.
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 × 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 soaked 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;
b) the name and address of the manufacturer and, where appropriate, the name and address of the manufacturers’ authorized representative;
c) the details necessary for the user to identify the enteral feeding device or contents of the packaging;ISO 20695 pdf download.ISO 20695 pdf download
