ISO 20695 pdf download

ISO 20695 pdf download Enteral feeding systems — Design and testing
1 Scope
This document specifies requirements for enteral feeding systems comprising enteral giving sets,enteral extension sets,enteral syringes,enteral feeding catheters,and enteral accessories.
This document is not applicable to oral syringes.
2Normative references
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references, only the edition cited applies. Forundated references, the latest edition of the referenced document (including any amendments) applies.ISo 7000,Graphical symbols for use on equipment — Registered symbols
ISo 7886-1:2017, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
IS0 7886-2:1996, Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-drivensyringe pumps
ISo 10993-1，Biological evaluation of medical devices — Part 1: Evaluation and testing within a riskmanagement process
IS0 11135,Sterilization of health-care products — Ethylene oxide —Requirements for the development.validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products —Radiation — Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
ISO 11607-1，Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,sterile barrier systems and packaging systems
ISO 11607-2,Packaging for terminally sterilized medical devices — Part 2: Validation requirements forforming, sealing and assembly process
IS0 14937,Sterilization of health care products —General requirements for characterization of a sterilizingagent and the development, validation and routine control of a sterilization process for medical devicesIS0 15223-1,Medical devices —Symbols to be used with medical device labels, labelling and information tobe supplied -Part 1: General requirements
ISO17665-1,Sterilization of health care products—Moist heat—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
ISO 18250-3:2018，Medical devices – Connectors for reservoir delivery systems for healthcareapplications — Part 3: Enteral applications
ISO 25424，Sterilization of health care products – Low temperature steam and formaldehyde -Requirements for development, validation and routine control of a sterilization process for medical devicesISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications — Part 1: Generalrequirements
ISO 80369-3,Small-bore connectors for liquids and gases in healthcare applications — Part 3:Connectorsfor enteral applications
ASTM F640, Standard Test Methods for Determining Radiopacity for Medical Use
DIN 13273-7, Catheter for medical use- Part 7: Determination of the x-ray attenuation of catheters;
requirements and testing
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
-ISO Online browsing platform: available at https://www.iso.org/obp
-IEC Electropedia: available at http://www.electropedia.org/
3.1
distal end
end of the medical device furthest from the source of the nutrient or diet intended to be administered
via an enteral feeding catheter (3.5)
Note 1 to entry: See Eigure 1.
3.2
proximal end
end of the medical device closest to the source of nutrient or diet intended to be administered via an
enteral feeding catheter (3.5)
Note 1 to entry: See Figure 1
3.3
enteral feeding system
system comprising the following enteral feeding devices: enteral giving sets (3.6), enteral syringes (3.8),
enteral feeding catheters (3.5), and enteral accessories (3.4)
3.4
enteral accessory
medical device that is used within the enteral system for the purposes of device placement or access
of an enteral device; or for the purposes of flling, directing, stopping, or controlling flow of nutrients,
medication, or aspirates
EXAMPLE
Sheaths, guidewires, introducers.
3.5
enteral feeding catheter
indwelling tubular medical device to facilitate delivery or removal of fluids or substances into or from
the gastrointestinal tract
3.6
enteral giving set
medical device for transferring enteral fluids or substances from an enteral reservoir to an enteral
feeding catheter (3.5)
Note 1 to entry: Also known as enteral feeding sets.