ISO 20695:2020 -Enteral feeding systems — Design and testing
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.
Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated 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
- ISO 7886-2:1996, Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps
- ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- ISO 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 for forming, sealing and assembly process
- ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
- ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
- ISO 17665-1, 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 healthcare applications — 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 devices
- ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
- ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for 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
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