ISO 20695:2020
Enteral feeding systems — Design and testing

Standard No.

ISO 20695:2020

Release Date

2020

Published By

International Organization for Standardization (ISO)

Latest

ISO 20695:2020

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.

ISO 20695:2020 Referenced Document

• DIN 13273-7 Catheter for medical use - Part 7: Determination of the x-ray attenuation of catheters; requirements and testing*， 2020-12-01 Update
• 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 AMENDMENT 1: Revision of Annex E, Single batch release
• 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 AMENDMENT 2: Revision to 4.3.4 and 11.2
• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
• ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
• 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 information to be supplied by the manufacturer-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 — Amendment*， 2022-01-12 Update
• ISO 7000 Graphical symbols for use on equipment — Index and synopsis
• 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 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 — Amendment 2: .

ISO 20695:2020 history

• 2020 ISO 20695:2020 Enteral feeding systems — Design and testing