ISO 20695-2020 pdf free.Enteral feeding systems — Designand 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.
2.Normative 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 700o, 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-drivensyringe pumps
ISO 10993-1，Biological evaluation of medical devices — Part 1: Evaluation and testing within a riskmanagement 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 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 devices.
ISO 15223-1,Medical devices —Symbols to be used with medical device labels, labelling and information tobe supplied — Part 1: General requirements
ISO 17665-1,Sterilization of health care products—Moist heat—Part 1: Requirements forthe 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 一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.ISO 20695 pdf download.