ISO 20697:2018
Sterile drainage catheters and accessory devices for single use

Standard No.

ISO 20697:2018

Release Date

2018

Published By

International Organization for Standardization (ISO)

Latest

ISO 20697:2018

Scope

This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior. The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation. This document is not applicable to: a) suction catheters; c) urethral catheters; b) tracheal catheters; NOTE NOTE d) ureteral stents, biliary stents, and other stents; e) f) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique; neuraxial catheters used for removal of cerebrospinal fluid; NOTE NOTE g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract; h) coatings.

ISO 20697:2018 Referenced Document

• ASTM F1828-97 Standard Specification for Ureteral Stents
• ASTM F1842-15 Standard Test Method for Determining Ink or Coating Adhesion on Flexible Substrates for a Membrane Switch or Printed Electronic Device*， 2024-04-20 Update
• ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment*， 2024-04-20 Update
• ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants*， 2024-04-20 Update
• ASTM F2182-11 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging*， 2024-04-20 Update
• ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use*， 2024-04-20 Update
• DIN 13273-7:2003 Catheters for medical use - Part 7: Determination of the x-ray attenuation of catheters; Requirements and testing
• EN 1041:2008 Information supplied by the manufacturer of medical devices
• EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-20 Update
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
• ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
• ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
• ISO 14630:2012 Non-active surgical implants - General requirements
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• ISO 17665-1:2006 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 20695 Enteral feeding systems — Design and testing*， 2020-03-27 Update
• ISO 20696:2018 Sterile urethral catheters for single use
• ISO 20698 Catheter systems for neuraxial application — Sterile and single-use catheters and accessories*， 2018-07-26 Update
• ISO 8036 Microscopes - Immersion liquids for light microscopy (includes Redline Version)
• ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters

ISO 20697:2018 history

• 2018 ISO 20697:2018 Sterile drainage catheters and accessory devices for single use