DIN EN ISO 10555-1:2018
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013 + Amd 1:2017); German version EN ISO 10555-1:2013 + A1:2017

Standard No.

DIN EN ISO 10555-1:2018

Release Date

2018

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 10555-1:2018-04

Latest

DIN EN ISO 10555-1:2024-03

Replace

DIN EN ISO 10555-1:2013 DIN EN ISO 10555-1/A1:2016

Scope

This part of DIN EN ISO 10555 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.

DIN EN ISO 10555-1:2018 Referenced Document

• 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
• DIN 51366:2013 Testing of mineral oil hydrocarbons - Measurement of kinematic viscosity by means of the Cannon-Fenske viscometer for opaque liquids
• DIN EN 1707:1997 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings; German version EN 1707:1996
• DIN EN 20594-1:1995 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986); German version EN 20594-1:1993
• DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
• DIN EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); English version of DIN EN ISO 11135-1:2007-08
• DIN EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013); German version EN ISO 11137-1:2015
• DIN EN ISO 11607-1:2017 Packaging for medical devices to be sterilized in the final packaging – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1.:2014); German version EN ISO 11607-1:2017
• DIN EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017
• DIN EN ISO 14971:2013 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012
• DIN EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03); German version EN ISO 15223-1:2016, with CD-ROM
• DIN EN 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 17665-1:2006); English version of DIN EN ISO 17665-1:2006-11
• DIN EN ISO 3104:1999 Petroleum products - Transparent and opaque liquids - Determination of kinematic viscosity and calculation of dynamic viscosity (ISO 3104:1994 + Cor. 1:1997); German version EN ISO 3104:1996 + AC:1999
• DIN EN ISO 7886-1:1997 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995); German version EN ISO 7886-1:1996
• DIN EN ISO 80369-1:2011 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010); German version EN ISO 80369-1:2010
• DIN EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for 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 1160 Rolling bearings for railway axle-boxes — Acceptance inspection
• ISO 3104:1994 Petroleum products - Transparent and opaque liquids - Determination of kinematic viscosity and calculation of dynamic viscosity
• ISO 3105:1994 Glass capillary kinematic viscometers - Specifications and operating instructions
• ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
• ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
• ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

DIN EN ISO 10555-1:2018 history

• 2024 DIN EN ISO 10555-1:2024-03 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023); German version EN ISO 10555-1:2023
• 2022 DIN EN ISO 10555-1:2022-12 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO/DIS 10555-1:2022); German and English version prEN ISO 10555-1:2022 / Note: Date of issue 2022-11-18*Intended as replacement for DIN EN ISO 10555-1 (2018-04).
• 2018 DIN EN ISO 10555-1:2018-04 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013 + Amd 1:2017); German version EN ISO 10555-1:2013 + A1:2017 / Note: To be replaced by DIN EN ISO 10555-1 (2022-12).
• 2018 DIN EN ISO 10555-1:2018 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013 + Amd 1:2017); German version EN ISO 10555-1:2013 + A1:2017
• 2013 DIN EN ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013); German version EN ISO 10555-1:2013
• 1970 DIN EN ISO 10555-1:2009 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
• 1997 DIN EN ISO 10555-2:1997 Sterile single-use intravascular catheters Part 2: Angiography catheters