ISO 10555-1:2013
Withdrawn
Withdrawn
View Superseded by
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
Amended by
Available format(s)
Hardcopy , PDF
Published date
06-06-2013
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
ISO 10555-1:2013 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.
| Committee |
ISO/TC 84
|
| DevelopmentNote |
Supersedes ISO/DIS 10555-1. (06/2013) Supersedes ISO 10555-2. (08/2013)
|
| DocumentType |
Standard
|
| Pages |
24
|
| ProductNote |
THIS STANDARD HAVE CORRECT VERSION FOR FR AND EN-2014
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes | |
| UnderRevision |
| Standards | Relationship |
| DIN EN ISO 10555-1:2018-04 | Identical |
| EN ISO 10555-1:2013 | Identical |
| PN-EN ISO 10555-1:2013 | Identical |
| NBN EN ISO 10555-1 : 2013 | Identical |
| NF EN ISO 10555-1:2013 | Identical |
| I.S. EN ISO 10555-1:2013 | Identical |
| SS-EN ISO 10555-1:2013 | Identical |
| BS EN ISO 10555-1 : 2013 | Identical |
| GOST ISO 10555-1 : 2011 | Identical |
| DIN EN ISO 10555-1:2013-11 | Identical |
| NEN-EN-ISO 10555-1:2013 | Identical |
| PN EN ISO 10555-1 : 2013 AMD 1 2018 | Identical |
| BIS IS/ISO 10555-1 : 1995(R2009) | Identical |
| UNE-EN ISO 10555-1:2013 | Identical |
| NF EN ISO 10555-1 : 2013 AMD 1 2017 | Identical |
| NS EN ISO 10555-1 : 2013 AMD 1 2017 | Identical |
| NEN EN ISO 10555-1 : 2013 AMD 1 2018 | Identical |
| GOST R ISO 10555-1 : 1999 | Identical |
| DIN 13273-8:2012-09 | CATHETER FOR MEDICAL USE - PART 8: EPIDURAL CATHETERS |
| 13/30261812 DC : 0 | BS ISO 10555-6 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS |
| 13/30276989 DC : 0 | BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS |
| DD ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products |
| DIN EN ISO 12417-1:2016-02 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| I.S. EN ISO 10555-6:2017 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015) |
| 08/30170025 DC : DRAFT AUG 2008 | BS ISO 28620 - MEDICAL DEVICES - NON-ELECTRICALLY DRIVEN PORTABLE INFUSION DEVICES |
| 16/30282706 DC : 0 | BS ISO 11608-6 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 6: ON-BODY DELIVERY SYSTEMS |
| ANSI/AAMI/ISO 25539-2:2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
| DIN EN ISO 5840-3:2013-06 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| DIN EN ISO 10555-6:2017-11 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015) |
| DIN EN ISO 11070:2015-03 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014) |
| ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and guidewires |
| ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products |
| DIN EN ISO 10555-3:2013-11 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 3: CENTRAL VENOUS CATHETERS (ISO 10555-3:2013) |
| DIN EN ISO 10555-4:2013-11 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| ISO 10555-5:2013 | Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters |
| ISO 25539-3:2011 | Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters |
| I.S. EN ISO 10555-4:2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS (ISO 10555-4:2013) |
| I.S. EN ISO 10555-3:2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 3: CENTRAL VENOUS CATHETERS (ISO 10555-3:2013) |
| EN ISO 25539-3:2011 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| 17/30345938 DC : 0 | BS ISO 20698 - CATHETER SYSTEMS FOR NEURAXIAL APPLICATION - STERILE AND SINGLE-USE CATHETERS AND ACCESSORIES |
| 11/30235362 DC : 0 | BS EN ISO 10555-3 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 3: CENTRAL VENOUS CATHETERS |
| 14/30251609 DC : 0 | BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
| DIN EN ISO 25539-3:2012-03 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| AAMI ISO 12417-1 : 2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| ASTM F 2394 : 2007 : R2017 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
| BS EN ISO 11070 : 2014 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES |
| NF EN ISO 10555-6 : 2017 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS |
| ASTM F 2394 : 2007 : R2013 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
| BS EN 14299:2004 | Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents |
| I.S. EN ISO 10555-5:2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS (ISO 10555-5:2013) |
| EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| DIN EN 14299:2004-08 | NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
| 10/30196945 DC : 0 | BS ISO 25539-3 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| ISO 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
| ASTM F 2081 : 2006 : R2017 | Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| DIN 13230-2:1997-01 | AIRCRAFT FOR THE PATIENT TRANSPORT - PART 2: EQUIPMENT OF AIRCRAFTS |
| BS EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements |
| EN ISO 10555-6:2017 | Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015) |
| 01/564791 DC : DRAFT NOV 2001 | BS EN 14299 - NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
| BS ISO 28620:2010 | Medical devices. Non-electrically driven portable infusion devices |
| ANSI/AAMI/ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| ASTM F 2081 : 2006 : R2013 | Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| 11/30235365 DC : 0 | BS EN ISO 10555-4 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS |
| BS ISO 25539-1 : 2003 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| BS EN ISO 5840-3:2013 | Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques |
| I.S. EN ISO 12417-1:2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
| AAMI ISO 25539-3 : 2011 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| I.S. EN ISO 11070:2014 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014) |
| I.S. EN ISO 25539-3:2011 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011) |
| BS EN ISO 10555-6:2017 | Intravascular catheters. Sterile and single-use catheters Subcutaneous implanted ports |
| ISO 10555-6:2015 | Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports |
| DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| ISO 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
| BS EN ISO 10555-4:2013 | Intravascular catheters. Sterile and single-use catheters Balloon dilatation catheters |
| ISO 10555-2:1996 | Sterile, single-use intravascular catheters — Part 2: Angiographic catheters |
| EN ISO 25539-2:2012 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| ASTM F 2394 : 2007 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
| PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| I.S. EN ISO 25539-2:2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012) |
| BS EN ISO 25539-2:2012 | Cardiovascular implants. Endovascular devices Vascular stents |
| 16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| 01/563350 DC : DRAFT AUG 2001 | BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| 11/30219211 DC : 0 | BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
| ISO/TR 12417-2:2017 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information |
| DIN EN ISO 25539-2:2013-05 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
| ISO 5840-3:2013 | Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques |
| ISO 25539-2:2012 | Cardiovascular implants — Endovascular devices — Part 2: Vascular stents |
| BS EN ISO 10555-5:2013 | Intravascular catheters. Sterile and single-use catheters Over-needle peripheral catheters |
| BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
| I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| ISO 10555-3:2013 | Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters |
| ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
| I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| EN ISO 10555-5:2013 | Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013) |
| EN ISO 10555-3:2013 | Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013) |
| EN 14299:2004 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents |
| EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| EN ISO 10555-4:2013 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| AAMI ISO TIR 12417 : 2011 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| BS ISO 10555-6 : 2015 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS |
| BS EN ISO 25539-3:2011 | Cardiovascular implants. Endovascular devices Vena cava filters |
| ASTM F 2081 : 2006 | Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| 16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
| 11/30235338 DC : 0 | BS EN ISO 10555-5 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS |
| EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| ISO 28620:2010 | Medical devices — Non-electrically driven portable infusion devices |
| DIN EN ISO 10555-5:2013-11 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS (ISO 10555-5:2013) |
| ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| BS EN ISO 10555-3:2013 | Intravascular catheters. Sterile and single-use catheters Central venous catheters |
| BS EN ISO 10555-2:1997 | Sterile, single-use intravascular catheters Angiographic catheters |
| DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| DIN EN ISO 25539-1:2017-09 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| UNE-EN ISO 25539-3:2012 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| UNE-EN ISO 12417-1:2016 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| UNE-EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| UNE-EN ISO 25539-2:2013 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| UNE-EN ISO 10555-5:2014 | Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013) |
| UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| UNE-EN ISO 11070:2015 | Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014) |
| UNE-EN ISO 10555-3:2013 | Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013) |
| UNE-EN ISO 10555-4:2014 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| 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 11607-2:2006 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| 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 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 3105:1994 | Glass capillary kinematic viscometers — Specifications and operating instructions |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings |
| 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 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — 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 |
| ASTM F 640 : 2012 : REDLINE | Standard Test Methods for Determining Radiopacity for Medical Use |
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US$96.00
Excluding Tax where applicable
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