ISO 10555-1:2013
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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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Withdrawn date
09-04-2025
Superseded by
€63.00
Excluding VAT
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Withdrawn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 |
| ONORM EN ISO 10555-1 : 2018 | 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) |
| ANSI/AAMI/ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
| 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 |
| ONORM EN 13718-2 : 2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| 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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