ISO 10555-4 : 2013(R2018)

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INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS

Publisher: International Organization for Standardization

Published: 01-01-2013

Available Formats: PDF - Russian, Hardcopy - Russian, PDF - French, Hardcopy - French, PDF - English, Hardcopy - English
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Table of Contents - (Show below) - (Hide below)

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (normative) - Test for balloon rated burst
        pressure (RBP)
Annex B (normative) - Balloon fatigue test for freedom
        from leakage and damage on inflation
Annex C (normative) - Test for balloon deflation time
Annex D (normative) - Test for balloon diameter to
        inflation pressure
Annex E (informative) - Guidance on the selection of
        balloon materials
Bibliography

Abstract - (Show below) - (Hide below)

This part of ISO 10555 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.

General Product Information - (Show below) - (Hide below)

Published
Document Type	Revision
Status	Current
Publisher	International Organization for Standardization
ProductNote	THIS STANDARD ALSO REFER-CEI 80369-6
Pages
ISBN
Committee	TC 84
Supersedes	ISO 10555-4 : 1996 ISO/DIS 10555-4 : 60.00 (2013)

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
DIN EN ISO 10555-4 E : 2013	Identical
DS EN ISO 10555-4 : 2013	Identical
GOST ISO 10555-4 : 2012	Identical
NF EN ISO 10555-4 : 2013	Identical
NBN EN ISO 10555-4 : 2013	Identical
NEN EN ISO 10555-4 : 2013	Identical
NS EN ISO 10555-4 : 2013	Identical
I.S. EN ISO 10555-4:2013	Identical
PN EN ISO 10555-4 : 2013	Identical
SN EN ISO 10555-4 : 2013	Identical
UNI EN ISO 10555-4 : 2013	Identical
SS-EN ISO 10555-4:2013	Identical
UNE EN ISO 10555-4 : 2014	Identical
BS EN ISO 10555-4 : 2013	Identical
EN ISO 10555-4 : 2013	Identical
DIN EN ISO 10555-4 : 2013	Identical
DIN EN ISO 10555-4 : 2013	Identical
DS EN ISO 10555-4 : 2013	Identical
UNE EN ISO 10555-4 : 2014	Identical
BIS IS/ISO 10555-4 : 1996(R2009)	Identical
BS EN ISO 10555-4 : 2013	Identical
PN EN ISO 10555-4 : 2013	Identical
SS-EN ISO 10555-4:2013	Identical
GOST R ISO 10555-4 : 1999	Identical
NBR ISO 10555-4 : 2003	Identical
GOST ISO 10555-4 : 2012	Identical
DIN EN ISO 10555-4 E : 2013	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

UNE-EN ISO 25539-2:2013	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
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 - PART 1: ENDOVASCULAR PROSTHESES
DIN EN ISO 25539-2 E : 2013	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
ASTM F 2081 : 2006	GUIDE FOR CHARACTERIZATION AND PRESENTATION OF THE DIMENSIONAL ATTRIBUTES OF VASCULAR STENTS
DD ISO/TS 12417 : 2011	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
13/30276989 DC : 0	BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS
DIN EN ISO 25539-1 : 2015	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
ASTM F 2081 : 2006 : R2017	Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
14/30251609 DC : 0	BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
EN ISO 11070:2014	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
DIN EN ISO 12417-1 : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
BS EN ISO 12417-1 : 2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
DIN EN ISO 11070 E : 2015	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
ASTM F 2081 : 2006	Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
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 EN ISO 25539-2 : 2012	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
01/563350 DC : DRAFT AUG 2001	BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
DIN EN ISO 25539-1 E : 2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
ASTM F 2081 : 2006 : R2013	Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
AAMI ISO 25539-2 : 2012	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
AAMI ISO 25539-1 : 2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
BS ISO 25539-1 : 2003	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
UNE EN ISO 12417-1 : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
UNI EN ISO 25539-2 : 2013	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
ISO/TR 12417-2:2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 2: LOCAL REGULATORY INFORMATION
I.S. EN ISO 25539-2:2012	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
UNE EN ISO 11070 : 2015	Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
DIN EN ISO 25539-2 : 2013	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
AAMI ISO 12417-1 : 2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
BS EN ISO 11070 : 2014	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
I.S. EN ISO 25539-1:2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
ISO TS 12417 : 2011	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
I.S. EN ISO 11070:2014	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
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)
DIN EN ISO 11070 : 2015	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
UNI EN ISO 11070 : 2015	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
DIN EN ISO 12417-1 E : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
ISO 11070 : 2014	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
BS EN 14299 : 2004	NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
ISO 25539-1 : 2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
BS EN 12006-3 : 1999	NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES
ISO 25539-2 : 2012	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
UNE EN ISO 11070 : 2015	Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
ISO 12417-1 : 2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
EN ISO 25539-2 : 2012	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)

Standards Referencing This Book - (Show below) - (Hide below)

ISO 11070 : 2014	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
ISO 25539-2 : 2012	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
ISO 14630 : 2012	NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
93/42/EEC : 1993 AMD 5 2007	COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES
ISO TS 12417 : 2011	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
ISO 10555-1 : 2013(R2018)	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
ISO 80369-7 : 2016	SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
ISO 594-2 : 1998	CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 2: LOCK FITTINGS
ISO 594-1 : 1986	CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS

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ISO 10555-4 : 2013(R2018)

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Standards Referenced By This Book - (Show below) - (Hide below)

Standards Referencing This Book - (Show below) - (Hide below)

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