Standard
[WITHDRAWN]
ISO 10555-4:2013-06
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
German title
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4: Ballondilatationskatheter
Publication date
2013-06
Original language
English
Pages
12
Publication date
2013-06
Original language
English
Pages
12
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Content
Content (en)
Foreword
Scope
Normative references
Terms and definitions
Requirements
Show subsection Close subsection General
Radio-detectability
Designation of nominal size
Physical requirements
Show subsection Close subsection Balloon rated burst pressure (RBP)
Balloon fatigue; freedom from leakage and damage on inflation
Balloon deflation time
Balloon diameter to inflation pressure
Information to be supplied by the manufacturer
Test for balloon rated burst pressure (RBP) (normative)
Show subsection Close subsection Principle
Apparatus
Test procedure
Test report
Balloon fatigue test for freedom from leakage and damage on inflation (normative)
Show subsection Close subsection Principle
Apparatus
Test procedure
Test report
Test for balloon deflation time (normative)
Show subsection Close subsection Principle
Apparatus
Test procedure
Test report
Test for balloon diameter to inflation pressure (normative)
Show subsection Close subsection Principle
Apparatus
Test procedure
Test report
Guidance on the selection of balloon materials (informative)
Bibliography
Cooperation at DIN
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