I.S. EN ISO 10555-4:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS (ISO 10555-4:2013)
Hardcopy , PDF
07-12-2023
English
01-01-2013
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC amended by Directive 2007/47/EEC
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