Name: EN ISO 10555-1:2013/A1:2017
Brand: CEN

INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)

Published date

12-20-2017

Publisher

Comite Europeen de Normalisation

European Foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Designation of nominal size
6 Information to be supplied by the manufacturer
Annex A (normative) - Test method for corrosion
        resistance
Annex B (normative) - Method for determining peak
        tensile force
Annex C (normative) - Test method for liquid leakage
        under pressure
Annex D (normative) - Test method for air leakage
        into hub assembly during aspiration
Annex E (normative) - Determination of flowrate
        through catheter
Annex F (normative) - Test for burst pressure under
        static conditions
Annex G (normative) - Power injection test for
        flowrate and device pressure(only for products
        indicated for power injection)
Annex H (informative) - Units of measurement systems
        other than those specified in this part of
        ISO 10555, which may additionally be used
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC amended by Directive
         2007/47/EEC
Bibliography

Describes general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.

Committee	CEN/TC 205
DevelopmentNote	Supersedes EN ISO 10555-2. (10/2013)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current
Supersedes	EN ISO 10555-1:2013

Standards	Relationship
ISO 10555-1:2013	Identical
UNI EN ISO 10555-1 : 2013	Identical
NS EN ISO 10555-1 : 2013 AMD 1 2017	Identical
UNI EN ISO 10555-1:2018	Identical
I.S. EN ISO 10555-1:2013	Identical
SN EN ISO 10555-1 : 2013	Identical
BS EN ISO 10555-1 : 2013	Identical
NBN EN ISO 10555-1 : 2013	Identical
UNE-EN ISO 10555-1:2013	Identical
ONORM EN ISO 10555-1 : 2018	Identical
NF EN ISO 10555-1:2013	Identical
DIN EN ISO 10555-1:2013-11	Identical
DIN EN ISO 10555-1:2018-04	Identical
UNE-EN ISO 10555-1:2013/A1:2018	Identical
BS EN ISO 10555-1:2013+A1:2017	Identical

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