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BS EN ISO 10555-1 : 2013

Current
Current

The latest, up-to-date edition.

INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2013

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
CH/84
DevelopmentNote
Supersedes BS 7174-1(1990), 91/53634 DC and 97/565005 DC. (05/2005) Supersedes 02/563163 DC. (02/2006) Supersedes 11/30228364 DC. (07/2013)
DocumentType
Standard
Pages
36
PublisherName
British Standards Institution
Status
Current
Supersedes

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