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BS EN ISO 10555-1-2013 Intravascular catheters. Sterile and single-use catheters. General requirements

Standard Number:  BS EN ISO 10555-1-2013
Title:  Intravascular catheters. Sterile and single-use catheters. General requirements
Language:  English
Replacing Standard:  BS EN ISO 10555-1-2009

Publication Date:  2013/7/31
Execute Date:  2013/7/31
Adopted International Standard:  EN ISO 10555-1-2013,ISO 10555-1-2013
Status:  Current
International Classification for Standards (ICS)
Publisher:  British Standards
Price:  
Number of Pages:36  

Description:Describes general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.  
Cross References:ISO 594-1, ISO 594-2, ISO 7886-1, ISO 15223-1, ISO 3104, ISO 3105, ISO 80369-1, ISO 80369-7, ISO 10993-1, ISO 11135-1, ISO 11137-1, ISO 11607-1, ISO 11607-2, ISO/TS 12417, ISO 14971, ISO 17665-1, IEC 80369-6, ASTM F640-12, 2007/47/EEC, 93/42/EEC  
Catalog: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  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  119KB
Tile in English:  Intravascular catheters. Sterile and single-use catheters. General requirements

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