Sterile, single-use intravascular catheters – Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)
DIN EN ISO 10555-1:2013-11 (E nglisch)
Intravascular catheters – Sterile and single-use catheters – Part 1: General req
uirements (ISO 10555-1:2013)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
1 Scope …………………………………………………………………………………………………………………………….. 4
2 Normative references …………………………………………………………………………………………………….. 4
3 Terms and definitions …………………………………………………………………………………………………….. 4
4 Requirements ………………………………………………………………………………………………………………… 7
4.1 General ………………………………………………………………………………………………………………………….. 7
4.2 Radio-detectability …………………………………………………………………………………………………………. 7
4.3 Biocompatibility …………………………………………………………………………………………………………….. 7
4.4 Surface ………………………………………………………………………………………………………………………….. 7
4.5 Corrosion resistance ……………………………………………………………………………………………………… 7
4.6 Peak tensile force …………………………………………………………………………………………………………… 7
4.7 Freedom from leakage ……………………………………………………………………………………………………. 8
4.8 Hubs ……………………………………………………………………………………………………………………………… 8
4.9 Flowrate …………………………………………………………………………………………………………………………. 8
4.10 Power injection ………………………………………………………………………………………………………………. 8
4.11 Side holes ……………………………………………………………………………………………………………………… 8
4.12 Distal tip ………………………………………………………………………………………………………………………… 8
5 Designation of nominal size ……………………………………………………………………………………………. 8
5.1 Outside diameter ……………………………………………………………………………………………………………. 8
5.2 Nominal effective length …………………………………………………………………………………………………. 9
6 Information to be supplied by the manufacturer ……………………………………………………………… 9
6.1 General ………………………………………………………………………………………………………………………….. 9
6.2 Marking on the device and/or primary packaging ……………………………………………………………. 9
6.3 Instructions for use ………………………………………………………………………………………………………. 10
6.4 Marking on the secondary packaging ……………………………………………………………………………. 10
Annex A (normative) Test method for corrosion resistance ………………………………………………………….. 11
Annex B (normative) Method for determining peak tensile force …………………………………………………… 12
Annex C (normative) Test method for liquid leakage under pressure …………………………………………….. 14
Annex D (normative) Test method for air leakage into hub assembly during aspiration …………………. 16
Annex E (normative) Determination of flowrate through catheter ………………………………………………….. 18
Annex F (normative) Test for burst pressure under static conditions ……………………………………………. 20
Annex G (normative) Power injection test for flowrate and device pressure (only for products
indicated for power injection) ……………………………………………………………………………………….. 22
Annex H (informative) Units of measurement systems other than those specified in this part of ISO
10555, which may additionally be used …………………………………………………………………………. 25
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC ……………….. 27
Bibliography ……………………………………………………………………………………………………………………………….. 29