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NEN EN ISO 10555-1 : 2013 AMD 1 2018

Current

Current

The latest, up-to-date edition.

INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS

Published date

01-12-2013

Committees responsible
      National foreword
      Foreword
1 Scope
2 Normative References
3 Definitions
4 Requirements
5 Designation of nominal size
6 Information to be supplied by manufacturer
Annex A (normative) Test method for corrosion resistance
Annex B (normative) Method for determining force at break
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 (informative) Bibliography
Annex ZA (normative) Normative references to international
                     publications with their relevant
                     European publications
Annex ZB (informative) Clauses of this European Standard
                       addressing essential requirements or
                       other provisions of the EU Directives
Figure 1 - Examples of effective length of catheters
Table 1 - Force at break of catheter test pieces
Table B.1 - Examples of conditions for 20mm/min/mm strain rate
Table ZB.1 - Correspondence between clauses of this European
             Standard and the essential requirements of EU
             Directives
List of references

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

DevelopmentNote
Supersedes NEN EN ISO 10555-2. (04/2014)
DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

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