EN ISO 10555-1:2009
Sterile, single-use intravascular catheters - Part 1: General requirements

Standard No.

EN ISO 10555-1:2009

Release Date

2009

Published By

European Committee for Standardization (CEN)

Status

Be replaced 2013-07

Replace By

EN ISO 10555-1:2013

Latest

EN ISO 10555-1:2023

Scope

This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices

EN ISO 10555-1:2009 history

• 2023 EN ISO 10555-1:2023 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)
• 2017 EN ISO 10555-1:2013/A1:2017 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements - Amendment 1 (ISO 10555-1:2013/Amd 1:2017)
• 2013 EN ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
• 2009 EN ISO 10555-1:2009 Sterile, single-use intravascular catheters - Part 1: General requirements
• 1996 EN ISO 10555-1:1996 Sterile@ Single-Use Intravascular Catheters - Part 1: General Requirements (Incorporates Amendments A1: 1999 and A2: 2004)