EN ISO 10555-1:2013
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements

Standard No.
EN ISO 10555-1:2013
Release Date
2013
Published By
European Committee for Standardization (CEN)
Status
 2018-03
Replace By
EN ISO 10555-1:2013/A1:2017
Latest
EN ISO 10555-1:2023
Replace
FprEN ISO 10555-1:2013
Scope
This part of ISO 10555 specifies general requirements for intravascular catheters of any intended use, supplied sterile and intended for single use. It does not apply to accessories for intravascular catheters, e.g. B. which are recorded in ISO 11070.

EN ISO 10555-1:2013 Referenced Document

  • ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
  • ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
  • ISO 7886-1:1993 Sterile hypodermic syringes for single use; part 1: syringes for manual use

EN ISO 10555-1:2013 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)

EN ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements has been changed from EN ISO 10555-2:1997 Sterile, single-use intravascular catheters - Part 2: Angiographic catheters (Incorporating corrigendum July 2002).

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements



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