Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
ISO 10555 consists of the following parts, under the general title Intravascular catheters — Sterile and single-use catheters:
— Part 1: General requirements
— Part 3: Central venous catheters
— Part 4: Balloon dilatation catheters
— Part 5: Over-needle peripheral catheters
The following part is under preparation:
— Part 6: Subcutaneous implanted ports
The following part has been withdrawn and the content has been included in ISO 10555‑1:
— Part 2: Angiographic catheters
Attention is drawn to ISO 11070, which specifies requirements for accessory devices for use with intravascular catheters.
This corrected version of ISO 10555-1:2013 incorporates an editorial correction in H.3.
This part of ISO 10555 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.
lt is not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
- ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements1
- ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings1)
- ISO 7886-1, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
- ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements