ISO 11070 Sterile single-use intravascular introducers, dilators and guidewires test machine
ISO 11070:2014-Sterile single-use intravascular introducers, dilators and guidewires
Scope
This International Standard specifies requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in ISO 10555-1.
NOTE Guidance on materials and design of accessory devices is given in Annex A.
Normative references
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 594-11, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
- ISO 594-22, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
- ISO 7886-1, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
- ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times
- ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
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