ISO 10555-1:2023 Intravascular Catheters (Sterile, Single-Use) — General Requirements

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ISO 10555 is the international standard for sterile, single-use intravascular catheters, setting general requirements for design verification and quality control. To match this to your program, talk with our team.

What ISO 10555 Covers

It defines the requirements, including tensile and related mechanical checks, used to verify catheter integrity and performance.

How the Test Is Run

Catheter specimens are subjected to the applicable tests, including tensile pull on the catheter and its bonds, and results are checked against the requirements.

Why It Matters

Mechanical verification supports catheter safety and reliability; low-force grips and sensitive measurement suited to delicate tubing are essential.

Reading the Designation

Cited as ISO 10555 with its edition year. Confirm the edition and specimen or fixture requirements before finalizing setup. To configure a testing setup, request a quote.

Related Standards

ISO 7206-4, ISO 7206-13, and ISO 14879-1 cover orthopedic implant testing.

Request a Quote

Setting up intravascular catheter testing to ISO 10555? Request a quote and our team will help you build a system matched to your catheter size and grip fixturing.

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Equip your lab for ISO 10555 with TensileMill CNC

TensileMill CNC builds testing systems used across quality control, research, and production. For this work we supply universal testing machines, specimen-preparation systems, grips, and fixtures. Tell us your materials, specimen forms, and required test sections, and our team will match the right configuration.