ISO 10555-1-2023 PDF

Full title and description

ISO 10555-1:2023 — Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements. This International Standard specifies general requirements for intravascular catheters supplied sterile and intended for single use, covering design, performance, labelling and information to be supplied by the manufacturer for safe clinical use.

Abstract

ISO 10555-1:2023 sets out the general requirements and test considerations applicable to sterile, single-use intravascular catheters for any application. It addresses risk-based requirements including usability engineering, sterilization, biocompatibility, mechanical performance (tensile, leakage, burst), dimensional designation, packaging and information for safe use; it explicitly excludes intravascular catheter accessories covered by ISO 11070.

General information

• Status: Published.
• Publication date: November 2023 (Edition 3, published 14 November 2023 in the ISO record).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: Edition 3 (2023).
• Number of pages: 43 pages (ISO bibliographic entry).

Scope

Applies to intravascular catheters that are supplied in the sterile condition and intended for single use, for any clinical application. The standard provides general, risk‑based requirements and test methods to determine conformity for design and performance aspects relevant to safe use. ISO 10555-1:2023 does not apply to intravascular catheter accessories (for example, those covered by ISO 11070).

Key topics and requirements

• Risk management and usability engineering: adoption of a risk‑based approach and consideration of usability (references to IEC 62366-1 where applicable).
• Sterilization and shelf-life: requirements for sterile barrier systems and packaging validation (references to ISO 11607 series where applicable).
• Biocompatibility and materials: biological evaluation per ISO 10993 series and corrosion/resistance considerations.
• Mechanical performance tests: tensile strength, leakage under pressurization and aspiration, burst/power injection tests, kink and torque testing as applicable to design and risk analysis.
• Dimensional designation and labelling: designation of nominal sizes (outside/inside diameters), colour coding where applicable, and required user information (instructions for use and markings in SI units, with additional units for some neurovascular measurements).
• Packaging and identification: requirements for sterile packaging systems, marking, traceability and information to be supplied to the user.
• Device‑specific considerations to be selected based on device design and risk: simulated use, coating integrity/particulate testing, distal tip stiffness testing for neurovascular applications and other performance evaluations as required by the risk assessment.

Typical use and users

Primary users are medical device manufacturers (design, testing and regulatory teams), conformity assessment bodies and test laboratories, hospital procurement and clinical engineering teams, and regulatory authorities. Clinicians and clinical educators may refer to the standard for understanding device labelling, performance expectations and safe use instructions.

Related standards

ISO 10555-1 is part of the ISO 10555 series for sterile, single-use intravascular catheters (other parts cover item-specific requirements such as central venous catheters, balloon dilatation catheters, over‑needle peripheral catheters and PICCs). Relevant related standards include ISO 11070 (accessory devices for intravascular catheters), ISO 10993-1 (biological evaluation), IEC 62366-1 (usability engineering) and ISO 11607-1 (packaging for terminally sterilized medical devices).

Keywords

intravascular catheter; sterile; single-use; catheter testing; catheter labelling; biocompatibility; sterilization; packaging; ISO 10555; vascular access; medical device standard.

FAQ

Q: What is this standard?

A: ISO 10555-1:2023 is the third edition of the International Standard that defines general requirements for sterile, single‑use intravascular catheters, covering design, performance and information supplied for safe clinical use.

Q: What does it cover?

A: It covers general, risk‑based requirements and test considerations relevant to intravascular catheters: usability, sterilization, biocompatibility, mechanical performance (tensile, leakage, burst), dimensional designation, packaging and manufacturer information. It excludes accessories covered by ISO 11070.

Q: Who typically uses it?

A: Device manufacturers, test laboratories, regulatory and conformity assessment organizations, hospital procurement/clinical engineering teams, and clinicians reviewing device instructions and performance characteristics.

Q: Is it current or superseded?

A: Current. ISO 10555-1:2023 (Edition 3) supersedes ISO 10555-1:2013 and related amendments; the 2023 edition is the published, active version.

Q: Is it part of a series?

A: Yes — ISO 10555 is a multipart series addressing sterile, single‑use intravascular catheters. Specific parts address device‑type requirements (for example, over‑needle peripheral catheters, central venous catheters, balloon dilatation catheters and PICCs) while Part 1 gives the general requirements.

Q: What are the key keywords?

A: Intravascular catheter, sterile, single‑use, catheter testing, biocompatibility, sterilization, packaging, labelling, ISO 10555.