ISO 10555-2-1996 PDF

Full title and description

ISO 10555-2:1996 — Sterile, single-use intravascular catheters — Part 2: Angiographic catheters. This part of ISO 10555 specifies requirements for angiographic catheters supplied in the sterile condition and intended for single use, including general product requirements, marking and packaging considerations specific to angiographic catheter types.

Abstract

Short (5-page) technical specification that sets out essential requirements for non-reusable angiographic intravascular catheters supplied sterile. The document includes normative references to the general requirements for single‑use intravascular catheters and notes related standards for accessories and sterile processing. A technical corrigendum was published in 2002.

General information

• Status: Withdrawn / Retired (the part has been withdrawn from active use by ISO).
• Publication date: June 1996 (original publication: 20 June 1996).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: Edition 1 (1996-06).
• Number of pages: 5.

Scope

This part of ISO 10555 defines the specific requirements that apply to angiographic catheters supplied sterile for single use — covering product definition, essential characteristics, labelling, packaging and related normative references. It is intended to be read together with the general requirements for single‑use intravascular catheters in the ISO 10555 family and other applicable standards for accessories and sterility assurance. Note: the part has been withdrawn and the ISO 10555 series was subsequently consolidated and updated in later publications.

Key topics and requirements

• Product definition and classification for angiographic catheters (intended use: angiography and diagnostic/interventional vascular access).
• Essential performance and safety characteristics required for single‑use sterile catheters (materials, biocompatibility expectations inherited from general requirements).
• Labelling and packaging requirements to ensure traceability, sterility status and appropriate instructions for use.
• Relevant normative references and cross‑references to general catheter requirements and accessories standards (for example, references to ISO standards on accessory devices and sterility assurance practices).
• Technical corrigendum clarifications issued after original publication (ISO 10555-2:1996/Cor 1:2002).

Typical use and users

Used as a technical reference by medical device manufacturers, product designers, regulatory and quality assurance professionals, testing labs and standards committees during the design, labelling, packaging and regulatory submission processes for sterile single‑use angiographic catheters. End users (hospitals, interventional radiology and cardiology departments) rely indirectly on manufacturers’ conformity to such standards.

Related standards

Related and referenced documents include the general requirements for sterile single‑use intravascular catheters in the ISO 10555 family, and other standards covering accessories and sterility/packaging such as ISO 11070 and applicable parts of the broader ISO 10555 series and regional/adopted equivalents. The part was later withdrawn as the series was consolidated and updated.

Keywords

angiographic catheter, intravascular catheter, single‑use, sterile, ISO 10555, catheter labelling, catheter packaging, medical device standard, corrigendum

FAQ

Q: What is this standard?

A: ISO 10555-2:1996 is the ISO technical specification that defined requirements for sterile, single‑use angiographic intravascular catheters (Part 2 of the ISO 10555 series).

Q: What does it cover?

A: It covers product definition and essential requirements specific to angiographic catheters supplied sterile for single use, including labelling, packaging and references to general catheter requirements; a technical corrigendum was issued in 2002.

Q: Who typically uses it?

A: Manufacturers, QA/regulatory teams, conformity assessment bodies and testing laboratories use the standard when specifying, testing and documenting angiographic catheters; clinicians rely on manufacturers’ conformance to such standards for device selection and use.

Q: Is it current or superseded?

A: It has been withdrawn/retired by ISO. The ISO 10555 series has been consolidated and later editions of the series (notably ISO 10555-1 and related updates) provide the current, active requirements; historically this part was published in June 1996 and subsequently withdrawn.

Q: Is it part of a series?

A: Yes — ISO 10555 is a multi‑part series covering sterile, single‑use intravascular catheters; Part 2 covered angiographic catheters specifically. The series’ structure and numbering have been updated in later revisions and consolidations.

Q: What are the key keywords?

A: Angiographic catheter, intravascular catheter, sterile single‑use, ISO 10555, catheter labelling, catheter packaging, medical device standard.