ISO 10555-2-1996 cor1-2002 PDF

Full title and description

ISO 10555-2:1996/Cor 1:2002 — Sterile, single-use intravascular catheters — Part 2: Angiographic catheters — Technical Corrigendum 1. This corrigendum provides technical corrections and clarifications to the original ISO 10555-2:1996 text; it was published as a one-page corrigendum to amend specific technical details in the 1996 Part 2 document. The corrigendum was made available in PDF form when published.

Abstract

This one-page technical corrigendum corrects, clarifies or updates limited technical content of ISO 10555-2:1996 (the part of the ISO 10555 series that covers angiographic catheters). It does not constitute a new full edition of the standard but provides targeted errata to ensure the normative requirements, measurements and/or references in the 1996 text are accurate and unambiguous for manufacturers, testing laboratories and conformity assessment bodies.

General information

• Status: Withdrawn (corrigendum to ISO 10555-2:1996).
• Publication date: June 2002 (published as Edition 1, 2002‑06; some listings show 6 June 2002).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters — medical devices).
• Edition / version: Edition 1 (ISO 10555-2:1996/Cor 1:2002 — Technical Corrigendum 1).
• Number of pages: 1 (corrigendum). The base standard ISO 10555-2:1996 comprises 5 pages.

Scope

The corrigendum applies only to ISO 10555-2:1996 and is intended to correct specific technical errors, editorial slips or ambiguous requirements in the angiographic catheters part of the ISO 10555 series. It does not expand the scope of the original part; rather, it refines the existing technical content (for example, correcting figures, tables, dimensions, references or test method descriptions) so that manufacturers and conformity assessors have a clear and consistent normative text to apply.

Key topics and requirements

• Targeted corrections to the normative text of ISO 10555-2:1996 (editorial and technical errata).
• Clarifications affecting dimensional tolerances or specifications referenced in the Part 2 text.
• Amendments that ensure referenced test methods, markings or labeling requirements are consistent with the base standard.
• Does not introduce new substantive requirements beyond those already in ISO 10555-2:1996; intended to remove ambiguity and correct errors.

Typical use and users

Primary users are manufacturers of angiographic (intravascular) catheters, quality and regulatory affairs personnel, conformity assessment and test laboratories, standards administrators, procurement specialists in healthcare institutions, and national standards bodies. The corrigendum is applied by organizations already using ISO 10555-2:1996 to ensure their interpretation of the normative requirements matches the corrected text.

Related standards

This corrigendum is associated with ISO 10555-2:1996 (the base Part 2 document). Users of the ISO 10555 series should also consider other parts of the series (e.g., ISO 10555-1 and other part numbers covering different catheter types and general requirements), relevant EN adoptions of ISO 10555 parts, and related medical-device standards such as ISO 10993 (biological evaluation of medical devices) and applicable national/regional medical device regulations. The ISO 10555 series has later revisions and consolidated editions; organizations should check for the most recent applicable part(s) in the ISO 10555 family.

Keywords

ISO 10555, corrigendum, angiographic catheters, intravascular catheter, single-use, sterile, technical correction, standard, medical device, catheter specifications.

FAQ

Q: What is this standard?

A: ISO 10555-2:1996/Cor 1:2002 is a technical corrigendum (one-page erratum) to ISO 10555-2:1996, which covers sterile, single-use angiographic intravascular catheters. The corrigendum amends and clarifies specific technical points in the 1996 Part 2 document.

Q: What does it cover?

A: It provides narrowly scoped corrections and clarifications to the normative content of ISO 10555-2:1996 (for example, correcting figures, numeric values, references or wording that could lead to inconsistent interpretation). It does not create new substantive requirements beyond the original Part 2 standard.

Q: Who typically uses it?

A: Manufacturers of angiographic catheters, regulatory and quality personnel, testing laboratories, standards committees and procurement or compliance teams in healthcare and medical-device organizations use the corrigendum alongside ISO 10555-2:1996 to ensure accurate application of that part.

Q: Is it current or superseded?

A: The corrigendum itself is listed as withdrawn. The ISO 10555 series has been revised since 1996; users should consult the latest editions or consolidated parts of ISO 10555 for the current normative requirements. In practice, organizations normally move to the newer/revised ISO 10555 parts that supersede the older documents.

Q: Is it part of a series?

A: Yes — it is a corrigendum to Part 2 of the ISO 10555 series (Sterile, single-use intravascular catheters). The ISO 10555 family contains multiple parts addressing different catheter types and general requirements; this corrigendum only applies to Part 2 (angiographic catheters).

Q: What are the key keywords?

A: Angiographic catheters, intravascular, sterile, single-use, corrigendum, ISO 10555-2, technical correction, medical device standard.