UNE-EN ISO 10993-1-2010 AC-2010 PDF

Full title and description

STB UNE-EN ISO 10993-1-2010 AC-2010 — Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process — Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010). This document is a technical corrigendum (AC/Cor 1:2010) amending the ISO 10993-1:2009 text and related national/adopted editions to clarify and correct specific expressions and diagram elements used in the biological evaluation flow and testing decision process.

Abstract

This entry covers the 2010 Technical Corrigendum (Cor 1 / AC:2010) to ISO 10993-1:2009, which provides limited technical corrections and clarifications to Part 1 of the ISO 10993 series (biological evaluation of medical devices). The corrigendum addresses specific wording and diagrammatic expressions (notably corrections in the figure/flowchart used to define test selection) intended to improve clarity of the risk‑based evaluation and testing process. The corrigendum was published in 2010 and has since been superseded by later editions of ISO 10993-1.

General information

• Status: Withdrawn / superseded (corrigendum to ISO 10993-1:2009).
• Publication date: 2010 (Technical Corrigendum 1, June 2010 / national adoptions in 2010).
• Publisher: Original: ISO (ISO/TC 194); national adoptions published by respective national standards bodies (e.g., UNE/AENOR, STB national adoption entries).
• ICS / categories: 11.100.20 — Biological evaluation of medical devices.
• Edition / version: Technical Corrigendum 1 to ISO 10993-1:2009 (Corr.1 / AC:2010; applies to the 4th edition (2009) text).
• Number of pages: Corrigendum (ISO): typically 1 page for the ISO corrigendum; national adopted AC documents vary (several pages) depending on the national publication format.

Scope

This corrigendum makes limited technical corrections and clarifications to ISO 10993-1:2009. Its scope is restricted to correcting specific expressions and the decision flow used to determine which biological endpoints and tests are applicable to a medical device within a risk‑management framework. It does not introduce new test methods or substantive changes to biological safety requirements; rather, it refines wording and diagram elements to improve consistency and interpretation during biological evaluation.

Key topics and requirements

• Technical corrections to wording and diagrams in ISO 10993-1:2009 intended to clarify the test-selection flow and decision points.
• Emphasis on performing biological evaluation within a risk‑management process (alignment with ISO 14971 principles for medical device risk management).
• Guidance to consider the nature and duration of body contact when selecting endpoints (e.g., systemic toxicity, local effects, sensitization, cytotoxicity).
• Clarification that all available data (literature, supplier information, prior testing) should inform the need for further testing, consistent with a weight‑of‑evidence approach.
• Limited editorial and diagrammatic amendments only — not a substantive reworking of Part 1 test requirements.

Typical use and users

Manufacturers of medical devices and their design/biocompatibility teams use this corrigendum as part of the historical record for ISO 10993-1:2009 to understand clarifications applied in 2010. Test laboratories, regulatory affairs professionals, notified bodies, and consultants refer to the corrigendum when reviewing legacy submissions or when national/adopted versions reference the 2009 edition plus Corrigendum 1. For current projects, users are typically directed to the later editions (ISO 10993-1:2018 and subsequent adopted EN versions and further revisions).

Related standards

This corrigendum is part of the ISO 10993 series. Relevant related documents include ISO 10993-1 (main Part 1 editions), other parts of ISO 10993 (e.g., Parts 2–18 for specific endpoints and test methods), and ISO 14971 (medical device risk management). National adoptions (EN ISO 10993-1:2020/2021 and related national standards) supersede the corrigendum for current regulatory use.

Keywords

ISO 10993-1, biological evaluation, biocompatibility, technical corrigendum, AC-2010, medical devices, risk management, test selection, corrigendum, EN ISO 10993-1.

FAQ

Q: What is this standard?

A: It is the 2010 Technical Corrigendum (AC / Cor 1:2010) to ISO 10993-1:2009 — a short corrective document that amends and clarifies specific expressions and the decision flow in Part 1 (biological evaluation of medical devices).

Q: What does it cover?

A: The corrigendum covers limited editorial and diagrammatic corrections to the ISO 10993-1:2009 text (not new testing methods). Its purpose was to improve clarity of the flowchart and certain expressions used to determine which biological endpoints and tests are applicable within a risk‑management approach.

Q: Who typically uses it?

A: Historically, manufacturers, biocompatibility specialists, test laboratories, regulators and notified bodies consulted the corrigendum when using or interpreting ISO 10993-1:2009 and national adoptions that incorporated the corrigendum. For current compliance work, users generally refer to later editions/adoptions (2018/2020/2021 and later).

Q: Is it current or superseded?

A: The 2010 corrigendum is superseded/withdrawn as later editions of ISO 10993-1 were published (notably the 2018 5th edition and subsequent national EN adoptions around 2020–2021). For up‑to‑date requirements, consult the current edition of ISO 10993-1 and applicable national/adopted versions.

Q: Is it part of a series?

A: Yes — it is part of the ISO 10993 family (biological evaluation of medical devices). Part 1 is the general framework; other parts (Parts 2–18 and technical reports) cover specific endpoints and methods.

Q: What are the key keywords?

A: Biocompatibility, biological evaluation, ISO 10993-1, corrigendum, AC-2010, risk management, test selection, medical devices.