ANSI AAMI ISO 10993-1-2018 PDF

Full title and description

ANSI/AAMI/ISO 10993-1:2018 — Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. This document defines the principles and general requirements for assessing the biological safety of materials and medical devices (including implantable and non‑implantable devices and personal protective equipment) within a documented risk‑management framework.

Abstract

ISO 10993-1:2018 provides a risk‑based approach to biological evaluation: it establishes device categorization by nature and duration of body contact, requires evaluation of existing data, identification of data gaps via risk analysis, selection of additional tests where needed, and assessment of overall biological safety. The standard excludes biological hazards related to pathogens (bacteria, viruses, TSEs) and is intended to be used alongside other parts of the ISO 10993 series and ISO 14971 (risk management).

General information

• Status: Published (2018) — later superseded by ISO 10993-1:2025 (Edition 6).
• Publication date: August 2018 (corrected versions issued October 2018).
• Publisher: International Organization for Standardization (ISO); published/adopted in the U.S. as ANSI/AAMI/ISO 10993-1:2018 by AAMI/ANSI.
• ICS / categories: 11.100.20 — Biological evaluation of medical devices / Laboratory medicine.
• Edition / version: Edition 5 (2018).
• Number of pages: 41 pages (ISO 2018 edition).

Scope

ISO 10993-1:2018 applies to the biological evaluation of medical devices and materials that have direct or indirect contact with the patient or user during intended use. It provides principles for: categorizing devices by contact nature and duration, assembling and evaluating existing toxicological and biological data, identifying gaps through risk analysis, and determining what additional tests or data are necessary to demonstrate biological safety. The document is applicable across device types (active, non‑active, implantable, non‑implantable) and is intended to be used in conjunction with device‑specific standards and regulatory guidance.

Key topics and requirements

• Risk‑based biological evaluation integrated into the overall device risk‑management process (alignment with ISO 14971 principles).
• Device categorization by nature of contact (skin, mucosal, blood, implant) and exposure duration (transient, short‑term, long‑term, permanent).
• Systematic review of existing data (materials information, prior testing, clinical data) and identification of data gaps.
• Formulation of a biological evaluation plan and selection of targeted tests only where justified by risk analysis (reduces unnecessary testing and animal use).
• Requirements for toxicological risk assessment and scientific justification for testing choices; emphasis on chemical characterization for leachables and degradants.
• Explicit exclusions (infectious agents such as bacteria, viruses, TSEs) and note that device‑specific standards cover mechanical or other specific test needs.

Typical use and users

Primary users include medical device manufacturers (regulatory, R&D, biocompatibility/toxicology teams), testing laboratories, notified/competent bodies, and regulatory reviewers preparing product submissions (e.g., 510(k), PMA, CE technical files). ISO 10993-1 is used to plan, justify, and document biological evaluation strategies during design, premarket review, and post‑market changes. Regulatory guidance (for example from the U.S. FDA) references ISO 10993-1 when assessing biocompatibility approaches.

Related standards

ISO 10993-1 is Part 1 of the ISO 10993 biological evaluation series; related parts include ISO 10993-2 through ISO 10993-23 (and newer parts addressing specific tests such as cytotoxicity, sensitization, irritation, systemic toxicity, chemical characterization, etc.). It is commonly used together with ISO 14971 (risk management) and national/adopted versions such as ANSI/AAMI/ISO 10993-1:2018. Regulatory guidance documents (e.g., FDA guidance on use of ISO 10993-1) and later ISO 10993-1:2025 (Edition 6) provide further context and updates.

Keywords

biological evaluation, biocompatibility, medical devices, risk management, ISO 10993, ANSI/AAMI, toxicological risk assessment, device contact categorization, chemical characterization, biological safety.

FAQ

Q: What is this standard?

A: ISO 10993-1:2018 is Part 1 of the ISO 10993 series outlining principles and requirements for the biological evaluation of medical devices within a risk‑management process; in the U.S. it is available/adopted as ANSI/AAMI/ISO 10993-1:2018.

Q: What does it cover?

A: It covers device contact categorization (nature and duration), evaluation of existing biological and toxicological data, identification of gaps by risk analysis, justification and selection of additional tests, and overall biological safety assessment; it excludes infectious agents and relies on other parts of ISO 10993 for specific test methods.

Q: Who typically uses it?

A: Manufacturers (R&D, regulatory, biocompatibility/toxicology), test laboratories, notified/competent bodies, and regulatory agencies reviewing premarket and postmarket submissions use ISO 10993-1 to plan and document biological evaluations.

Q: Is it current or superseded?

A: The 2018 edition (Edition 5) was published in August 2018; it has since been superseded by ISO 10993-1:2025 (Edition 6), so users should confirm which edition is required by their regulator or notified body and reference the appropriate edition in submissions.

Q: Is it part of a series?

A: Yes — ISO 10993-1 is Part 1 of the ISO 10993 series (numerous other parts address specific biological tests and methods). It is intended to be used with other parts of the series and with ISO 14971 (risk management).

Q: What are the key keywords?

A: Biocompatibility, biological evaluation, risk management, device contact categorization, chemical characterization, toxicological risk assessment, ISO 10993, ANSI/AAMI.