ISO 10993-1-2018 PDF

Full title and description

St ISO 10993-1-2018 — Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. This standard specifies principles and framework for evaluating the biocompatibility of medical devices as part of an overall risk management process. It provides guidance on identifying biological hazards, selecting appropriate tests, interpreting results and determining acceptability of biological risks associated with medical devices and their constituent materials.

Abstract

ISO 10993-1:2018 defines a structured approach to the biological evaluation of medical devices. The standard integrates biocompatibility assessment into device risk management, describing how to gather and evaluate information from device design, material characterization, toxicological risk assessment, and biological testing. It emphasizes a rationale-driven, case-by-case selection of tests, reduction of unnecessary animal testing, and use of existing data where appropriate. The goal is to ensure patient safety by identifying and controlling biological risks posed by medical devices and their materials.

General information

• Status: International standard (published and current as of 2018 edition)
• Publication date: 2018
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040 (Medical equipment and supplies) / Biocompatibility, medical device safety
• Edition / version: 3rd edition (ISO 10993-1:2018)
• Number of pages: Approximately 38 pages

Scope

This part of ISO 10993 establishes the general principles for evaluating the biological safety of medical devices as part of a risk management process. It applies to devices, device materials and their combinations, across all contact durations and body contact types. The standard guides manufacturers in collecting existing data, characterizing materials, identifying biological hazards, selecting appropriate in vitro and in vivo tests, and integrating results into risk assessment and mitigation decisions. It is not a stand-alone test method but a framework for selecting and justifying tests from the broader ISO 10993 series.

Key topics and requirements

• Integration of biological evaluation into overall device risk management.
• Identification and characterization of materials, including chemical characterization and leachables/leachable assessments.
• Use of a decision-based process to select relevant biological endpoints and tests (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, implantation, etc.).
• Emphasis on use of existing data, literature, supplier information and prior evaluations to reduce unnecessary testing.
• Toxicological risk assessment (TRA) for estimating potential systemic effects from device-related exposures.
• Principles for interpreting test results, determining acceptability, and implementing risk control measures.
• Guidance on sample selection, test specimen preparation, exposure conditions and justification for deviations from standard test methods.
• Consideration of implantation and contact duration categories (limited, prolonged, permanent) and routes of exposure.
• Encouragement of replacement, refinement and reduction of animal testing where scientifically justified.

Typical use and users

Manufacturers of medical devices and their suppliers use ISO 10993-1:2018 to plan and document biological evaluations required for regulatory submissions and product development. Regulatory affairs professionals, quality and compliance teams, biomedical engineers, toxicologists and contract testing laboratories apply the standard to justify test selection, conduct risk assessments, and interpret biocompatibility data. Notified bodies and regulatory authorities commonly reference this standard when assessing device safety.

Related standards

ISO 10993-1 is the foundational part of the ISO 10993 series. Related parts include guidelines and test methods such as ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), ISO 10993-11 (systemic toxicity), ISO 10993-12 (sample preparation and reference materials), ISO 10993-18 (chemical characterization), and others covering hemocompatibility, implantation and genotoxicity. National and regional regulations on medical device biocompatibility also reference this series.

Keywords

ISO 10993-1, biocompatibility, biological evaluation, medical devices, risk management, toxicological risk assessment, cytotoxicity, sensitization, irritation, implantation, chemical characterization, leachables

FAQ

Q: What is this standard?

A: ISO 10993-1:2018 is an international standard that defines principles and a framework for the biological evaluation of medical devices as part of a risk management process.

Q: What does it cover?

A: It covers the approach to identifying biological hazards from devices and materials, selecting appropriate tests from the ISO 10993 series, using existing data and toxicological risk assessment, interpreting results, and integrating findings into risk management and mitigation decisions.

Q: Who typically uses it?

A: Medical device manufacturers, material suppliers, quality and regulatory professionals, toxicologists, biomedical engineers, testing laboratories, and regulatory reviewers use this standard to plan and justify biocompatibility evaluations.

Q: Is it current or superseded?

A: The 2018 edition is the current third edition of ISO 10993-1. Users should confirm whether newer revisions have been published since 2018 before relying on it for compliance.

Q: Is it part of a series?

A: Yes. ISO 10993-1 is the introductory and decision-making part of the ISO 10993 series on biological evaluation of medical devices; other parts define specific tests and methods.

Q: What are the key keywords?

A: Biocompatibility, biological evaluation, medical device safety, toxicological risk assessment, chemical characterization, cytotoxicity, sensitization, irritation, implantation.