Biocompatibility and Materials
ISO 10993 Series: Biological Evaluation of Medical Devices
ISO 10993 is a multi-part series on the biological evaluation of medical devices. One part sets the overall framework, and the others cover specific biological endpoints, test methods, sample preparation, chemical characterization and toxicological risk assessment.
At a Glance
- Standard
- ISO 10993 Series
- Subject
- Biological Evaluation of Medical Devices
- Group
- Biocompatibility and Materials
- Industries
- 1 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The series exists so biological safety is judged consistently, using existing information and targeted testing rather than a fixed battery of tests for every device. Individual parts address endpoints such as cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, local effects after implantation and interactions with blood, along with supporting topics like sample preparation, chemical characterization of materials, degradation products and sterilization residuals.
ISO 10993-1 is the entry point. It describes how to plan and carry out a biological evaluation within a risk management process and identifies which endpoints need to be addressed. The other parts are then used as needed to generate or assess data for those endpoints. Chemical characterization and toxicological risk assessment can address some endpoints with less reliance on animal testing, which the series encourages where it's scientifically justified.
In practice, a biological evaluation is a living part of the design history and the risk management file. Changes to materials, suppliers, manufacturing processes, processing aids, cleaning agents or sterilization can all affect biological safety, and each needs an assessment of whether the existing data still applies.
Who It Applies To
- Manufacturers of devices with direct or indirect patient or user contact
- Makers of implants, catheters, wound care products and other body-contacting devices
- Firms changing materials, suppliers, processing aids or sterilization methods
- Laboratories and toxicologists supporting device submissions
What Auditors Check
Biological Evaluation Plan and Report
A plan and report for each device that identify the endpoints, cite the data relied on and reach a conclusion approved by qualified people.
Material and Supplier Control
Specifications and supplier controls that keep production materials the same as the materials that were evaluated.
Representative Test Articles
Evidence that tested samples were finished, sterilized devices or justified equivalents.
Change Assessments
Biological safety assessments for material, process, supplier and sterilization changes, documented before the change is released.
Link to Risk Management
Biological hazards and their controls appearing in the risk management file, consistent with the evaluation report.
Related Services
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
Industry Guides That Reference ISO 10993 Series
ISO 10993 Series
Check Your Quality System Against ISO 10993 Series
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
