ISO 10993:2025 vs 2018 – Key Differences | Accuprec - CRO India

ISO 10993:2025 vs 2018 – Key Differences

Introduction

The ISO 10993 series is the global benchmark for evaluating the biocompatibility of medical devices. Among its parts, ISO 10993-1 plays a central role by defining the overall framework for biological evaluation. In recent years, regulatory authorities have moved away from checklist-based testing toward a more scientific, risk-based approach.

This shift is clearly reflected in the transition from ISO 10993-1:2018 to ISO 10993-1:2025.

For medical device manufacturers, understanding the key differences between ISO 10993:2018 and ISO 10993:2025 is essential. These differences directly affect biocompatibility strategies, regulatory submissions, timelines and costs.

In this blog, Accuprec Research Labs Pvt. Ltd. provides a clear comparison of the two versions and explains what has changed, why it matters and how manufacturers should adapt.

Overview of ISO 10993-1:2018

ISO 10993-1:2018 introduced a structured approach to biological evaluation based on:

• Nature of body contact
• Duration of contact
• Selection of biological endpoints

The 2018 version already encouraged the use of risk management and existing data, but in practice, many manufacturers still relied heavily on predefined testing matrices.

Biological evaluation was often treated as a separate regulatory activity rather than an integrated part of product development.

While ISO 10993-1:2018 represented progress compared to earlier editions, regulators increasingly observed gaps such as over-testing, insufficient toxicological justification and weak documentation.

Why a New Revision Was Needed

Between 2018 and 2025, the regulatory landscape changed significantly. Authorities like the US FDA and EU Notified Bodies began expecting:

• Stronger scientific justification
• Clear links between risk management and biocompatibility
• Reduced use of animal testing
• Better chemical and toxicological assessments

ISO 10993-1:2025 was developed to address these expectations and align the standard with modern regulatory thinking.

Key Differences Between ISO 10993:2018 and ISO 10993:2025

1. Risk Management Integration

2018 Version:

Risk management was referenced but not deeply integrated. Many biological evaluations were performed independently of ISO 14971 activities.

2025 Version:

Risk management is now central. ISO 10993-1:2025 clearly requires biological evaluation to be aligned with ISO 14971.

Biological hazards must be identified, evaluated, controlled and documented as part of the overall risk management process.

Impact:

Manufacturers must demonstrate a clear connection between biocompatibility decisions and risk management files.

2. Shift from Test-Driven to Science-Driven Approach

2018 Version:

Although flexibility existed, many evaluations followed a test-first mindset based on device category tables.

2025 Version:

The emphasis is now on scientific rationale. Testing is performed only when necessary and justified.

Decisions must be supported by chemical characterization, toxicological assessment and existing data.

Impact:

Better planning is required, but unnecessary tests and costs can be avoided.

3. Stronger Focus on Chemical Characterization

2018 Version:

Chemical characterization was encouraged but often treated as optional or secondary.

2025 Version:

Chemical characterization is a core element of biological evaluation.

Manufacturers are expected to understand material composition, extractables and leachables before deciding on biological testing.

Impact:

Greater reliance on ISO 10993-18 and ISO 10993-17 for exposure-based risk assessment.

4. Reduced Reliance on Animal Testing

2018 Version:

Animal testing was still commonly used to meet regulatory expectations.

2025 Version:

The new version strongly supports alternative methods and the 3Rs principle.

Animal testing should be a last resort and must be scientifically justified.

Impact:

More emphasis on in vitro testing, toxicological risk assessment and literature review.

5. Use of Existing and Clinical Data

2018 Version:

Existing data could be used, but guidance on how to evaluate relevance and adequacy was limited.

2025 Version:

Clear expectations are provided for evaluating existing data, including clinical experience and post-market surveillance.

Impact:

Manufacturers can leverage prior knowledge more effectively, reducing duplication.

6. Improved Clarity on Device Categorization

2018 Version:

Some ambiguity existed in interpreting contact types and durations.

2025 Version:

Clearer definitions and explanations reduce misclassification and improve endpoint selection.

Impact:

More consistent and defensible biological evaluation strategies.

7. Stronger Expectations for Documentation (BEP & BER)

2018 Version:

BEP and BER requirements varied across submissions and reviewers.

2025 Version:

The standard clearly outlines expectations for Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER), including traceability and scientific justification.

Impact:

Higher documentation quality is expected during regulatory review.

Regulatory Perspective on the Changes

Regulatory authorities view ISO 10993-1:2025 as a major improvement.

Submissions aligned with the 2025 version are more likely to:

• Pass technical review smoothly
• Avoid deficiency letters
• Demonstrate patient safety effectively

Notified Bodies and the FDA increasingly expect compliance with the latest revision, even during transition periods.

What Manufacturers Should Do Now

To move from ISO 10993:2018 to 2025, manufacturers should:

• Review existing biocompatibility files
• Update risk management integration
• Strengthen chemical characterization strategies
• Revise BEP and BER documentation
• Engage toxicology experts early

Early alignment reduces delays and regulatory risk.

How Accuprec Research Labs Supports the Transition

Accuprec Research Labs Pvt. Ltd. helps manufacturers bridge the gap between ISO 10993:2018 and 2025 by providing:

• Gap assessments and strategy updates
• Chemical characterization and toxicological evaluations
• BEP and BER preparation aligned with 2025 expectations
• Regulatory support for FDA and EU submissions

Our expertise ensures that biocompatibility evaluations are scientifically sound and regulator-ready.

Conclusion

The transition from ISO 10993:2018 to ISO 10993:2025 represents a clear shift toward risk-based, science-driven biocompatibility evaluation.

While the new requirements demand more upfront planning and expertise, they ultimately lead to better patient safety, stronger regulatory submissions and more efficient development timelines.

Manufacturers who adapt early will be better positioned for global approvals. With the right guidance, ISO 10993:2025 compliance becomes an opportunity rather than a challenge.

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