Lifetime and Lifecycle in the Upcoming ISO 10993-1 Standard (2025): Who, When, What, and How?

The biological evaluation of a medical device (MD) is a critical aspect that must be considered at every stage of its lifecycle, as outlined in the General Safety and Performance Requirements of Annex I of the Medical Device Regulation (MDR) 2017/745 and clause 4.7 of ISO 10993-1:2018. The forthcoming revision of this standard, currently available as a Final Draft (ISO/FDIS 10993-1:2025) awaiting final approval prior publication, reinforces this concept further by integrating a dedicated clause throughout the standard. This emphasizes the need to clearly define the lifecycle and lifetime of a MD to better understand and anticipate the challenges associated with biological evaluations.

This article therefore aims to provide a clear and practical analysis of the concepts of lifecycle and lifetime for MD, offering insights to better anticipate and address the challenges of biological evaluations within the framework of the upcoming ISO 10993-1:2025 standard.

1. Key Terms and Definitions

Understanding the concepts of lifetime and lifecycle is crucial to anticipate compliance challenges and ensure patient safety.

• Lifecycle: This term “Lifecycle” encompasses all stages of the device’s existence—from initial design (including material selection) to final disposal. This includes production, storage, transport, and clinical use.
• Lifetime: The “Lifetime” forms an integral part of the lifecycle and defines the period during which the device fulfills its intended function (clinical use). This could mean a single-use disposable device, a reusable instrument subjected to recurring cleaning, disinfection and/or sterilization cycles, or an implant designed to remain functional within the human body for several years. Lifetime evaluations focus on biological risks caused by cumulative stresses, such as material degradation, wear, and substance release. These assessments also consider device-specific factors, such as systemic effects linked to implant degradation over time within the body.

Once these fundamental concepts are clear, it is essential to explore their practical implications across various types of medical devices.

2. Lifecycle vs. Lifetime: Practical Applications Based on MD Types

The biological safety challenges of medical devices vary significantly depending on whether they are single-use, reusable, or implantable, with each category requiring careful evaluation.

2.1 Single-Use MDs

Single-use disposable MDs typically have a limited lifetime, corresponding to their usage period, which can range from a few minutes to several hours. The biological safety impact of this limited lifetime is usually minor, with risk assessments primarily focused on critical lifecycle parameters such as the types and quality of raw material quality, manufacturing processes, and additives used.

However, when friction or interaction generates particulates or leachables (e.g., actuation of a valve or tap or interaction between silicone coatings and tissue), biological risk assessment becomes essential. The forthcoming standard emphasizes the need to account for repeated or cumulative use to determine total exposure periods. Prolonged exposure to particles or materials—even during brief or intermittent contact—can     affect tissues or the circulatory system.

In addition, ISO 10993-1 places importance on considering lifecycle aspects such as storage and transport, as these phases can impact the physico-chemical properties of a device, which in turn impacts its biocompatibility. Manufacturers often overlook these risks, focusing instead on maintaining product performance and packaging integrity after transport and storage. To manage these risks, testing programs involving expired MDs or those subjected to transport conditions may need to be implemented according to ISO 10993-1.

2.2. Implantable MDs

For implantable MDs, whether resorbable or permanent, the lifetime evaluation mustconsider material degradation within the patient’s body. Standards such as ISO 10993-9, along with its related parts -13, -14, or -15, assist manufacturers in modeling long-term biological responses to corrosion, particle release, or systemic effects caused byleachables migrating  from the MD.

These risks are closely linked to lifecycle factors such as the grade of materials used, storage conditions, and consistency in manufacturing practices, all of which play a critical role in shaping the device’s degradation profile. Manufacturers are therefore required to clearly define the lifetime of their implantable devices to effectively and comprehensively address these risks.

2.3 Reusable MDs

Determining the lifetime of reusable MDs is an important aspect of their safety and functionality. Manufacturers must define conditions that ensure safe and repeated use of their devices. MDR 2017/745 proposes two methods for determining the end-of-life of reusable MDs: (1) specifying the maximum number of allowable reuse cycles or (2) identifying specific wear  indicators, such as corrosion or coating deterioration. Once these criteria are met, the device is deemed to have reached the end of its lifetime, at which point its performance and biological safety can no longer be guaranteed.

Manufacturers must establish clear end-of-life criteria as part of the device’s lifetime definition. This entails not only demonstrating biocompatibility during initial use but also ensuring that repeated reprocessing cycles do not lead to risks such as contamination buildup, cleaning residue accumulation, or material deterioration. These risks can be evaluated through physico-chemical or biological testing programs, conducted on devices subjected to repeated cycles under either “worst-case” scenarios or actual conditions of use.

3. Integrating Lifetime and Lifecycle Within a Comprehensive Biological Safety Framework

By systematically incorporating the concept of lifetime into the biological evaluation of MDs across their entire lifecycle, manufacturers can meet the requirements of MDR 2017/745 and ISO 10993-1, while ensuring biological safety at every stage. Lifetime evaluations focus specifically on the cumulative impacts that materials endure during clinical use, while lifecycle analyses broaden the scope to consider risks associated with raw materials, manufacturing, transport, and storage. Together, these methodologies establish a holistic risk management framework that prioritizes patient safety across all phases of the device’s existence.

Need help?

Covering all critical lifecycle phases can pose significant challenges and demand substantial effort in planning and justification. Do you need expert support to align with ISO 10993-1 requirements or train your team? Reach out to our specialists for tailored support and services:

• Strategic support and analysis of biological and chemical testing in your evaluations.
• Full drafting of biological and toxicological evaluation plans and reports.
• File remediation and addressing non-conformities.
• Detailed impact analysis of standard revisions.
• On-demand team availability via hotline support.
• Accredited training on biological evaluation through our TREE training organization, certified Qualiopi.

Our Technical Direction teams are available to assist with your projects. Contact us directly at TechnicalDivision@efor-group.com for expert guidance.