# #445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-02-02
- Length: 37m
- Episode: 445
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech
- Listen: https://podcast.greenlight.guru/episode/iso-10993-1-2025-mastery-navigating-risk-based-biocompatibility-mdr

## Summary

Thor Rollins, a leader at Nelson Labs and convener of the ISO committee revising ISO 10933-1, explains the 2025 standard's shift from checkbox testing to a risk-based approach aligned with ISO 14971. He details new requirements for lifecycle evaluation, particularly for reprocessed devices, and the concept of biological equivalence to reduce redundant testing. Rollins also discusses the US's rejection of the draft due to lack of guidance, the upcoming technical specifications, and practical advice for companies at different stages of development.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech#t=0) Introduction: Thor Rollins and the ISO 10933-1 Revision
- [1:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech#t=106) The Shift from Checkbox Testing to Risk-Based Biocompatibility
- [6:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech#t=364) Lifecycle Evaluation and Reprocessing Challenges
- [8:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech#t=491) Foreseeable Misuse and Biological Equivalence
- [15:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech#t=930) US Vote Against the Draft and Future Guidance
- [19:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech#t=1169) Notified Body Requirements and Chemistry Testing
- [25:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech#t=1540) Advice for Small vs. Large Companies on Databases
- [30:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech#t=1812) Regulatory Strategy: FDA vs. Europe for Different Company Stages

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies, companies scaling up, established companies

## Mentioned

- Nelson Labs (company)
- ISO 10933-1 (other)
- ISO 14971 (other)
- FDA (other)
- MHRA (other)
- MDR (other)
- DSC (tool)
- GPC (tool)
- FTIR (tool)

## Related episodes from other shows

- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (Let's Combinate)
- [161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products](https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-06-161-iso-14971-and-ich-q9-explained-risk-management-frameworks-in-medical-devices) (Let's Combinate)
- [127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin) (Let's Combinate)
- [232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-01-232-medtech-material-selection-cost-compliance-sustainability-and-biocompatibili) (Let's Combinate)
- [081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.