--- title: "ISO 10993-1, Definition | MedTech Terms" description: "Biological evaluation of medical devices within a risk management process. 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It guides the selection of appropriate tests based on risk assessment." } }, { "@type": "Question", "name": "How does ISO 10993-1 relate to risk management?", "acceptedAnswer": { "@type": "Answer", "text": "ISO 10993-1 mandates that the biological evaluation be conducted within a risk management process, as described in standards like ISO 14971. This integration ensures that potential biological hazards are identified, analyzed, and controlled." } }, { "@type": "Question", "name": "Does ISO 10993-1 specify all necessary biocompatibility tests?", "acceptedAnswer": { "@type": "Answer", "text": "No, it outlines a framework for biological evaluation and provides considerations for test selection. Specific tests, such as cytotoxicity, sensitization, and irritation, are detailed in other parts of the ISO 10993 series, depending on the device category and contact type." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ISO 10993-1 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system)[Startup Lifecycle](/ecosystems/startup-lifecycle) # ISO 10993-1 Biological evaluation of medical devices within a risk management process. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 10993-1:2018 describes the general principles governing the biological evaluation of medical devices within a risk management process, including selection of evaluation tests based on tissue contact and duration. What the regulation says ISO 10993-1:2018 outlines a structured approach to biological evaluation as part of a risk management process, emphasizing that [biocompatibility](/terms/biocompatibility) assessment should consider the nature and duration of device contact with the body. The FDA recognizes ISO 10993-1:2018, often supplementing it with specific FDA guidance documents, such as the "Use of International Standard ISO 10993-1, ## What this means in practice [Biocompatibility](/terms/biocompatibility) documentation is a routine requirement for any patient-contacting device. FDA's recognized version aligns with ISO 10993-1:2018 plus FDA-specific guidance. ## Examples - A manufacturer of an implantable bone screw uses ISO 10993-1 to determine the necessary biological tests, including cytotoxicity, sensitization, and implantation studies, based on its permanent tissue contact. - For a single-use external bandage, a company applies the principles of ISO 10993-1 to justify conducting only cytotoxicity and skin irritation tests, considering its limited skin contact duration. - When redesigning a catheter with a new coating, a company refers to ISO 10993-1 to reassess biocompatibility implications and identifies the need for additional material characterization and systemic toxicity tests. Common pitfalls - • Failing to integrate biocompatibility evaluation into the overall risk management process can lead to overlooked hazards. - • Selecting inappropriate test methods based on incorrect assumptions about device contact or duration can result in inadequate biological evaluation. - • Not considering the manufacturing process and its potential impact on the device's biocompatibility can lead to non-conformance. - • Ignoring changes in device materials or intended use can invalidate previous biocompatibility assessments. - • Solely relying on material certificates without conducting device-specific testing when necessary is a common pitfall. ## Frequently asked questions What is the primary purpose of ISO 10993-1? The primary purpose is to establish general principles for the biological evaluation of MedTech devices, ensuring their safety regarding interaction with biological systems. It guides the selection of appropriate tests based on risk assessment. How does ISO 10993-1 relate to risk management? Does ISO 10993-1 specify all necessary biocompatibility tests? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility) ### Standards Stack for Medical Devices · From this learning path [ Standards ISO 11135 Standard for development, validation, and routine control of ethylene oxide (EO) sterilization. Adjacent lesson ](/terms/iso-11135?from=standards-stack)[ Standards IEC 62366-1 Application of usability engineering to medical devices. Adjacent lesson ](/terms/iec-62366-1?from=standards-stack)[ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. ](/terms/iec-60601-1?from=standards-stack)[ Standards IEC 60601-1-2 EMC requirements for medical electrical equipment. ](/terms/iec-60601-1-2?from=standards-stack) ### Manufacturing & Supply Chain · From this learning path [ Quality & Risk Shelf Life Period during which a device remains suitable for its intended use under specified conditions. Adjacent lesson ](/terms/shelf-life?from=manufacturing-and-supply-chain)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control?from=manufacturing-and-supply-chain)[ Manufacturing Cleanroom Classes (ISO 14644) ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9). ](/terms/cleanroom-iso-14644?from=manufacturing-and-supply-chain)[ Manufacturing Design Transfer Translating design into production specifications. ](/terms/design-transfer?from=manufacturing-and-supply-chain) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [Standards Stack for Medical Devices](/paths/standards-stack)Lesson 7 of 10 - [Manufacturing & Supply Chain](/paths/manufacturing-and-supply-chain)Lesson 7 of 14 Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 IEC· 1 1. [1 ISO 10993-1:2018 Verified ISO · iso.org ](https://www.iso.org/standard/68936.html) 2. [2 ISO Standards Catalogue - Health Verified ISO · iso.org ](https://www.iso.org/ics/11/x/) 3. [3 IEC Webstore - Medical Equipment Verified IEC · webstore.iec.ch ](https://webstore.iec.ch/searchform&q=medical) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Implementing this standard on a device program? Blue Goat Cyber helps MedTech teams operationalize cybersecurity standards across the design and post-market lifecycle. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Standards Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=iso-10993-1) Learn in 60 seconds Card Lesson Quiz Biological evaluation of medical devices within a risk management process. - · Biocompatibility documentation is a routine requirement for any patient-contacting device. - · FDA's recognized version aligns with ISO 10993-1:2018 plus FDA-specific guidance. Remember this Watch out: Failing to integrate biocompatibility evaluation into the overall risk management process can lead to overlooked hazards. Related terms - [Biocompatibility ](/terms/biocompatibility) You may also need Auto-suggested from Standards and shared keywords. - [ISO 14971 ](/terms/iso-14971) - [AAMI TIR57 ](/terms/aami-tir57) - [ISO/TR 24971 ](/terms/tr24971) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [ICS Medical Advisory(ICSMA) ](/terms/ics-medical-advisory) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) [All Standards terms](/terms?cat=Standards) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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