Understanding SN EN ISO 10993-17:2023 - Toxicological Risk Assessment
SN EN ISO 10993-17:2023
Biologische Beurteilung von Medizinprodukten - Teil 17: Toxikologische Risikobewertung von Medizinproduktbestandteilen (ISO 10993-17:2023)
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1. The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable. The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as: — constituents, excluding cohort of concern or excluded chemicals, that are present in or extracted from a medical device at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see applicable requirements in ISO 10993-18:2020, Annex E and ISO/TS 21726); — a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see applicable requirements in ISO 10993-18:2020, Annex C). The process described in this document is also not applicable to: — medical device constituents that do not contact the body (e.g. in vitro diagnostics); — biological risks associated with physical interactions of the medical device with the body (i.e. application of mechanical forces, energy or surface morphology, etc.), provided that the chemical exposure is not changed; — active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations can apply; — exposure to a particular constituent that arises from sources other than the device, such as food, water or air.
=== SECTION 1 ===
What SN EN ISO 10993-17:2023 covers
SN EN ISO 10993-17:2023 specifies the methodologies and criteria for conducting toxicological risk assessments on the constituents of medical devices. This standard is integral to the biological evaluation process as described in ISO 10993-1, ensuring that any chemicals present do not pose significant risks to patients. The standard emphasizes evaluating chemical characterization data—obtained in accordance with ISO 10993-18—to determine safety levels. Notably, it excludes constituents that do not contact the body, cases of established biological equivalence, and exposure from other sources such as food or air. By clearly defining what is included and excluded, the standard provides a focused framework for assessing toxicological risks.
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Who needs to comply with SN EN ISO 10993-17:2023
Compliance with SN EN ISO 10993-17:2023 is essential for various stakeholders in the healthcare technology industry, including manufacturers of medical devices, regulatory bodies, and laboratories focused on biocompatibility testing. It is relevant for organizations of all sizes, from small startups to large multinational corporations, as they must ensure that their products meet safety standards to achieve market access. Roles involved may include quality assurance professionals, regulatory affairs specialists, and toxicologists, all of whom play critical roles in ensuring compliance and protecting patient safety. The standard serves as a guiding framework for these professionals in their assessment processes.
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Key requirements
- Toxicological risk assessment process: Clearly outlines the steps necessary to assess the risks associated with medical device constituents.
- Chemical characterization information: Requires detailed information on the chemical constituents of medical devices to support risk evaluations.
- Risk evaluation criteria: Specifies the criteria for determining whether exposure levels are considered tolerable or negligible.
- Identification of hazardous constituents: Mandates the identification and assessment of any potentially hazardous substances present in device materials.
- Tolerable contact doses: Establishes acceptable exposure limits for constituents, ensuring patient safety during device use.
- Toxicological screening thresholds: Defines thresholds that help differentiate between significant and negligible risks.
These requirements are typically audited through a combination of documentation review, interviews, and assessments of the risk management process.
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How to implement SN EN ISO 10993-17:2023
Implementing SN EN ISO 10993-17:2023 involves several critical steps. First, organizations should conduct a gap analysis to identify areas needing compliance enhancement. Following this, thorough documentation of current processes and constituent assessments must be created or updated. Training staff on the standard’s requirements is crucial to ensure understanding and effective implementation. An internal audit should then be performed to evaluate compliance and identify any further improvements needed. Finally, organizations can prepare for a certification audit by engaging with third-party auditors to validate their adherence to the standard. This systematic approach helps integrate the standard into the organization’s quality management system effectively.
=== SECTION 5 ===
Related standards
- ISO 10993-1: Provides a general framework for the biological evaluation of medical devices, including risk management principles.
- ISO 10993-18: Focuses on the chemical characterization of materials used in medical devices, which is pivotal for toxicological assessments.
- ISO/TS 21726: Offers guidance on evaluating the safety of device-drug combination products, relevant for assessing biological equivalence.
- ISO 14971: Sets out the requirements for risk management processes, complementing the risk assessment outlined in ISO 10993-17.
- ISO 10993-5: Covers the tests for in vitro cytotoxicity, essential for assessing biological safety of device materials.
These related standards collectively enhance the framework for ensuring the safety and efficacy of medical devices.
=== SECTION 6 ===
Why SN EN ISO 10993-17:2023 matters
Adhering to SN EN ISO 10993-17:2023 is crucial for organizations in the healthcare technology sector as it enhances competitive advantage by fostering consumer trust and ensuring legal compliance. It provides a structured approach to risk management, facilitating market access for medical devices worldwide. By implementing these standards, companies can demonstrate their commitment to safety and quality, ultimately leading to improved patient outcomes. For further knowledge and training opportunities, explore the options available below.
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