ISO 10993-17:2023 医疗器械的生物学评价 第17部分：医疗器械成分的毒理学风险评估

标准编号：ISO 10993-17:2023

中文名称：医疗器械的生物学评价 第17部分：医疗器械成分的毒理学风险评估

英文名称：Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

发布日期：2023-09

标准范围

本文件规定了医疗器械成分毒理学风险评估的流程和要求。还规定了用于评估暴露于成分是否没有明显危害的方法和标准。毒理学风险评估可以是最终产品生物学评价的一部分，如ISO 10993-1所述。本文件中描述的过程适用于根据ISO？10993-18.当需要对成分信息或分析化学数据（例如可提取数据或可沥滤数据）进行毒理学风险评估以确定与成分相关的毒理学风险是可忽略的还是可耐受的时。本文件中描述的工艺不适用于已通过其他方法估计毒理学风险的情况，例如:—？医疗器械中存在或从医疗器械中提取的成分（不包括关注队列或排除的化学品），其含量代表患者暴露量低于相关的基于毒理学的报告阈值（参见ISO？10993-18:20 20，附件？E和ISO/TS？21726中的适用要求）；—？已确定与现有生物相容性或临床确定的医疗器械具有化学或生物学等效性的新的或变更的医疗器械（参见ISO？10993-18:20 20，附件？C）中的适用要求。本文件中描述的过程也不适用于:—？不接触身体的医疗器械成分（例如体外诊断）；—？与医疗器械与身体的物理相互作用（即施加机械力、能量或表面形态等）相关的生物风险。），前提是化学暴露不变；—？器械—药物组合产品的活性药物成分或器械—生物组合产品的生物成分可作为额外的监管考虑因素；—？暴露于器械以外来源（如食物、水或空气）产生的特定成分。

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.

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