This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.

该指南代表美国食品和药物管理局（FDA）对此主题的当前思考。它不为任何人设立权利，并且对 FDA 或公众没有约束力。如果符合适用法规的要求，您可以采用替代方法。要讨论替代方法，请联系负责此指南的 FDA 工作人员或办公室，其联系信息列在标题页上。

Introduction

FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Exemption (IDE) Applications , Premarket Notifications (510(k)s) , and De Novo requests for medical devices that come into direct contact or indirect contact with the human body[1] in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process” to support applications to FDA. This guidance replaces Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled “Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing.” This guidance document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, which were not previously discussed in G95-1.

FDA 制定了本指南文件，以协助行业准备前市场申请（PMA）、人道设备例外（HDE）、调查性设备豁免（IDE）申请、预市通知（510(k)）和 De Novo 请求，这些申请涉及直接或间接与人体[1:1]接触的医疗器械，以确定器械的组分材料与人体接触可能导致不可接受的不良生物反应的潜在风险。本指南的目的是进一步明确和更新有关使用国际标准 ISO 10993-1《医疗器械的生物学评价 — 第 1 部分：在风险管理过程中的评估和测试》以支持向 FDA 提交申请的信息。本指南取代了 1995 年 FDA 器械评估办公室（ODE）的蓝皮书备忘录 #G95-1，题为《国际标准 ISO-10993 的使用，'医疗器械的生物学评价 — 第 1 部分：评估和测试》。本指南文件还融入了几个新的考虑因素，包括使用基于风险的方法确定是否需要生物相容性测试、化学评估建议以及对具有亚微米或纳米技术组分以及由原位聚合和/或可吸收材料制成的器械的生物相容性试验物品准备的建议，这些在 G95-1 中以前没有讨论过。在评估新设备时，赞助商应明确说明设备是否没有直接或间接组织接触，并且不需要进一步的生物相容性信息。

When assessing new devices, the sponsor should specifically state if the device does not have any direct or indirect tissue contact[2], and no further biocompatibility information would be needed.

在评估新设备时，赞助商应明确说明设备是否没有直接或间接组织接触[2:1]，并且不需要进一步的生物相容性信息。

When assessing device modifications, the sponsor should specifically state if the modification does not result in a change to any direct or indirect tissue-contacting components, and no further biocompatibility information would typically be needed. However, if the change could affect other parts of the device with direct or indirect contact that were not changed, a biocompatibility evaluation should be conducted to assess the potential impact of the change. For example, if a new non-contact internal component is added, but it requires the application of heat in order to join to another component that has patient contact, the patient-contacting component may be impacted by the application of heat such that biocompatibility could be impacted, and should be assessed.

在评估设备修改时，赞助商应明确说明修改是否不会导致任何直接或间接与组织接触的组分发生变化，并且通常不需要进一步的生物相容性信息。然而，如果变更可能影响未更改的设备的其他部分，这些部分与直接或间接接触有关，则应进行生物相容性评估以评估变更的潜在影响。例如，如果添加了一个新的非接触式内部组件，但它需要应用热量与另一个与患者接触的组件连接，那么受热应用可能影响与患者接触的组件，从而需要进行生物相容性评估。

For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database#footnote[3].

有关本文档中引用的 FDA 认可的共识标准的最新版本，请参阅 FDA 认可的共识标准数据库[3:1]。

Throughout this guidance document, the terms “we”, “us”, and “our” refer to FDA staff . “You” and “your” refers to the sponsor.

在本指南文件中，“我们”、"我们的"指的是 FDA 工作人员。"您"和"您的"指的是赞助商。

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

FDA 的指南文件，包括本指南，不确定法律上可执行的责任。相反，指南描述了机构对某一主题的当前思考，只应视为建议，除非引用了具体的法规或法定要求。指南中使用的"应该"一词表示建议或推荐，但不是必需的。

  1. For the purposes of this document, the term “human body” refers to either patient tissues or the clinical practitioner. For example, masks or gloves intended for protective purposes by clinical practitioners should be assessed for biocompatibility. Similarly, medical devices such as implants or skin electrodes also should be assessed for biocompatibility.
    根据本文件的目的，“人体”一词指的是患者组织或临床医生。例如，临床医生用于保护目的的口罩或手套应进行生物相容性评估。同样，植入物或皮肤电极等医疗器械也应进行生物相容性评估。 ↩︎ ↩︎

  2. For non-contact devices, there is no direct or indirect contact with the body (e.g., stand alone software), so it would be sufficient for the biocompatibility evaluation to confirm that there are no direct or indirect tissue contacting components, and no further biocompatibility information is needed. However, for devices with transient contact, assessment of biocompatibility risk should be conducted to determine if testing is needed.
    对于非接触式设备，其与人体没有直接或间接接触（例如，独立软件），因此，生物相容性评估只需确认不存在直接或间接与组织接触的组件即可，无需进一步的生物相容性信息。然而，对于有瞬时接触的设备，应进行生物相容性风险评估以确定是否需要进行测试。 ↩︎ ↩︎

  3. Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
    请参考 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm。 ↩︎ ↩︎