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生物评估医疗器械的技术信息报告 风险管理过程中的生物评估指导

Biological Evaluation Guidance for Technical Information Reporting of Medical Devices in Risk Management

医疗器械的生物学评估.风险管理过程评估和测试

Biological evaluation of medical devices - Evaluation and testing within a risk management process

医疗器械的生物评估 在风险管理过程中评估生物安全性的要求和一般原则

Biological evaluation of medical devices - Requirements and general principles for the evaluation of biological safety within a risk management process

医疗器械的生物学评价 潜在降解产物的识别和量化框架

Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products

医疗器械生物学评价 第9部分：潜在降解产物的识别和量化框架

Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products

一次性医用手套.第3部分:生物评定要求和试验;德文版本EN 455-3-2015

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German version EN 455-3:2015

医疗器械的生物学评估 第9部分：可能降解产物的识别和量化框架 (ISO 10993-9:2019)

Biological assessment of medical devices – Part 9: Framework for the identification and quantification of possible degradation products (ISO 10993-9:2019)

医疗器械的生物学评估 - 第 9 部分：潜在降解产物的识别和量化框架 (ISO 10993-9:2019)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021

医疗器械的生物学评价.第9部分:潜在降解产物的识别和量化框架

Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products

医疗器械生物学评价.第1部分：风险管理过程中的评价与试验

Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process

生物医学美利体育官网首页网址的生物学评估 第1部分：评估与测试

Biological evaluation of medical devices. Part 1: Evaluation and testing.

医疗器械的生物学评价 第1部分：在风险管理过程中对生物学安全性的评价要求和一般原则

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

医疗器械生物学评价 第23部分:刺激性试验 修正案1:附加体外重建人表皮模型

Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models

医疗器械的生物学评价.第9部分:潜在降解产物的识别和量化框架

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

医疗器械生物学评价 第1部分：风险管理过程中的生物学安全评价要求和通用原则

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

医疗器械的生物学评价 第1部分：风险管理过程中生物学安全评价的要求和一般原则（ISO 10993-1:2025）

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)

医疗器械的生物评价 第9部分：潜在降解产物的识别和量化框架 (ISO 10993-9:2019)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

医疗器械的生物学评价 第9部分：潜在降解产物的识别和量化框架

Biological evaluation of medical devices - Part 9: framework for the identification and quantification of potential degradation products

医疗器械的生物学评价 第9部分：潜在降解产物的鉴定和量化框架

Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products

医疗器械生物学评价 第1部分：评价与试验（ISO 10993-1:1997）

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)

医疗器械的生物学评价 第1部分：在风险管理过程中评价生物学安全性的要求和一般原则（ISO 10993-1:2025 等同采用）

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025, IDT)

医疗器械生物学评价 第8部分:生物学试验用参考材料的选择和鉴定(ISO 10993-8:2000)

Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)

医疗器械的生物学评价 第9部分：潜在降解产物识别和定量框架（ISO 10993-9:2019）

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

医疗器械的生物学评价 第1部分：在风险管理过程中对生物学安全性的评价要求和一般原则（ISO 10993-1:2025 等同采用）

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025, IDT)

医疗器械的生物学评价 第1部分：风险管理过程中的评价和测试（ISO 10993-1:2009）

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

医疗器械的生物学评估 第9部分：潜在降解产物的识别和量化框架

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

医疗器械生物学评价 第1部分：风险管理过程中生物安全性评价的要求和一般原则

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

医疗器械生物学评价 第9部分：潜在降解产物的识别和量化框架

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

口腔医疗器械生物学评价第7部分：牙髓牙本质应用试验

Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test

眼科光学 接触镜护理产品 第2部分：基本要求

Ophthalmic optical contact lens care products Part 2: Basic requirements

眼科光学.接触镜护理产品.第7部分：生物学评价试验方法

Ophthalmic optics.Contact lens care products.Part 7:Biological evaluation test methods

荷包缝合针

Purse string needle(with suture)

牙科学.口腔医疗器械生物学评价.第1单元：评价与试验

Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test

医疗器械生物学评价风险管理过程中生物学评价的实施指南

Implementation Guidelines for Biological Evaluation in the Risk Management Process of Biological Evaluation of Medical Devices

牙科学 牙科器械用材料 第1部分：不锈钢

Dentistry - Materials for dental instruments - Part 1: Stainless steel