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用于制药和生物制药制造的一次性系统的辐射验证和日常维护指南

Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

信息安全技术 密码模块安全功能测试规范

Information security technology - Cryptographic module security function test specification

保健品灭菌 辐射 使用修改方法 2 设定剂量的指南

Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2

保健品灭菌 辐射 第2部分：灭菌剂量的确定

Sterilization of health care products—Radiation— Part 2: Establishing the sterilization dose

技术信息报告 保健品灭菌—辐射—所选灭菌剂量的证实：方法VDmax SD

Technical Information Report Sterilization of health care products—Radiation— Substantiation of a selected sterilization dose: Method VDmax SD

保健品灭菌 辐射 确定灭菌剂量

Sterilization of health care products. Radiation - Establishing the sterilization dose

健康卫生产品 — 辐射灭菌 第2部分：确定灭菌剂量

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

医疗保健产品灭菌 辐射 选定灭菌剂量的证实：方法 VDmaxSD（ISO 13004:2022）

Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

医疗器械辐射灭菌 第1部分：方法开发、验证和常规控制要求

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

保健产品的灭菌 辐射 第2部分：杀菌剂量的确定（草案）

Sterilizing radiation for health care products Part 2: Determination of germicidal dose (draft)

保健品灭菌 辐射 所选灭菌剂量的证实：方法 VD（ISO 13004:2022）

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD (ISO 13004:2022); German and English version prEN ISO 13004:2023

保健品灭菌-辐射-选定灭菌剂量的证实：方法VD＜

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German and English version prEN ISO 13004:2023 / Note: Date of issue 2023-02-10*Intended as...

保健品灭菌-辐射-所选灭菌剂量的证实：方法VD<(Index)max><(hoch)SD> （ISO 13004:2022）；德文版 EN ISO 13004:2023

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German version EN ISO 13004:2023

医疗产品灭菌 辐射 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求

Medical Device Sterilization - Radiation - Part 1: Requirements for the Development, Validation and Routine Control of Sterilization Processes for Medical Devices

医疗保健产品灭菌 辐射 第2部分:建立灭菌剂量

Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose

医疗产品灭菌 辐射 第2部分：建立灭菌剂量

Medical Device Sterilization - Radiation - Part 2: Establishing the Sterilization Dose

医疗产品灭菌 辐射 第3部分：开发、确认和常规控制的剂量测量指南

Medical product sterilization - Radiation - Part 3: Guidance on dose measurement for development, validation, and routine control

确保测量一致性的国家体系. 医疗产品. 辐射灭菌. 剂量测定技术

State system for ensuring the uniformity of measurements. Medical products. Radiation sterilization. Dosimetric techniques

医疗保健产品的灭菌 辐射 第2部分 灭菌剂量的测定

Sterilization of health care products. Radiation. Part 2 - Establishing the sterilization dose.

保健产品的灭菌.辐射.第2部分:杀菌剂量的确定

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

保健产品的灭菌.辐射.第2部分:确定灭菌剂量.修改件1

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1

保健产品的灭菌.辐射.选定的灭菌剂量的证实:VD<(Index)max><(hoch)SD>方法

Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD>

保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认、和常规控制的要求

Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

保健产品的灭菌.辐射.第2部分:杀菌剂量的确定

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

保健产品的灭菌.辐射.第3部分:剂量测定方面指南

Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects

医疗保健产品灭菌 辐射 选定灭菌剂量的依据 VDmaxSD方法 (ISO 13004:2022)

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

医疗保健产品灭菌 辐射 选定灭菌剂量的证实：方法VDmaxSD

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose : method VDmaxSD

医疗保健产品灭菌 辐射 选定灭菌剂量的证实：方法VDmaxSD

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose : method VDmaxSD

纳米技术 词汇 第3部分：碳纳米物体

Nanotechnologies - Vocabulary - Part 3: Carbon nano-objects

医疗器械的灭菌 辐射 选定灭菌剂量的证实：方法VDmaxSD（ISO 13004:2022）

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

保健品灭菌 辐射 第2部分：确定灭菌剂量

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

保健品灭菌 辐射 选定灭菌剂量的证实：方法 VDmaxSD (ISO 13004:2022)

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

保健品灭菌 辐射 所选灭菌剂量的证实：方法VDmaxSD

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD