C30 医疗器械综合 标准查询与下载
共找到 1389 条与 医疗器械综合 相关的标准，共 93 页
Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral standards: Requirements for the development of physiological closed-loop controllers
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standards: Availability
- ICS
- 11.040
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standards: General requirements, testing and guidance for alarm systems in medical electrical equipment and medical electrical systems
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Blastocyst cell staining and counting methods for medical devices used in human assisted reproductive technology
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Medical electrical equipment Part 1-12: General requirements for basic safety and essential performance Collateral standards: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services envir
- ICS
- 11.040
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standards: Requirements for medical electrical equipment and medical electrical systems used in home care environments
- ICS
- 11.040
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Medical device thrombosis testing Part 1: In vivo thrombosis testing in dogs
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Biological Evaluation of Absorbable Medical Devices Part 1: Guidelines for Absorbable Implants
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Methods for evaluating immunogenicity of medical devices Part 7: Flow liquid phase multiplex protein quantification technology
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standards: Electromagnetic compatibility requirements and tests
- ICS
- 11.140
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2023-05-01
This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the characterization of a medical device through: - the identification of its materials of
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020
- ICS
- CCS
- C30
- 发布
- 2021-03-00
- 实施
The project defines dimensions and marking of probes with eye, as used in surgery and public health service.
Medical instruments - Probes with eye
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-02-00
- 实施
The project defines dimensions and marking of probes, as used in surgery and public health service.
Medical instruments - Probes
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-02-00
- 实施
The project defines dimensions and marking of fixation forceps, as used in surgery and public health service.
Medical instruments - Fixation forceps
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-02-00
- 实施
The project defines dimensions and marking of retractors type Volkmann, as used in surgery and public health service.
Medical instruments - Retractor type Volkmann
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-02-00
- 实施
The project defines dimensions and marking of towel clamps type Backhaus, as used in surgery and public health service.
Medical instruments - Towel clamps type Backhaus
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-02-00
- 实施
The project defines dimensions and marking of needle holders type Mayo-Hegar with carbide inserts, as used in surgery and public health service.
Medical instruments - Needle holder type Mayo-Hegar with carbide inserts
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-02-00
- 实施
The project defines dimensions and marking of directors type König, as used in surgery and public health service.
Medical instruments - Director type König
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-02-00
- 实施
本文件规定了系统性开展医用电气设备（ME设备）和医用电气系统（ME系统）失效模式、影响及危害度分析（FMECA）的程序和方法。
Guidelines for Failure Mode Effects and Criticality Analysis of Medical Electrical Equipment
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-01-16
- 实施
- 2021-03-01
本文件规定了心肌肌钙蛋白I定量测定试剂（盒）（荧光免疫层析法）的技术要求、试验方法、标志、包装、运输和贮存。
Cardiac troponin-I quantitative Assay (kit) (fluorescence immunochromatography)
- ICS
- 11.040.55
- CCS
- C30
- 发布
- 2021-01-16
- 实施
- 2021-03-01
