C37 医疗设备通用要求 标准查询与下载
共找到 713 条与 医疗设备通用要求 相关的标准，共 48 页
Medical electrical equipment - Part 1 : general requirements for basic safety and essential performance.
- ICS
- 11.040.01
- CCS
- C37
- 发布
- 2012-07-01
- 实施
- 2012-07-27
Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
- ICS
- 11.040.01;35.110;35.240.80
- CCS
- C37
- 发布
- 2012-07
- 实施
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-07
- 实施
Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
- ICS
- 11.040.01;35.110;35.240.80
- CCS
- C37
- 发布
- 2012-07
- 实施
This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO 10993 addresses the following: — test sample selection; — selection of representative portions from a device; — test sample preparation; — experimental controls; — selection of, and requirements, for reference materials; — preparation of extracts. This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-07
- 实施
Medical device software -- Software life cycle processes
- ICS
- 11.040
- CCS
- C37
- 发布
- 2012-03-01
- 实施
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-03-01
- 实施
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-03-01
- 实施
Medical electrical equipment -- Glossary of defined terms
- ICS
- 01.040.11;11.040.50
- CCS
- C37
- 发布
- 2012-03-01
- 实施
이 표준에서는 의료용 전기기기[이후로는 의료용 전기기기(ME 기기)라고 함.]의 기본안전
Medical electrical equipment-Part 1-6:General requirements for basic safety and essential performance-Collateral Standard:Usability
- ICS
- 11.040
- CCS
- C37
- 发布
- 2012-01-02
- 实施
- 2012-01-02
이 표준은 이후로는 ME 기기(MEDICAL ELECTRICAL EQUIPMENT)와 ME
Medical electrical equipment-Part 1-10:General requirements for basic safety and essential performance-Collateral Standard:Requirements for the development of physiologic closed-loop controllers
- ICS
- 11.040
- CCS
- C37
- 发布
- 2012-01-02
- 实施
- 2012-01-02
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-01
- 实施
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Amendment 1
- ICS
- 11.040.01
- CCS
- C37
- 发布
- 2012
- 实施
Medical instruments - Gauges type Alexander
- ICS
- 11.040.30
- CCS
- C37
- 发布
- 2011-12
- 实施
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 80001-1:2010); German version EN 80001-1:2011
- ICS
- 11.040.01;35.110;35.240.80
- CCS
- C37
- 发布
- 2011-11
- 实施
- 2011-11-01
Magnetic resonance equipment for medical imaging - Part 2 : classification criteria for pulse sequences.
- ICS
- 11.040.55;35.240.80
- CCS
- C37
- 发布
- 2011-09-01
- 实施
- 2011-09-17
Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2011-07
- 实施
Health informatics - Personal health device communication - Part 10415 : device specialization - Weighing scale.
- ICS
- 35.240.80
- CCS
- C37
- 发布
- 2011-06-01
- 实施
- 2011-06-04
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009); German version EN 62083:2009
- ICS
- 11.040.60
- CCS
- C37
- 发布
- 2011-01
- 实施
- 2011-01-01
