GB/Z 42217-2022
医疗器械 用于医疗器械质量体系软件的确认
Medical device —Validation of software for medical device quality system
2022-12-30
BS PD ISO/TR 80002-2-2017
Medical device software-Validation of software for medical device quality systems
医疗器械软件
2017-10-31
JIS T 14971-2012
Medical devices -- Application of risk management to medical devices (Foreign Standard)
医疗器械风险管理在医疗器械中的应用（国外标准）
2012-01-01
UL 2800-1
Standard for Medical Device Interoperability
医疗设备互操作性标准
2022-06-10
HY/T 019-1992
海洋行业标准体系表
Table of the standard system for marine industry
1989-03-15
ASTM F1980-21
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
无菌屏障系统和医疗设备加速老化的标准指南
2021-12-15
AAMI/ISO TIR80002-2-2017
Medical device software - Part 2: Validation of software for medical device quality systems
医疗器械软件第2部分:医疗器械质量体系软件的验证
2017-08-18
KS P ISO TR 80002-2
의료기기 소프트웨어 — 제2부: 의료기기 품질시스템에서 사용하는 소프트웨어 밸리데이션
医疗器械软件.第2部分:医疗器械质量体系软件的验证
2021-06-28
GOST R 58976-2020
Изделия медицинские. Программное обеспечение. Часть 2. Валидация программного обеспечения, используемого в системах качества медицинских изделий
医疗器械 软件 第二部分 医疗器械质量体系软件的验证
GOST ISO 10993-11-2021
Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 11. Исследования общетоксического действия
医疗设备 医疗器械生物学评价 第11部分:全身毒性试验
ISO/TR 80002-2-2017
Medical device software — Part 2: Validation of software for medical device quality systems
医疗器械软件 - 第2部分:验证医疗器械质量体系的软件
2017-06-13
ISO TR 80002-2-2017
Medical device software - Part 2: Validation of software for medical device quality systems
医疗器械软件第2部分:医疗器械质量体系软件的验证
2017-06-13
UNE-ENV 12611-1998
MEDICAL INFORMATICS. CATEGORIAL STRUCTURE OF SYSTEMS OF CONCEPTS. MEDICAL DEVICES.
医学信息学 概念系统的范畴结构 医疗设备
1998-07-29
BS DD ENV 12611-1998
Medical informatics. Categorical structure of systems of concepts. Medical devices
医学信息学 概念系统的范畴结构 医疗器械
1998-11-15
VDI/VDE 2426 Sheet 2
Catalogues in maintenance and management of medical devices - Standardized device catalogue
医疗器械维护和管理目录.标准化器械目录
2000-05-01
ANSI C12.19-2021
American National Standard for Utility Industry End Device Data Tables
美国公用事业行业终端设备数据表国家标准
2021-10-18
BS ISO 16571-2014
Systems for evacuation of plume generated by medical devices
医疗设备产生的烟羽疏散系统
2014-05-31
ISO 16571-2024
Systems for evacuation of plume generated by medical devices
医疗设备产生的烟羽疏散系统
2024-03-28
AAMI/ISO TIR16142-2005
Medical devices- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
医疗器械.支持医疗器械安全和性能公认基本原则的标准选择指南
2005-10-19
YY/T 0467-2016
医疗器械 保障医疗器械安全和性能公认基本原则的标准选用指南
Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
2016-01-26