作废 YY 0678-2008
医用冷冻外科治疗设备性能和安全 医用冷冻外科治疗设备性能和安全 Standard performance and safety specification for cryosurgical medical instruments
发布日期:2008-10-17
实施日期:2010-06-01
分类信息
研制信息

归口单位: 国家食品药品监督管理局杭州医疗器械质量监督检验中心

起草单位: 国家食品药品监督管理局杭州医疗器械质量监督检验中心

起草人: 孙瑜、 杜堃、 叶岳顺、 方乐、 韩坚城、 马莉

标准简介

本标准规定了医用冷冻外科治疗设备在冷冻系统性能和复现性、公布、标记、文件和安全方面所应遵循的基本要求。本标准所指医用冷冻外科治疗设备采用相变汽化潜热或焦耳-汤姆逊效应原理,在冷冻探杆内或直接在靶组织产生低温,用于产生冷冻坏死、炎性反应或冷冻粘连。医用冷冻外科设备使用时是由可显示冷冻探头或冷冻区域温度的附件来对治疗过程进行监测的,本标准的要求适用于这些附件

相似标准/计划/法规
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
GOST R ISO/TR 16142-2008
Изделия медицинские. Руководство по выбору стандартов, поддерживающих важнейшие принципы обеспечения безопасности и эксплуатационных характеристик медицинских изделий
医疗设备 关于选择支持公认的医疗器械安全和性能基本原则的标准的指导意见
ASTM F2100-25
Standard Specification for Performance of Materials Used in Medical Face Masks
医用口罩材料性能标准规范
2025-05-01
ASTM F2011-02(2018)
Standard Specification for Safety and Performance of Fun-Karts
Fun-Karts的安全和性能标准规范
2018-02-01
ASTM F2950-14(2021)
Standard Safety and Performance Specification for Soccer Goals
足球目标的标准安全和性能规范
2021-01-01
BS ISO 16142-2-2017
Medical devices. Recognized essential principles of safety and performance of medical devices-General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
医疗设备 公认的医疗器械安全和性能基本原则
2017-09-20
ASTM F3660-23
Standard Consumer Safety Performance Specification for Motorized Partitions
电动隔板的消费者安全性能规范
2023-08-01
ASTM F2710-19
Standard Consumer Safety Performance Specification for Commercial Cribs
商业婴儿床的标准消费者安全性能规范
2019-12-01
ASTM F833-21
Standard Consumer Safety Performance Specification for Carriages and Strollers
车厢和婴儿车的标准消费者安全性能规范
2021-06-15
ASTM F2372-15(2021)
Standard Consumer Safety Performance Specification for Shopping Carts
购物车的标准消费者安全性能规范
2021-09-01
BS ISO 16142-1-2016
Medical devices. Recognized essential principles of safety and performance of medical devices-General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
医疗设备 医疗器械安全和性能的公认基本原则第1部分:所有非IVD医疗器械的一般基本原则和附加特定基本原则及标准选择指南
2016-03-31
BS EN 60601-1-6-2010+A2-2021
Medical electrical equipment-General requirements for basic safety and essential performance. Collateral standard: Usability
医用电气设备
2021-08-13
AAMI/ISO 16142-2-2017
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
医疗器械.医疗器械安全和性能的公认基本原则.第2部分:所有IVD医疗器械的一般基本原则和附加特定基本原则及标准选择指南
2017-07-31
ASTM F1148-24
Standard Consumer Safety Performance Specification for Home Playground Equipment
家用游乐场设备的标准消费者安全性能规范
2024-08-15
ASTM F2000-19
Standard Safety Performance Specification for Fences for Baseball and Softball Fields
棒球场和垒球场用栅栏的标准安全性能规范
2019-04-15
ASTM F1918-21
Standard Safety Performance Specification for Soft Contained Play Equipment
软式游戏设备的标准安全性能规范
2021-08-01
ASTM F2012-24e1
Standard Consumer Safety Performance Specification for Stationary Activity Centers
固定活动中心的标准消费者安全绩效规范
2024-11-01
AAMI/ISO 16142-1-2016
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
医疗器械.医疗器械安全和性能的公认基本原则.第1部分:所有非IVD医疗器械的一般基本原则和附加特定基本原则及标准选择指南
2016-08-10
BS EN 60601-1-12-2015+A1-2020
Medical electrical equipment-General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
医用电气设备
2020-09-04
外科冷冻性能治疗设备

最后更新时间 2025-08-31