Browse Standards

医疗器械灭菌 环氧乙烷灭菌过程参数放行指南

Sterilization of medical devices—Guidance on using parametric release for ethylene oxide sterilization process

制造商对医疗器械的上市后监测

Post-market surveillance of medical devices for manufacturers

躺卧保护组织完整性的辅助器具 第7部分：泡沫的属性、特征和性能

Assistive products for tissue integrity when lying down—Part 7:Foam properties, characteristics and performance

医学实验室 生物标本染色用试剂 用户指南

Medical laboratories—Reagents for staining biological specimen—Guidance for users

体外诊断检验系统 核酸扩增法检测新型冠状病毒（SARS-CoV-2）的要求和建议

In vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods

医用成像部门的评价及例行试验 第2-10部分:稳定性试验 乳腺X射线摄影设备

Evaluation and routine testing in medical imaging departments--Part 2-10: Constancy tests--X-ray equipment for mammography

医用成像部门的评价及例行试验 第2-9部分: 稳定性试验 间接透视和间接摄影X射线设备

Evaluation and routine testing in medical imaging departments--Part 2-9: Constancy tests--Equipment for indirect radioscopy and indirect radiography

医用成像部门的评价及例行试验 第2-7部分: 稳定性试验 口内牙科X射线摄影设备不包括牙科全景设备

Evaluation and routine testing in medical imaging departments--Part 2-7: Constancy tests--Equipment for intra-oral dental radiography excluding dental panoramic equipment

医用成像部门的评价及例行试验 第2-11部分:稳定性试验 普通直接摄影X射线设备

Evaluation and routine testing in medical imaging departments--Part 2-11: Constancy tests--Equipment for general direct radiography

猪水泡病诊断技术

Diagnostic techniques for swine vesicular disease

麻醉呼吸设备 术语

Anaesthetic and respiratory equipment--Vocabulary

牛海绵状脑病诊断技术

Diagnostic techniques for bovine spongiform encephalopathy

枸杞栽培技术规程

Lycium culture technics operatings

医疗器械生物学评价 第5部分: 体外细胞毒性试验

Biological evaluation ofmedical devices--Part 5: Test for in vitro cytotoxicity

医疗器械生物学评价 第4部分: 与血液相互作用试验选择

Biological evaluation of medical devices--Part 4:Selection of tests for interactions with blood

医疗器械生物学评价 第15部分:金属与合金降解产物的定性与定量

Biological evaluation of medical devices--Part 15:Identification and quantification of degradation products from metals and alloys

医疗器械生物学评价 第14部分:陶瓷降解产物的定性与定量

Biological evaluation of medical devices--Part 14:Identification and quantification of degradation products from ceramics

放射治疗设备 坐标系、运动与刻度

Radiotherapy equipment--Coordinates，movements and scales

医用成像部门的评价及例行试验 第3-1部分:X射线摄影和透视系统用X射线设备成像性能验收试验

Evaluation and routine testing in medical imaging departments--Part 3-1: Acceptance test--Imaging performance of X-ray equipment for radiographic and radioscopic systems

医用成像部门的评价及例行试验 第2-4部分: 硬拷贝照相机稳定性试验

Evaluation and routine testing in medical imaging departments--Part 2-4 Constancy tests--Hard copy cameras