Browse Standards

臭氧消毒器卫生要求

Hygienic requirements for ozone disinfector

过氧化氢气体等离子体低温灭菌器卫生要求

Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer

黏膜消毒剂通用要求

General requirements for disinfectant of mucous membrane

疫源地消毒剂通用要求

General requirements on disinfectant for infectious focus

普通物体表面消毒剂通用要求

General requirements for ordinary objects surface disinfectant

手消毒剂通用要求

General requirements for hand disinfectant

空气消毒剂通用要求

General requirements for air disinfectant

酸性电解水生成器卫生要求

Hygienic requirements for acidic electrolyzed water generator

体外诊断医疗器械 生物源性样品中量的测量 有证参考物质及支持文件内容的要求

In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation

牛海绵状脑病诊断技术

Diagnostic techniques for bovine spongiform encephalopathy

传染性法氏囊病诊断技术

Diagnostic techniques for infectious bursal disease

体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的表述和内容的要求

In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures

体外诊断检验系统 自测用血糖监测系统通用技术条件

In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing

皮肤消毒剂通用要求

General requirements for skin disinfectant

六自由度外固定支架

Six degree of freedom external fixator

医疗器械生物学评价 第11部分：全身毒性试验

Biological evaluation of medical devices—Part 11: Tests for systemic toxicity

医疗器械生物学评价 第6部分：植入后局部反应试验

Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

医疗器械生物学评价 第19部分：材料物理化学、形态学和表面特性表征

Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials

医疗器械生物学评价 第18部分：风险管理过程中医疗器械材料的化学表征

Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process

医用X射线管通用技术条件

General specifications for X-ray tube