Browse Standards

医疗保健产品灭菌 化学指示物 第1部分：通则

Sterilization of health care products—Chemical indicator—Part 1: General requirements

医疗保健产品灭菌 生物指示物 第5部分：低温蒸汽甲醛灭菌用生物指示物

Sterilization of health care products—Biological indicator—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

医疗保健产品灭菌 生物指示物 第4部分：干热灭菌用生物指示物

Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes

医疗保健产品灭菌 生物指示物 第3部分：湿热灭菌用生物指示物

Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes

医疗保健产品灭菌 生物指示物 第2部分：环氧乙烷灭菌用生物指示物

Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes

医疗保健产品灭菌 生物指示物 第1部分：通则

Sterilization of health care products—Biological indicators—Part 1: General requirements

医疗保健产品灭菌 环氧乙烷 第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求

Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices

医疗保健产品灭菌 湿热 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求

Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

医用电气设备 第2部分：放射治疗模拟机安全专用要求

Medical electrical equipment—Part 2: Particular requirements for the safety of radiotherapy simulators

手术植入物 有源植入式医疗器械 第2部分：心脏起搏器

Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

手术植入物 有源植入式医疗器械 第1部分：安全、标记和制造商所提供信息的通用要求

Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

医疗保健产品灭菌 辐射 第2部分：建立灭菌剂量

Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose

医疗保健产品灭菌 辐射 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求

Sterilization of health care products—Radiation—Part 1：Requirements for development，validation and routine control of a sterilization process for medical devices

一次性使用无菌注射针

Sterile hypodermic needles for single use

医用电子加速器 性能和试验方法

Medical electron accelerators—Functional performance characteristics and test methods

针灸针

Acupuncture needles

外科植入物 金属材料 第1部分：锻造不锈钢

Implants for surgery—Metallic materials—Part 1: Wrought stainless steel

心肺转流系统 热交换水箱

Cardiopulmonary bypass systems—Water heating/cooling system

心肺转流系统 滚压式血泵

Cardiopulmonary bypass systems—Roller blood pump

气囊式体外反搏装置

Air-bag type sequential external counter-pulsation device