标准号: |
ANSI/AAMI/ISO 11137-1AMD 1-2013 |
英文名称: |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 |
中标分类: |
医药卫生劳动保护>>医疗器械综合 |
发布日期: |
2013-01-01 |
发布单位: |
US-ANSI |
标准状态: |
请与本站工作人员进行确认 |
ICS分类: |
有关消毒和灭菌的其他标准>>有关消毒和灭菌的其他标准 |
起草单位/标准公告: |
ANSI |
正文语言: |
英语 |
采用关系: |
ISO 11137-1 AMD 1-2013,IDT |
内容提要(EN): |
Acceptance (approval);Biological hazards;Calibration;Characterisations;Checks;Clearing;Containers;Definitions;Dose;Dosimeters;Dosimetry;Efficiency;Elections;Electron beams;Evaluations;Gamma-radiation;Germicides;Guide books;Health protection;Hygiene;Inspection;Ionizing radiation;Irradiation apparatus;Jets;Maintenance;Medical devices;Medical equipment;Medical products;Medical sciences;Medical technology;Methods;Performance;Personnel;Phototherapy;Plant;Product information;Public health;Qualifications;Quality management;Radiation;Ray treatment;Routine tests;Specification (approval);Sterilization by irradiation;Sterilization (hygiene);Surveillance (approval);Val |
归属: |
美国 |