灭菌剂是具有足够杀真菌活性的物理或化学实体或其组合,在规定条件下实现无菌状态,可杀灭一切微生物(包括真菌芽孢)使其达到灭菌要求的制剂。
| 标准号 & 类别 | 标准名称 | 发布 |
|---|---|---|
| ANSI/AAMI/ISO 13408-5:2006(2015) 规程标准 |
Aseptic processing of health care products — Part 5: Sterilization in place
无菌保证水平 |
2015 美国国家标准学会 |
| ANSI/AAMI/ISO 14937:2009(2013) 规范标准 |
医疗保健产品灭菌 医疗器械灭菌剂特性及灭菌过程开发、验证和常规控制的一般要求 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
灭菌过程 |
2013 美国国家标准学会 |
| ASTM E1766-95(2002) Test Method |
Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
回收效率 孢子 接种物 无菌 灭菌器 生物负载 菌落形成单位 |
1995 美国材料与试验协会 |
| ASTM E1766-95(2007) Test Method |
Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
回收效率 孢子 接种物 无菌 灭菌器 生物负载 菌落形成单位 |
1995 美国材料与试验协会 |
| ASTM E2756-19 术语 |
Standard Terminology Relating to Antimicrobial and Antiviral Agents
抗菌剂 消毒剂 |
2019-11-01 美国材料与试验协会 |
| CSA ISO 14937-2011(R2021) 规范标准 |
消毒医疗器械 灭菌剂的特性描述及灭菌过程开发、验证和常规控制的一般要求 General requirements for the characterization of sterilizing agents for sterilizing medical devices and for the development, validation and routine control of sterilization processes
灭菌过程 |
2021 加拿大标准协会 |
| DIN 58950-7:2022-06 规范 |
Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and local environment; Text in German and English / Note: DIN 58950-7 (2011-01) remains valid alongside this standard until 2023-05-31.
灭菌过程 蒸汽灭菌器 |
2022-06 德国标准化学会 |
| GB/T 33419-2016 试验 |
Test method of biological indicator for ethylene oxide sterilization processes
D值 生物指示物 |
2016-12-30 国家市场监督管理总局 |
| GOST R ISO 13408-5-2011 规范 |
Aseptic processing of health care products. Part 5. Sterilization in place
|
2011-01-01 俄罗斯标准局 |
| GOST R ISO 14937-2012 规范 |
医疗保健产品的消毒. 医疗器械消毒方法的制定, 确认和常规控制及消毒剂特定的通用标准 Sterilization of health care products. General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
生物负载 |
2012 俄罗斯标准局 |
| IRAM 37007-1:2008 术语 |
Sterilization of health care products. Sterilization by water steam. Part 1 - Vocabulary.
安装确认 |
2008-08-25 阿根廷标准化研究所 |
| NF C42-724:1997 规范 |
测量、控制和试验室用电气美利体育官网首页网址的安全要求.第2-042部分:医疗材料处理及试验室加工用毒气高压消毒蒸锅和消毒器的特殊要求 Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 2-042 : particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes.
高压灭菌器 |
1997-09-01 法国标准化协会 |
| SIS-ISO/TS 22421:2021 规范标准 |
Sterilization of health care products - Common requirements for sterilizers forterminal sterilization of medical devices in health care facilities (ISO/TS 22421:2021)
灭菌器 |
2021 瑞典标准研究所 |
| SS-EN 14180:2003 规范 |
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
灭菌过程 |
2003 瑞典标准研究所 |
| SS-EN ISO 13408-5:2011 规范标准 |
医疗保健产品无菌加工 第5部分:现场灭菌(ISO 13408-5:2006) Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
无菌保证水平 |
2011-08-17 瑞典标准研究所 |
| SS-EN ISO 14160:2021 规范 |
医疗产品消毒 利用动物组织及其衍生物的一次性医用美利体育官网首页网址液体化学消毒剂 消毒 characterization、开发、验证和常规控制的要求... Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization...
生物负载 |
2021 瑞典标准研究所 |
| SS-EN ISO 14937:2009 规范 |
医疗器械灭菌产品 灭菌剂的特性、灭菌过程开发、验证和常规控制的一般要求(ISO 14937:2009) Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
无菌医疗器械 灭菌过程 |
2009-11-18 瑞典标准研究所 |
| T/FDSA 027-2021 规范标准 |
General technical criteria of peroxyacetic acid low temperature sterilizer
灭菌周期 |
2021-12-14 中国团体标准 |
| UNE-EN ISO 14937:2010 规范标准 |
医疗保健产品灭菌 灭菌剂表征的一般要求以及医疗器械灭菌过程的开发、验证和常规控制(ISO 14937:2009) Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
灭菌过程 |
2010-05-26 西班牙标准化协会 |
| YY 0503-2016 规范标准 |
Ethylene oxide sterilizer
灭菌周期 环氧乙烷灭菌器 |
2018-01-01 行业标准-医药 |
Copyright ?2007-2026 ANTPEDIA, All Rights Reserved
京ICP备07018254号 京公网安备1101085018 电信与信息服务业务经营许可证:京ICP证110310号
页面更新时间: 2026-06-03 15:47