现行

BS EN 866-4-2000

Biological systems for testing sterilizers and sterilization processes-Particular systems for use in irradiation sterilizers
用于测试灭菌器和灭菌过程的生物系统 用于辐照消毒器的特殊系统

2000-06-15

现行

BS EN ISO 7886-2-2020

Sterile hypodermic syringes for single use-Syringes for use with power-driven syringe pumps
一次性使用无菌皮下注射器

2020-05-20

现行

GOST ISO 11737-2-2011

Стерилизация медицинских изделий. Микробиологические методы. Часть 2. Испытания на стерильность, проводимые при валидации процессов стерилизации
医疗器械灭菌微生物方法 第2部分:验证灭菌过程中进行的无菌试验

2011-11-29

现行

UNE-EN 1422-1998+A1-2009

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
医用灭菌器.环氧乙烷灭菌器.要求和试验方法

2009-09-09

现行

BS EN 1422-2014

Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
医用消毒器 环氧乙烷灭菌器 要求和试验方法

2014-05-31

现行

GOST R 57623-2017

Стерилизаторы для медицинских целей. Стерилизаторы на основе этиленоксида. Требования и методы испытаний
杀菌剂用于医疗用途 环氧乙烷灭菌器要求和测试方法

现行

DOXPUB 09-0210-SOP

Investigation of Sterility Test Failures
无菌检测失败的调查

2007-08-01

现行

DOXPUB 09-0039-SOP

Sterility Testing by Direct Inoculation
直接接种无菌检测

2007-08-01

现行

CID A-A-30163

STERILIZATION TEST PACK, BIOLOGICAL
生物灭菌测试包

1992-04-30

现行

BS EN ISO 11737-2-2020

Sterilization of health care products. Microbiological methods-Tests of sterility performed in the definition, validation and maintenance of a sterilization process
医疗保健产品的消毒 微生物学方法

2020-05-19

现行

GOST EN 14180-2011

Стерилизаторы медицинского назначения. Стерилизаторы низкотемпературные пароформальдегидные. Технические требования и методы испытаний
杀菌剂用于医疗用途 低温蒸汽和甲醛灭菌器 要求和测试

2011-11-29

现行

BS EN 14180-2014

Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
医用消毒器 低温蒸汽和甲醛灭菌器 要求和测试

2014-05-31

现行

BS EN 868-2-2017

Packaging for terminally sterilized medical devices-Sterilization wrap. Requirements and test methods
最终灭菌医疗器械的包装

2017-02-28

现行

UNE-EN 14180-2004

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
医用消毒器.低温蒸汽和甲醛消毒器.要求和试验

2004-03-18

现行

UNE-EN 14180-2004+A2-2010

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
医用消毒器.低温蒸汽和甲醛消毒器.要求和试验

2010-01-13

现行

KS B 6307

기어펌프 및 나사펌프의 시험방법
测试方法齿轮泵和螺杆泵

2020-11-24

现行

GB/T 19973.2-2018

医疗器械的灭菌　微生物学方法　第2部分：用于灭菌过程的定义、确认和维护的无菌试验
Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the definition,validation and maintenance of a sterilization process

2018-03-15

现行

KS P ISO 11737-2

의료기기의 멸균 — 미생물학적 방법 — 제2부: 멸균 공정의 정의, 유효성 확인 및유지에서 수행되는 멸균확인 시험
医疗器械的灭菌 - 微生物方法 - 第2部分:灭菌过程的定义 验证和维护中执行的无菌检测

2018-11-05

现行

AAMI/ISO 11737-2-2019

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
医疗器械的灭菌.微生物学方法.第2部分:在灭菌过程的定义、验证和维护中进行的无菌试验

2019-07-11

现行

DOXPUB 09-0240-SOP

Bacteriostasis/Fungistasis Testing (Sterility Test Validation)
抑菌/抑菌试验（无菌试验验证）

2007-08-01