Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
保健品灭菌微生物学方法生物制品和组织制品生物负荷测定和无菌试验指南

2021-03-19

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

Sterilization of health care products. Microbiological methods-Determination of a population of microorganisms on products
医疗保健产品的消毒 微生物学方法

2021-06-18

의료제품의 멸균 — 미생물학적 방법 —제2부: 멸균 공정의 정의, 유효성 확인 및 유지에서 수행되는 멸균 확인 시험
保健产品的灭菌.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

2021-06-28

Sterilization of health care products — 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 - 微生物方法 - 第2部分:灭菌过程的定义 验证和维护中进行的无菌检测

2019-12-02

의료제품의 멸균 — 미생물학적 방법 —제1부: 제품상의 미생물군의 평가
保健产品的灭菌.微生物方法.第1部分:产品上微生物种群的测定

2021-06-28

의료제품의 멸균 미생물학적 방법 제제1부부: 제품상의 미생물수의 결정
保健产品的灭菌.微生物学方法.第1部分:产品上微生物群的测定

2022-12-28

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
保健品的灭菌.微生物方法.第1部分:产品上微生物种群的测定

2018-01-12

医疗保健产品灭菌 微生物学方法 第1部分:产品上微生物总数的确定
Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products

2023-03-17

의료기기의 멸균 — 미생물학적 방법 — 제1부: 제품상의 미생물군의 평가
医疗器械灭菌 - 微生物方法 - 第1部分:产品中微生物群体的测定

2018-11-05

Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
卫生保健产品的灭菌.微生物学方法.第3部分:细菌内毒素检验

2023-06-26

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
医疗器械的灭菌.微生物方法.第1部分:产品上微生物种群的测定

2018-01-24

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
保健产品的灭菌.微生物方法.第1部分:产品上微生物种群的测定.修改件1

2021-05-19

Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
保健产品的灭菌.辐射.使用改进方法2的剂量设置指南

2018-01-31

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
医疗器械的灭菌.微生物方法.第1部分:产品上微生物种群的测定（ISO 11737-1-2006）

2007-03-14

STERILIZATION OF MEDICAL DEVICES. ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT. PART 3: GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES.
医疗器械的消毒 产品上微生物数量的估计 第3部分:微生物技术验证方法指南

1997-04-08

Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method — Amendment 1: Revision of qualitative method comparison study data evaluation, relative level of detection calculations in the interlaboratory study, calculation and interpretation of the relative trueness study, and inclusion of a commercial sterility testing protocol for specific products
食品链微生物学——方法验证——第2部分:对照参考方法验证替代（专有）方法的方案——修正案1:修订定性方法比较研究数据评估、实验室间研究中检测计算的相对水平、相对真实性研究的计算和解释 以及纳入特定产品的商业无菌测试方案

2024-09-03