现行

BS EN ISO 11737-1-2018+A1-2021

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

现行

KS P ISO 11737-1

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

现行

ISO 11737-1-2018

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

现行

GB/T 19973.1-2023

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

现行

ISO 11737-3-2023

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

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

KS P ISO 11737-2

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

现行

ISO 11737-2-2019

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

现行

ISO 11737-1-2018/Amd 1-2021

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

现行

KS P ISO 11137-2

의료제품의 멸균 — 방사선 —제2부: 멸균 선량의 설정
保健产品的灭菌 - 辐射 - 第2部分:建立灭菌剂量

2020-12-30

现行

GB 18280.2-2015

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

2015-12-31

现行

AAMI/ISO 11137-2-2013(R2019)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
医疗保健产品的灭菌.辐射.第2部分:确定灭菌剂量

2013-07-10

现行

GOST ISO 11137-2-2011

Стерилизация медицинской продукции. Радиационная стерилизация. Часть 2. Установление стерилизующей дозы
保健产品的灭菌 辐射 第二部分建立灭菌剂量

2011-11-29

现行

ISO 11137-2-2013

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
保健品灭菌——辐射第2部分:确定灭菌剂量

2013-05-21

现行

ISO 13004-2022

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
保健产品的灭菌.辐射.选定灭菌剂量的验证:方法VDmaxSD

2022-10-07

现行

GB/T 31995-2015

医疗保健产品灭菌 辐射 证实选定的灭菌剂量 VDmax方法
Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose method VDmax

2015-09-11

现行

KS P ISO 13408-2

의료제품의 무균 공정 —제2부: 멸균을 위한 여과
保健品的无菌处理.第2部分:消毒过滤

2021-12-28

现行

KS P ISO 13408-5

의료제품의 무균 공정 —제5부: SIP(Sterilization in place)
保健品的无菌处理.第5部分:就地灭菌

2021-12-28

现行

AAMI/ISO 13408-5-2006/(R)2015

Aseptic processing of health care products - Part 5: Sterilization in place
保健品的无菌处理.第5部分:就地灭菌

2008-09-23

现行

AAMI/ISO 13408-2-2018

Aseptic processing of health care products - Part 2:Sterilizing filtration
保健品的无菌处理.第2部分:消毒过滤

2017-11-17