现行

GB/T 19971-2015

医疗保健产品灭菌 术语
Sterilization of health care products—Vocabulary

2015-12-10

现行

BS EN ISO 11139-2018

Sterilization of health care products. Vocabulary. Terms used in sterilization and related equipment and process standards
医疗保健产品的消毒 词汇灭菌及相关设备和工艺标准中使用的术语

2018-10-11

现行

KS P ISO 11139

의료제품의 멸균 — 멸균 및 관련 장비 용어와 공정 표준에 사용하는 용어
保健品灭菌.灭菌和相关设备及工艺标准用术语词汇

2020-12-30

现行

ISO 11139-2018

Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards
保健品灭菌.灭菌和相关设备及工艺标准用术语词汇

2018-08-03

现行

BS PD ISO/TS 22421-2021

Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
医疗保健产品的消毒 医疗设施医疗器械终端灭菌用灭菌器的通用要求

2021-01-26

现行

ISO/TS 22421-2021

Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
保健品灭菌 医疗机构医疗器械终端灭菌用消毒器通用要求

2021-01-25

现行

AAMI TIR 15844

Sterilization of health care products - Radiation sterilization - Selection of a sterilization dose for a single production batch
保健产品的灭菌.辐射灭菌.单个生产批次灭菌剂量的选择

1999-02-18

现行

AAMI/ISO TIR 15844-1998

Sterilization of health care products - Radiation sterilization - Selection of a sterilization dose for a single production batch
保健产品的灭菌.辐射灭菌.单个生产批次灭菌剂量的选择

1999-02-18

现行

AAMI TIR37-2013

Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
保健品灭菌生物制品和组织制品灭菌辐射指南

2013-12-30

现行

ISO/TS 5111-2022

Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
卫生保健产品用消毒器、消毒器和清洗消毒器的水质指南

2022-12-19

现行

GB 18280-2000

医疗保健产品灭菌确认和常规控制要求辐射灭菌
Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization

2000-12-13

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

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

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

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

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

AAMI ST67-2019

Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
医疗保健产品的灭菌.标签为“无菌”的产品选择无菌保证水平（SAL）的要求和指南

2019-07-29

现行

BS EN ISO 11140-1-2014

Sterilization of health care products. Chemical indicators-General requirements
医疗保健产品的消毒 化学指标 一般要求

2015-01-31

现行

BS EN ISO 11138-1-2017

Sterilization of health care products. Biological indicators-General requirements
医疗保健产品的消毒 生物指标

2017-04-30

现行

YY/T 0884-2013

适用于辐射灭菌的医疗保健产品的材料评价
Evaluation of materials of health care product subject to radiation sterilization

2013-10-21