现行

AAMI TIR104-2022

Guidance on transferring health care products between radiation sterilization sources
关于在辐射灭菌源之间转移医疗保健产品的指南

2022-04-19

现行

ISO/TS 11137-4-2020

Sterilization of health care products — Radiation — Part 4: Guidance on process control
保健产品的灭菌 - 辐射 - 第4部分:过程控制指南

2020-06-30

现行

GB/T 18280.3-2015

医疗保健产品灭菌 辐射 第3部分：剂量测量指南
Sterilization of health care products—Radiation—Part 3：Guidance on dosimetric aspects

2015-12-31

现行

AAMI/ISO TIR 11137-4-2022/(R)2023

Sterilization of health care products-Radiation-Part 4: Guidance on process control
保健品灭菌辐射第4部分:过程控制指南

2022-06-12

现行

AS/NZS ISO 11137.3-2006

Sterilization of health care products - Radiation, Part 3: Guidance on dosimetric aspects
医疗保健产品的灭菌.辐射.第3部分:剂量学方面的指南

2006-12-19

现行

GOST R ISO 11137-3-2008

Стерилизация медицинской продукции. Радиационная стерилизация. Часть 3. Руководство по вопросам дозиметрии
保健产品的灭菌 辐射 第3部分剂量学方面的指导

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 TIR40-2018(R2022)

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

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 18280-2000

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

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

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

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

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

AAMI/ISO 11137-3-2017(R)2023

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
医疗保健产品的灭菌.辐射.第3部分:开发、验证和常规的剂量学方面的指南

2017-10-06

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

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