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

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 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 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

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

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

ISO 11137-2-2013/Amd 1-2022

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
保健产品的灭菌.辐射.第2部分:确定灭菌剂量.修改件1

2022-06-13

现行

AAMI TIR35-2016(R2021)

Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
医疗保健产品的灭菌.辐射灭菌.验证剂量试验和灭菌剂量审计的产品采用和替代取样计划

2016-06-04

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

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

AAMI TIR76-2021

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S
医疗保健产品的灭菌.辐射.规定无菌保证水平下选定灭菌剂量的证实:方法Vdmax SD-S

2021-03-31

现行

BS EN ISO 11137-1-2015+A2-2019

Sterilization of health care products. Radiation-Requirements for development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 辐射

2019-11-27

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