现行

AAMI TIR29-2012/(R)2017

Guide for process characterization and control in radiation sterilization of medical devices
医疗器械辐射灭菌过程特性和控制指南

2012-12-31

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

BS ISO 14470-2011

Food irradiation. Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
食物辐照 使用电离辐射处理食品的辐照过程的开发、验证和常规控制要求

2012-01-31

现行

ISO 14470-2011

Food irradiation — Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
食品辐照——食品处理用电离辐射辐照过程的开发、验证和常规控制要求

2011-11-23

现行

GOST ISO 14470-2014

Радиационная обработка пищевых продуктов. Требования к разработке, валидации и повседневному контролю процесса облучения пищевых продуктов ионизирующим излучением
食物辐射 使用电离辐射照射食品过程的开发 验证和常规控制要求

2014-08-29

现行

BS EN ISO 14937-2009

Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 医疗器械用杀菌剂的特性、杀菌过程的开发、验证和常规控制的一般要求

2010-03-31

现行

KS P ISO 14937

의료용품의 멸균 — 의료기기용 멸균제 특성 분석 및 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 일반 요구사항
保健产品的灭菌 - 杀菌剂的一般要求以及医疗器械灭菌过程的开发 验证和日常控制

2018-11-05

现行

KS P ISO 14937

의료제품의 멸균 — 의료기기용 멸균제 특성 분석과 멸균 공정의 개발, 유효성 확인, 일상관리에 대한 일반 요구사항
卫生保健产品灭菌.灭菌剂特性和医疗器械灭菌过程的开发、验证和常规控制的一般要求

2023-12-28

现行

AAMI/ISO 14937-2009/(R)2013

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.医疗器械用灭菌剂特性和灭菌过程的开发、验证和常规控制的一般要求

2009-10-14

现行

ISO 14937-2009

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
保健品灭菌——医疗器械用杀菌剂特性和杀菌过程的开发、验证和常规控制的一般要求

2009-10-14

现行

GB/T 19974-2018

医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求
Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices

2018-05-14

现行

AS/NZS ISO 11137.1-2006

Sterilization of health care products - Radiation, Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌辐射第1部分:医疗器械灭菌过程的开发、验证和常规控制要求

2006-12-19

现行

KS P ISO 11137-1

의료제품의 멸균 — 방사선 — 제1부: 의료기기 멸균 공정의 개발, 유효성 확인 및 일상 관리에 대한 요구사항
保健产品的灭菌 - 辐射 - 第1部分:医疗器械灭菌过程的开发 验证和日常控制要求

2019-11-25

现行

GB 18280.1-2015

医疗保健产品灭菌　辐射　第1部分： 医疗器械灭菌过程的开发、确认和常规控制要求
Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

2015-12-31

现行

KS P ISO 11137-1

의료제품의 멸균 ─ 방사선 ─ 제1부: 의료기기 멸균 공정의 개발, 유효성 확인 및 일상 관리에 대한 요구사항
保健品灭菌─ 辐射─ 第1部分:医疗器械灭菌过程的开发、验证和常规控制要求

2022-12-28

现行

GOST ISO 11137-1-2011

Стерилизация медицинской продукции. Радиационная стерилизация. Часть 1. Требования к разработке, валидации и текущему контролю процесса стерилизации медицинских изделий
保健产品的灭菌 辐射 第一部分医疗器械灭菌过程的开发 验证和常规控制要求

2011-11-29

现行

ISO 11137-1-2006

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
保健品灭菌——辐射第1部分:医疗器械灭菌过程的开发、验证和常规控制要求

2006-04-19

现行

UNE-EN ISO 14937-2010

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
医疗保健产品的灭菌.医疗器械用灭菌剂特性和灭菌过程的开发、验证和常规控制的一般要求（ISO 14937-2009）

2010-05-26

现行

ISO 11137-1-2006/Amd 1-2013

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
医疗保健产品的灭菌辐射第1部分:医疗器械灭菌过程的开发、验证和常规控制要求修改1

2013-07-16

现行

UNE-EN ISO 11137-1-2007

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
医疗保健产品的灭菌辐射第1部分:医疗器械灭菌过程的开发、验证和常规控制要求

2007-03-14