医疗器械辐照灭菌过程特征及控制要求
Requirements for process characterization and control in radiation sterilization of medical devices

2018-09-29

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

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

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

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

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

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

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

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

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

Radiation protection accessories for medical use of X-radiation - Part 2: Quality control of protective clothes being in use
医用X射线辐射防护附件第2部分:使用中防护服的质量控制

2021-04-01

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

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2
对4.3.4和11.2的修订

2018-11-08

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019
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 包括A1:2013和A2:2019

2013-12-30

Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Adopted ISO 11137-1:2006, First Edition, 2006-04-15)
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

2007-03-01