现行

GOST R ISO 20857-2016

Стерилизация медицинской продукции. Горячий воздух. Требования к разработке, валидации и текущему контролю процесса стерилизации медицинских изделий
医疗器械灭菌干热 对医疗器械灭菌过程的开发 验证和常规控制的要求

现行

UNE-EN 556-1-2002

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Part 1: Requirements for terminally sterilized medical devices.
医疗器械的消毒 医疗器械被指定为“无菌”的要求 第1部分:最终灭菌医疗器械的要求

2002-02-28

现行

GOST EN 556-1-2011

Стерилизация медицинских изделий. Требования к медицинским изделиям категории «стерильные». Часть 1. Требования к медицинским изделиям, подлежащим финишной стерилизации
医疗器械灭菌医疗器械要求被指定为“无菌” 第一部分终末消毒医疗器械的要求

2011-11-29

现行

DIN EN 15424

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
医疗器械灭菌-低温蒸汽和甲醛-医疗器械灭菌过程的开发、验证和常规控制要求；德文版EN 15424:2007

2007-08-01

现行

UNE-EN 15424-2007

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
医疗器械的灭菌.低温蒸汽和甲醛.医疗器械灭菌过程的开发、验证和常规控制要求

2007-09-26

现行

GOST R ISO 25424-2013

Стерилизация медицинских изделий. Стерилизация низкотемпературная пароформальдегидная. Требования к разработке, валидации и рутинному контролю процесса стерилизации
医疗器械灭菌低温蒸汽和甲醛 对医疗器械灭菌过程的开发 验证和常规控制的要求

现行

BS EN 556-2-2015

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE"-Requirements for aseptically processed medical devices
医疗器械的消毒 指定为“无菌”医疗器械的要求

2015-09-30

现行

UNE-EN 556-2-2004

Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
医疗器械的灭菌.指定无菌医疗器械的要求.第2部分:无菌处理医疗器械的要求

2004-06-25

现行

YY/T 0615.1-2007

标示"无菌"医疗器械的要求　第1部分:最终灭菌医疗器械的要求
Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices

2007-07-02

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

YY/T 1276-2016

医疗器械干热灭菌过程的开发、确认和常规控制要求
Requirements for the development,validation and routine control of dry heat sterilization process for medical devices

2016-03-23

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

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

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

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

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

DIN EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; English version of DIN EN 556-1
医疗器械的灭菌.指定为“无菌”的医疗器械的要求.第1部分:最终灭菌医疗器械的要求；德文版EN 556-1:2001

2002-03-01

现行

KS P ISO 11135

의료제품의 멸균 — 산화에틸렌 — 의료기기용 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 요구사항
保健产品的灭菌 - 环氧乙烷 - 用于医疗器械灭菌过程的开发 验证和日常控制的要求

2018-11-05

现行

KS P ISO 11135

의료제품의 멸균 ─ 산화에틸렌 ─ 의료기기용 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 요구사항
保健品灭菌─ 环氧乙烷─ 医疗器械灭菌过程的开发、验证和常规控制要求

2022-12-28