Validation and Control Series of Medical Device Sterilization Process

Validation and Control Series of Medical Device Sterilization Process, Total:46 items.

The international standard classification for "Validation and Control Series of Medical Device Sterilization Process" includes: Surgical instruments and materials , Sterilization and disinfection in general , Sterilization and disinfection , Other standards related to sterilization and disinfection .

The Chinese standard classification for "Validation and Control Series of Medical Device Sterilization Process" includes: Public medical equipment .

Professional Standard - Medicine

YY 1276-2016 Requirements for the development, validation and routine control of dry heat sterilization process for medical devices
YY/T 1464-2016 Sterilization of medical devices—Requirements for the development,validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
YY/T 1276-2016 Requirements for the development,validation and routine control of dry heat sterilization process for medical devices

未注明发布机构

DIN EN ISO 25424 E:2017-02 Sterilization of medical devices: Development, validation and routine control requirements for low-temperature steam and formaldehyde medical device sterilization processes (draft)

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization
GB 18279.1-2015 Sterilization of health care products―Ethylene oxide―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB/T 19974-2005 GB/T 1997 4-2005 Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization proce
GB/T 19974-2018 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
GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
GB 18278.1-2015 Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18280.1-2015 Sterilization of health care products―Radiation―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

国家药监局

YY 0970-2023 Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes
YY/T 1464-2022 Sterilization of health care products-Low temperature steam and formaldehyde-Requirements for development,validation and routine control of a sterilization process for medical devices

国家食品药品监督管理局

YY/T 1613-2018 Requirements for process characterization and control in radiation sterilization of medical devices

European Committee for Standardization (CEN)

EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
EN ISO 25424:2019/prA1:2021 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021)
EN ISO 25424:2019/A1:2022 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)

Association Francaise de Normalisation

NF S98-104*NF EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF S98-105:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat.
NF S98-103-1/A1:2013 Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices
NF S98-103:1994 Sterilization of medical devices. Validation and routine control of sterilization by irradiation.
NF S98-101:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization.
NF EN ISO 20857:2013 Sterilization of healthcare products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

British Standards Institution (BSI)

BS 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
BS EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

International Organization for Standardization (ISO)

ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
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
ISO 11135:1994/Cor 1:1994 Medical devices - Validation and routine control of ethylene oxide sterilization; Technical Corrigendum 1
ISO 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process

UNKNOWN

GB/T 18279.1-2015 Ethylene oxide for sterilization of healthcare products Part 1: Requirements for the development, validation and routine control of sterilization processes for medical devices

German Institute for Standardization

DIN EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009); German version EN ISO 25424:2011
DIN 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; English version of DIN EN 15424:2007-08

GSO

OS GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
BH GSO ISO 25424:2017 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices

Danish Standards Foundation

DS/EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

SCC

NS-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
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
DANSK DS/EN ISO 25424:2011 Sterilization of medical devices – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices
DANSK DS/EN ISO 17665:2024 Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices

CEN - European Committee for Standardization

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

American National Standards Institute （ANSI)

AAMI TIR29:2012(R2017) Guide for process characterization and control in radiation sterilization of medical devices

US-AAMI

AAMI TIR29-2012 Guide for process characterization and control in radiation sterilization of medical devices

RU-GOST R

GOST R ISO 25424-2013 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

VN-TCVN

TCVN 7393-1-2009 Sterilization of health care products.Radiation.Part 1: Requirements for developement, validation and routine control of a sterilization process for medical devices.

Others: Requirements for development, validation and routine control of dry heat sterilization process for medical devices,Validation and Control Series of Medical Device Sterilization Process