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Sterilizer Validation
Sterilizer Validation, Total:88 items.
In the international standard classification, Sterilizer Validation involves: Sterilization and disinfection.
German Institute for Standardization, Sterilizer Validation
- DIN SPEC 58929:2012-08 Operation of small steam sterilizers in the health-care system - Guidance for validation and routine control of sterilization processes / Note: Applies in conjunction with DIN EN ISO 17665-1 (2006-11).
- DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
- DIN EN ISO 17665:2022-11 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022 / Note: Date of is...
- DIN EN ISO 11135:2020-04 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
- DIN EN ISO 17665-1:2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006 / Note: To be replaced b...
- DIN EN ISO 11137-1:2020-04 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, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1...
- DIN EN ISO 25424:2020 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)
- DIN EN ISO 14937:2010-03 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); German version EN ISO 14937:2009
- DIN EN ISO 11135:2023-05 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023 / Note: Date o...
- DIN EN ISO 11137-1:2023-05 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023 / Note:...
European Committee for Standardization (CEN), Sterilizer Validation
- EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
- EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
- EN 552:1994/A1:1999 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation Includes Amendment A1:1999
- prEN ISO 17665 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022)
- prEN ISO 11135 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023)
未注明发布机构, Sterilizer Validation
- BS EN 552:1994(2001) Sterilization of medical devices — Validation and routine control of sterilization by irradiation
- BS EN 554:1994(1998) Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat
- BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
- BS EN ISO 11135:2014+A1:2019(2020) Sterilization of health - care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
- DIN EN ISO 25424:2022 Sterilization of healthcare products – Low temperature vapor formaldehyde – Requirements for the development, validation and routine monitoring of sterilization procedures for medical devices
- BS EN ISO 25424:2018+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
American National Standards Institute (ANSI), Sterilizer Validation
- ANSI/AAMI TIR39:2009(R2022) Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
- ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
国家食品药品监督管理局, Sterilizer Validation
- YY/T 1608-2018 Sampling methods for radiation sterilization verification dose experiments and sterilization dose audits of medical devices
International Organization for Standardization (ISO), Sterilizer Validation
- ISO/DIS 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO/FDIS 17665:2023 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO/DIS 11135 Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO/DIS 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Danish Standards Foundation, Sterilizer Validation
- DS/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
- DS/EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- 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
- DS/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
- DS/EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- DS/EN 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
- DS/EN ISO 11137-1/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
CEN - European Committee for Standardization, Sterilizer Validation
- EN 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)
- 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
British Standards Institution (BSI), Sterilizer Validation
- BS 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
- BS 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
- 22/30409085 DC BS EN ISO 17665. Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
- BS ISO 22441:2022 Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
- 23/30424625 DC BS EN ISO 11135. Sterilization of health care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
- 23/30426672 DC BS EN ISO 11137-1. Sterilization of health care products. Radiation - Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
- 17/30363659 DC BS EN ISO 11137-1 AMD2. Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
- 21/30427336 DC BS EN ISO 25424 AMD1. Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
Association Francaise de Normalisation, Sterilizer Validation
- NF EN ISO 14937:2009 Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux
- NF S98-101*NF EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- NF EN ISO 20857:2013 Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la validation et le contrôle de routine d'un processus de stérilisation pour dispositifs médicaux
- NF EN ISO 17665-1:2006 Stérilisation des produits de santé - Chaleur humide - Partie 1 : exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation des dispositifs médicaux
- NF EN ISO 25424:2019 Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux
- NF EN ISO 11137-1:2016 Stérilisation des produits de santé - Irradiation - Partie 1 : exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux
- NF EN ISO 11135:2014 Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux
- NF ISO 22441:2022 Stérilisation des produits de santé - Vapeur de peroxyde d'hydrogène à basse température - Exigences pour la mise au point, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux
- NF S98-103-1*NF EN ISO 11137-1:2016 Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices
KR-KS, Sterilizer Validation
- KS P ISO 11135-2022 Sterilization of health-care products ─ Ethylene oxide ─ Requirements for the development, validation and routine control of a sterilization process for medical devices
- KS P ISO 11137-1-2022 Sterilization of health care products ─ Radiation ─ Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- KS P ISO 14937-2018 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 devi
- KS P ISO 11137-1-2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- KS P ISO 17665-1-2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- KS P ISO 11135-2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
- KS P ISO 25424-2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
RU-GOST R, Sterilizer Validation
- GOST ISO 11135-2017 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
Canadian Standards Association (CSA), Sterilizer Validation
- CAN/CSA-Z11135-2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (First Edition)
- CAN/CSA-Z11137-2007 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (First Edition)
- CAN/CSA-ISO 14937:2011 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 (Second Edition)
- CSA ISO 14937-01-CAN/CSA:2001-b 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 First Edition; ISO 14937:2000
NZ-SNZ, Sterilizer Validation
- 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
AENOR, Sterilizer Validation
- UNE-EN ISO 11135:2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
- UNE-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 (ISO 20857:2010)
- UNE-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)
- 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)
- UNE-EN ISO 17665-1:2007 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
ES-UNE, Sterilizer Validation
- UNE-EN ISO 25424:2020 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)
- UNE-EN ISO 11137-1:2015 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, including Amd 1:2013)
- UNE-EN ISO 25424:2020/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)
Korean Agency for Technology and Standards (KATS), Sterilizer Validation
- KS P ISO 14937:2018 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 devi
- KS P ISO 11137-1:2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- KS P ISO 17665-1:2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- KS P ISO 11135:2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
- KS P ISO 25424:2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
TH-TISI, Sterilizer Validation
- TIS 2612.1-2013 Sterilization of heal th care products-ethylene oxide part 1:requirements for development,validation and routine control of a sterilization process for medical devices
Lithuanian Standards Office , Sterilizer Validation
- LST 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)
- LST 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)
- LST EN 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 (ISO 11137-1:2006)
- LST EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
- LST EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Japanese Industrial Standards Committee (JISC), Sterilizer Validation
- JIS T 0806-1:2022 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices