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Sterile isolator requirements
Sterile isolator requirements, Total:68 items.
In the international standard classification, Sterile isolator requirements involves: Pharmaceutics, Sterilization and disinfection, Farming and forestry, Transformers. Reactors, Veterinary medicine, Medical equipment, Vibrations, shock and vibration measurements, Plant and equipment for the food industry, Electromechanical components for electronic and telecommunications equipment, Components and accessories for telecommunications equipment, Telecommunication systems, Fibre optic communications.
Professional Standard - Machinery, Sterile isolator requirements
Group Standards of the People's Republic of China, Sterile isolator requirements
CENELEC - European Committee for Electrotechnical Standardization, Sterile isolator requirements
- EN 60742:1989 Isolating Transformers and Safety Isolating Transformers - Requirements
- EN 60742:1995 Isolating Transformers and Safety Isolating Transformers Requirements
British Standards Institution (BSI), Sterile isolator requirements
- BS EN 60742:1996 Isolating transformers and safety isolating transformers - Requirements
- BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
- 19/30361785 DC BS EN ISO 13408-6. Aseptic processing of health care products. Part 6. Isolator systems
- BS EN 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
- 23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices
- 23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
Association Francaise de Normalisation, Sterile isolator requirements
- NF C52-742:1997 Isolating transformers and safety isolating transformers. Requirements.
- NF S98-117-6:2011 Aseptic processing of health care products - Part 6 : isolator systems.
- NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
- NF S98-052-1:2006 Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems.
- NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique
RU-GOST R, Sterile isolator requirements
- GOST 30030-1993 Isolating transformers and safety isolating transformers. Technical requirements
- GOST 28695-1990 Aseptic tanks. Main parameters, dimensions and technical requirements
- GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
- GOST 23585-1979 Mounting of electric and radioelectronic equipment and instruments. Technical requirements for wire screens termination and connection
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Sterile isolator requirements
- GB 13028-1991 Isolating transformers and safety isolating transformers--Requirements
- GB/T 8540-1987 Vibration and shock-Isolators-Procedure for specifying characteristics
International Electrotechnical Commission (IEC), Sterile isolator requirements
- IEC 60742:1983 Isolating transformers and safety isolating transformers - Requirements
- IEC 60742/AMD1:1992 Isolating transformers and safety isolating transformers; requirements; amendment 1
YU-JUS, Sterile isolator requirements
- JUS N.H8.023-1987 Isolating transformers and safety isolating transformers. Safety isolating transformers for general use. Additional reguirements
- JUS N.H8.021-1987 Isolating and safety isolating transformers. Bell transformers. Additional reguirements
- JUS N.H8.010-1987 Isolating transformers and safety isolating transformers. General reguirements and testings
- JUS N.H8.020-1987 Isolating transformers and safety isolating transformers. Transformers for toys. Additional requirements
- JUS N.H8.024-1987 Isolating transformers and safety isolating transformers. Isolating transformers for general use, shaver transformers and shaver supply units. Additional reguirements
- JUS N.H8.022-1987 Isolating tranformers and safety isolating transformers. Transformers for class III luminaries incorpora- ting incadescent lamps. Additional reguirements
- JUS L.R0.103-1980 Ekctrical office machines. Safety isokting transformers. Additional requirements
International Organization for Standardization (ISO), Sterile isolator requirements
Korean Agency for Technology and Standards (KATS), Sterile isolator requirements
European Committee for Standardization (CEN), Sterile isolator requirements
- EN ISO 13408-6:2021 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
- EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
- EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (Incorporates Amendment A1: 2013)
- EN ISO 13408-6:2011/A1:2013 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005/Amd 1:2013)
- prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
Professional Standard - Medicine, Sterile isolator requirements
- YY/T 0567.6-2011 Aseptic processing of health care products.Part 6:Isolator systems
- YY/T 0567.6-2022 Aseptic processing of healthcare products Part 6: Isolator systems
- YY/T 0615.2-2007 Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices
- YY/T 0615.1-2007 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
Standard Association of Australia （SAA）, Sterile isolator requirements
- AS/NZS 3108:1994 Approval and test specification - particular requirements for isolating transformers and safety isolating transformers
AT-ON, Sterile isolator requirements
CH-SNV, Sterile isolator requirements
- SN EN ISO 13408-6:2021 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
Lithuanian Standards Office , Sterile isolator requirements
- LST EN ISO 13408-6:2021 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
- LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
- LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
ES-UNE, Sterile isolator requirements
- UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
- UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
Danish Standards Foundation, Sterile isolator requirements
- DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
- DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
- DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
Heilongjiang Provincial Standard of the People's Republic of China, Sterile isolator requirements
- DB23/T 2057.8-2017 General technical requirements for laboratory animal transport isolators
- DB23/T 2057.6-2017 General Technical Requirements for Experimental Animal Duck Breeding Isolator
CEN - European Committee for Standardization, Sterile isolator requirements
- EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
Professional Standard - Electron, Sterile isolator requirements
- SJ/T 10686-1995 Optocouplers for safe electrical isolation-Requirements,tests
German Institute for Standardization, Sterile isolator requirements
- DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
- DIN EN 556-2:2015-11 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).
- DIN EN ISO 11607-1 Berichtigung 1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2006, Corrigenda to DIN EN ISO 11607-1:2006-07
- DIN EN 61202-1:2010 Fibre optic interconnecting devices and passive components - Fibre optic isolators - Part 1: Generic specification (IEC 61202-1:2009); German version EN 61202-1:2009
- DIN EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); English version of DIN EN ISO 11607-1:2009-09
国家市场监督管理总局、中国国家标准化管理委员会, Sterile isolator requirements
- GB 27955-2020 Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer
工业和信息化部, Sterile isolator requirements
- YD/T 3545-2019 Technical requirements and test methods for power supply lightning protection isolation transformers for communications
International Telecommunication Union (ITU), Sterile isolator requirements
- ITU-R REPORT M.2171-2009 Characteristics of unmanned aircraft systems and spectrum requirements to support their safe operation in non-segregated airspace