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DIN EN 14563:2009-02
Действует
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2); German version EN 14563:2008 — 38 стр.
DIN EN 16615:2015-06
Действует
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2); German version EN 16615:2015 — 45 стр.
DIN EN 14347:2005-08
Действует
Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1); German version EN 14347:2005 — 40 стр.
DIN EN 14562:2006-08
Действует
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2); German version EN 14562:2006 — 43 стр.
DIN EN 14348:2005-04
Действует
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1); German version EN 14348:2005 — 38 стр.
DIN EN 14561:2006-08
Действует
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2); German version EN 14561:2006 — 41 стр.
DIN EN 12353:2021-11
Действует
Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity; German version EN 12353:2021 — 40 стр.
DIN EN 13624:2022-08
Действует
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1); German version EN 13624:2021 — 61 стр.
DIN 58953-8:2019-03
Действует
Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices — 10 стр.
DIN 58953-9:2010-05
Действует
Sterilization - Sterile supply - Part 9: Use of sterilization container — 9 стр.
DIN 58953-6:2016-12
Действует
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized — 16 стр.
DIN 58953-7:2020-11
Действует
Sterilization - Sterile supply - Part 7: Use of sterilization paper, nonwoven wrapping material, paper bags and sealable pouches and reels — 14 стр.
DIN 58952-3:2012-04
Действует
Sterilization - Transport baskets for sterile barrier systems - Part 3: Instrument trays for sterilizing goods made of metal — 5 стр.
DIN 58952-2:2012-04
Действует
Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal — 8 стр.
DIN EN ISO 11607-2:2020-05
Действует
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020 — 23 стр.
DIN EN ISO 11607-1:2020-05
Действует
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020 — 60 стр.
DIN EN ISO 11137-2:2015-11
Действует
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015 — 92 стр.
DIN EN ISO 11137-1:2020-04
Действует
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 11137-1:2015 + A2:2019 — 68 стр.
DIN 58948-17:2016-10
Действует
Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources — 28 стр.
DIN 58950-6:2019-03
Действует
Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English — 27 стр.
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