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DIN EN ISO 11607-1:2014-11

Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014 — 45 стр.
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Ссылочные документы

ÖNORM EN ISO 17665-1:2006-11
Действует
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)
ÖNORM EN ISO 14937:2010-03
Действует
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)
ÖVE/ÖNORM EN ISO 13485:2017-08
Действует
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (consolidated version)
DIN EN ISO 11607-2:2017-10
Отменен
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1.:2014); German version EN ISO 11607-2:2017 — 24 стр.
ISO/TS 11139:2006
Заменен
Sterilization of health care products -- Vocabulary — 20 стр.
DIN EN ISO 11137-3:2015-08
Отменен
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO/DIS 11137-3:2015); German and English version prEN ISO 11137-3:2015
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/A2:2017-10
Проект
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/DAM 2:2017); German and English version prEN ISO 11137-1:2015/prA2:2017
DIN EN ISO 11135/A1:2017-09
Отменен
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/DAM 1:2017); German and English version EN ISO 11135:2014/prA1:2017
DIN EN ISO 10993-1:2017-04
Отменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017
ÖNORM EN ISO 9001:2015-11
Действует
Quality management systems - Requirements (ISO 9001:2015)
ÖNORM EN ISO 9000:2015-11
Действует
Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
BS ISO 5636-5:2013
Действует
Paper and board. Determination of air permeance (medium range). Gurley method — 20 стр.
ISO 5636-1:1984
Действует
Paper and board; Determination of air permeance (medium range); Part 1 : General method — 6 стр.
DIN ISO 2859-1:2014-08
Действует
Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859-1:1999 + Cor. 1:2001 + Amd.1:2011); Text in German and English — 195 стр.
DIN EN ISO 18674-2:2017-03
Действует
Geotechnical investigation and testing - Geotechnical monitoring by field instrumentation - Part 2: Measurement of displacements along a line: Extensometers (ISO 18674-2:2016); German version EN ISO 18674-2:2016 — 55 стр.
DIN EN 868-10:2017-08
Отменен
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; Version allemande et anglaise prEN 868-10:2017
DIN EN 868-9:2017-08
Отменен
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods; German and English version prEN 868-9:2017
DIN EN 868-8:2017-08
Отменен
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German and English version prEN 868-8:2017
DIN EN 868-7:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2017 — 30 стр.
DIN EN 868-6:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017 — 23 стр.
DIN EN 868-5:2017-08
Отменен
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods; German and English version prEN 868-5:2017
DIN EN 868-4:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017 — 18 стр.
DIN EN 868-3:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN 868-3:2017 — 22 стр.
DIN EN 868-2:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017 — 26 стр.
DIN ISO 3781:2012-07
Действует
Paper and board - Determination of tensile strength after immersion in water (ISO 3781:2011) — 11 стр.
DIN ISO 3689:1994-07
Действует
Paper and board; determination of bursting strength after immersion in water; identical with ISO 3689:1983 — 4 стр.
DIN ISO 2859-1:2004-01
Отменен
Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859-1:1999 including Technical Corrigendum 1:2001) — 191 стр.
DIN ISO 1924-3:2007-06
Действует
Paper and board - Determination of tensile properties - Part 3: Constant rate of elongation method (100 mm/min) (ISO 1924-3:2005) — 16 стр.
DIN ISO 187:1982-09
Отменен
Paper and board; conditioning of samples — 4 стр.
DIN EN ISO 17665-1:2006-11
Действует
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 — 51 стр.
DIN EN ISO 14937:2001-05
Отменен
Sterilization of health care products - General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000); German version EN ISO 14937:2000 — 37 стр.
DIN EN ISO 13485:2007-10
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007 — 75 стр.
DIN EN ISO 11607-2:2006-07
Отменен
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006 — 18 стр.
DIN EN ISO 11137-3:2006-07
Отменен
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006); German version EN ISO 11137-3:2006 — 25 стр.
DIN EN ISO 11137-2:2007-09
Отменен
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version EN ISO 11137-2:2007 — 76 стр.
DIN EN ISO 11137-1:2006-07
Отменен
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); German version EN ISO 11137-1:2006 — 49 стр.
DIN EN ISO 10993-1:2010-04
Отменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009 — 35 стр.
DIN EN ISO 9073-9:2008-06
Действует
Textiles - Test methods for nonwovens - Part 9: Determination of drapability including drape coefficient (ISO 9073-9:2008); German version EN ISO 9073-9:2008 — 20 стр.
DIN EN ISO 9001:2008-12
Отменен
Quality management systems - Requirements (ISO 9001:2008); Trilingual version EN ISO 9001:2008 — 91 стр.
DIN EN ISO 9000:2005-12
Отменен
Quality management systems - Fundamentals and vocabulary (ISO 9000:2005); Trilingual version EN ISO 9000:2005 — 68 стр.
DIN EN ISO 4180:2010-12
Отменен
Packaging - Complete, filled transport packages - General rules for the compilation of performance test schedules (ISO 4180:2009) — 26 стр.
DIN EN ISO 2758:2014-02
Отменен
Paper - Determination of bursting strength (ISO/FDIS 2758:2013); German version FprEN ISO 2758:2013 — 20 стр.
DIN EN ISO 2233:2001-11
Действует
Packaging - Complete, filled transport packages and unit loads - Conditioning for testing (ISO 2233:2000); German version EN ISO 2233:2001 — 6 стр.
DIN EN ISO 1974:2012-09
Действует
Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012); German version EN ISO 1974:2012 — 20 стр.
DIN EN ISO 1924-2:2009-05
Действует
Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008); German version EN ISO 1924-2:2008 — 20 стр.
DIN EN ISO 536:2012-11
Отменен
Paper and board - Determination of grammage (ISO 536:2012); German version EN ISO 536:2012 — 14 стр.
DIN EN ISO 534:2012-02
Действует
Paper and board - Determination of thickness, density and specific volume (ISO 534:2011); German version EN ISO 534:2011 — 22 стр.
DIN EN ISO 186:2002-08
Действует
Paper and board - Sampling to determine average quality (ISO 186:2002); German version EN ISO 186:2002 — 15 стр.
DIN EN 811:1996-12
Отменен
Safety of machinery - Safety distances to prevent danger zones being reached by the lower limbs; German version EN 811:1996 — 7 стр.
DIN EN ISO 11607-1:2017-10
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1.:2014); German version EN ISO 11607-1:2017 — 49 стр.
DIN EN ISO 11607-1 Berichtigung 1:2016-09
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014, Corrigendum to DIN EN ISO 11607-1:2014-11 — 2 стр.
DIN EN ISO 11607-1:2009-09
Отменен
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 11607-1:2009 — 34 стр.
DIN EN ISO 11607-1/A1:2013-04
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/DAM 1:2013); German version EN ISO 11607-1:2009/prA1:2013

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Действует
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DIN EN ISO 5367:2015-02
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Отменен
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 + Amd 1:2013); German version EN ISO 11137-1:2006 + A1:2013 — 53 стр.
DIN EN ISO 11140-1:2015-03
Действует
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DIN EN ISO 11607-1:2009-09
Отменен
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 11607-1:2009 — 34 стр.
DIN EN ISO 14534:2015-08
Действует
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DIN EN ISO 14534:2011-06
Отменен
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2011 — 21 стр.
DIN EN ISO 16061:2010-01
Отменен
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15); German version EN ISO 16061:2009 — 27 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 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 58948-17:2016-04
Отменен
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 58953-6:2016-06
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DIN EN ISO 5364:2017-01
Действует
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DIN EN ISO 5361:2017-01
Действует
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016); German version EN ISO 5361:2016 — 59 стр.
DIN 58948-7:2017-03
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DIN EN ISO 1135-3:2017-05
Действует
Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016); German version EN ISO 1135-3:2017 — 26 стр.
DIN EN ISO 7198:2017-07
Действует
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016); German version EN ISO 7198:2017 — 76 стр.
DIN EN ISO 11607-1 Berichtigung 1:2016-09
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014, Corrigendum to DIN EN ISO 11607-1:2014-11 — 2 стр.
DIN EN ISO 11607-2:2014-11
Отменен
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014); German version EN ISO 11607-2:2006 + A1:2014 — 21 стр.
DIN 13152:2017-10
Действует
Surgical dressings - Surgical sheets — 6 стр.
DIN 13152:2017-04
Отменен
Surgical dressings - Surgical sheets — 6 стр.
DIN EN ISO 16671:2015-12
Отменен
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015); German version EN ISO 16671:2015 — 33 стр.
DIN EN ISO 11607-1:2017-11
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO/DIS 11607-1:2017); German and English version prEN ISO 11607-1:2017 — 49 стр.
DIN EN ISO 11607-1:2017-10
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1.:2014); German version EN ISO 11607-1:2017 — 49 стр.
DIN EN ISO 11137-1:2015-11
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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) — 54 стр.
DIN EN ISO 16061:2015-09
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Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015 — 28 стр.
DIN EN ISO 8836:2015-02
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DIN EN ISO 7199:2017-05
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Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016); German version EN ISO 7199:2017 — 31 стр.
DIN EN ISO 13485:2016-08
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DIN EN ISO 16672:2015-12
Отменен
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DIN 13200-2:2015-06
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Voice prostheses - Part 2: General requirements; Text in German and English — 19 стр.