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ISO 10993-10:2010

Действует
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization — 74 стр.
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На этот документ ссылаются

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BS EN ISO 16672:2003
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BS ISO 15675:2009
Действует
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17/30359567 DC
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BS EN ISO 7198:2017
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BS EN ISO 4074:2015
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BS EN ISO 15621:2017
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BS EN ISO 14534:2015
Действует
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BS EN ISO 11979-5:2006
Действует
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BS EN ISO 10993-7:2008
Действует
Biological evaluation of medical devices. Ethylene oxide sterilization residuals — 98 стр.
BS EN ISO 10993-12:2012
Действует
Biological evaluation of medical devices. Sample preparation and reference materials — 32 стр.
BS EN 14683:2014
Действует
Medical face masks. Requirements and test methods — 22 стр.
DD ISO/TS 10993-20:2006
Действует
Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices — 26 стр.
BS EN 455-3:2015
Действует
Medical gloves for single use. Requirements and testing for biological evaluation — 38 стр.
BS ISO 8009:2014
Действует
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BS ISO 20308:2017
Действует
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BS ISO 19611:2017
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BS ISO 18763:2016
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BS ISO 18666:2015
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BS ISO 18562-4:2017
Действует
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BS ISO 17218:2014
Действует
Sterile acupuncture needles for single use — 36 стр.
BS ISO 16038:2017
Действует
Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms — 22 стр.
BS ISO 25841:2014
Заменен
Female condoms. Requirements and test methods — 52 стр.
PD CEN/TR 16953:2017
Действует
Medical gloves for single use. Guidance for selection — 26 стр.
PD ISO/TR 37137:2014
Действует
Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants — 26 стр.
17/30358661 DC
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BS EN 13795-2. Surgical clothing and drapes. Requirements and test methods. Part 2. Clean air suits — 31 стр.
17/30358658 DC
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BS ISO 16840-2:2018
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Wheelchair seating. Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity — 34 стр.
18/30324477 DC
Действует
BS ISO 20487. Traditional chinese medicine. Test method of single-use acupuncture needle for electrical stimulation — 18 стр.
18/30357483 DC
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BS EN ISO 3826-1. Plastics collapsible containers for human blood and blood components. Part 1. Conventional containers — 33 стр.
BS EN ISO 22803:2005
Действует
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BS EN ISO 9394:2012
Действует
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BS ISO 29942:2011
Действует
Prophylactic dams. Requirements and test methods — 38 стр.
BS ISO 23409:2011
Действует
Male condoms. Requirements and test methods for condoms made from synthetic materials — 54 стр.
18/30376766 DC
Действует
BS ISO 19351. Fallopian rings. Requirements and test methods — 34 стр.
BS EN ISO 3826-1:2013
Действует
Plastics collapsible containers for human blood and blood components. Conventional containers — 32 стр.
BS EN ISO 3826-4:2015
Действует
Plastics collapsible containers for human blood and blood components. Aphaeresis blood bag systems with integrated features — 42 стр.
BS EN ISO 4074:2002
Заменен
Natural latex rubber condoms. Requirements and test methods — 54 стр.
BS EN ISO 22794:2009
Действует
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BS ISO 15675:2016
Действует
Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters — 16 стр.
18/30375452 DC
Действует
BS EN ISO 22442-1. Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management — 35 стр.
BS EN ISO 22442-1:2015
Действует
Medical devices utilizing animal tissues and their derivatives. Application of risk management — 38 стр.
BS EN ISO 10993-1:October 2009
Действует
Biological evaluation of medical devices. Evaluation and testing within a risk management process — 32 стр.
BS ISO 27427:2013
Действует
Anaesthetic and respiratory equipment. Nebulizing systems and components — 58 стр.
BS EN ISO 7405:2008+A1:2013
Действует
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry — 44 стр.
BS ISO 25841:2017
Действует
Female condoms. Requirements and test methods — 64 стр.
ÖNORM EN ISO 11979-5:2010-11
Заменен
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
ÖNORM EN ISO 10993-1:2011-03
Заменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
ÖNORM EN ISO 7405:2013-12
Заменен
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008 + Amd 1:2013) (consolidated version)
ÖNORM EN ISO 25539-1:2011-03
Заменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) (consolidated version)
ÖNORM EN ISO 3826-1:2013-09
Заменен
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
ÖNORM EN ISO 4074:2016-12
Заменен
Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
ÖVE/ÖNORM EN 60601-1:2014-02
Действует
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)
ÖNORM EN ISO 10993-7:2010-12
Действует
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009) (consolidated version)
ÖNORM EN ISO 10993-1:2021-04
Действует
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
ÖNORM EN ISO 11979-5:2021-04
Действует
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
ÖNORM EN ISO 18562-4:2020-06
Действует
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2017)
ÖNORM EN ISO 9394:2012-12
Действует
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
ÖNORM EN ISO 7405:2019-03
Действует
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, corrected version 2018-12)
ÖNORM EN ISO 3826-4:2015-12
Действует
Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
ÖNORM EN ISO 4074:2017-11
Действует
Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
ÖNORM EN ISO 3826-1:2020-02
Действует
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)