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ISO 10993-12:2012

Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.
ОписаниеИзмененияСсылкиВерсии

На этот документ ссылаются

BS EN ISO 11979-6:2007
Заменен
Ophthalmic implants. Intraocular lenses. Shelf-life and transport stability — 22 стр.
BS EN ISO 14534:2011
Заменен
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements — 20 стр.
BS EN ISO 16061:2009
Заменен
Instrumentation for use in association with non-active surgical implants. General requirements — 28 стр.
BS EN ISO 10993-6:2009
Заменен
Biological evaluation of medical devices. Tests for local effects after implantation — 32 стр.
PD ISO/TR 15499:2012
Заменен
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process — 24 стр.
BS EN ISO 10993-11:2006
Заменен
Biological evaluation of medical devices. Tests for systemic toxicity — 38 стр.
BS EN ISO 10993-4:2009
Заменен
Biological evaluation of medical devices. Selection of tests for interactions with blood — 46 стр.
BS EN ISO 10993-16:2010
Заменен
Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables — 22 стр.
BS EN ISO 7198:2017
Действует
Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches — 68 стр.
BS EN ISO 5667-16:2017
Действует
Water quality. Sampling. Guidance on biotesting of samples — 34 стр.
BS EN ISO 22112:2017
Действует
Dentistry. Artificial teeth for dental prostheses — 26 стр.
BS EN ISO 15621:2017
Действует
Absorbent incontinence aids for urine and/or faeces. General guidelines on evaluation — 20 стр.
BS EN ISO 14534:2015
Действует
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements — 22 стр.
BS EN ISO 11979-5:2006
Действует
Ophthalmic implants. Intraocular lenses. Biocompatibility — 36 стр.
BS EN ISO 10993-7:2008
Действует
Biological evaluation of medical devices. Ethylene oxide sterilization residuals — 98 стр.
BS EN ISO 10993-6:2016
Действует
Biological evaluation of medical devices. Tests for local effects after implantation — 44 стр.
BS EN ISO 10993-5:2009
Действует
Biological evaluation of medical devices. Tests for in vitro cytotoxicity — 46 стр.
BS EN ISO 10993-4:2017
Действует
Biological evaluation of medical devices. Selection of tests for interactions with blood — 42 стр.
BS EN ISO 10993-3:2014
Действует
Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity — 46 стр.
BS EN ISO 10993-14:2009
Действует
Biological evaluation of medical devices. Identification and quantification of degradation products from ceramics — 22 стр.
BS EN ISO 10993-10:2013
Действует
Biological evaluation of medical devices. Tests for irritation and skin sensitization — 78 стр.
BS ISO 19611:2017
Действует
Traditional Chinese medicine. Air extraction cupping device — 18 стр.
BS ISO 18562-4:2017
Действует
Biocompatibility evaluation of breathing gas pathways in healthcare applications. Tests for leachables in condensate — 18 стр.
BS ISO 11350:2012
Действует
Water quality. Determination of the genotoxicity of water and waste water. Salmonella/microsome fluctuation test (Ames fluctuation test) — 44 стр.
PD ISO/TS 20787:2017
Действует
Nanotechnologies. Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. Nauplii — 24 стр.
PD ISO/TS 18827:2017
Действует
Nanotechnologies. Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials — 30 стр.
PD ISO/TR 10993-22:2017
Действует
Biological evaluation of medical devices. Guidance on nanomaterials — 70 стр.
PD ISO/TR 37137:2014
Действует
Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants — 26 стр.
PD ISO/TR 15499:2016
Действует
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process — 24 стр.
BS EN ISO 10993-16:2017
Действует
Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables — 22 стр.
BS EN ISO 13408-2:2018
Действует
Aseptic processing of health care products. Sterilizing filtration — 42 стр.
BS ISO 19227:2018
Действует
Implants for surgery. Cleanliness of orthopedic implants. General requirements — 26 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
Действует
BS EN ISO 3826-1. Plastics collapsible containers for human blood and blood components. Part 1. Conventional containers — 33 стр.
BS EN ISO 11979-6:2014
Действует
Ophthalmic implants. Intraocular lenses. Shelf-life and transport stability testing — 20 стр.
BS EN ISO 10993-15:2009
Действует
Biological evaluation of medical devices. Identification and quantification of degradation products from metals and alloys — 22 стр.
BS EN ISO 22803:2005
Действует
Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file — 16 стр.
BS EN ISO 10993-11:2009
Заменен
Biological evaluation of medical devices. Tests for systemic toxicity — 38 стр.
18/30354781 DC
Действует
BS EN ISO 10993-15. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys — 26 стр.
BS EN ISO 3826-1:2013
Действует
Plastics collapsible containers for human blood and blood components. Conventional containers — 32 стр.
BS EN ISO 16061:2015
Действует
Instrumentation for use in association with non-active surgical implants. General requirements — 28 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 22794:2009
Действует
Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file — 20 стр.
BS EN ISO 10993-13:2010
Действует
Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices — 26 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.
18/30358832 DC
Действует
BS EN ISO 10993-18. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process — 71 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.
ÖNORM EN ISO 10993-6:2009-09
Заменен
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
ÖNORM EN ISO 10993-10:2010-10
Заменен
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
ÖNORM EN ISO 10993-11:2009-09
Заменен
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
ÖNORM EN ISO 11979-6:2007-10
Заменен
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2007)
ÖNORM EN ISO 10993-16:2010-06
Заменен
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
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 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)
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 10993-4:2018-01
Действует
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
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 10993-10:2014-10
Действует
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2013)
ÖNORM EN ISO 10993-6:2017-06
Действует
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
ÖNORM EN ISO 10993-5:2009-12
Действует
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
ÖNORM EN ISO 11979-6:2015-01
Действует
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
ÖNORM EN ISO 10993-23:2021-09
Действует
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
ÖNORM EN ISO 10993-3:2015-01
Действует
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
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 10993-13:2010-10
Действует
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
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)