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DIN EN ISO 10993-6:2009-08

Отменен
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2009 — 31 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

DIN EN ISO 10993-16:2016-04
Отменен
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO/DIS 10993-16:2016); German and English version prEN ISO 10993-16:2016
DIN EN ISO 10993-12:2012-10
Действует
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012 — 33 стр.
DIN EN ISO 10993-11:2015-12
Отменен
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2015); German and English version prEN ISO 10993-11:2015
DIN EN ISO 10993-9:2010-04
Отменен
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) — 19 стр.
ÖNORM EN ISO 10993-2:2006-11
Действует
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
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
DIN EN ISO 7405:2017-04
Отменен
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2017); German and English version prEN ISO 7405:2017
DIN ISO 6474:2001-06
Отменен
Implants for surgery - Ceramic materials based on high purity alumina (ISO 6474:1994) — 10 стр.
DIN ISO 5834-2:2014-02
Отменен
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms (ISO 5834-2:2011) — 9 стр.
DIN ISO 5832-8:2000-08
Отменен
Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy (ISO 5832-8:1997) — 4 стр.
DIN ISO 5832-7:2017-09
Отменен
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016) — 9 стр.
DIN ISO 5832-6:2001-04
Отменен
Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997) — 4 стр.
DIN ISO 5832-5:2008-04
Действует
Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy (ISO 5832-5:2005) — 6 стр.
DIN ISO 5832-4:2015-12
Действует
Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy (ISO 5832-4:2014) — 6 стр.
DIN EN ISO 5832-3:2017-03
Отменен
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2016); German version EN ISO 5832-3:2016 — 18 стр.
DIN EN ISO 5832-2:2017-02
Отменен
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO/DIS 5832-2:2017); German and English version prEN ISO 5832-2:2017
DIN ISO 5832-1:2017-04
Отменен
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016) — 12 стр.
ASTM F1983-99
Заменен
Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications — 5 стр.
ASTM F981-99
Заменен
Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone — 5 стр.
ASTM F763-99
Заменен
Standard Practice for Short-Term Screening of Implant Materials — 4 стр.
ASTM F748-98
Заменен
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices — 7 стр.
DIN EN ISO 10993-16:2009-08
Отменен
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997); German version EN ISO 10993-16:2009 — 21 стр.
DIN EN ISO 10993-12:2009-08
Отменен
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); German version EN ISO 10993-12:2009 — 28 стр.
DIN EN ISO 10993-11:2009-08
Отменен
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); German version EN ISO 10993-11:2009 — 36 стр.
DIN EN ISO 10993-2:2006-10
Действует
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); German version EN ISO 10993-2:2006 — 20 стр.
DIN EN ISO 10993-1:2007-04
Отменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO/DIS 10993-1:2006); German version prEN ISO 10993-1:2007
DIN EN ISO 10993-6:2007-08
Отменен
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2007 — 28 стр.
DIN EN ISO 10993-6/A1:2009-02
Отменен
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); English version prEN ISO 10993-6:2008, Amendment 1

На этот документ ссылаются

DIN EN ISO 22794:2009-11
Действует
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15); German version EN ISO 22794:2009 — 18 стр.
DIN EN ISO 22794:2007-10
Отменен
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007); German version EN ISO 22794:2007 — 16 стр.
DIN EN ISO 21649:2010-01
Действует
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006); German version EN ISO 21649:2009 — 41 стр.
DIN EN ISO 22794:2009-04
Отменен
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007); German version FprEN ISO 22794:2009 — 18 стр.
DIN EN ISO 25539-2:2009-01
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008); German version EN ISO 25539-2:2008 — 125 стр.
DIN EN ISO 25539-1:2009-01
Отменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 + Amd 1:2005); German version EN ISO 25539-1:2008 — 113 стр.
DIN EN ISO 10993-1:2003-12
Отменен
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003); German version EN ISO 10993-1:2003 — 20 стр.
DIN EN ISO 10993-6:2007-08
Отменен
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2007 — 28 стр.
DIN EN ISO 10993-3:2004-02
Отменен
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2003 — 25 стр.
DIN EN ISO 10993-3:2009-08
Отменен
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2009 — 27 стр.
DIN EN ISO 10993-1:2009-10
Отменен
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003); German version EN ISO 10993-1:2009 — 24 стр.
DIN EN ISO 15883-1:2014-10
Действует
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014); German version EN ISO 15883-1:2009 + A1:2014 — 90 стр.
DIN EN ISO 15883-1:2006-07
Отменен
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006); German version EN ISO 15883-1:2006 — 84 стр.
DIN EN ISO 15883-1:2009-09
Отменен
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006); German version EN ISO 15883-1:2009 — 89 стр.
DIN EN ISO 15798:2001-12
Отменен
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001); German version EN ISO 15798:2001 — 23 стр.
DIN EN ISO 15798:2010-06
Отменен
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010); German version EN ISO 15798:2010 — 27 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 25539-1:2009-08
Отменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005); German version EN ISO 25539-1:2009 — 112 стр.
DIN EN ISO 15798:2014-02
Отменен
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013); German version EN ISO 15798:2013 — 28 стр.
DIN EN ISO 25539-2:2013-05
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012); German version EN ISO 25539-2:2012 — 115 стр.
DIN EN ISO 15747:2012-07
Отменен
Plastic containers for intravenous injections (ISO 15747:2010); German version EN ISO 15747:2011 — 20 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 13097-4:2009-08
Отменен
Hypodermic needles - Part 4: Point geometry, requirements and testing — 20 стр.
DIN EN ISO 7405:2013-12
Отменен
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008 + Amd. 1:2013); German version EN ISO 7405:2008 + A1:2013 — 45 стр.
DIN EN ISO 10993-12:2012-10
Действует
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012 — 33 стр.