Стандарты BSI

BS EN ISO 10993-6:2009

Заменен

Biological evaluation of medical devices. Tests for local effects after implantation — 32 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

ISO 10993-2:2006

Действует

Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.

ISO 10993-11:2006

Заменен

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.

ISO 10993-12:2012

Действует

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

ISO 10993-16:2010

Заменен

Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables — 18 стр.

BS ISO 5832-1:2016

Действует

Implants for surgery. Metallic materials. Wrought stainless steel — 18 стр.

ISO 5832-2:1999

Заменен

Implants for surgery; Metallic materials; Part 2 : Unalloyed titanium — 8 стр.

ISO 5832-3:1996

Заменен

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy — 8 стр.

BS ISO 5832-4:2014

Действует

Implants for surgery. Metallic materials. Cobalt-chromium-molybdenum casting alloy — 14 стр.

BS ISO 5832-5:2005

Действует

Implants for surgery. Metallic materials. Wrought cobalt-chromium-tungsten-nickel alloy — 12 стр.

ISO 5832-6:1997

Действует

Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy — 8 стр.

ISO 5832-7:1994

Заменен

Implants for surgery; metallic materials; part 7: forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy — 8 стр.

ISO 5832-8:1997

Действует

Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy — 8 стр.

BS ISO 5834-2:2011

Действует

Implants for surgery. Ultra-high-molecular-weight polyethylene. Moulded forms — 12 стр.

BS ISO 6474-2:2012

Действует

Implants for surgery. Ceramic materials. Composite materials based on a high-purity alumina matrix with zirconia reinforcement — 22 стр.

ISO 7405:2008

Заменен

Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry — 42 стр.

ISO 10993-9:2009

Действует

Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products — 16 стр.

ASTM F748-16

Действует

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices — 7 стр.

ASTM F763-04(2016)

Заменен

Standard Practice for Short-Term Screening of Implant Materials — 4 стр.

ASTM F981-04(2016)

Заменен

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone — 5 стр.

ASTM F1983-14

Заменен

Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications — 6 стр.

BS EN ISO 10993-6:2016

Действует

Biological evaluation of medical devices. Tests for local effects after implantation — 44 стр.

На этот документ ссылаются

BS EN ISO 7198:2017

Действует

Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches — 68 стр.

BS EN ISO 10993-6:2016

Действует

Biological evaluation of medical devices. Tests for local effects after implantation — 44 стр.

PAS 84:2012

Действует

Cell therapy and regenerative medicine. Glossary — 58 стр.

BS EN ISO 10993-6:2007

Заменен

Biological evaluation of medical devices, Tests for local effects after implantation — 34 стр.