BS EN ISO 10993-4:2009

Заменен

Biological evaluation of medical devices. Selection of tests for interactions with blood — 46 стр.

Ссылочные документы

DIN 58361-4:1980-09

Отменен

Transfusion, infusion; transfusion containers and accessories, plastic containers for blood, requirements, tests, supervision and labelling — 12 стр.

ASTM F2065-00(2010)

Отменен

Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016) — 7 стр.

ASTM F1984-99

Заменен

Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials — 5 стр.

ASTM F756-00

Заменен

Standard Practice for Assessment of Hemolytic Properties of Materials — 5 стр.

ISO 3826-4:2015

Действует

Plastics collapsible containers for human blood and blood components -- Part 4: Aphaeresis blood bag systems with integrated features — 38 стр.

ISO 10993-12:2012

Действует

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

ISO 7199:2009/Amd.1:2012

Заменен

Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators) -- Amendment 1: Clarifications for test methodologies, labelling, and sampling schedule — 8 стр.

ISO 7198:2016

Действует

Cardiovascular implants and extracorporeal systems -- Vascular prostheses -- Tubular vascular grafts and vascular patches — 62 стр.

ISO 5841-3:2013

Действует

Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers — 20 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 10993-4:2002

Заменен

Biological evaluation of medical devices. Selection of tests for interactions with blood — 48 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.

BS EN ISO 10993-4:2017

Действует

Biological evaluation of medical devices. Selection of tests for interactions with blood — 42 стр.

BS EN ISO 1135-5:2015

Действует

Transfusion equipment for medical use. Transfusion sets for single use with pressure infusion apparatus — 32 стр.

BS EN ISO 1135-4:2015

Действует

Transfusion equipment for medical use. Transfusion sets for single use, gravity feed — 28 стр.

BS EN ISO 10993-4:2002

Заменен

Biological evaluation of medical devices. Selection of tests for interactions with blood — 48 стр.

BS EN ISO 7199:2017

Действует

Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) — 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 8536-11:2015

Действует

Infusion equipment for medical use. Infusion filters for single use with pressure infusion equipment — 20 стр.

BS EN ISO 8536-10:2015

Действует

Infusion equipment for medical use. Accessories for fluid lines for single use with pressure infusion equipment — 20 стр.