BS EN ISO 10993-4:2017

Действует

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

Ссылочные документы

ISO 5841-3:2013

Действует

Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers — 20 стр.

ISO 12891-1:2015

Действует

Retrieval and analysis of surgical implants -- Part 1: Retrieval and handling — 32 стр.

ISO 14708-2:2012

Действует

Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers — 76 стр.

ISO 15674:2016

Действует

Cardiovascular implants and artificial organs -- Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — 16 стр.

ISO 7199:2016

Действует

Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators) — 20 стр.

ISO 7198:2016

Действует

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

ISO 8637:2010

Заменен

Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators — 26 стр.

ISO 15675:2016

Действует

Cardiovascular implants and artificial organs -- Cardiopulmonary bypass systems -- Arterial blood line filters — 14 стр.

ISO/IEC 17025:2005

Заменен

General requirements for the competence of testing and calibration laboratories — 36 стр.

ISO 5840:2005

Заменен

Cardiovascular implants -- Cardiac valve prostheses — 92 стр.

ISO 10993-4:2002/Amd.1:2006

Заменен

Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood -- Amendment 1 — 10 стр.

ISO 10993-12:2012

Действует

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

ISO 10993-1:2009

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 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 10993-4:2002

Заменен

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

На этот документ ссылаются

BS EN ISO 10993-4:2009

Заменен

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

BS EN ISO 8637-2:2018

Действует

Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters — 22 стр.