Category: ANSI Standards

ANSI AAMI ISO 18241-2016 pdf download ANSI AAMI ISO 18241-2016 pdf download.Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems— Venous bubble traps 1 Scope This document specifies requirements for sterile, single-use, […]

ANSI AAMI ISO 16142-2-2017 pdf download ANSI AAMI ISO 16142-2-2017 pdf download.Medical devices—Recognized essential principles of safety and performance of medical devices 4 Essential principles of safety and performance of […]

ANSI AAMI ISO 17664-2017 pdf download ANSI AAMI ISO 17664-2017 pdf download.Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices […]

ANSI AAMI ISO 16142-1-2016 pdf download ANSI AAMI ISO 16142-1-2016 pdf download.Medical devices—Recognized essential principles of safety and performance of medical devices 1 Scope This part of ISO 16142, which […]

ANSI AAMI ISO 15676-2016 pdf download ANSI AAMI ISO 15676-2016 pdf download.Cardiovascular implants and artificial organs— Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) 1 […]

ANSI AAMI ISO 15675-2016 pdf download ANSI AAMI ISO 15675-2016 pdf download.Cardiovascular implants and artificial organs— Cardiopulmonary bypass systems—Arterial blood line filters 5.4.1.2 Procedure Two sets of appropriate, identical circuit […]

ANSI AAMI ISO 15674-2016 pdf download ANSI AAMI ISO 15674-2016 pdf download.Cardiovascular implants and artificial organs— Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags 5.2.2 Biocompatibility Compliance […]

ANSI AAMI ISO 14708-3-2017 pdf download ANSI AAMI ISO 14708-3-2017 pdf download.Implants for surgery — Active implantable medical devices Prior to testing, risks shall be identified, taking into account the […]

ANSI AAMI ISO 15225-2016 pdf download ANSI AAMI ISO 15225-2016 pdf download.Medical devices—Quality management—Medical device nomenclature structire 4.2.1 Description A term describes a generic device group of medical devices, i.e. […]

ANSI AAMI ST72-2019 pdf download ANSI AAMI ST72-2019 pdf download.Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing 7.3 The sampling group is generally defined as the production batch. […]