Category: ANSI Standards

ANSI AAMI RD52-2004 pdf download.Dialysate for hemodialysis 1.1 General The intent of this recommended practice is to provide dialysis practitioners with guidance on the preparation of dialysate for hemodialysis and […]

ANSI AAMI RD5-2003 pdf download ANSI AAMI RD5-2003 pdf download.Hemodialysis equipment 1.2 Inclusions This standard covers apparatus for preparing dialysate; monitors of the dialysate including blood leak detectors, ultrafiltration monitors, […]

ANSI AAMI ISO 80369-20-2015 pdf download ANSI AAMI ISO 80369-20-2015 pdf download.Small-bore connectors for liquids and gases in healthcare applications This annex provides a rationale for some requirements of this […]

ANSI AAMI ISO 80369-7-2016 pdf download ANSI AAMI ISO 80369-7-2016 pdf download.Small-bore connectors for liquids and gases in healthcare applications 4.1 General requirements for LUER CONNECTORS LUER CONNECTORS made in […]

ANSI AAMI ISO 80369-5-2016 pdf download ANSI AAMI ISO 80369-5-2016 pdf download.Small-bore connectors for liquids and gases in healthcare applications 1 Scope This part of International Standard 80369 specifies dimensions […]

ANSI AAMI ISO 25539-2-2012 pdf download ANSI AAMI ISO 25539-2-2012 pdf download.Cardiovascular implants – Endovascular devices 1 Scope 1.1 This part of ISO 25539 specifies requirements for vascular stents, based […]

ANSI AAMI ISO 25539-1-2017 pdf download ANSI AAMI ISO 25539-1-2017 pdf download.Cardiovascular implants—Endovascular devices 1 Scope This document specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) […]

ANSI AAMI ISO 22442-2-2016 pdf download ANSI AAMI ISO 22442-2-2016 pdf download.Medical devices utilizing animal tissues and their derivatives 1 Scope This part of ISO 22442 specifies requirements for controls […]

ANSI AAMI ISO 22442-1-2016 pdf download ANSI AAMI ISO 22442-1-2016 pdf download.Medical devices utilizing animal tissues and their derivatives 1 Scope This part of ISO 22442 applies to medical devices […]

ANSI AAMI ISO 18242-2016 pdf download ANSI AAMI ISO 18242-2016 pdf download.Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps 5.4.1.1 Test liquid The test liquid shall be a blood analogue or […]