Category: ANSI Standards

ANSI SCTE 03-2016 pdf download ANSI SCTE 03-2016 pdf download.Test Method for Coaxial Cable Structural Return Loss 4. Compliance Notation This word or the adjective“required’ means that the item is […]

ANSI H35.3-2017 pdf download ANSI H35.3-2017 pdf download.American National Standard Designation System for Aluminum Hardeners 1 . Scope 1 .1  This standard provides a system for des- ignating aluminum hardeners […]

ANSI AAMI ISO 14708-1-2014 pdf download ANSI AAMI ISO 14708-1-2014 pdf download.Implants for surgery — Active implantable medical devices 1 Scope This part of ISO 1 4708 specifies requirements that […]

ANSI AAMI ISO 13488-1996 pdf download ANSI AAMI ISO 13488-1996 pdf download.Quality systems – Medical devices – Particular requirements for the application of ISO 9002 1 Scope This International Standard […]

ANSI AAMI ISO 13485-2016 pdf download ANSI AAMI ISO 13485-2016 pdf download.Medical devices—Quality management systems— Requirements for regulatory purposes 1 Scope This International Standard specifies requirements for a quality management […]

ANSI AAMI ISO 13022-2012 pdf download ANSI AAMI ISO 13022-2012 pdf download.Medical products containing viable human cells – Application of risk management and requirements for processing practices 1 Scope This […]

ANSI AAMI ISO 11737-3-2004 pdf download ANSI AAMI ISO 11737-3-2004 pdf download.Sterilization of medical devices – Microbiological methods 4.1.2 In some cases, the most significant contributor to product or component […]

ANSI AAMI ISO 11658-2012 pdf download ANSI AAMI ISO 11658-2012 pdf download.Cardiovascular implants and extracorporeal systems – Blood/tissue contact surface modifications for extracorporeal perfusion systems 1 Scope This International Standard […]

ANSI AAMI ISO 11140-1-2014 pdf download ANSI AAMI ISO 11140-1-2014 pdf download.Sterilization of health care products — Chemical indicators 5.9 The manufacturer shall retain documentary evidence that the indicator, when […]

ANSI AAMI ISO 11138-3-2017 pdf download ANSI AAMI ISO 11138-3-2017 pdf download.Sterilization of health care products—Biological indicators 1 Scope This document specifies requirements for test organisms, suspensions, inoculated carriers, biological […]