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 system where an organization needs to demonstrate its...
ANSI AAMI ISO 13022:2012 pdf download – Medical products containing viable human cells – Application of risk management and requirements for processing practices
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 International Standard specifies requirements and guidance for processing practices and managing...
ANSI AAMI ISO 11737-3:2004 pdf download – Sterilization of medical devices – Microbiological methods
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 bioburden is a raw material. Raw materials of natural origin often...
ANSI AAMI ISO 11658:2012 pdf download – Cardiovascular implants and extracorporeal systems – Blood/tissue contact surface modifications for extracorporeal perfusion systems
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 specifies requirements for the physical, biological and performance testing of biocompatible...
ANSI AAMI ISO 11140-1:2014 pdf download – Sterilization of health care products – Chemical indicators
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 used as intended by the manufacturer, does not release any substance...
ANSI AAMI ISO 11138-3:2017 pdf download – Sterilization of health care products – Biological indicators
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 indicators and test methods intended for use in assessing...
ANSI AAMI ISO 11135:2014 pdf download – Sterilization of health care products – Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 11135:2014 pdf download - Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices 5.1 General The purpose of this activity...
ANSI AAMI ISO 11134:1993 pdf download – Sterilization of health care products – Requirements for validation and routine control Industrial moist heat sterilization
ANSI AAMI ISO 11134:1993 pdf download - Sterilization of health care products - Requirements for validation and routine control Industrial moist heat sterilization A maintenance scheme should be developed from the schedules provided by the sterilizer manufacturer,...
ANSI AAMI ISO 10993-15:2000 pdf download – Biological evaluation of medical devices
ANSI AAMI ISO 10993-15:2000 pdf download - Biological evaluation of medical devices 1.Scope This part of IsO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic...
ANSI AAMI ISO 10993-12:2012 pdf download – Biological evaluation of medical devices
ANSI AAMI ISO 10993-12:2012 pdf download - Biological evaluation of medical devices 5.2 Certification of RMs for biological safety testing 5.2.1 Qualification of an RM is a procedure that establishes the numerical or qualitative value of the...