ANSI AAMI ISO 22442-1:2016 pdf download - Medical devices utilizing animal tissues and their derivatives 4.4.2 Risk control for viruses and TSE agents Risk control shall be implemented by separately addressing the risks related to different categories...
ANSI AAMI ISO 18472:2006 pdf download – Sterilization of health care products – Biological and chemical indicators – Test equipment
ANSI AAMI ISO 18472:2006 pdf download - Sterilization of health care products - Biological and chemical indicators - Test equipment 1 Scope 1.1 This International Standard specifies the requirements for test equipment to be used to test...
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 17664:2017 pdf download - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices 1 Scope This document specifies requirements for the information...
ANSI AAMI ISO 16142-2:2017 pdf download – Medical devices – Recognized essential principles of safety and performance of medical devices
ANSI AAMI ISO 16142-2:2017 pdf download - Medical devices - Recognized essential principles of safety and performance of medical devices 1 Scope This document, which includes the essential principles of safety and performance, identifies significant standards and...
ANSI AAMI ISO 16142-1:2016 pdf download – Medical devices – Recognized essential principles of safety and performance of medical devices
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 includes the essential principles of safety and performance, identifies...
ANSI AAMI ISO 15675:2016 pdf download – Cardiovascular implants and artificial organs – Cardiopulmonary bypass systems – Arterial blood line filters
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 components, including a pump, connecting tubing, a reservoir...
ANSI AAMI ISO 14708-5:2010 pdf download – Implants for surgery – Active implantable medical devices
ANSI AAMI ISO 14708-5:2010 pdf download - Implants for surgery - Active implantable medical devices 6.101 Intended clinical use/indications The intended use and indications for the device system shall be described. The intended use describes what the...
ANSI AAMI ISO 14708-3:2017 pdf download – Implants for surgery – Active implantable medical devices
ANSI AAMI ISO 14708-3:2017 pdf download - Implants for surgery - Active implantable medical devices The risk assessment process, performed in accordance with ISO 1 4971 , could result in hazardous situations being identified (see ISO 1...
ANSI AAMI ISO 14708-1:2014 pdf download – Implants for surgery – Active implantable medical devices
ANSI AAMI ISO 14708-1:2014 pdf download - Implants for surgery - Active implantable medical devices 19.3 An ACTIVE IMPLANTABLE MEDICAL DEVICE shall be designed so that the failure of any single component, part, software of the ACTIVE...
ANSI AAMI ISO 13488:1996 pdf download – Quality systems – Medical devices – Particular requirements for the application of ISO 9002
ANSI AAMI ISO 13488:1996 pdf download - Quality systems - Medical devices - Particular requirements for the application of ISO 9002 1 Scope This International Standard specifies, in conjunction with ISO 9002, the quality system requirements for...