Free Standards PDF Download

ANSI AAMI ISO 10993-8:2000 pdf download – Biological evaluation of medical devices

ANSI AAMI ISO 10993-8:2000 pdf download - Biological evaluation of medical devices 1 Scope This part of ISO 10993 specifies requirements on the use of reference materials or certified reference materials used to determine the biological response...

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ANSI AAMI ISO 10993-4:2002 pdf download – Biological evaluation of medical devices

ANSI AAMI ISO 10993-4:2002 pdf download - Biological evaluation of medical devices 6.1.1 Figure 1 illustrates a decision tree that can be used to determine whether testing for interaction with blood is necessary. Blood interactions can be...

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ANSI AAMI ISO 8836:2015 pdf download – Suction catheters for use in the respiratory tract

ANSI AAMI ISO 8836:2015 pdf download - Suction catheters for use in the respiratory tract Closed suction catheters are used for endotracheal or artificial airway suctioning to minimize disturbance of the VBS. Closed suction catheters are provided...

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ANSI AAMI ISO 8638:2010 pdf download – Cardiovascular implants and extracorporeal systems – Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters

ANSI AAMI ISO 8638:2010 pdf download - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters 4.4.9.1 Integral transducer protectors Extracorporeal blood circuits supplied with integral transducer protectors shall be capable of...

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ANSI AAMI ISO 5841-2:2014 pdf download – Implants for surgery – Cardiac pacemakers

ANSI AAMI ISO 5841-2:2014 pdf download - Implants for surgery - Cardiac pacemakers 1 Scope This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators...

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ANSI AAMI ISO 5840-2:2015 pdf download – Cardiovascular implants – Cardiac valve prostheses

ANSI AAMI ISO 5840-2:2015 pdf download - Cardiovascular implants - Cardiac valve prostheses Test specimens shall represent, as closely as possible, the finished product to be supplied for clinical use, including exposure to the maximum number of...

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ANSI AAMI ISO 5840-1:2015 pdf download – Cardiovascular implants – Cardiac valve prostheses

ANSI AAMI ISO 5840-1:2015 pdf download - Cardiovascular implants - Cardiac valve prostheses 1 Scope This part of ISO 5840 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of...

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ANSI AAMI ISO 5367:2015 pdf download – Anaesthetic and respiratory equipment – Breathing sets and connectors

ANSI AAMI ISO 5367:2015 pdf download - Anaesthetic and respiratory equipment - Breathing sets and connectors 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for...

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AAMI ISO TIR17137:2014 pdf download – Cardiovascular implants and extracorporeal systems – Cardiovascular absorbable implants

AAMI ISO TIR17137:2014 pdf download - Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants 1 Scope This Technical Specification outlines design verification and validation considerations for absorbable cardiovascular implants. NOTE Due to the variations in the...

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AAMI ISO TIR16775:2014 pdf download – Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2

AAMI ISO TIR16775:2014 pdf download - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 The following aspects should be considered: a) The size of the pouch and the...

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