Free Standards PDF Download

AAMI ISO 80369-1:2018 pdf download – Small-bore connectors for liquids and gases in healthcare applications

AAMI ISO 80369-1:2018 pdf download - Small-bore connectors for liquids and gases in healthcare applications To prevent misconnection between MEDICAL DEVICES that should not connect, the rigidity of the materials from which SMALL - BORE CONNECTORS are...

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AAMI ISO 23500-5:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies

AAMI ISO 23500-5:2019 pdf download - Preparation and quality management of fluids for haemodialysis and related therapies 4.1.2 Microbiological requirements for standard dialysis fluid Standard dialysis fluid shall contain a total viable microbial count of less than...

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AAMI ISO 23500-4:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies

AAMI ISO 23500-4:2019 pdf download - Preparation and quality management of fluids for haemodialysis and related therapies 4.1.1.1 Liquid solute concentrations All electrolytes identified on the label shall be present within ± 5 % or ± 0,1...

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AAMI ISO 23500-3:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies

AAMI ISO 23500-3:2019 pdf download - Preparation and quality management of fluids for haemodialysis and related therapies 4.2.1 General Dialysis water shall not contain chemicals at concentrations in excess of those listed in Tables 1 and 2,...

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AAMI ISO 23500-2:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies

AAMI ISO 23500-2:2019 pdf download - Preparation and quality management of fluids for haemodialysis and related therapies 4.1.1 General The requirements contained in this document apply to the dialysis water as it enters the equipment used to...

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AAMI ISO 23500-1:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies

AAMI ISO 23500-1:2019 pdf download - Preparation and quality management of fluids for haemodialysis and related therapies 1.1 General This document is the base standard for a number of other standards dealing with water treatment equipment, water,...

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AAMI ISO 14155:2020 pdf download – Clinical investigation of medical devices for human subjects – Good clinical practice

AAMI ISO 14155:2020 pdf download - Clinical investigation of medical devices for human subjects - Good clinical practice 1 Scope This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried...

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AAMI ISO 13488:1996 pdf download – Quality systems – Medical devices – Particular requirements for the application of ISO 9002

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 the...

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AAMI ISO 13408-2:2018 pdf download – Aseptic processing of health care products

AAMI ISO 13408-2:2018 pdf download - Aseptic processing of health care products 6.1 General The purpose of this activity is to define the entire sterilizing fltration process so that it is both safe and reproducible. 6.2 Risk...

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AAMI ISO 11607:2000 pdf download – Packaging for terminally sterilized medical devices

AAMI ISO 11607:2000 pdf download - Packaging for terminally sterilized medical devices 1.1 This International Standard specifies the requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical devices, whether produced industrially or...

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