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5.1 In the battle to reduce medical device and implant-related infections, prevention of bacterial colonization of surfaces is a logical strategy. Bacterial colonization of a surface is a precursor to biofilm formation. Biofilm is the etiological agent of many implant and...
This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen...
This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen...
This International Standard applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. This International Standard provides requirements and test methods for the tubes manufactured...
This International Standard applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. This International Standard provides requirements and test methods for the tubes manufactured...
ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. It provides requirements and test methods for the tubes manufactured for needles as component used in...
This document specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such...
This document specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such...
This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants. The...
