ANSI/AAMI/ ISO 8638:2015 pdf download – Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiaflters and hemoflters.
3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 air capture chamber component intended to capture air and which can provide compliance to the blood circuit or allow pressure to be monitored NOTE Air capture chambers are also known as drip chambers, bubble traps or venous and arterial blood chambers. 3.2 extracorporeal blood circuit blood tubing and integral accessory tubing, including fluid and infusion tubing, for attaching the extracorporeal blood circuit to pressure monitors and integral components EXAMPLES (Of integral components.) Air-capture chambers and transducer protectors. 3.3 fluid pathway internal surfaces of the extracorporeal blood circuit 3.4 labeling written, printed, graphic or electronic matter that: ⎯ is affixed to a medical device or any of its containers or wrappers or ⎯ accompanies a medical device and which is related to identification, technical description and use of that medical device, but excluding shipping documents 3.5 pump segment portion of the extracorporeal blood circuit (3.2) that is acted upon by the blood pump 3.6 transducer protector pressure-transmitting sterile barrier component of the extracorporeal blood circuit (3.2) that is intended to provide an interconnection between the extracorporeal blood circuit and the hemodialysis machine while allowing the pressure within the extracorporeal blood circuit to be measured by the machine.
4 Requirements 4.1 Biological safety Parts of the device that are intended to come into direct or indirect contact with blood shall be evaluated for freedom from biological hazards, in accordance with 5.2. NOTE Attention is drawn to the need to establish whether national regulations or national standards governing toxicology and biocompatibility testing exist in the country in which the device is produced and, if applicable, in the countries in which the device is to be marketed. 4.2 Sterility All fluid contacting surfaces of the device, and the mating surfaces of all connectors integral to the device, shall be sterile. Compliance shall be verified in accordance with 5.3. 4.3 Nonpyrogenicity The blood pathway of the device shall be non-pyrogenic. Compliance shall be verified in accordance with 5.4. 4.4 Mechanical characteristics 4.4.1 Structural integrity The device shall be capable of withstanding a positive pressure of 1 .5 × the manufacturer’s recommended maximum pressure and a negative pressure not exceeding 700 mmHg (93.3 kPa below atmospheric pressure) or the highest obtainable negative pressure if at high elevation, when tested in accordance with 5.5.1 .