ANSI AAMI ISO 11658-2012 pdf download
ANSI AAMI ISO 11658-2012 pdf download.Cardiovascular implants and extracorporeal systems – Blood/tissue contact surface modifications for extracorporeal perfusion systems
1 Scope
This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have modifications on the blood and tissue-contacting surfaces of the device. The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If hyperthermia (>37 C) applications are indicated, then testing is performed over the indicated range.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 7199, Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
ISO 10993-1，Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
ISO 10993-7, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
ISO 11135-1，Sterilization of health care products- Ethylene oxide- Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products一Radiation 一Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
ISO 14937，Sterilization of health care products 一General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 15674，Cardiovascular implants and artificial organs – Hard- shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 surface modification
modification that can be biologically derived or non-biologically derived and can be applied to blood-contacting surfaces or additives incorporated into a material as part of the manufacturing process
3.2 coverage
extent to which a surface modification applied to a blood contact device effectively covers the blood or tissue-contacting surface of the device
3.3 leaching
extent to which a surface modification applied to the surface of a blood contact device may elute from the surface of the device directly contacting the patient or into the fluid stream which in turn contacts the patient
3.4 bioactivity
quantification of any biological activity that a surface modification applied to the surface of a blood contact device imparts to the blood or tissues to which it is exposed
5.1.2 Operating variables shall be those specified by the manufacturer for intended clinical use, unless otherwise specified.
5.1.3 The temperature of the test liquid(s) shall be representative of a range of the intended clinical temperatures during device use (e.g. hypothermic, normothermic and/or hyperthermic). Tests should be performed at multiple temperatures over the range of the intended clinical use, or justification for testing at a single temperature should be provided (e.g. why this temperature is representative of the worst-case condition).
5.1.4 If the relationship between variables is non-linear, sufficient determinations shall be made to permit valid interpolation between data points.
5.1.5 The test or measurement procedures are to be regarded as reference procedures. Other procedures can be accepted, provided that the alternative procedure has been shown to be of comparable precision and reproducibility.
