ISO 13960:2010
Cardiovascular implants and extracorporeal systems - Plasmafilters
- Standard No.
- ISO 13960:2010
- Release Date
- 2010
- Published By
- International Organization for Standardization (ISO)
- Status
- Latest
- ISO 13960:2010
- Scope
- This International Standard specifies requirements for sterile, single-use plasmafilters, intended for use on humans. This International Standard does not apply to the extracorporeal circuits used for plasmapheresis or other extracorporeal blood exchange devices, such as haemodialysers, haemodiafilters, haemofilters, haemoperfusion devices, vascular access devices, oxygenators or active medical devices. This International Standard does not address the replacement fluid.
ISO 13960:2010 Referenced Document
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
- ISO 10993-4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
- ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
- 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 — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
- ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- ISO 8637 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports*， 2013-04-01 Update
ISO 13960:2010 history
- 2010 ISO 13960:2010 Cardiovascular implants and extracorporeal systems - Plasmafilters
- 2003 ISO 13960:2003 Cardiovascular implants and artificial organs - Plasmafilters
