IS0 11070:2014 pdf download.Sterile single-use intravascular introducers, dilators and guidewires.
4.1 Sterilization
The device shall have been sterilized by a validated method, and shall comply with 42 to 4A In the sterile condition.
NOTE See applicable part(s) or ISO 17665, ISO 11135. and ISO 11137 for appropriate methods aisterilization.
4.2 Biocompatibility
The device shall he free from biological hazard in accordance with appropriate testing under Iso 10993-1.
4.3 Surface
When examined by normal or corrected-to-normal vision with minimum 2,Sx magnification, the external surface of the effective length of the device shall appear free from extraneous matter.
The external surface of the effective length of the device, including the distal end, shall be free from process and surface defects, which could cause trauma to vessels during use.
If the Intravascular catheter Introducer Is lubricated, the lubricant shall not be visible as drops of fluid on the external surface of the effective length of the device when the device is examined under normal or corrected-to-normal vision.
4.4 CorrosIon resistance
When tested in accordance with the method given In Annex B. If metallic components of the device show visible signs of corrosion that can affect functional performance, the level of corrosion shall be evaluated with respect to intended use and risk assessment.
4.5 Radio-detectability
Parts of the device shall be radio-detectable if required as determined by the risk assessment.
Compliance should be demonstrated by an appropriate test method, such as ASTM F640-1 2 or DIN 13273-7.
4.6 Information to be supplied by the manufacturer
The manufacturer shall supply at least the information listed in a) to i). All dimensions given shall be expressed in SI units of measurement.
The device shall have been sterilized by a validated method, and shall comply with 42 to 4A In the sterile condition.
NOTE See applicable part(s) or ISO 17665, ISO 11135. and ISO 11137 for appropriate methods aisterilization.
4.2 Biocompatibility
The device shall he free from biological hazard in accordance with appropriate testing under Iso 10993-1.
4.3 Surface
When examined by normal or corrected-to-normal vision with minimum 2,Sx magnification, the external surface of the effective length of the device shall appear free from extraneous matter.
The external surface of the effective length of the device, including the distal end, shall be free from process and surface defects, which could cause trauma to vessels during use.
If the Intravascular catheter Introducer Is lubricated, the lubricant shall not be visible as drops of fluid on the external surface of the effective length of the device when the device is examined under normal or corrected-to-normal vision.
4.4 CorrosIon resistance
When tested in accordance with the method given In Annex B. If metallic components of the device show visible signs of corrosion that can affect functional performance, the level of corrosion shall be evaluated with respect to intended use and risk assessment.
4.5 Radio-detectability
Parts of the device shall be radio-detectable if required as determined by the risk assessment.
Compliance should be demonstrated by an appropriate test method, such as ASTM F640-1 2 or DIN 13273-7.
4.6 Information to be supplied by the manufacturer
The manufacturer shall supply at least the information listed in a) to i). All dimensions given shall be expressed in SI units of measurement.
