ISO 11070:2014 pdf download – Sterile single-use intravascular introducers, dilators and guidewires
ISO 11070:2014 pdf download – Sterile single-use intravascular introducers, dilators and guidewires.
6.6 InformatIon to be supplied by the manufacturer
If the introducer catheter is supplied with a needle, the manufacturer shall give a statement warning
against attempting to re-insert a partially or completely withdrawn needle.
7 Additional requirements for sheath introducers
Sheath introducers shall comply with Clause 4.
7.2 Size designation
The nominal size of the sheath introducer shall be designated by the following:
a) the minimum inside diameter of the sheath expressed in millimetres. rounded down to the nearest 0.1 mm;
NOTE The recommended compatible-sized device that can be accepted throughout the sheath, including fittings, and valves, can also be expressed.
b) the nominal effective length expressed in millimetres or centimetres.
7.3 Freedom from leakage from sheath introducer
When tested as described in Aunuxi). using a minimum test pressure u1300 kPa 3OU kI’a bar), there shall be no leakage sufFicient to form a falling drop.
7.4 Freedom from leakage through haemostasis valve
If the sheath Introducer has an integral hacmostasis valve, when tested as described in AnnexE, there shall be no leakage past the haemustasls valve.
If a huh orhubs are provided, hubs shall havea female 6% (Luer taper lock fittingcomplyingwith ISO 594-2.
7.6 Peak tensile force
When tested by the method given in Annex C. the minimum peak tensile force of the sheath introducer and the Iunction between the sheath introducer and the hub shall be as given in Table 2.
7.7 Information to be supplied by the manufacturer
The manufacturer shall give the nominal size of the sheath introducer as designated In 72.
8 Additional requirements for guidewires
Guldewires shall comply with Clause 4.
8.7 InformatIon to be supplied by the manufacturer
The manufacturer shall give the following information:
a) the nominal size of the guide, as designated in 8.2
b) the nominal type of distal end, e.g. straight, J (including radius of curve), or other form;
c) if the core wire is moveable, a statement to that effect.
9 Additional requirements for dilators
Dilators shall comply with Clause 4.
9.2 Size designation
The nominal size of the dilator shall be designated by
a) the maximum outside diameter, in millimetres, rounded up to the nearest 0,1 mm,
b) the minimum internal diameter, expressed in millimetres, rounded down to the nearest 0.1 mm, and
c the effective length, expressed in centimetres.
A hub shall be provided.
9.3.2 Conical fitting
If the hub includes a female 6% (Luer) fitting, the litting shall comply with ISO 594-1 and/or ISO 594-2.
9.3.3 Strength of union between hub and dilator
When tested by the method given in Annx. the minimum force at break of the dilator and the junction between the dilator and the hub shall be as given in Table 2.
9.4 Information to be supplied by the manufacturer
The manufacturer shall give the nominal size of the dilator as designated In 9.2.
10 Additional requirements for kits containing combinations of devices specified
In this International Standard
For kits of combinations of two or more different devices specified in this International Standard, the manufacturer shall give the appropriate dimensions listed in Table 4.
Sizes shall be designated as specified In the relevant clauses of this International Standard.
NOTE Many devices covered by this International Standard are commonly packaged in kits, thus, all the dimensions specified for Individual devices in this International Standard might not be nel:essary because the manufacturer will have ensured that the components of the kit will mate together property.
A.1 Sheath introducers
The tip of the sheath introducer should be designed so as to minimize rollback of the sheath whenentering the body tissues.
The tip of the sheath introducer should fit closely to the dilator and remain free from cracks duringnormal use.
The radial rigidity of the sheath introducer should be such that the introducer remains patent uponremoval of the dilator. The sheath introducer should be sufficiently flexible to permit manipulation butshould not kink under conditions of normal use.
Surface coatings can be applied.If coating is applied, the guidewire shall meet all applicable requirementsof this International Standard.
Guidewire tip should be designed to minimize trauma; clinical risk assessment can be applied.A.3 Dilators
The dilator should have a certain flexibility, but sufficient rigidity to dilate the opening of the bloodvessel into which it is percutaneously inserted.The tip should be designed so as to minimize rollbackwhen entering body tissues.