YY/T 0695-2008Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices (English PDF)

Foreword

This Standard modifies and adopts ASTM F 2129-06 "Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small Implant devices".

Compared with ASTM F 2129-06, this Standard has no technical differences. Only some editorial changes are made.

Appendixes A, B, and C of this Standard are informative appendixes.

1 Scope

1.1 This test method assesses the corrosion susceptibility of small, metallic, implant medical devices, or components thereof, using cyclic (forward and reverse) potentiodynamic polarization. Examples of device types that may be evaluated by this test method include, but are not limited to, vascular stents, ureteral stents, filters, support segments of endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and so forth.

1.2 This test method is used to assess a device in its final form and finish, as it would be implanted. These small devices should be tested in their entirety. The upper limit on device size is dictated by the maximum current output of the test apparatus (see Section 6). It is assumed that test methods, such as ASTM G 5 and ASTM G 61 have been used for material screening.

1.3 Because of the variety of configurations and sizes of implants, this test method provides a variety of specimen holder configurations.

1.4 This test method is intended for use on implantable devices made from metals with a relatively high resistance to corrosion.

1.5 This Standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this Standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

2 Normative references

The following documents contain provisions which, through reference in this Standard, constitute provisions of this Standard. For the dated references, their subsequent amendments (excluding corrections) or revisions do not apply to this Standard. However, the parties who enter into agreement based on this Standard are encouraged to investigate whether the latest editions of these documents are applicable. For undated reference documents, the latest editions apply to this Standard.

GB 6682 Water for analytical laboratory use - Specification and test methods

ASTM F 1828 Specification for Ureteral Stents

ASTM G 3 Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing

ASTM G 5 Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic Polarization Measurements

ASTM G 15 Terminology Relating to Corrosion and Corrosion Testing

ASTM G 61 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements for Localized Corrosion Susceptibility of Iron-, Nickel-, or Cobalt-Based Alloys

3 Terms and definitions

The following terms and definitions apply to this Standard.