EN ISO 13402:2000 – Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure

1 Scope This Intemational Standard describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure. The requirements for such tests are detined and stated in the product standard along with the number of cycles for each test procedure. Other, additional, tests may also be required (see the Introduction).
2 Normative reference The fllowing standard contains provisions which, through reference in this text, constilute provisions of this International Standard. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the pssibility of applying the most recent edition of the standard indicated below. Members of IEC and Iso maintain registers of currently valid International Standards. ISO 3696:1987, Water for analytical laboratory use一Specification and test methods.
3 Autoclave test for corrosion The autoclave test attempts to simulate the service environment; it is theretore based on recommended methods of sterilization.
3.1 Reagent The water used for the test shall be of quality 3 in accordance with ISO 3696:1987.
3.2 Apparatus Autoclave, operating in the non-vacuum mode, capable of being operated at 134 C to 138 and 0,22 MN m-2. °C
3.3 Preparation Scrub the instrument using soap and warm water. Rinse thoroughly in water (3.1) and dry.
3.4 Test procedure Place the instrument,. unwrapped on a tray, into the autoclave. Using the water (3.1) subject the, instrument to an autoclaving cycleof(3 + 85 ) min at 134 C to 138 °C and 0,22 MNm-2. After the cycle, open the door. Remove the tray and allow the contents to cool to room temperature.
4 Boiling water test for corrosion The bolling water test is specitied for determining corrosion resistance.
4.1 Reagent The water used for the test shall be of quality 3 in accordance with ISO 3696:1987. 4.2 Apparatus Glass or ceramic beaker or suitable corrosion-resistant stainless steel vessel.
EN ISO 13402:2000 – Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure