AAMI 11140-3 pdf free download

AAMI 11140-3 pdf free download.Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test.
3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1 1 1 40-1 apply. 4 General requirements 4.1 The requirements of ISO 1 1 1 40-1 apply. 4.2 Test samples shall be conditioned in accordance with ISO 1 87 prior to testing for performance. 5 Indicator system format The indicator system format shall meet the following requirements. a) It shall consist of indicator reagent uniformly distributed on a substrate to cover not less than 30 % of the surface area of the substrate. The distance between adjacent areas of indicator reagent shall not exceed 20 mm. The pattern of indicator reagent distribution should permit easy comparison of the color change at the margin with the color change in the central region. b) It shall have an air porosity not less than 1 .7 µm/(Pa . s) when tested in accordance with ISO 5636-3 at an air pressure of 1 .47 kPa. c) It shall have sufficient strength to withstand steam sterilization. Compliance shall be tested in accordance with Annex A. d) It shall have a substrate of a color that is uniform to visual observation. e) It shall have a difference in reflectance density of not less than 0.3 between the substrate and either the changed indicator or the unchanged indicator as specified by the manufacturer. Compliance shall be tested in accordance with Annex B. f) It shall permit writing in permanent ink to be made legibly on both processed and unprocessed materials. Markings made before processing shall be legible after processing. g) It shall be of size A4 in accordance with ISO 5457.6 Performance requirements 6.1 The indicator shall meet the following requirements. a) It shall show a uniform color change complying with 5 e) after exposure to dry saturated steam at 1 34 ( ) °C for 3.5 min ± 5 s or after exposure to dry saturated steam at 1 21 ( ) °C for 1 5 min ± 5 s or both. 1.5 0 + 1.5 0 + Compliance shall be tested in accordance with Annex C.b) When placed in the center of a standard test pack, it shall show a non-uniform color change when the temperature at the center of the standard test pack is 2 K lower than the temperature of the chamber drain of the steam exposure apparatus (see Annex H). Compliance shall be tested in accordance with Annex I. c) It shall show no discernible color change after exposure to dry heat at (1 40 ± 2) °C for not less than 30 min. Compliance shall be demonstrated in accordance with Annex D. With some indicators a slight color change can occur. This shall be acceptable if the change that occurs is markedly different from that brought about by exposure to steam in accordance with 6.1 a) and within the limits specified by the manufacturer. d) It shall not visibly transfer indicator reagent to the material of the test load in intimate contact with the indicator during processing. Compliance shall be demonstrated in accordance with Annex F. 6.2 The indicator shall comply with the requirements of this part of ISO 1 1 1 40 for the duration of the shelf life specified by the manufacturer. If any change in the indicator occurs during aging, it shall be different to the change on exposure to dry saturated steam [as described in 6.1 a)], and shall have either inactivated the indicator so that no further change can take place or not affected the performance of the indicator with respect to the requirements of 6.1 a) and 6.1 b).AAMI 11140-3 pdf download.