BS ISO 12505-2:2016 pdf download

BS ISO 12505-2:2016 pdf download.Skin barrier for ostomy aids — Test methods — Part 2: Wet integrity and adhesive strength
1 Scope
This part of ISO 12505 specifies test methods dealing with face plates of skin barriers for ostomy aids.
This part of ISO 12505 does not cover medical properties (cytotoxicity, sensitization,irritation/intracutaneous reactivity, buffering effect, microbiological effects, etc.).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 24214, Skin barrier for ostomy aids — Vocabulary
ISO 12505-1, Skin barrier for ostomy aids — Test methods — Part 1: Size, surface pH and water-absorbency
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 24214, ISO 12505-1 and the following apply.
3.1 wet integrity
ability of a skin barrier to maintain its physical form when exposed to fluid
3.2 adhesive strength
force required to peel a skin substitute from the surface of a skin barrier specimen
3.3 specimen
single typical part or example taken from the trial sample sheet as a test piece
4 Evaluation of skin barriers
4.1 General
This part contains the following tests/measurements:Wet integrity test and adhesive strength (resistance upon removal) test.
The test methods do not individually or collectively define or recommend a product of a specific design,style or size, and do not recommend medical affairs such as treatment, nursing, etc. The test methods,however, shall be utilized for the market need to fulfil the product property of the skin barrier.
4.2 General conditions of test
4.2.1 Standard conditions of test place: The preferred standard test conditions shall be a temperature of (23 ± 2) °C and a relative humidity of (50 ± 5) %. If not available, state the used conditions in the test report.
4.2.2 Pretreatment of a sample: The sample is left under the conditions in 4.2.1 for 24 h or more.
4.2.3 Accuracy requirement/rounding of test results: The results shall be rounded and expressed by number of digits as shown in Table 1.
4.3.2.6 Punching tools, cutting two holes in lid (4.3.2.5); 8 mm and 2 mm in diameter, and cutting out a 65 mm diameter plate (4.3.2.9) with an 8 mm diameter centre hole, a 65 mm outer diameter and 45 mm inner diameter ring of foam (4.3.2.11), and a 55 mm outer diameter and 25 mm inner diameter ring-formed specimen of skin barrier.
4.3.2.7 Distance tube, fixing tube with a distance between the lid (4.3.2.5) and the plate (4.3.2.9). For example, Quick Star push-in fittings QSH-10-50 130726 2) by Festo Co.
4.3.2.8 Fasteners, auto cover clips, plastic (7 × 22) mm axis and 18 mm diameter head. The head shall not exceed 18 mm diameter. For example, Art.nr. 05009405 3) by Würth-Danmark A/S.
4.3.2.9 Mounting disc plate, APET (Amorphous Polyethylene Terephthalate) disk of 0,8 mm thickness, 65 mm diameter with an 8 mm diameter centre hole (for example, Axpet ® 4) by Bayer Material Science AG).