Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment – Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)
Abstract
ISO 22610:2006 specifies a test method, with associated test apparatus, which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.
DIN EN ISO 22610:2006-10 (E)
Surgical drapes, gowns and clea n air suits, used as medical devices, for patients,
clinical staff and equipment – Test method to determine the resistance to wet
bacterial penetration (ISO 22610:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….2
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 Principle …………………………………………………………………………………………………………………………6
5 Reagents and materials …………………………………………………………………………………………………..7
6 Apparatus ……………………………………………………………………………………………………………………….7
7 Preparation of test samples and pieces …………………………………………………………………………..7
7.1 Agar plates ……………………………………………………………………………………………………………………..7
7.2 Carrier material ……………………………………………………………………………………………………………….8
7.3 Test specimen ………………………………………………………………………………………………………………..8
8 Procedure ……………………………………………………………………………………………………………………….8
8.1 Preparation of donor ……………………………………………………………………………………………………….8
8.2 Conditioning …………………………………………………………………………………………………………………..8
8.3 Test set-up ……………………………………………………………………………………………………………………..8
8.4 Application of materials ………………………………………………………………………………………………….8
8.5 Test ………………………………………………………………………………………………………………………………..9
9 Test report ………………………………………………………………………………………………………………………9
10 Performance monitoring ……………………………………………………………………………………………….10
10.1 General …………………………………………………………………………………………………………………………10
10.2 With carbon paper …………………………………………………………………………………………………………10
10.3 With reference material …………………………………………………………………………………………………10
Annex A (normative) Apparatus for testing resistance to wet bacterial penetration ………………………..11
Annex B (normative) Nutrient media ……………………………………………………………………………………………..14
Annex C (informative) Examples of how to use the test results to characterize a barrier material …..16
Bibliography …………………………………………………………………………………………………………………………………18
ANNEX ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………….19