ISO 22610:2018
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
This document 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Equipment, reagents and materials
6 Test apparatus and accessories
7 Preparation of the agar plates
8 Bacterial inoculum
9 Procedure
9.1 General
9.2 Preparation of the agar plates, 14 cm in diameter
9.2.1 Drying of the plates
9.2.2 Determination of the distance agar-to-brim
9.3 Inoculation of the donor
9.4 Test material
9.5 Preparation of the test assembly
9.6 Test procedure
9.7 Control plates
9.7.1 Environmental controls
9.7.2 Bacterial challenge
10 Evaluation
10.1 Required conditions for a valid test
10.2 Determination of the number of colonies of Bacillus atrophaeus
11 Expression of the results
12 Precision
12.1 Reference material
12.2 Sample material
13 Test report
Annex A (normative) Media
Annex B (normative) Test apparatus and accessories
Annex C (normative) Equipment and laboratory performance monitoring
Annex D (informative) Estimation of the bacterial contamination on the upper side of the test specimen and the bacterial load remaining on the donor
Annex E (informative) Transmission of infective agents during invasive surgical procedures
Annex F (informative) Precision of the Wet Bacterial Penetration test
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Equipment, reagents and materials
6 Test apparatus and accessories
7 Preparation of the agar plates
8 Bacterial inoculum
9 Procedure
9.1 General
9.2 Preparation of the agar plates, 14 cm in diameter
9.2.1 Drying of the plates
9.2.2 Determination of the distance agar-to-brim
9.3 Inoculation of the donor
9.4 Test material
9.5 Preparation of the test assembly
9.6 Test procedure
9.7 Control plates
9.7.1 Environmental controls
9.7.2 Bacterial challenge
10 Evaluation
10.1 Required conditions for a valid test
10.2 Determination of the number of colonies of Bacillus atrophaeus
11 Expression of the results
12 Precision
12.1 Reference material
12.2 Sample material
13 Test report
Annex A (normative) Media
Annex B (normative) Test apparatus and accessories
Annex C (normative) Equipment and laboratory performance monitoring
Annex D (informative) Estimation of the bacterial contamination on the upper side of the test specimen and the bacterial load remaining on the donor
Annex E (informative) Transmission of infective agents during invasive surgical procedures
Annex F (informative) Precision of the Wet Bacterial Penetration test
Bibliography