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)
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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.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Reagents and materials 1)
6 Apparatus
7 Preparation of test samples and pieces
7.1 Agar plates
7.2 Carrier material
7.3 Test specimen
8 Procedure
8.1 Preparation of donor
8.2 Conditioning
8.3 Test set-up
8.4 Application of materials
8.5 Test
9 Test report
10 Performance monitoring
10.1 General
10.2 With carbon paper
10.3 With reference material
Annex A Apparatus for testing resistance to wet bacterial penetration (normative)
Annex B Nutrient media (normative)
Annex C Examples of how to use the test results to characterize a barrier material (informative)
EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
ISO 11607:2003 Packaging for terminally sterilized medical devices
EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 13683:1997 Sterilization of health care products -- Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO 13934-1:1999 Textiles -- Tensile properties of fabrics -- Part 1: Determination of maximum force and elongation at maximum force using the strip method
ISO 13937-2:2000 Textiles -- Tear properties of fabrics -- Part 2: Determination of tear force of trouser-shaped test specimens (Single tear method)
ISO 139:2005 Textiles -- Standard atmospheres for conditioning and testing
ISO 15797:2002 Textiles -- Industrial washing and finishing procedures for testing of workwear
ISO 6330:2000 Textiles -- Domestic washing and drying procedures for textile testing