ISO-22610-2006.pdf

Reference number ISO 22610:2006(E) © ISO 2006 INTERNATIONAL STANDARD ISO 22610 First edition 2006-07-01 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 Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux, pour les patients, le personnel et les équipements Méthode d'essai de résistance à la pénétration de la barrière bactérienne à l'état humide Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22610:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. 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ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii © ISO 2006 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22610:2006(E) © ISO 2006 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Principle. 2 5 Reagents and materials 3 6 Apparatus 3 7 Preparation of test samples and pieces. 3 7.1 Agar plates 3 7.2 Carrier material . 4 7.3 Test specimen. 4 8 Procedure 4 8.1 Preparation of donor 4 8.2 Conditioning 4 8.3 Test set-up. 4 8.4 Application of materials. 4 8.5 Test. 5 9 Test report . 5 10 Performance monitoring 6 10.1 General. 6 10.2 With carbon paper 6 10.3 With reference material 6 Annex A (normative) Apparatus for testing resistance to wet bacterial penetration 7 Annex B (normative) Nutrient media 10 Annex C (informative) Examples of how to use the test results to characterize a barrier material 12 Bibliography. 14 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22610:2006(E) iv © ISO 2006 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 22610 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in collaboration with Technical Committee ISO/TC 94, Personal safety Protective clothing and equipment, Subcommittee SC 13, Protective clothing, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22610:2006(E) © ISO 2006 All rights reserved v Introduction There are numerous examples of situations where bacteria carried by a liquid may migrate through a barrier material in the wet state. The wet penetration of skin flora through a covering material is one example. European Medical Device regulations specifically place the responsibility for avoiding device-related infections on the manufacturer. In order to demonstrate compliance with this requirement and to describe a product to the user, there is a need to use harmonized and recognized international test methods. The test method described in this international standard uses microbiological techniques and is therefore intended to be performed exclusively by laboratories experienced in and equipped for such work. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 22610:2006(E) © ISO 2006 All rights reserved 1 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 WARNING The use of this standard may involve hazardous materials, operations and equipment. This standard does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use. 1 Scope This International Standard specifies a test method, with associated test apparatus (see Annex A), which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 139, Textiles Standard atmospheres for conditioning and testing ISO 6330, Textiles Domestic washing and drying procedures for textile testing ISO 11607, Packaging for terminally sterilized medical devices ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes ISO 13683, Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities ISO 13934-1, Textiles Tensile properties of fabrics Part 1: Determination of maximum force and elongation at maximum force using the strip method ISO 13937-2, Textiles Tear properties of fabrics Part 2: Determination of tear force of trouser-shaped test specimens (Single tear method) ISO 15797, Textiles Industrial washing and finishing procedures for testing of workwear EN 554, Sterilization of medical devices Validation and routine control of sterilization by moist heat 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 agar plate Petri dish containing sterile nutrient agar medium NOTE See Annex B for composition of nutrient media. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22610:2006(E) 2 © ISO 2006 All rights reserved 3.2 carrier material material used to prepare the donor 3.3 covering material material, e.g. surgical drapes, used for covering the patient, equipment and certain surfaces to prevent the patient's skin bacteria and/or bacteria from other non-sterile sources from reaching the operation wound 3.4 donor material that has been contaminated with a known number of viable cells of a defined strain of test bacterium 3.5 finger part of the apparatus for testing resistance to wet bacterial penetration, used to bring donor and test specimen into contact with the surface of an agar plate 3.6 replicate test one complete evaluation of a single test piece, from the test specimen, comprising five plate counts directly against the donor and a sixth plate to estimate the residual bacterial challenge on the reverse of the test piece 3.7 test material piece of covering material, 25 cm × 25 cm, for which the resistance to wet bacterial penetration is being determined 3.8 reference material standardized material to assess the precision of the laboratory when performing the test for resistance to wet bacterial penetration 3.9 resistance to wet bacterial penetration the resistance of a barrier to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing 4 Principle A test specimen is placed on an agar plate. A sheet of donor material, of corresponding size and carrying the bacteria, is placed on the test specimen with the contaminated side face down and covered by a sheet of approximately 10 µm high density polyethylene (HDPE) film. Two tithing conical steel rings hold the three sheets together, applying a tensile force. An abrasion-resistant finger is placed on top of the materials with a specified force to bring the test specimen in contact with the agar. The finger is moved over the entire surface of the plate in less than 15 min by means of a pivoted lever moved by an exocentric cam. The assemblage of materials, stretched by the weight of the steel rings, ensures that only a small area of the test specimen is brought into contact with the agar surface at any one time. Due to the combined effect of rubbing and liquid migration, bacteria may pass from the donor material through the test specimen down to the agar surface. After being tested for 15 min, the agar plate is replaced by a fresh one, and the test is repeated with the same donor and test specimen. Allowing 15 min for each test, five tests are performed with the same pair of donor and test specimen. In this way, the test allows for an estimation of the penetration over time. Finally, the bacterial contamination on the top side of the test specimen is estimated using the same technique. The agar plates are incubated in order to observe the bacterial colonies, which are then enumerated. The results may be processed in accumulated form in order to characterize the barrier capability and penetration over time of the material (see Annex C). Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22610:2006(E) © ISO 2006 All rights reserved 3 5 Reagents and materials 1) 5.1 5 sets of 6 agar plates, 14 cm diameter, filled with nutrient agar (see B.4 and 7.1). 5.2 Five pieces of carrier material, 25 cm × 25 cm, to produce donors (see 7.2). 5.3 Five pieces of HDPE film, 25 cm × 25 cm, or with a diameter of 25 cm, of approximate thickness 10 µm, for use as finger covers. The HDPE film shall have a density of (950 ± 2) kg/m3 and a mass flow rate (190 °C, 5 kg) of 0,027 g/min. 5.4 Staphylococcus aureus ATCC 29213 strain. 5.5 Five test specimens, 25 cm × 25 cm (see 7.3). 5.6 Reference material (for use in 10.3) comprising a 135 g/m2 microfilament polyester fabric, washed three times in accordance with an appropriate wash process in ISO 6330 or ISO 15797. 6 Apparatus 6.1 Cylindrical body, approximately 9 cm in diameter and 4 cm in height. 6.2 Apparatus, as shown in Annex A. The apparatus has an electrically-driven, timer-controlled turntable which holds a 14 cm diameter agar plate. A horizontal lever with a vertical finger at its end is fitted to a pivot, allowing sideways movements of the finger from the centre to the periphery and back of the rotatable (60 r/min) agar plate. A weight can be slid along the lever to adjust the force exerted by the finger on the materials. The lever is guided by an eccentric cam rotating at 5,60 r/min. The finger, which has a semi-spherical, polished end of radius 11 mm, is removable and shall be disinfected between tests. The force of (3 ± 0,02) N exerted by the finger on the materials may be measured by a dynamometer attached to the lever, or by a balance placed on the turntable, and shall be set using the slidable weight. The material being tested shall only be in contact with the agar at one point at any given time. To ensure that the finger moves over the entire surface, it shall be regularly monitored using the method described in Clause 10. By applying this method, a quality record is obtained which shall be retained. 7 Preparation of test samples and pieces 7.1 A