Interlaboratory Proficiency Trial of Glove Testing Laboratories, 2018 [ILG2018 INSTRUCTION BOOKLET]

Transcription

1 SERVING THE GLOBAL MEDICAL DEVICE INDUSTRY ENERSOL Pty Ltd 235 Nelson Street, Annandale, NSW 2038 AUSTRALIA Phone Fax Web ABN enquiries@enersol.com.au Interlaboratory Proficiency Trial of Glove Testing Laboratories, 2018 [ILG2018 INSTRUCTION BOOKLET]

2 CONTENTS Test Methods in this Proficiency Trial... 2 Alternate Methods... 2 Test Period... 2 Reporting data units... 2 Test Samples... 3 Test Instructions Dimensions Watertightness Tensile Before accelerated aging After accelerated aging Samples Cut by Enersol and Tested by Laboratory Samples Cut by Laboratory and Tested by Enersol Powder Removal Powder free gloves Powdered gloves... 7 Data Return... 8 Our Details... 9 Page 1

3 Test Methods in this Proficiency Trial The 2018 trial includes the following test methods: ISO :2008 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution ISO10282:2014 Single-use sterile surgical rubber gloves -Specification (for force at 300% elongation only) ASTM D Standard test methods for vulcanized rubber and thermoplastic elastomers tension (for stress at 500% elongation and tensile strength at break only) ISO21171:2006 Medical gloves - Determination of removable surface powder ASTM D (2017) Standard test method for residual powder on medical gloves The relevant sections are shown in the following notes for each test. Alternate Methods If your laboratory is not equipped to perform the tests according to these standards, or you are using an alternate method to those in the standards, please enter the details (and test data) into the trial spreadsheet. Please send a copy of the method and equipment specifications when you return your data spreadsheet to Enersol. Test Period Tests should be carried out and results returned by or before 24 August Please perform Watertightness and TEN 6 tests as soon as possible. Return the samples with holes (WTS 1 and WTS 2) and cut pieces (all TEN 6 samples) to Enersol so that they arrive at Enersol BY OR BEFORE the due date of 24 August Results submitted after the due date including receiving the samples with holes or TEN 6 samples after the due date will not be included in the analysis and main report (and will receive a modified report at a later date) Reporting the data units Please report test data in the units specified in this booklet, and the data spreadsheet. Should you report in different units than those requested you must state this in the data spreadsheet otherwise Enersol WILL NOT convert data to the required units. Page 2

4 Test Samples Each participant has been provided with samples for the tests requested on the invitation. Table 1: Number of samples to test Test ID Test Name No. samples to test LWT 1 Dimensions (Length, Width, Thickness) LWT 2 Dimensions (Length, Width, Thickness) WTS 1 Freedom from holes (Watertightness) 100 gloves WTS 2 Freedom from holes (Watertightness) 100 gloves TEN 1-3mm Tensile 3mm sample TEN 2-3mm Tensile 3mm sample TEN 3-3mm Tensile (to be aged) 3mm sample TEN 4-3mm Tensile (to be aged) 3mm sample TEN 5-3mm Tensile, cut by ENERSOL (3mm sample pieces) TEN 6-3mm Tensile (cut and return 3mm pieces to ENERSOL) TEN 1-4mm Tensile 4mm sample TEN 2-4mm Tensile 4mm sample TEN 3-4mm Tensile (to be aged) 4mm sample TEN 4-4mm Tensile (to be aged) 4mm sample TEN 5-4mm Tensile, cut by ENERSOL (4mm sample pieces) TEN 6-4mm Tensile (cut and return 4mm pieces to ENERSOL) TEN 1-6mm Tensile 6mm sample TEN 2-6mm Tensile 6mm sample TEN 3-6mm Tensile (to be aged) 6mm sample TEN 4-6mm Tensile (to be aged) 6mm sample TEN 5-6mm Tensile, cut by ENERSOL (6mm sample pieces) TEN 6-6mm Tensile (cut and return 6mm pieces to ENERSOL) 15 test pieces 5 gloves 15 test pieces 5 gloves 15 test pieces 5 gloves RPF 1 Powder Removal (Powder-free gloves) 6 gloves RPF 2 Powder Removal (Powder-free gloves) 5 gloves RPP 3 Powder Removal (Powdered gloves) 6 gloves RPP 4 Powder Removal (Powdered gloves) 6 gloves Page 3

5 Test Instructions Alternate methods Please refer to section Alternate Methods in this booklet. Extra samples For extra samples, download the spreadsheet for each extra set. Indicate they are extra samples in the spreadsheet file name, when returning to Enersol. 1. Dimensions a) Bags labelled LWT 1 and LWT 2 Complete length and width measurements first. Use the same samples for thickness. b) Test the number of samples specified in Table 1. Perform following tests in accordance with ISO , Clause 6.1 i) Length ii) Width iii) Thickness c) Enter test data into the ILG2018 spreadsheet 2. Watertightness (please complete this test ASAP after receipt) a) Bags labelled WTS 1 and WTS 2 b) Test the number of samples specified in Table 1. Perform following tests in accordance with ISO , Annex A. i) Mark the location of any holes with a waterproof pen or marker. ii) Ensure the gloves with holes are dry before returning them to Enersol. iii) Place the holed/failed gloves into the bag the sample was received and return to Enersol (Example: WTS 1 holed samples into the bag labeled WTS 1). iv) Write your lab number on the label on the bag in the allocated space (LAB NUMBER: ) c) Enter test data into the ILG2018 spreadsheet. d) Return the samples to Enersol ASAP so that they arrive at Enersol BY OR BEFORE the due date. Page 4

6 3. Tensile (please complete the TEN 6 tests ASAP after receipt) 3.1. Before accelerated aging a) Bags labelled TEN 1 and TEN 2 (4mm, 3mm and 6mm) b) Test THREE pieces cut from each glove. Record the median value of the three test pieces. Test the number of gloves listed in Table 1. i) 4mm dumbbell Cut the test pieces from each of the gloves using a 4mm dumbbell. Test the Force and Elongation at Break in accordance with ISO11193 clause and the Force at 300% Elongation in accordance with ISO10282, clause ii) 3mm and 6mm dumbbells Cut the test pieces from each gloves using the 3mm and / or 6mm dumbbells (depending on your selection). Test the Force, Elongation, Tensile Strength at Break and Stress at 500% in accordance with ASTM D 412, method A. c) Enter test data into the ILG2018 spreadsheet 3.2. After accelerated aging a) Bags labelled TEN 3 and TEN 4 (4mm, 3mm and 6mm) b) Artificially age the samples in accordance with ISO clause i) 4mm dumbbell Cut the test pieces from each glove using a 4mm dumbbell Test the Force and Elongation at Break in accordance with ISO clause ii) 3mm and 6mm dumbbells Cut the test pieces from each glove using the 3mm and / or 6mm dumbbells (depending on your selection). Test the Force and Elongation at Break in accordance with ASTM D412, method A. c) Enter test data into the ILG2018 spreadsheet 3.3. Samples Cut by Enersol and Tested by Laboratory a) Bags labelled TEN 5 (4mm, 3mm and 6mm) These samples are the dumbbell test pieces cut by Enersol, to be tested by your laboratory and have been supplied based on your dumbbell selection. Page 5

7 - Each bag contains 15 test pieces that have been cut by ENERSOL. For each group of 3pieces, record the median value. Test the number listed in Table 1. NOTE: - 4mm dumbbell: test the Force and Elongation at Break in accordance with ISO clause and the Force at 300% Elongation in accordance with ISO10282, clause mm and 6mm dumbbells: test the Force, Elongation, Tensile Strength at Break and Stress at 500% in accordance with ASTM D412, method A. b) Enter test data into the ILG2018 spreadsheet 3.4. Samples Cut by Laboratory and Tested by Enersol a) Bags labelled TEN 6 (4mm, 3mm and 6mm) These samples are the gloves for your laboratory to cut dumbbell test pieces to return and be tested by Enersol. These have been supplied based on your dumbbell selection. - Cut 3 test pieces from the first glove and wrap the 3 pieces in tissue. Take care to keep the pieces as wrinkle-free as possible. Cut the remaining 4 gloves as per the step above. When all gloves are cut there should be 15 dumbbell pieces separated in groups of 3. Each group should be wrapped in tissue, and laid flat. If possible, please include cardboard to prevent the pieces from distorting during shipment to Enersol. b) Place the wrapped cut test pieces in the same bags that they were received (please lay the pieces flat). Return the cut test pieces to ENERSOL in these bags, please write your lab number on the label on the bag in the allocated place (LAB NUMBER: ) NOTE: Please ensure you wrap each group of 3 test pieces from each glove separately (do not send all the 15 cut pieces together). e) Return the samples to Enersol ASAP so that they arrive at Enersol BY OR BEFORE the due date. 4. Powder Removal 4.1. Powder free gloves a) Bags labelled RPF 1 and RPF 2 b) Test the number of samples specified in Table 1. Perform following tests in accordance with ISO21171, Method B or ASTM D6124, Clause 6. c) Enter test data into the ILG2018 spreadsheet (total and average mass in milligrams of powder from all 5 samples) Page 6

8 4.2. Powdered gloves a) Bags labelled RPF 3 and RPF 4 b) Test the number of samples specified in Table 1. Perform following tests in accordance with ISO21171, Method A or ASTM D6124, Clause 7. Record the method in the spreadsheet. c) Enter test data into the ILG2018 spreadsheet (total and average mass in milligrams of powder for each glove) Page 7

9 Data Return Download: Requirements: A suitable web browser to download files from the ENERSOL website and keep up-to date with the trial Microsoft Excel (v ) for data spreadsheet Adobe Acrobat Reader (v 8.0+) for instruction booklet Naming the data file: Please replace YourLabNo in the file name with your allocated lab number. Number tested: If the number of gloves tested in any test is not as specified on the bag label or Table 1, please include an explanation on the comments tab in the spreadsheet. Procedures: Entering test data: Return data file/s: If the procedures specified in the instruction booklet are not followed exactly, please send Enersol a copy of the detailed procedure used for the relevant tests. Enter the test data together with any other requested information into the spreadsheet. 1. Open the data spreadsheet and save the file as ILG2018_Data(XXX).xlsx where XXX is your lab number. 2. Navigate using the tabs at the bottom of the screen 3. Enter your laboratory details and test data in the spaces provided 4. Save the data by using File -> Save Please do not attempt to alter the format of the spreadsheet as cells are locked Send the spreadsheet(s) by as an ATTACHMENT (not in line with text) to the address in the Our Details section of this booklet Unless otherwise agreed upon with ENERSOL, do not send the data file/s to until all data has been entered. IMPORTANT: please check files for viruses before returning to ENERSOL and keep a backup of the spreadsheet file(s). Return samples: Follow the instructions for each relevant test regarding return samples. Please use airmail or courier to send the return samples to the address in the Our Details section of this booklet. Page 8

10 Our Details Address: Attn: Interlab Trials (gloves) Enersol Pty Ltd 235 Nelson Street, Annandale, NSW, 2038 AUSTRALIA Phone: Fax: CONTACTS Lisa Henretty Business Manager LHenretty@enersol.com.au Skype: Lisa.Henretty.Enersol Grace Iskander Laboratory/Trial Manager Giskander@enersol.com.au Grace.Iskander.Enersol Kely Silveira Admin/Trial Assistant KSilveira@enersol.com.au Kely.Silveira.Enersol Page 9