interlaboratory proficiency trial of glove testing laboratories, 2020 instruction booklet -...

INTERLABORATORY PROFICIENCY TRIALS

ENERSOL Pty Ltd 235 Nelson Street, Annandale, NSW 2038 AUSTRALIA

Phone Email Web ABN

| +61 2 9552 1707 | [email protected]

| www.enersol.com.au | 67 003 960 129

Interlaboratory Proficiency Trial of Glove

Testing Laboratories, 2020

INSTRUCTION BOOKLET

Interlaboratory Proficiency Trial of Glove Testing Laboratories, 2020

Page | 1

CONTENTS

Test Methods in this Proficiency Trial .................................................................................................. 2

Alternate Methods ............................................................................................................................... 2

Test Period ........................................................................................................................................... 2

Reporting data units ............................................................................................................................ 3

Test Samples ........................................................................................................................................ 4

Test Instructions................................................................................................................................... 5

1. Dimensions ................................................................................................................................ 5

2. Watertightness.......................................................................................................................... 5

3. Tensile ....................................................................................................................................... 7

3.1. Before accelerated aging ................................................................................................... 7

3.2. After accelerated aging ..................................................................................................... 7

3.3. Samples Cut by Enersol and Tested by Laboratory ........................................................... 7

3.4. Samples Cut by Laboratory and Tested by Enersol ........................................................... 8

4. Powder Removal ....................................................................................................................... 8

4.1. Powder free gloves ............................................................................................................ 8

4.2. Powdered gloves ............................................................................................................... 9

Data Return ........................................................................................................................................ 10

Our Details ......................................................................................................................................... 11


Page | 2

Test Methods in this Proficiency Trial

The 2020 trial includes the following test methods:

ISO11193-1:2020

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 412-16

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 6124-06 (2017)

Standard test method for residual powder on medical gloves

The relevant sections are shown in the following notes for each test.

Using Alternate Methods in this Proficiency Trial

Should your laboratory not be equipped to perform the tests according to the prescribed

methods above, or your laboratory is using an alternate method, please provide Enersol with a

copy of the procedure, along with equipment specifications when submitting the data

spreadsheet.

Instructions on data entry and the return of data and cut tensile samples appear on page 10 of

this booklet.

Test Period

Please return TEN 6 cut tensile samples to Enersol (if participating) by courier so

that the samples arrive at Enersol by or before 16 October 2020.

Please submit your results by email by or before 30 October 2020.

This year we have included instructions to return details about the locations of

the holes in the Freedom from holes (Watertightness) in lieu of sending the

holed samples back to Enersol.

Late results will not be included in the analysis and main report (they will receive a modified report at a

later date).


Page | 3

Test data

Download the spreadsheet from the Enersol website and enter your results. Please email the

spreadsheet to Enersol before the cut-off date above.

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 | 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) 10 gloves

LWT 2 Dimensions (Length, Width, Thickness) 10 gloves

WTS 1 Freedom from holes (Watertightness) 50 gloves

WTS 2 Freedom from holes (Watertightness) 50 gloves

TEN 1 - 3mm Tensile – 3mm sample 10 gloves


TEN 3 - 3mm Tensile (to be aged) – 3mm sample 10 gloves


TEN 5 - 3mm Tensile, cut by ENERSOL (3mm sample pieces) 15 test pieces

TEN 6 - 3mm Tensile (cut and return 3mm pieces to ENERSOL) 5 gloves













RPF 1 Powder Removal (Powder-free gloves) 5 gloves

RPF 2 Powder Removal (Powder-free gloves) 6 gloves

RPP 3 Powder Removal (Powdered gloves) 6 gloves

RPP 4 Powder Removal (Powdered gloves) 6 gloves


Page | 5

Test Instructions

Alternate methods

Please refer to section ‘Using Alternate Methods in this Proficiency Trial ’ 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 measurements at the finger and palm. Remember

the standard requires to measure double wall thickness and record the single-wall thickness

at each point as half the measured double-wall thickness.

b) Test the number of samples specified in Table 1.

Perform following tests in accordance with ISO11193-1, Clause 7.1

i) Length

ii) Width

iii) Thickness

c) Enter test data into the ILG2020 spreadsheet

2. Watertightness – Returning Results for Test Method

SAMPLES FOUND WITH HOLES

This year we have changed the method of returning holed samples. Please take photos and

send them by email to Enersol with the results spreadsheet. Please keep the file size compact.

1. Please dry your samples then with a marker pen draw a simple circle around the hole located during testing.

2. Mark the equivalent letter from the figure provided and report this letter in the spreadsheet.

3. Take photos by laying the marked glove/s flat on a piece of paper, like the example in the image below. Write the letter on the paper next to each glove, or write the letter on

the glove, or use photo editing software to write it on the photo.


Page | 6

You can submit a single photo for each bag, or multiple photos. Please submit the files

by email by keeping the file size as small as possible and using the file naming structure

described below.

Figure 1: Example photo of WTS holes found during testing

4. Name the WTS photos as follows: WTS1 - Lab XXX.jpg WTS2 - Lab XXX.jpg

Where more than one photo is needed for each bag, or the photo is for the extra samples set,

please name the files as above, with additional words to describe what the photo is for (e.g.

WTS1 – Lab XXX – extra sample bag 1.jpg)

Freedom from holes (Watertightness)

2.1. Freedom from holes (Watertightness)

Bags labelled WTS 1 and WTS 2

i) Test the number of samples specified in Table 1 following tests in accordance with

ISO11193-1, Annex A.

ii) Using a waterproof marker or pen, mark the location of any holes found. Dry the

glove/s.


Page | 7

i) Record the number of samples found with holes and the letter in the ILG2020

spreadsheet.

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 7.3.2 and the

Force at 300% Elongation in accordance with ISO10282, clause 6.3.4.

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, Elongation, Tensile Strength at Break and Stress at 500% in accordance

with ASTM D 412, method A.

c) Enter test data into the ILG2020 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 ISO11193-1 clause 7.3.3.

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 11193-1 clause 7.3.3.

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 ILG2020 spreadsheet.

3.3. Samples Cut by Enersol and Tested by Laboratory

a) Bags labelled TEN 5 (4mm, 3mm and 6mm).


Page | 8

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.

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 ISO11193-1

clause 7.3.2 and the Force at 300% Elongation in accordance with ISO10282, clause

6.3.4.

3mm 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 ILG2020 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).

a) 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.


Perform following tests in accordance with ISO21171, Method B or ASTM D6124, Clause

6.


Page | 9

c) Enter test data into the ILG2020 spreadsheet (total and average mass in milligrams of

powder from all gloves samples).

4.2. Powdered gloves

a) Bags labelled RPF 3 and RPF 4.


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 ILG2020 spreadsheet (total and average mass in milligrams of

powder for each glove).


Page | 10

Data Return

Download: http://www.enersol.com.au/Gloves2020.html

Requirements: A suitable web browser – to download files from the ENERSOL website and keep

up-to date with the trial.

Microsoft Excel – for data spreadsheet.

Adobe Acrobat Reader – for instruction booklet.

Camera or smart phone – for taking photos of the FFH (watertightness) gloves

samples with holes

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: 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.

Entering test

data:

Enter the test data together with any other requested information into the

spreadsheet.

1. Open the data spreadsheet and save the file as ILG2020_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

Return data

file/s:

Send the spreadsheet(s) and any FFH (watertightness) photos by email. Send them

as an ATTACHMENT (not in line with text) to the e-mail 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 / malware / etc before returning to

ENERSOL and keep a backup of the WTS photos and spreadsheet file(s).

Return samples: Follow the instructions for tensile test regarding return samples.

Please use a courier or other method with tracking to send the return cut tensile

samples to the address in the “Our Details” section of this booklet. Please consider

providing the tracking number to Enersol by email to enable tracking.


Page | 11

Our Details

Enersol head office address: Attn: Interlab Trials

Enersol Pty Ltd

235 Nelson Street, Annandale,

NSW, 2038 AUSTRALIA

When returning cut tensile samples for Enersol to test, please

state the samples are for destructive testing only and have no

commercial value.

Interlab Trials team E-Mail: [email protected]

Company Phone No.: +61 2 9552 1707

CONTACTS

Lisa Henretty

Business Manager

Email: [email protected]

Skype: Lisa.Henretty.Enersol

Grace Iskander

Laboratory/Trial Manager

[email protected]

Grace.Iskander.Enersol

Kely Silveira

Admin/Trial Assistant

[email protected]

Kely.Silveira.Enersol

interlaboratory proficiency trial of glove testing laboratories, 2020 instruction booklet -...

Documents