ISO 12243:2003/Amd 1:2012

INTERNATIONAL ISO
STANDARD 12243
First edition
2003-10-01
AMENDMENT 1
2012-12-15
Medical gloves made from natural rubber
latex — Determination of water-extractable
protein using the modified Lowry method
AMENDMENT 1
Gants médicaux à base de latex de caoutchouc naturel —
Détermination des protéines extractibles par l’eau par la méthode
modifiée de Lowry
AMENDEMENT 1
Reference number
ISO 12243:2003/Amd.1:2012(E)
©
ISO 2012

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ISO 12243:2003/Amd.1:2012(E)
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ISO 12243:2003/Amd.1:2012(E)
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
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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.
Amendment 1 to ISO 12243:2003 was prepared by Technical Committee ISO/TC 45, Rubber and rubber
products, Subcommittee SC 3, Raw materials (including latex) for use in the rubber industry.
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ISO 12243:2003/Amd.1:2012(E)
Medical gloves made from natural rubber latex — Determination
of water-extractable protein using the modified Lowry method
AMENDMENT 1
Page 1, Normative references
Delete Clause 2 and move the normative references to the Bibliography.
Renumber the subsequent clauses.
Renumber all cross-references to subclauses of Clauses 5, 6, 7 and 8, beginning with 7.2.1, i.e. replace “Use
protein-free gloves (5.1) to handle .” with “Use protein-free gloves (6.1) to handle .”.
Page 3, Clause 5
Following 5.11, add the following new paragraph: “5.12 Shaker”.
Page 3, 6.3.2
Replace the note with the following new note.
NOTE 2 N Folin reagent is available commercially. The concentration of some commercial Folin
reagents might not be 2 N.
Page 4, 6.4
Replace the first paragraph with the following: “Use ovalbumin prepared by ammonium sulfate fractionation
and repeated crystallization at pH 4,5.”.
Page 4, 7.2.1
Replace the first paragraph with the following (adding a sentence to clarify why there are two extraction procedures).
The entire surface of the glove shall be exposed to the extractant at 25 °C ± 5 °C for a period of
120 min ± 5 min.
Two extraction procedures are permitted, the so-called “cut-glove” procedure and also the “glove-in-
glove” procedure. In case of dispute, the “cut-glove” procedure is preferred as it is more practicable and
less time consuming.
In the case of the “glove-in-glove” procedure, if pin holes exist, discard the sample and repeat the
extraction with a fresh pair of gloves.
The procedure used shall be noted in the test report and all samples in a given series shall be extracted
by the same procedure. The extraction shall be carried out in triplicate and single determinations run on
each extract.
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ISO 12243:2003/Amd.1:2012(E)
Page 5, 7.2.2.3
Replace the second paragraph with the following.
Cut a rectangular piece from the back of the glove of about 0,5 dm by 0,5 dm and measure its
dimensions to the nearest 0,01 dm. Calculate the area A .
1
Page 5, 7.2.2.6
Replace the paragraph with the following.
Extract the test sample at 25 °C ± 5 °C for 120 min ± 5 min, shaking for 15 s initially and thereafter at
intervals not greater than 30 min. If practicable, continuous slow shaking at approximately 200 r/min is
desirable.
Page 5, 7.2.3.3
Replace the first sentence with the following: “Fix the gloves to a shaker and shake at approximately 200 r/min
for 120 min ± 5 min at 25 °C ± 5 °C.”.
Page 5, 7.2.3.5
Replace the paragraph with the following (in order to harmonize the text with 7.2.2.7).
Decant the extract from the outer glove into a centrifuge tube (5.3). If it is coloured blue, it is indicative
of a pin-hole or cross-contamination. In such cases, discard the solution and repeat the extraction with
2
a fresh pair of gloves. Clarify the extract by centrifugation at not less than 20 000 m/s (2 000 × g) for
15 min.
The extract is preferably used immediately but may be stored for up to 48 h at a temperature of not more
than 7 °C or frozen for up to 15 days at below −10 °C.
Page 5, 7.2.3.6
Add the following new paragraph
2
7.2.3.7 If the result is to be reported in mi
...