Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin

This document specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with No. 27 Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH).
Spectacle frames and sunglasses are excluded from the scope of this document.
NOTE   Spectacle frames and sunglasses are subject to the requirements of EN 16128.

Referenzprüfverfahren zur Bestimmung der Nickellässigkeit von sämtlichen Stäben, die in durchstochene Körperteile eingeführt werden und Erzeugnissen, die unmittelbar und länger mit der Haut in Berührung kommen

Dieses Dokument legt ein Verfahren fest, um die Nickellässigkeit von sämtlichen Stäben, die in durchstochene Ohren und in andere durchstochene Teile des menschlichen Körpers eingeführt werden sowie von Erzeugnissen, die unmittelbar und länger mit der Haut in Berührung kommen, zu bestimmen, um festzustellen, ob diese Erzeugnisse Nr. 27 Anhang XVII der Verordnung (EG) Nr. 1907/2006 des Europäischen Parlaments und des Rates (REACH) entsprechen.
Brillenfassungen und Sonnenbrillen sind von dem Anwendungsbereich dieses Dokuments ausgenommen.
ANMERKUNG   Brillenfassungen und Sonnenbrillen unterliegen den Anforderungen von EN 16128.

Méthode d'essai de référence relative à la libération du nickel par tous les assemblages de tiges qui sont insérés dans les parties percées du corps humain et les articles destinés à entrer en contact direct et prolongé avec la peau

Le présent document spécifie une méthode pour simuler la libération du nickel par tous les assemblages de tiges insérés dans les oreilles percées et d’autres parties percées du corps humain et les articles destinés à venir en contact direct et prolongé avec la peau dans le but de déterminer si ces articles sont conformes au Règlement (CE) n° 1907/2006 du Parlement européen et du Conseil (REACH), en ce qui concerne le n° 27 de l'Annexe XVII.
Les montures de lunettes et les lunettes de soleil sont exclues du domaine d’application du présent document.
NOTE   Les montures de lunettes et les lunettes de soleil sont soumises aux exigences de l’EN 16128.

Primerjalna preskusna metoda za sproščanje niklja iz izdelkov, vstavljenih v prebodene dele človeškega telesa, in izdelkov, ki so v neposrednem in daljšem stiku s kožo

General Information

Status
Not Published
Current Stage
4060 - Closure of enquiry - Enquiry
Due Date
12-Feb-2022
Completion Date
12-Feb-2022

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SLOVENSKI STANDARD
oSIST prEN 1811:2021
01-november-2021
Primerjalna preskusna metoda za sproščanje niklja iz izdelkov, vstavljenih v
prebodene dele človeškega telesa, in izdelkov, ki so v neposrednem in daljšem
stiku s kožo

Reference test method for release of nickel from all post assemblies which are inserted

into pierced parts of the human body and articles intended to come into direct and

prolonged contact with the skin

Referenzprüfverfahren zur Bestimmung der Nickellässigkeit von sämtlichen Stäben, die

in durchstochene Körperteile eingeführt werden und Erzeugnissen, die unmittelbar und

länger mit der Haut in Berührung kommen

Méthode d'essai de référence relative à la libération du nickel par les assemblages de

tiges qui sont introduites dans les parties percées du corps humain et les produits

destinés à entrer en contact direct et prolongé avec la peau
Ta slovenski standard je istoveten z: prEN 1811
ICS:
39.060 Nakit Jewellery
oSIST prEN 1811:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 1811:2021
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oSIST prEN 1811:2021
DRAFT
EUROPEAN STANDARD
prEN 1811
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2021
ICS 39.060 Will supersede EN 1811:2011+A1:2015
English Version
Reference test method for release of nickel from all post
assemblies which are inserted into pierced parts of the
human body and articles intended to come into direct and
prolonged contact with the skin

Méthode d'essai de référence relative à la libération du Referenzprüfverfahren zur Bestimmung der

nickel par les assemblages de tiges qui sont introduites Nickellässigkeit von sämtlichen Stäben, die in

dans les parties percées du corps humain et les durchstochene Körperteile eingeführt werden und

produits destinés à entrer en contact direct et prolongé Erzeugnissen, die unmittelbar und länger mit der Haut

avec la peau in Berührung kommen

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

CEN/TC 347.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations

which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other

language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC

Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1811:2021 E

worldwide for CEN national Members.
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Contents Page

European foreword ...................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 6

4 Principle of the procedure ........................................................................................................................... 7

5 Reagents ............................................................................................................................................................. 7

6 Apparatus .......................................................................................................................................................... 8

7 Samples ............................................................................................................................................................... 9

7.1 Number of test samples ................................................................................................................................ 9

7.2 Sample area ....................................................................................................................................................... 9

7.2.1 Definition of sample area ............................................................................................................................. 9

7.2.2 Determination of sample area ................................................................................................................... 9

7.2.3 Masking of areas other than sample area .............................................................................................. 9

7.3 Sample degreasing before testing ........................................................................................................... 10

8 Procedure ........................................................................................................................................................ 10

8.1 Preparation of test solution ...................................................................................................................... 10

8.2 Release procedure ........................................................................................................................................ 10

8.3 Blank tests ....................................................................................................................................................... 11

8.4 Determination of nickel .............................................................................................................................. 11

8.4.1 General .............................................................................................................................................................. 11

8.4.2 Calibration solutions ................................................................................................................................... 11

8.4.3 Detection limit and quantification limit ............................................................................................... 11

8.4.4 Number of replicate measurements ...................................................................................................... 11

9 Calculations ..................................................................................................................................................... 12

9.1 Nickel release ................................................................................................................................................. 12

9.2 Interpretation of results ............................................................................................................................. 12

9.2.1 General .............................................................................................................................................................. 12

9.2.2 Conformity assessment ............................................................................................................................... 12

9.2.3 Uncertainty budget ....................................................................................................................................... 13

10 Test report ....................................................................................................................................................... 13

Annex A (informative) Expanded measurement uncertainty of the test procedure and

compliance assessment .............................................................................................................................. 14

Annex B (informative) Preparation of all post assemblies which are inserted into pierced

parts of the human body and of articles intended to come into direct and prolonged

contact with the skin prior to nickel testing ....................................................................................... 16

B.1 General .............................................................................................................................................................. 16

B.2 Principle ........................................................................................................................................................... 16

B.3 Determination of the nickel release test method .............................................................................. 16

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B.4 Determination of surfaces coming into direct and prolonged contact with the skin or

pierced parts of the body ........................................................................................................................... 16

B.5 Methods of determining the surface areas .......................................................................................... 26

B.6 Vessel for nickel release testing .............................................................................................................. 27

Annex C (informative) Articles made from dissimilar materials ............................................................... 28

Bibliography ................................................................................................................................................................. 29

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oSIST prEN 1811:2021
prEN 1811:2021 (E)
European foreword

This document (prEN 1811:2021) has been prepared by Technical Committee CEN/TC 347 “Methods

for analysis of allergens”, the secretariat of which is held by SNV.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 1811:2011+A1:2015.

This document has been prepared under a Standardization Request given to CEN by the European

Commission and the European Free Trade Association.
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oSIST prEN 1811:2021
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Introduction

Nickel is the most frequent cause of contact allergy in Europe and adverse skin reaction to nickel has

been known for many decades.

Skin absorption of a sufficient amount of nickel ions, which are released from some nickel-containing

materials which are inserted into pierced ears or other pierced parts of the human body or which are in

direct and prolonged contact with the skin, is required to cause sensitization.

Once sensitized, further exposure to soluble nickel salts ions results in allergic contact dermatitis. It is

known that sensitization to nickel requires higher exposure levels than does the elicitation in already

sensitized individuals. There is a large variation in the degree of sensitivity to nickel between

individuals. This widespread health problem has forced the introduction of a number of measures

designed to reduce its prevalence. These measures include the requirements of this document which

provides an in vitro chemical test that correlates as far as possible with the variable human biological

reactions that occur when metallic or metallic coated articles containing nickel are in direct and

prolonged contact with the skin or inserted into pierced parts of the body. This document provides a

measure of the release of nickel from an article immersed for one week in artificial sweat. Clinical

patch-testing of a small selection of nickel-containing alloys and coatings on nickel-sensitized persons

indicates that high and low results achieved with the present analytical method correspond closely with

patch-test reactivity. Moreover, a nickel migration limit of 0,5 µg/cm /week for articles intended to

come into direct and prolonged contact with the skin and a limit of less than 0,2 µg/cm /week for all

post piercing assemblies inserted into pierced ears and other pierced parts of the human body has been

set in Commission Regulation (EC) No 1907/2006 of the European Parliament and the Council (in the

current version).
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1 Scope

This document specifies a method for simulating the release of nickel from all post assemblies which

are inserted into pierced ears and other pierced parts of the human body and articles intended to come

into direct and prolonged contact with the skin in order to determine whether such articles are in

compliance with No. 27 Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and

of the Council (REACH).
Spectacle frames and sunglasses are excluded from the scope of this document.

NOTE Spectacle frames and sunglasses are subject to the requirements of EN 16128.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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.

EN 12472, Method for the simulation of accelerated wear and corrosion for the detection of nickel release

from coated items

EN ISO 3696, Water for analytical laboratory use - Specification and test methods (ISO 3696)

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1
homogeneous

of uniform composition throughout that cannot be separated into different materials

Note 1 to entry: A coated material is not homogeneous.
3.2
representative

best estimate for the effective release rate of all surfaces which are in direct and prolonged contact with

the skin or pierced parts of the body under normal and foreseeable conditions of use

3.3
surface finish
appearance and texture of a surface characterized by its smoothness or roughness

Note 1 to entry: In order of increasing smoothness, the surface finish can be typically described as machined

finish, cut finish, brushed finish, matt finish, satin finish, mirror or polished finish.

3.4
sample area

surface(s) that is/are immersed in the test solution and not covered with a masking agent

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3.5
disassemble

separate into its constituent parts without damaging these parts or their surface condition

3.6
post assembly
ear stud or body piercing article
3.7
test solution
solution as prepared according to 8.1
3.8
release solution
solution resulting from the release procedure according to 8.2
4 Principle of the procedure

The article to be tested for nickel release is placed in a solution of artificial sweat for one week. The

concentration of dissolved nickel in the solution is determined by an appropriate analytical method, for

example inductively-coupled plasma spectrometry. The nickel release is expressed in micrograms per

square centimetre per week (µg/cm /week).

Articles with non-nickel-containing outer coatings that come into direct and prolonged contact with the

skin shall be tested according to EN 12472, followed by this standard.

NOTE Information on the presence of nickel can be obtained by performing one of the tests specified in

CEN/TR 12471 (under preparation).
5 Reagents

Except where indicated, all reagents, materials and apparatus that can come into contact with test parts

or reagents shall be demonstrably free of nickel, and all reagents shall be of recognized analytical grade

or better.
5.1 Deionised water according to EN ISO 3696, grade 2.
5.2 Sodium chloride, NaCl.
5.3 DL-lactic acid, CH CHOHCOOH, > 88 % (m/m).
5.4 Urea, CO(NH ) .
2 2
5.5 Sodium hydroxide pellets, purity ≥ 98 %, anhydrous.
5.5.1 Preparation of 1 M sodium hydroxide solution.

Weigh 4 g ± 0,01 g sodium hydroxide (5.5), transfer to a 100 ml beaker and add 50 ml deionised

water (5.1). Stir and cool to room temperature. Transfer the solution to a 100 ml volumetric flask and

make up to volume with deionised water (5.1).
Alternatively, it is possible to use 1 M ready-to-use solution.
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5.5.2 Preparation of 0,1M sodium hydroxide solution.

Transfer 25 ml of the 1 M sodium hydroxide solution (5.5.1) to a 250 ml volumetric flask and make up

to volume with deionised water (5.1).
Alternatively, it is possible to use 0,1 M ready-to-use solution.
5.6 Hydrochloric acid, 32 % (m/m).
5.6.1 Preparation of 0,1 M hydrochloric acid solution.

Transfer 1 ml of hydrochloric acid (5.6) into a 100 ml volumetric flask and make up to volume with

deionised water (5.1).
Alternatively, it is possible to use 0,1 M ready-to-use solution.
5.7 Nitric acid, 65 % to 70 % (m/m).
5.7.1 Diluted nitric acid, approximately 5 % (m/m).

Transfer 30 ml of nitric acid (5.7) into a 500-ml beaker containing about 350 ml of deionised water

(5.1). Stir and cool to room temperature. Transfer the solution to a 500-ml volumetric flask and make

up to volume with deionised water.
5.8 Degreasing solution.

Dissolve 5 g of an anionic surface-active agent such as sodium dodecylbenzene sulfate or sodium

alkylaryl sulfate in 1 000 ml deionised water (5.1). An appropriately diluted, neutral, commercially

available detergent may be used.

5.9 Wax or lacquer (e.g. suitable for electroplating purposes) capable of protecting a surface from

nickel release.

The wax or lacquer shall be shown to prevent nickel release from a nickel-releasing surface when one

or more coats are applied in the same manner as on a test sample and shall not affect the nickel content

of the release solution. The wax/ lacquer shall be tested to demonstrate its suitability for the intended

purpose.

NOTE 1 When using wax, the samples are dipped into the molten wax. To improve the adhesion of the wax, the

article can be pre-warmed, provided that article properties are not changed.

NOTE 2 To cover cracks and fissures, it might be necessary to apply more than one coating of lacquer, 2 to 3

coats might be required to achieve the desired outcome. It can be helpful to inspect the quality of masking visually

with a low-powered (e.g. 2x to 5x) magnifier.
6 Apparatus
6.1 Usual laboratory apparatus.
6.2 A pH-meter, accurate to ± 0,05 pH.

6.3 An analytical instrument capable of detecting a concentration of 0,01 mg nickel per litre in the

final release solution.

It is recommended to use either an inductively-coupled plasma spectrometer (ICP-OES, optical

emission, or ICP-MS, mass spectrometer) or an electro thermal excitation atomic absorption

spectrometer (GFAAS).
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6.4 Thermostatically controlled water-bath or oven with or without cooling option, capable of

maintaining a temperature of (30 ± 2) °C.

6.5 A vessel with lid, both composed of a non-metallic, nickel-free and nitric-acid-resistant material,

such as glass and/or polypropylene and/or polytetrafluoroethylene and/or polystyrene.

The sample shall be suspended in the liquid by a holder made from the same materials as listed above,

so as to limit contact of the sample area (7.2.1) with the walls and base of the vessel. The size and shape

of vessel and holder shall be chosen so as to minimize the volume of test solution required to

completely cover the article to be tested.

NOTE A thread can be used to hang the samples in the liquid without touching the vessel.

In order to remove any trace of nickel, the vessel and holder shall be pre-treated by being stored in a

solution of diluted nitric acid (5.7.1) for at least 4 h. After acid cleaning, rinse the vessel and holder with

deionised water and dry.

6.6 Device for measuring length, for example a digital calliper accurate to at least 50 μm or a

micrometer accurate to at least 5 μm.
7 Samples
7.1 Number of test samples

A minimum of three test samples of the same batch shall be tested wherever possible.

7.2 Sample area
7.2.1 Definition of sample area

Only the surface(s) that come(s) into direct and prolonged contact with the skin and/or that has/have

contact with the pierced parts of the body shall be tested (i.e. the sample area).

The test laboratory shall refer to B.4 in order to determine which surfaces are to be tested.

For the calculation of the sample area for the nickel release determination, the areas of non-nickel-

containing parts, shall not be included in the calculation.
7.2.2 Determination of sample area

Determination of the sample area (a) in square centimetres is achieved by marking the contour of the

sample area assuming that the article is worn or used as intended (refer to Annex B) and measuring it

by an appropriate measuring device (6.6).

In order to achieve the required degree of analytical sensitivity, a minimum sample area of 0,2 cm shall

be tested. If necessary, identical articles may be tested together to obtain this minimum area.

The closer the nickel release is to the limits specified in the REACH regulation, or the smaller the sample

area is, the more precise the surface measurement needs to be.
7.2.3 Masking of areas other than sample area

In order to prevent release of nickel from areas other than the sample area, such areas shall be removed

or protected from the test solution. This can be achieved after degreasing (see 7.3) by the application of

one or more coatings of a wax or lacquer (5.9) that has been shown to protect from nickel release.

The test laboratory should see B.4 in order to determine which surfaces are to be tested.

NOTE If the contact zone with the skin is representative of the whole article, consider testing it without

masking. See B.4 for guidance.
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7.3 Sample degreasing before testing

Gently swirl the sample for 2 min in degreasing solution (5.8) at room temperature. Rinse thoroughly

with deionised water and dry using absorbing paper. After degreasing, articles shall be handled with

plastic forceps or clean protective gloves.

NOTE This cleaning stage is intended to remove extraneous grease and skin secretions due to handling, but

not any protective coatings.
8 Procedure
8.1 Preparation of test solution
The test solution consists of deionised water (5.1) containing:
— 0,5 % (m/m) sodium chloride (5.2);
— 0,1 % (m/m) lactic acid (5.3);
— 0,1 % (m/m) urea (5.4); and
— 1 M (5.5.1) and 0,1 M (5.5.2) sodium hydroxide solution.
The test solution shall be prepared as follows:

Pour 900 ml of freshly prepared deionised water (5.1) into a 1 000 ml beaker. Add 1,00 ± 0,01 g of urea

(5.4), 5,00 ± 0,05 g of sodium chloride (5.2) and 1,00 ± 0,01 g of lactic acid (5.3), and stir until dissolved.

Calibrate a pH meter in accordance with the manufacturer’s instructions using freshly prepared buffer

solutions.

Immerse the pH electrode into the test solution and measure the pH. Slowly and gently, add drop by

drop a volume of 1 M sodium hydroxide (5.5.1) until a pH of 5,5 is reached and subsequently with

continuous stirring, add slowly and gently drop by drop a volume of 0,1 M sodium hydroxide (5.5.2)

until a pH 6,5 ± 0,05 is reached and remains stable.

Measure the pH after 10 min from the last addition of 0,1 M sodium hydroxide to ensure that the pH is

in the range 6,5 ± 0,05.

Transfer the solution to a 1 000 ml volumetric flask and make up to volume with deionised water.

Before use, ensure that the pH of the test solution is in the range of pH 6,5 ± 0,05.

If it is necessary to reduce the pH of the solution to 6,5 ± 0,05 before testing, this shall be done by

adding slowly and gently with continuous stirring drop by drop a volume of 0,1 M hydrochloric acid

(5.6.1).
For each test, the test solution shall have been prepared within the last 24 h.
8.2 Release procedure

NOTE 1 In the following text the term “test solution” represents the solution as prepared according to 8.1, the

“release solution” is the solution resulting from the release procedure. See also definitions 3.8 and 3.7.

Place the degreased sample (7.3), suspended by its holder, in the test vessel (6.5). Add an amount of test

solution corresponding to approximately 1 ml per cm sample area (see B.5 and B.6). The suspended

sample area shall be totally immersed. It is not necessary to immerse areas that are completely

protected by wax or lacquer (see 7.2.3). The minimum volume of test solution shall be 0,5 ml

irrespective of the surface area. Note the sample area and the amount of the test solution used. Close the

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vessel with a tight lid in order to prevent evaporation of the test solution. Leave the vessel undisturbed

in a thermostatically controlled water-bath or oven (6.4) at (30 ± 2) °C for (168 ± 2) h without agitation.

For very small samples, it can be necessary to place more than one into the vessel in order to achieve

the required minimum surface area. In this case, the samples should not touch each other.

After (168 ± 2) h remove the sample from the release solution. To collect solution contained in cavities

of the sample, it shall be turned appropriately.

NOTE 2 Due to structure of the article rinsing with a small volume of test solution (8.1) can be necessary in

order to collect all the release solution. Add the rinsing solution to the release solution.

Quantitatively transfer the release solution to an appropriately sized volumetric flask washed with

diluted nitric acid (5.7.1). In order to prevent loss (deposition/precipitation) of dissolved nickel, add

diluted nitric acid (5.7.1), to achieve a concentration of about 1 % nitric acid when the flask is made up

to volume (V in ml) using the test solution.

The choice of size of the volumetric flask shall take into account the sensitivity of the instrumentation

used for the nickel determination (see 6.3). The minimum final volume to which the release solution

may be diluted is 2 ml.

If filtering is necessary to avoid damage to the analytical spectrometer or blocking of the instrument's

capillary, a syringe filter of appropriate membrane size should be used to remove particulates from the

release solution prior to analysis.
8.3 Blank tests

For each sample, duplicate blank tests shall be carried out at the same time as the testing of the sample.

Identical vessels and holders shall be used and the test procedure is identical except that no sample is

placed in the vessels. Identical amounts of test solution, and dilute nitric acid shall be used.

8.4 Determination of nickel
8.4.1 General

Determine the nickel content of the release solution using an analytical spectrometer (refer to 6.3) by

the following procedures.
8.4.2 Calibration solutions

The calibration solutions used for the nickel determination shall match the matrix of the test solution

plus any added nitric acid and adequately cover the expected concentration range of nickel in the

release solutions.
8.4.3 Detection limit and quantification limit

For the determination of the limit of detection and quantification, it is recommended to apply an

established method such as the IUPAC standard as described in [4] and to report concentration values

close to the detection limit and limit of quantification in terms of release rate. If it is necessary to dilute

the release solution, the nickel concentration of the diluted release solution shall exceed the limit of

quantification.
8.4.4 Number of replicate measurements

At least two replicate measurements of each release solution shall be carried out.

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9 Calculations
9.1 Nickel release

The nickel release of a sample, d, expressed in micrograms per square centimetre per week

(µg/cm /week), is given by Formula (1):
VC×− C
( )
1 2
d= (1)
1000× a
where
is t
...

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