Textiles - Determination of metal content - Part 3: Determination of lead release by artificial saliva solution

This document describes a testing procedure to determine the rate of lead release from all materials of textile articles.
NOTE   With this test procedure it can be demonstrated that the rate of lead release from such an article or any accessible part of an article, whether coated or uncoated, does or does not exceed 0,05 μg/cm2 per hour, and, for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article (Annex XVII of Regulation (EC) No 1907/2006, column 2 of entry 63 paragraph 7, second clause) [5].

Textilien - Bestimmung des Metallgehaltes - Teil 3: Bestimmung der Bleilässigkeit mit Speichelsimulanzlösung

Dieses Dokument beschreibt ein Prüfverfahren zur Bestimmung der Bleilässigkeitsrate von allen Materialien von Textilwaren.
ANMERKUNG   Mit diesem Prüfverfahren kann nachgewiesen werden, ob die Bleilässigkeitsrate von einem derartigen Erzeugnis oder jeglichem zugänglichen Teil eines Erzeugnisses, beschichtet oder unbeschichtet, 0,05 μg/cm2 je Stunde überschreitet bzw. nicht überschreitet, und dass bei beschichteten Erzeugnissen die Beschichtung ausreichend ist, um sicherzustellen, dass diese Lässigkeitsrate unter üblichen oder nach vernünftigem Ermessen vorhersehbaren Verwendungsbedingungen des Erzeugnisses in einem Zeitraum von mindestens zwei Jahren nicht überschritten wird, vergleiche Anhang XVII zu Verordnung (EG) Nr. 1907/2006, Spalte 2 von Eintrag 63, Absatz 7, zweiter Abschnitt.

Textiles - Détermination de la teneur en métaux - Partie 3 : Dosage du plomb libéré par une solution de salive artificielle

Le présent document décrit un mode opératoire d’essai pour déterminer le taux de plomb libéré par tous les matériaux des articles textiles.
NOTE   Ce mode opératoire d’essai permet de démontrer que le taux de libération du plomb d’un tel article, ou de toute partie accessible d’un article, qu’il soit revêtu ou non, dépasse ou non 0,05 μg/cm2 par heure et, pour les articles revêtus, que le revêtement est suffisant pour garantir que ce taux de libération n’est pas dépassé pendant une durée minimale de deux ans d’utilisation de cet article dans des conditions normales ou raisonnablement prévisibles (voir Annexe XVII du Règlement (CE) No 1907/2006, colonne 2 de l’entrée 63 paragraphe 7, second alinéa) [5].

Tekstilije - Določevanje kovin - 3. del: Določevanje sproščanja svinca z raztopino umetne sline

Ta dokument opisuje preskusni postopek za določevanje stopnje sproščanja svinca iz vseh materialov tekstilnih izdelkov.
OPOMBA: S tem preskusnim postopkom je mogoče dokazati, da stopnja sproščanja svinca iz takega izdelka ali katerega koli dostopnega dela izdelka, prevlečenega ali neprevlečenega, presega ali ne presega 0,05 μg/cm2 na uro, in, v primeru prevlečenih izdelkov, da prevleka zagotovi, da ta stopnja sproščanja ni presežena v obdobju najmanj dveh let ob običajnih ali razumno predvidljivih pogojih uporabe izdelka (priloga XVII Uredbe (ES) št. 1907/2006, drugi stavek 7. odstavka vnosa 63, stolpec 2) [5].

General Information

Status
Published
Publication Date
14-May-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-May-2019
Completion Date
15-May-2019

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SLOVENSKI STANDARD
SIST EN 16711-3:2019
01-julij-2019

Tekstilije - Določevanje kovin - 3. del: Določevanje sproščanja svinca z raztopino

umetne sline

Textiles - Determination of metal content - Determination of lead release by artificial

saliva solution
Textilien - Bestimmung von Metallen - Teil 3: Bestimmung von Bleilässigkeit mit
künstlicher Spechellösung

Textiles - Détermination de la teneur en métaux - Partie 3 : Détermination de la libération

de plomb dans une solution de salive artificielle
Ta slovenski standard je istoveten z: EN 16711-3:2019
ICS:
59.060.01 Tekstilna vlakna na splošno Textile fibres in general
SIST EN 16711-3:2019 en,fr,de

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

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SIST EN 16711-3:2019
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SIST EN 16711-3:2019
EN 16711-3
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2019
EUROPÄISCHE NORM
ICS 59.060.01
English Version
Textiles - Determination of metal content - Part 3:
Determination of lead release by artificial saliva solution

Textiles - Détermination de la teneur en métaux - Textilien - Bestimmung des Metallgehaltes - Teil 3:

Partie 3 : Dosage du plomb libéré par une solution de Bestimmung der Bleilässigkeit mit

salive artificielle Speichelsimulanzlösung
This European Standard was approved by CEN on 15 March 2019.

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. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 16711-3:2019 E

worldwide for CEN national Members.
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SIST EN 16711-3:2019
EN 16711-3:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 5

4 Principle ............................................................................................................................................................. 6

5 Safety precautions .......................................................................................................................................... 6

6 Reagents ............................................................................................................................................................. 6

7 Apparatus and materials .............................................................................................................................. 7

8 Preparation of test specimens .................................................................................................................... 7

8.1 Sampling ............................................................................................................................................................. 7

8.2 Determination of the specimen surface area ........................................................................................ 7

8.3 Simulation of wear .......................................................................................................................................... 8

8.4 Masking ............................................................................................................................................................... 8

8.5 Specimen pre-treatment before testing .................................................................................................. 8

9 Procedure........................................................................................................................................................... 8

9.1 Extraction ........................................................................................................................................................... 8

9.2 Determination of lead.................................................................................................................................... 8

9.2.1 Analysis ............................................................................................................................................................... 8

9.2.2 Calibration solutions ...................................................................................................................................... 8

9.2.3 Blank solutions ................................................................................................................................................ 9

9.2.4 Number of replicate measurements ......................................................................................................... 9

10 Calculation and expression of results — Lead release ...................................................................... 9

11 Test report ......................................................................................................................................................... 9

Annex A (normative) Requirements for preparation of artificial saliva ................................................ 10

A.1 General ............................................................................................................................................................. 10

A.2 Composition ................................................................................................................................................... 10

A.3 Preparation of the artificial saliva ......................................................................................................... 10

Bibliography ................................................................................................................................................................. 11

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SIST EN 16711-3:2019
EN 16711-3:2019 (E)
European foreword

This document (EN 16711-3:2019) has been prepared by Technical Committee CEN/TC 248 “Textiles

and textile products”, the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by November 2019, and conflicting national standards

shall be withdrawn at the latest by November 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

EN 16711 consists of the following parts, under the general title Textiles — Determination of metal

content:
— Part 1: Determination of metals using microwave digestion

— Part 2: Determination of metals extracted by acidic artificial perspiration solution

— Part 3: Determination of lead release by artificial saliva solution

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

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

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
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SIST EN 16711-3:2019
EN 16711-3:2019 (E)
Introduction

Repeated exposure to lead from mouthing of articles containing lead or its compounds can result in

severe and irreversible neurobehavioural and neurodevelopmental effects to which children are

particularly sensitive given that their central nervous system is still under development. The placing on

the market and use of lead and its compounds in articles that are supplied to the general public, and

which can be placed in the mouth by children [3][4], should therefore be prohibited if the concentration

of lead (expressed as metal) in that article, or part of the article, exceeds a certain threshold. Annex XVII

to Regulation (EC) No 1907/2006, column 2 of entry 63 paragraph 7, second clause [5].

The testing follows the instructions for the determination of nickel-release from materials with direct

and prolonged skin contact, EN 1811. The limit value for nickel release is defined in the unit

µg/cm /week and is tested over the period of one week. Therefore, as the limit value of the present

regulation applies the unit µg/cm /h, the test period is correspondingly set to 1 h. According to the

publication "Migration protocol to estimate metal exposure from mouthing copper and tin alloy objects“

[3], the release of lead in the tested materials is mostly linear with time, thus the influence of the testing

period is considered secondary.

For coated articles it should be ensured that the release rate is not exceeded for a period of at least two

years of normal or reasonably foreseeable conditions of use of the article. Such articles/materials are

treated following the abrasion-test EN 12472 before the above described test procedure for lead-

release.

Testing is performed using an artificial saliva solution, because “COMMISSION REGULATION (EU)

2015/628 of 22 April 2015 amending Annex XVII to Regulation (EC) No 1907/2006 of the European

Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of

Chemicals (‘REACH’) as regards lead and its compounds“, applies to materials that can be taken into the

mouth by children (mouthing) [3].

Exposure from swallowing lead-containing materials is not explicitly addressed in this regulation. This

type of exposure is considered in the frame of testing of toys (EN 71-3:2013+A3:2018), which is exempt

from this regulation [1].
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SIST EN 16711-3:2019
EN 16711-3:2019 (E)
1 Scope

This document describes a testing procedure to determine the rate of lead release from all materials of

textile articles.

NOTE With this test procedure it can be demonstrated that the rate of lead release from such an article or any

accessible part of an article, whether coated or uncoated, does or does not exceed 0,05 μg/cm per hour, and, for

coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least

two years of normal or reasonably foreseeable conditions of use of the article (Annex XVII of Regulation (EC) No

1907/2006, column 2 of entry 63 paragraph 7, second clause) [5].
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 1811, 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

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

items

EN ISO 3696:1995, Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)

EN ISO 3071, Textiles - Determination of pH of aqueous extract (ISO 3071)

EN ISO 11885, Water quality - Determination of selected elements by inductively coup

...

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