EN 16711-3:2019

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

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.

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

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.
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].
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 coupled plasma optical
emission spectrometry (ICP-OES) (ISO 11885)
EN ISO 17294-2, Water quality - Application of inductively coupled plasma mass spectrometry (ICP-MS) -
Part 2: Determination of selected elements including uranium isotopes (ISO 17294-2)
EN ISO 15586, Water quality - Determination of trace elements using atomic absorption spectrometry
with graphite furnace (ISO 15586)
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
4 Principle
The test specimens are tested for migration in artificial saliva-solution (according to Annex A) for 1 h,
using the surface-volume ratio of 1 ml artificial saliva solution per square centimetre of the sample area
of the test specimen as described in EN 1811; then the saliva solution is analysed for lead.
For coated items (except coated fabrics) it has to 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 according to EN 12472 before the above described test procedure for
lead-release.
5 Safety precautions
WARNING – The use of EN 16711-3
...