General Information

Abstract

This document specifies three techniques for the determination of free Bisphenol A (BPA) in plastics of electrotechnical products.
This document describes the use of liquid chromatography–diode array detector (LC-DAD), liquid chromatography mass spectrometry (LC-MS), liquid chromatography tandem mass spectrometry (LC-MS/MS) with these test methods detailed in Annex A and Annex B.
These test methods have been evaluated for use with PC, PC/ABS, PP matrices containing free BPA between 20 mg/kg to 500 mg/kg as shown in the Pre-IIS 13 results in Annex C and IIS 13 results in Annex D [1], [2]. The use of these methods for BPA concentration ranges of plastics, other than those specified in Annex C and Annex D, has not been evaluated.
This document is a basic environment horizontal publication focusing on test methods and is primarily intended for use by committees in the preparation of publications within the area of environment in accordance with the principles laid down in IEC Guide 123. Wherever applicable, it is the responsibility of committees to make use of environment basic publications in the preparation of their environment group and product publications. Committees can apply this document directly to products when they do not develop a product publication in the area of environment.
WARNING – Persons using this document should be familiar with normal laboratory practice. This document does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user to establish appropriate safety and health practices and to ensure compliance with any national regulatory conditions.

Status
Published
Public Enquiry End Date
08-Apr-2025
Publication Date
13-Sep-2026
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
02-Sep-2026
Due Date
07-Nov-2026
Completion Date
14-Sep-2026

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SIST EN IEC 62321-13:2026 - BARVE

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Overview

SIST EN IEC 62321-13:2026 outlines standardized test methods for determining the presence and concentration of free Bisphenol A (BPA) in plastics used in electrotechnical products. This document is part of the IEC 62321 series, which addresses the identification and quantification of hazardous substances commonly found in electrical and electronic equipment. The standard specifies three advanced techniques for BPA detection and quantification: liquid chromatography-diode array detection (LC-DAD), liquid chromatography-mass spectrometry (LC-MS), and liquid chromatography-tandem mass spectrometry (LC-MS/MS). These methods are intended to help manufacturers and laboratories meet regulatory controls and ensure compliance with global environmental and safety requirements.


Key Topics

  • Purpose: Standardizes the determination of free BPA in plastic materials from electrotechnical products.
  • Analytical Techniques:
    • LC-DAD: Liquid chromatography with diode array detection
    • LC-MS: Liquid chromatography with mass spectrometry
    • LC-MS/MS: Liquid chromatography with tandem mass spectrometry
  • Sample Types: Applies primarily to plastics such as polycarbonate (PC), polycarbonate/acrylonitrile-butadiene-styrene (PC/ABS), and polypropylene (PP).
  • Sample Preparation: Involves precise steps including homogenization, ultrasonic extraction, and avoidance of heat to prevent BPA formation during preparation.
  • Calibration and Quality Control: Requires detailed calibration routines, use of internal standards, and ongoing quality assurance procedures to maintain accuracy and reproducibility.
  • Reporting: Specifies that test results should include concentration calculations, repeatability and reproducibility metrics, and proper recording of calibration, blanks, and spiked sample recoveries.

Applications

SIST EN IEC 62321-13:2026 is targeted at a range of practical and regulatory scenarios in the electrotechnical sector, ensuring safe, compliant, and environmentally responsible product design and manufacturing:

  • Regulatory Compliance: Supports manufacturers in meeting national and international requirements for restricted substances in electrical and electronic products, especially those related to BPA.
  • Product Safety and Environmental Protection: Assists in minimizing the environmental and health impact linked with BPA exposure from electrotechnical equipment.
  • Quality Assurance in Manufacturing: Enables robust quality control in the supply chain by providing repeatable and reproducible test methods for detecting BPA in plastic components.
  • Laboratory Testing and Certification: Provides a reference for accredited test laboratories performing analyses of electrotechnical products prior to market release or regulatory inspection.
  • Supply Chain Responsibility: Empowers suppliers, OEMs, and other stakeholders to verify material compliance before products enter critical markets.

Related Standards

The method outlined in SIST EN IEC 62321-13:2026 should be used in conjunction with other standards in the IEC 62321 series and related documents for comprehensive substance analysis and compliance:

  • IEC 62321-1: Introduction and overview of substance determination in electrotechnical products.
  • IEC 62321-2: Procedures for disassembly, mechanical sample preparation, and reduction of contamination risks.
  • ISO 3696:1987: Specifies water quality for laboratory use, crucial in achieving accurate test results.
  • Other Parts in IEC 62321 Series: Cover the detection and quantification of lead, cadmium, hexavalent chromium, mercury, flame retardants, and phthalates.

Keywords: Bisphenol A, BPA, plastics, electrotechnical products, LC-DAD, LC-MS, LC-MS/MS, substance determination, IEC 62321, environmental compliance, hazardous substances, laboratory testing, regulatory standards.

Relations

Effective Date
04-Aug-2026
Effective Date
04-Aug-2026
Effective Date
04-Aug-2026

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SIST EN IEC 62321-13:2026 - BARVE

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Frequently Asked Questions

SIST EN IEC 62321-13:2026 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Determination of certain substances in electrotechnical products - Part 13: Bisphenol A in plastics by liquid chromatography-diode array detection (LC-DAD), liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS)". This standard covers: This document specifies three techniques for the determination of free Bisphenol A (BPA) in plastics of electrotechnical products. This document describes the use of liquid chromatography–diode array detector (LC-DAD), liquid chromatography mass spectrometry (LC-MS), liquid chromatography tandem mass spectrometry (LC-MS/MS) with these test methods detailed in Annex A and Annex B. These test methods have been evaluated for use with PC, PC/ABS, PP matrices containing free BPA between 20 mg/kg to 500 mg/kg as shown in the Pre-IIS 13 results in Annex C and IIS 13 results in Annex D [1], [2]. The use of these methods for BPA concentration ranges of plastics, other than those specified in Annex C and Annex D, has not been evaluated. This document is a basic environment horizontal publication focusing on test methods and is primarily intended for use by committees in the preparation of publications within the area of environment in accordance with the principles laid down in IEC Guide 123. Wherever applicable, it is the responsibility of committees to make use of environment basic publications in the preparation of their environment group and product publications. Committees can apply this document directly to products when they do not develop a product publication in the area of environment. WARNING – Persons using this document should be familiar with normal laboratory practice. This document does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user to establish appropriate safety and health practices and to ensure compliance with any national regulatory conditions.

This document specifies three techniques for the determination of free Bisphenol A (BPA) in plastics of electrotechnical products. This document describes the use of liquid chromatography–diode array detector (LC-DAD), liquid chromatography mass spectrometry (LC-MS), liquid chromatography tandem mass spectrometry (LC-MS/MS) with these test methods detailed in Annex A and Annex B. These test methods have been evaluated for use with PC, PC/ABS, PP matrices containing free BPA between 20 mg/kg to 500 mg/kg as shown in the Pre-IIS 13 results in Annex C and IIS 13 results in Annex D [1], [2]. The use of these methods for BPA concentration ranges of plastics, other than those specified in Annex C and Annex D, has not been evaluated. This document is a basic environment horizontal publication focusing on test methods and is primarily intended for use by committees in the preparation of publications within the area of environment in accordance with the principles laid down in IEC Guide 123. Wherever applicable, it is the responsibility of committees to make use of environment basic publications in the preparation of their environment group and product publications. Committees can apply this document directly to products when they do not develop a product publication in the area of environment. WARNING – Persons using this document should be familiar with normal laboratory practice. This document does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user to establish appropriate safety and health practices and to ensure compliance with any national regulatory conditions.

SIST EN IEC 62321-13:2026 is classified under the following ICS (International Classification for Standards) categories: 13.020.01 - Environment and environmental protection in general; 29.020 - Electrical engineering in general; 31.020 - Electronic components in general; 43.040.10 - Electrical and electronic equipment; 71.040.50 - Physicochemical methods of analysis. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST EN IEC 62321-13:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 3696:1998, SIST EN 62321-1:2014, SIST EN IEC 62321-2:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

SIST EN IEC 62321-13:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-oktober-2026
Določevanje posameznih snovi v elektrotehničnih izdelkih - 13. del: Določevanje
bisfenola A v plastiki s tekočinsko kromatografijo - določevanje s serijo diod (LC-
DAD), tekočinsko kromatografijo - masno spektrometrijo (LC-MS) in tekočinsko
kromatografijo - tandemsko masno spektrometrijo (LC-MS/MS)
Determination of certain substances in electrotechnical products - Part 13: Bisphenol A
in plastics by liquid chromatography-diode array detection (LC-DAD), liquid
chromatography-mass spectrometry (LC-MS) and liquid chromatography-tandem mass
spectrometry (LC-MS/MS)
Verfahren zur Bestimmung von bestimmten Substanzen in Produkten der Elektrotechnik
– Teil 13: Bisphenol A in Kunststoffen mittels Flüssigchromatographie-Diodenarray-
Detektion (LC-DAD), Flüssigchromatographie-Massenspektrometrie (LC-MS) und
Flüssigchromatographie-Tandem-Massenspektrometrie (LC-MS/MS)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Détermination de certaines substances dans les produits électrotechniques - Partie 13:
Bisphénol A dans les plastiques par chromatographie en phase liquide avec détection à
barrettes de diodes (LC-DAD), par chromatographie en phase liquide avec spectrométrie
de masse (LC-MS) et par chromatographie en phase liquide avec spectrométrie de
masse en tandem (LC-MS/MS)
Ta slovenski standard je istoveten z: EN IEC 62321-13:2026
ICS:
29.020 Elektrotehnika na splošno Electrical engineering in
general
31.020 Elektronske komponente na Electronic components in
splošno general
71.040.50 Fizikalnokemijske analitske Physicochemical methods of
metode analysis
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 62321-13

NORME EUROPÉENNE
EUROPÄISCHE NORM August 2026
ICS 13.020.01; 43.040.10
English Version
Determination of certain substances in electrotechnical products
- Part 13: Bisphenol A in plastics by liquid chromatography-diode
array detection (LC-DAD), liquid chromatography-mass
spectrometry (LC-MS) and liquid chromatography-tandem mass
spectrometry (LC-MS/MS)
(IEC 62321-13:2026)
Détermination de certaines substances dans les produits Verfahren zur Bestimmung von bestimmten Substanzen in
électrotechniques - Partie 13: Bisphénol A dans les Produkten der Elektrotechnik - Teil 13: Bisphenol A in
plastiques par chromatographie en phase liquide avec Kunststoffen mittels Flüssigchromatographie-Diodenarray-
détection à barrettes de diodes (LC-DAD), par Detektion (LC-DAD), Flüssigchromatographie-
chromatographie en phase liquide avec spectrométrie de Massenspektrometrie (LC-MS) und
masse (LC-MS) et par chromatographie en phase liquide Flüssigchromatographie-Tandem-Massenspektrometrie
avec spectrométrie de masse en tandem (LC-MS/MS) (LC-MS/MS)
(IEC 62321-13:2026) (IEC 62321-13:2026)
This European Standard was approved by CENELEC on 2026-07-28. CENELEC 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 62321-13:2026 E

European foreword
The text of document 111/884/FDIS, future edition 1 of IEC 62321-13, prepared by TC 111
"Environmental standardization for electrical and electronic products and systems" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 62321-13:2026.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2027-08-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2029-08-31
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 62321-13:2026 was approved by CENELEC as a European
Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
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.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 62321-1 2013 Determination of certain substances in EN 62321-1 2013
electrotechnical products - Part 1: Introduction
and overview
IEC 62321-2 - Determination of certain substances in EN IEC 62321-2 -
electrotechnical products - Part 2: Disassembly,
disjointment and mechanical sample preparation
ISO 3696 1987 Water for analytical laboratory use - EN ISO 3696 1995
Specification and test methods

IEC 62321-13 ®
Edition 1.0 2026-06
INTERNATIONAL
STANDARD
HORIZONTAL PUBLICATION
Determination of certain substances in electrotechnical products -
Part 13: Bisphenol A in plastics by liquid chromatography-diode array detector
(LC-DAD), liquid chromatography-mass spectrometry (LC-MS) and liquid
chromatography-tandem mass spectrometry (LC-MS/MS)
ICS 13.020.01; 43.040.10 ISBN 978-2-8327-1328-0

IEC 62321-13:2026-06(en)
IEC 62321-13:2026 © IEC 2026
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms, definitions and abbreviated terms . 6
3.1 Terms and definitions . 6
3.2 Abbreviated terms. 7
4 Principle . 7
5 Reagents and materials . 7
6 Apparatus . 8
7 Sampling . 8
8 Procedure . 8
8.1 General instructions for the analysis . 8
8.2 Sample preparation. 9
8.2.1 Stock solution . 9
8.2.2 Extraction. 9
8.3 Instrumental parameters . 9
8.3.1 General. 9
8.3.2 Stationary phase . 9
8.3.3 Liquid (mobile) phase . 9
8.4 Calibrants . 10
8.5 Calibration . 10
8.5.1 General. 10
8.5.2 Standard solutions . 10
9 Calculation of BPA concentration . 11
9.1 General . 11
9.2 Calculation . 12
10 Precision data . 13
10.1 LC-DAD method . 13
10.2 LC-MS method . 14
10.3 LC-MS/MS method . 15
11 Quality assurance and quality control . 16
11.1 Performance . 16
11.2 Internal control samples and blanks . 17
11.3 Method detection limit and reporting limit . 17
12 Test report . 18
Annex A (informative) Conditions of each instrument . 19
Annex B (informative) Examples of chromatograms at suggested conditions . 22
Annex C (informative) Results of preliminary international interlaboratory study (Pre-
IIS 13) . 24
Annex D (informative) Results of International Interlaboratory study (IIS 13) . 27
Bibliography . 30

Figure B.1 – Chromatogram of Bisphenol A standard solution (LC-DAD) . 22
Figure B.2 – Chromatogram of Bisphenol A standard analysis (LC-MS) . 22
IEC 62321-13:2026 © IEC 2026
Figure B.3 – Mass analysis spectrum of Bisphenol A standard solution (LC-MS) . 22
Figure B.4 – Chromatogram of Bisphenol A standard analysis (LC-MS/MS) . 23
Figure B.5 – Mass analysis spectrum of Bisphenol A standard solution (LC-MS/MS) . 23

Table 1 – CAS number of reference material and internal standards . 10
Table 2 – Preparation of low concentrations of calibration standard solutions of BPA . 10
Table 3 – Preparation of high concentrations of calibration standard solutions of BPA . 11
Table 4 – Pre-IIS 13 repeatability and reproducibility of LC-DAD . 13
Table 5 – IIS 13 repeatability and reproducibility of LC-DAD . 14
Table 6 – Pre-IIS 13 repeatability and reproducibility of LC-MS . 14
Table 7 – IIS 13 repeatability and reproducibility of LC-MS . 15
Table 8 – Pre-IIS 13 repeatability and reproducibility of LC-MS/MS . 15
Table 9 – IIS 13 repeatability and reproducibility of LC-MS/MS. 16
Table A.1 – Measurement condition LC-DAD . 19
Table A.2 – Measurement conditions of LC-MS . 20
Table A.3 – Measurement conditions of LC-MS/MS . 21
Table C.1 – Mean results and recovery rates for BPA using LC-DAD . 24
Table C.2 – Statistical data for LC-DAD . 24
Table C.3 – Mean results and recovery rates for BPA using LC-MS . 25
Table C.4 – Statistical data for LC-MS . 25
Table C.5 – Mean results and recovery rates for BPA using LC-MS/MS. 25
Table C.6 – Statistical data for LC-MS/MS . 26
Table D.1 – Mean results and recovery rates for BPA using LC-DAD . 27
Table D.2 – Statistical data for LC-DAD . 27
Table D.3 – Mean results and recovery rates for BPA using LC-MS . 28
Table D.4 – Statistical data for LC-MS . 28
Table D.5 – Mean results and recovery rates for BPA using LC-MS/MS. 28
Table D.6 – Statistical data for LC-MS/MS . 29

IEC 62321-13:2026 © IEC 2026
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Determination of certain substances in electrotechnical products -
Part 13: Bisphenol A in plastics by liquid chromatography-diode array
detector (LC-DAD), liquid chromatography-mass spectrometry (LC-MS)
and liquid chromatography-tandem mass spectrometry (LC-MS/MS)

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of patent, which may
be required to implement this document. However, implementers are cautioned that this may not represent the
latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC shall
not be held responsible for identifying any or all such patent rights.
IEC 62321-13 has been prepared by technical committee 111: Environmental standardization
for electrical and electronic products and systems. It is an International Standard.
This document has been given the status of a horizontal document in accordance with the
ISO/IEC Directives, Part 1.
The text of this International Standard is based on the following documents:
Draft Report on voting
111/884/FDIS 111/898/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
IEC 62321-13:2026 © IEC 2026
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
A list of all parts in the IEC 62321 series, published under the general title Determination of
certain substances in electrotechnical products, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
– reconfirmed,
– withdrawn, or
– revised.
IEC 62321-13:2026 © IEC 2026
INTRODUCTION
The widespread use of electrotechnical products has drawn increased attention to their impact
on the environment. In many countries this has resulted in the adaptation of regulations
affecting waste, substances and energy use of electrotechnical products.
The use of certain substances (e.g. lead (Pb), cadmium (Cd), mercury (Hg) and polybrominated
diphenyl ethers (PBDEs)) and phthalates in electronical products is a source of concern in
current and proposed regional legislation.
The purpose of the IEC 62321 series is therefore to provide test methods that will allow the
electrotechnical industry to determine the levels of certain substances of concern in
electrotechnical products on a consistent global basis.
This first edition of IEC 62321-13 introduces a new subject covering Bisphenol A in the
IEC 62321 series.
IEC 62321-13:2026 © IEC 2026
1 Scope
This document specifies three techniques for the determination of free Bisphenol A (BPA) in
plastics of electrotechnical products.
This document describes the use of liquid chromatography–diode array detector (LC-DAD),
liquid chromatography mass spectrometry (LC-MS), liquid chromatography tandem mass
spectrometry (LC-MS/MS) with these test methods detailed in Annex A and Annex B.
These test methods have been evaluated for use with PC, PC/ABS, PP matrices containing free
BPA between 20 mg/kg to 500 mg/kg as shown in the Pre-IIS 13 results in Annex C and IIS 13
results in Annex D [1], [2]. The use of these methods for BPA concentration ranges of plastics,
other than those specified in Annex C and Annex D, has not been evaluated.
This document is a basic environment horizontal publication focusing on test methods and is
primarily intended for use by committees in the preparation of publications within the area of
environment in accordance with the principles laid down in IEC Guide 123. Wherever applicable,
it is the responsibility of committees to make use of environment basic publications in the
preparation of their environment group and product publications. Committees can apply this
document directly to products when they do not develop a product publication in the area of
environment.
WARNING – Persons using this document should be familiar with normal laboratory practice.
This document does not purport to address all of the safety problems, if any, associated with
its use. It is the responsibility of the user to establish appropriate safety and health practices
and to ensure compliance with any national regulatory conditions.
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.
IEC 62321-1:2013, Determination of certain substances in electrotechnical products - Part 1:
Introduction and overview
IEC 62321-2, Determination of certain substances in electrotechnical products - Part 2:
Disassembly, disjointment and mechanical sample preparation
ISO 3696:1987, Water for analytical laboratory use - Specification and test methods
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 62321-1 and the
following apply.
ISO and IEC maintain terminology 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
IEC 62321-13:2026 © IEC 2026
3.1.1
free bisphenol A
chemically unbound bisphenol A (BPA), as present in material
3.2 Abbreviated terms
For the purpose of this document, the following abbreviated terms apply.
ABS acrylonitrile-butadiene-styrene
BPA bisphenol A
BPC bisphenol C
CCC continuing calibration check standard
CRM certified reference material
IS internal standard
LC liquid chromatography
LC-DAD liquid chromatography-diode array detector
LC-MS liquid chromatography-mass spectrometry
LC-MS/MS liquid chromatography-tandem mass spectrometry
MDL method detection limit
PC polycarbonate
PC/ABS polycarbonate/Acrylonitrile-butadiene-styrene
PP polypropylene
PTFE polytetrafluoroethylene
QC quality control
RSD relative standard deviation
RM raw material
4 Principle
Free BPA is determined using ultrasonic extraction followed by high-performance liquid
chromatography separation and tandem mass spectrometry and liquid chromatography-diode
array detection. When preparing a test specimen (see Clause 7) of polycarbonate (PC) or
similar type of epoxy resins, thermal stress of the specimen should be avoided, since heat can
affect the test results.
Free BPA is determined using ultrasonic extraction followed by high-performance liquid
chromatography separation with either mass-spectrometry (LC-MS), or tandem mass
spectrometry (LC-MS/MS), or diode array detector (LC-DAD).
5 Reagents and materials
The reagent chemicals used for the tests described in this document shall have a minimum
purity as described from a) to i) in Clause 5. This is intended to ensure the reagents are free
from contamination and prevent proliferation of blank values. There is a risk of elevated blank
values due to the ubiquitous nature of BPA (CAS #80-05-7). Laboratories should assure to
verify the blank value of the test method especially in case the calibration curve shows an offset.
These are the reagents used in the tests described in this document:
a) methanol (purity LC grade or higher);
b) tetrahydrofuran (purity LC grade or higher);
IEC 62321-13:2026 © IEC 2026
c) water (purified water, for quality of the mobile phase ingredients and solution or according
to ISO 3696:1987, Grade 1, applies);
d) acetonitrile (Purity LC grade or higher);
e) mixed solvent solution (1:1 Methanol and water): add 500 ml methanol and 500 ml water to
1 l beaker and mix;
f) 10 mM ammonium acetate buffer solution: add 0,771 g ammonium acetate in a 1 l beaker
(see Clause 6, item h)), dissolve with a little purified water (see Clause 5, item c)), then add
900 ml purified water. Transfer to 1 l volumetric flask and add 10 ml acetonitrile and dilute
with purified water to the marked line;
g) calibrants, BPA (purity of greater than a mass fraction of 99 %);
h) Internal standard (IS) used to correct for injection (e.g. BPA-d , BPA-d , BPC);
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i) 0,04 % Phosphoric acid buffer solution: add about 0,471 ml 85 % Phosphoric acid in a 1 l
volumetric flask (see Clause 6, item b)) and dilute with purified water to the marked line.
To prevent exothermal reaction, fill volumetric flask to half of water and then add acid. Then fill
to the mark with purified water.
6 Apparatus
The following items shall be used for the analysis:
a) analytical balance having an accuracy of 0,000 1 g;
b) 10 ml, 100 ml, 1 l volumetric flasks (glass);
c) ultrasonic bath with a minimum power of 200 W and a bath area of 706 cm , corresponding
to 0,28 W/cm , without a basket and with an internal or external thermostat;
d) Pasteur pipette (glass);
e) 1,5 ml sample vials with 100 µl glass insert and a screw cap with polytetrafluoroethylene
(PTFE) gasket or, depending on the analytical system, a comparable sample receptacle;
f) 0,45 µm PTFE membrane filter;
g) centrifuge with maximum rotation speed over 3 000 r/min;
h) 1 l beaker (glass);
i) minimum 40 ml vial (glass).
7 Sampling
The following procedure shall be used as described in IEC 62321-2. Cut samples approximately
to a size of 2 mm × 2 mm and homogenise. Contact with possible sources of BPA-contamination
shall be avoided during sampling.
NOTE Heat can cause the formation of additional free BPA. It is important to avoid using devices that generate
heat (e.g. circular saw).
8 Procedure
8.1 General instructions for the analysis
The following general instructions shall be followed.
a) In order to reduce blank values, ensure the cleanliness of all glass and analytical equipment.
b) If the amount of BPA in the sample is considerably above the calibration range, it is
necessary to carry out the analysis using an adjusted sample size or by repeating the
analysis using an extract that has been appropriately diluted prior to internal standard
addition.
IEC 62321-13:2026 © IEC 2026
8.2 Sample preparation
8.2.1 Stock solution
The following stock solutions shall be prepared.
a) Standard solution for calibration: prepare a standard solution containing 1 000 µg/ml
Bisphenol A in Tetrahydrofuran (see Clause 5, item b)).
b) Internal standard for LC-MS and LC-MS/MS: 4 µg/ml in Tetrahydrofuran (see Clause 5, item
b)) (e.g. BPC, BPA-d , BPA-d ).
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c) Internal standard for LC-DAD: 40 µg/ml in Tetrahydrofuran (see Clause 5, item b)) (e.g.
BPC).
d) Dilution solution: 10 ml of internal standard (8.2.1, item b) or 8.2.1, item c)) in 30 ml of mixed
solvent (see Clause 5, item e)).
8.2.2 Extraction
The following steps shall be followed for sample extraction.
a) Weigh approximately 1 g of the sample and transfer it into a tared vial. Record the mass to
the nearest 0,000 1 g. Lower sample weights can be tes
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