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Determination of certain substances in electrical and electronic products -- Part 1: Introduction and overview
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GB/T 39560.1-2020: PDF in English (GBT 39560.1-2020) GB/T 39560.1-2020
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 31.020
L 10
GB/T 39560.1-2020 / IEC 62321-1:2013
Determination of Certain Substances in Electrical and
Electronic Products – Part 1: Introduction and Overview
(IEC 62321-1:2013, Determination of Certain Substances in Electrotechnical
Products – Part 1: Introduction and Overview, IDT)
ISSUED ON: DECEMBER 14, 2020
IMPLEMENTED ON: JULY 01, 2021
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms, Definitions and Abbreviations ... 6
3.1 Terms and definitions ... 6
3.2 Abbreviations ... 7
4 Test Methods - Overview ... 8
4.1 Field of application ... 8
4.2 Sample ... 10
4.3 Test methods – flow chart ... 10
4.4 Quality assurance and control ... 12
4.5 Blank solution ... 13
4.6 Adjustment to the matrix ... 13
4.7 Limits of detection (LOD) and limits of quantification (LOQ) ... 13
4.8 Test report ... 14
4.9 Alternative test methods ... 14
Annex A (Informative) Limit of Detection (LOD) or Method Detection Limit (MDL) –
Example of Calculation ... 16
Bibliography ... 18
Determination of Certain Substances in Electrical and
Electronic Products – Part 1: Introduction and Overview
WARNING – Persons using this Part should be familiar with normal laboratory practice.
This Part 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.
1 Scope
This Part of GB/T 39560 refers to the sample as the object to be processed and measured. The
nature of the sample and the manner in which it is acquired is defined by the entity carrying out
the tests.
It is noted that the selection of the sample may affect the interpretation of the test results.
While this standard provides guidance on the disassembly procedure employed for obtaining a
sample, it does not determine or specify:
• the level of the disassembly procedure required for obtaining a sample;
• the definition of a “unit” or “homogenous material” as the sample;
• conformity assessment procedures.
NOTE: Further guidance on assessment procedures of the conformity may be found in GB/Z 30374-
2013[2].
2 Normative References
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document; for the
undated documents, only the latest version (including all the amendments) is applicable to this
document.
ISO 78-2:1999 Chemistry – Layouts for Standards – Part 2: Methods of Chemical Analysis
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration
Laboratories
Closeness of agreement between independent test results obtained under stipulated conditions.
3.1.7 Reference material
Material, sufficiently homogeneous and stable with reference to specified properties, which has
been established to be fit for its intended use in measurement or in examination of nominal
properties.
3.1.8 Repeatability
Precision under repeatability conditions.
[GB/T 6379.1-2004, definition 3.13] [1]
3.1.9 Reproducibility
Precision under reproducibility conditions.
[GB/T 6379.1-2004, definition 3.17] [1]
3.1.10 Screening
Analytical procedure to determine the presence or absence of substances in the representative
part or section of a product, relative to the value or values chosen as the criterion for presence,
absence or further testing.
NOTE: If the screening method produces values that are not conclusive, then additional analysis or other
follow-up actions may be necessary to make a final presence/absence decision.
3.2 Abbreviations
The following abbreviations are applicable to this Document.
AAS: Atomic Absorption Spectrometry;
C-IC: Combustion - Ion Chromatography;
CV-AAS: Cold Vapour Atomic Absorption Spectrometry;
CV-AFS: Cold Vapour Atomic Fluorescence Spectroscopy;
EPA: Environmental Protection Agency;
FRU: Field Replaceable Unit;
GC-MS: Gas Chromatography - Mass Spectrometry;
GLP: Good Laboratory Practice;
HPLC-UV: High-Performance Liquid Chromatography - Ultraviolet;
IC: Ion Chromatography;
IAMS: Ion Attached Mass Spectrometry;
ICP-MS: Inductively Coupled Plasma Mass Spectrometry;
ICP-OES: Inductively Coupled Plasma Optical Emission Spectrometry;
IS: Internal Standard;
IUPAC: International Union of Pure and Applied Chemistry;
LOD: Limit of Detection;
LOQ: Limit of Quantification;
MDL: Method Detection Limit;
PBB: Polybrominated Biphenyl;
PBDE: Polybrominated Diphenyl Ether;
PBMS: Performance-Based Measurement System;
PWB: Printed Wiring Board;
QC: Quality Control;
UV-VIS: Ultraviolet–Visible Spectroscopy;
XRF: X-Ray Fluorescence Spectroscopy.
4 Test Methods - Overview
4.1 Field of application
The contents of the test methods to determine the levels of certain substances are grouped into
important steps:
a) analytical test methods;
b) laboratory implementation.
Analytical test methods were developed and validated to ensure their suitability to the task. The
structure of each of the test methods are generally aligned in accordance with ISO 78-2:1999
where applicable, i.e.:
hexavalent chromium, etc.) in electrical and electronic equipment is widely used in reference
to analytical testing methods. Screening methods provide the analyst a convenient approach to
evaluate for the presence or quantity of certain substance(s) in samples. Screening may employ
qualitative or semi-quantitative methods. In some cases, a quantitative method may be used for
screening purposes if the actual targeted substance(s) are difficult to analyze directly (e.g.,
hexavalent Cr).
Depending on the screening results however, additional analysis methods may need to be
employed to definitively verify the presence or quantity of certain substances. These definitive
analysis methods are referred to as verification methods.
While X-ray fluorescence spectrometry (XRF) is the tool most commonly associated with the
screening approach, it is not limited to this analytical measurement technique. Users of this
family of standards will understand that multiple measurement techniques can be employed for
the purpose of “screening”.
Screening for hexavalent chromium [Cr(VI)] for example, can be accomplished by a total
chromium measurement using a non-destructive XRF analysis method. Similarly, total
chromium analysis could be performed by a destructive analysis using an inductively coupled
plasma measurement method. Either measurement can be effectively employed to evaluate for
the presence or quantity of hexavalent chromium since the concentration of the hexavalent
species can be no greater than the total chromium concentration value.
Likewise, a total bromine measurement using a non-destructive XRF analysis method or C-IC
method can be used in the same fashion. Either measurement can be effectively employed to
evaluate for the presence or quantity (PBBs) or (PBDEs) in a sample when relating the total
bromine content to the composition of these compounds.
In both examples however, the detection of elevated total element levels requires additional
verification method analysis (e.g., UV-VIS or GC-MS techniques) to confirm the potential
presence or quantity of hexavalent chromium [Cr (IV)] or PBB/PBDE compound species.
It can therefore be seen that the prudent analyst can effectively employ different screening
procedures to achieve the same result.
The screening procedure may be carried out either by directly measuring the sample
(nondestructive sample preparation) or by destroying the sample to make it uniform
(mechanical sample preparation). This decision shall be made by judging the uniformity of the
sample. A screening of representative samples of many uniform materials (such as polymers,
alloys, glass) may be carried out non-destructively, while for other more complex samples (such
as an FRU), mechanical sample preparation may be an appropriate solution. Mechanical sample
preparation is the same for both the screening and the verification test procedure.
Verification test procedures are often employed to confirm the presence or quantity of certain
substances of concern after a screening procedure has been performed (e.g., to determine if the
determination of limits of detection (LOD) and limits of quantification (LOQ). Where
applicable, the LOD and LOQ section shall be consistent with the descriptions in 4.7. Examples
of other method-specific quality control concerns include requirements regarding method
blanks, calibration check standards, spike or surrogate samples, internal standard responses and
the like.
4.5 Blank solution
Where applicable, the precision clause of the individual test method standards shall include
repeatability and reproducibility statements (see Annex B of ISO 78-2:1999) supported by
statistical data derived from interlaboratory study or the equivalent.
4.6 Adjustment to the matrix
Test methods for certain substances that are present at relatively low levels amongst other
chemical elements or compounds at relatively high concentrations, or those that represent the
major constituent of the sample, are very often material or matrix dependent. Therefore, the test
methods shall be adjusted to the materials to be tested, either by introducing the appropriate
blanks and matrix-adjusted calibration samples, or by a preparation step that separates the
analyte from the adherent materials or the main matrix. The main material types (or matrices)
in electronic equipment are polymers (mostly technical polymers containing additives and
sometimes having coated surfaces), metals or alloys (they may also be coated) and electronics.
Matrix adjustment may be difficult for electronic products.
4.7 Limits of detection (LOD) and limits of quantification (LOQ)
In its simplest form, a limit of detection (LOD) or method detection limit (MDL) is typically
described as the lowest amount or concentration of analyte in a test sample that can be reliably
differentiated from zero for a given measurement system.
Instrument detection limits represent an instrument’s ability to differentiate low concentrations
of analytes from “zero” in a blank or standard solution, and are commonly used by
manufacturers to demonstrate the measurement capability of a system (e.g., atomic absorption
spectrometer). Whilst instrument detection limits are useful, they are often considerably lower
than a limit of detection representing a complete analytical measurement process.
Complete analytical method detection limits (MDL) are most appropriately determined
experimentally by performing replicate, independent measurements on low-level or fortified
sample matrices (e.g., plastic) carried out through the entire test procedure, including sample
digestion or extraction. A minimum of six replicates and analyte concentrations of 3 ~ 5 times
the estimated method detection limit have been suggested as suitable for this analysis. The
complete method detection limit for an entire test procedure is determined by multiplying the
standard deviation of the replicates by an appropriate factor. IUPAC recommends a factor of 3
for a minimum of six replicates, whilst EPA utilizes a one-sided confidence interval with the
multiplier equal to Student’s t value chosen for the number of replicates and the level of
confidence (e.g., t = 3.36 for six replicates for 99 % confidence).
NOTE: An illustrative calculation example is given in Annex A.
The limit of quantification (LOQ) or estimated quantitation limit for a given measurement
system is typically described as the lowest concentration that can be reliably determined within
specified or acceptable limits of precision during routine laboratory operating conditions. The
acceptable precision limit is often defined as 10% relative standard deviation or simply
expressed as a fixed multiple (2 ~ 10) of the method detection limit.
4.8 Test report
The work carried out by the testing laboratory shall be covered by a report that accurately,
clearly and unambiguously presents the test results and other relevant information. Each test
report shall include at least the following information:
a) name, address and location of any laboratory involved in the analysis and name of the
operator;
b) date of receipt of sample and date(s) of performance of test(s);
c) unique identification of report (such as a serial number) and of each page and total number
of pages of the report;
d) description and identification of the sample, including a description of any product
disassembly performed to acquire the test sample;
e) a reference to this standard, the method used or performance-based equivalent (including
digestion method(s) and equipment);
f) the limit of detection (LOD) or limit of quantification (LOQ);
g) the results of the test expressed as milligram/kilogram (mg/kg) in samples tested;
h) any details not specified in this standard which are optional, and any other factors that
may have affected the results. Any deviation, by agreement or otherwise, from the test
procedure specified here.
The results of all quality control test (e.g., results from method blanks, matrix spikes, etc.) and
a list of reference materials used and their origin shall be available upon request.
Corrections or additions to a test report after issue shall be made only in a further document
suitably marked, e.g., “Amendment/Addendum to test report serial number XXX” (or as
otherwise identified), and shall meet the relevant requirements of 4.2 ~ 4.6).
4.9 Alternative test methods
Alternative test methods, digestion methods or analytical techniques may be utilized once the
performance effectiveness has been validated according to PBMS criteria, referenced in the
quality control clauses of the test methods. Any deviation from the described test methods shall
...... Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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