GBZ44383-2024 English PDF

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GBZ44383-2024: Test method development - Guidelines for substance selection
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/Z 44383-2024	319	Add to Cart	4 days	Test method development - Guidelines for substance selection	Valid

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Basic data

Standard ID: GB/Z 44383-2024 (GB/Z44383-2024)
Description (Translated English): Test method development - Guidelines for substance selection
Sector / Industry: National Standard
Classification of Chinese Standard: L10
Word Count Estimation: 16,147
Date of Issue: 2024-08-23
Date of Implementation: 2024-08-23
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GBZ44383-2024: Test method development - Guidelines for substance selection

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
GB /Z 44383-2024.Guidelines for material selection for test method development Guiding technical documents of the People's Republic of China on national standardization ICS 13.020.01; 19.040CCS L 10 Guide to Substance Selection for Assay Development Test method development-Guidelines for substance selection (IEC TR 62936.2016, MOD) 2024-08-23 Release 2024-12-01 Implementation State Administration for Market Regulation The National Standardization Administration issued

Table of Contents

Preface Ⅲ Introduction Ⅳ 1 Scope...1 2 Normative references ...1 3 Terms, definitions and abbreviations 1 3.1 Terms and Definitions 1 3.2 Abbreviations 1 4 Process Flow 1 5 Process steps ...2 5.1 List of Chemical Substances 2 5.2 Material selection procedure 2 5.3 Principles of material selection 4 5.4 Existence of other relevant standards 7 5.5 Final material selection 7 Appendix A (Informative) Pilot study on RoHSⅡ priority substances 8 References 9

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting is required. This document is modified to adopt IEC TR 62936.2016 "Guide to Material Selection for Test Method Development", and the document type is changed from IEC Technical The report was adjusted to become my country's national standardization guiding technical document. Technical differences between this document and IEC TR 62936.2016. a) The scope of the standard has been rewritten to comply with the requirements of the standard writing in my country (see Chapter 1); b) The IEC and ISO terminology database contents in the terms and definitions have been deleted. After being converted into Chinese standards, these contents are consistent with this document. Not relevant (see 3.1); c) In Table 1, the “IEC 62321 (all parts)” series standard is changed to the corresponding national standard “GB/T 39560 (all parts)”. In line with my country's national conditions. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document was proposed and coordinated by the National Technical Committee for Environmental Standardization of Electrical and Electronic Products and Systems (SAC/TC 297). This document was drafted by. China Electronics Technology Standardization Institute, Guangdong Midea Refrigeration Equipment Co., Ltd., Shenzhen CESI Information Technology Co., Ltd. Ltd., Beijing CESI Technology Development Co., Ltd., Xiamen Redley Calibration and Testing Technology Co., Ltd., Ministry of Industry and Information Technology Electronics No. Five Research Institutes, China Household Electrical Appliances Research Institute, ZTE Corporation, China Household Electrical Appliances Research Institute (Beijing) Testing and Certification Co., Ltd., China Inspection and Certification Group Southern Testing Co., Ltd., SGS-CSTC Standards Technical Services Co., Ltd., Ningbo Institute of Inspection and Quarantine Science and Technology, Guangzhou Customs Technical Center Center, Beijing University of Aeronautics and Astronautics, and China Industrial Internet Research Institute. The main drafters of this document are. Gao Jian, Zheng Chongkai, Gao Yaxin, Meng Yang, Ye Zhimin, Huang Qiuxin, Cao Yanxin, Wang Xian, Wang Chan, Si Feifei, Lu Ke, Cao Guozhou, Li Quanzhong, Li Weiping, Xia Jing.

Introduction

Many chemicals are being regulated or are under regulatory consideration, so it is necessary to develop a variety of reliable and acceptable detection methods. For consistency demonstration, the parties concerned must reach a consensus that a particular test method is technically It is correct in all respects (i.e. it provides reliable analytical results), suitable for the samples to be analyzed, tested and reviewed by technical experts, and applied without bias. Usually developed and published by a standardization technical organization (such as IEC /TC 111, SAC/TC 297 or related industry standardization technical organizations). Due to limited resources and the associated development process and time, only Develop detection methods for a limited number of chemical substances. This document provides a standard process for the development of test methods for the logical screening, prioritization, and selection of candidate substances. The candidate substances list is divided into several groups according to their relative importance. This document is aimed at electronic and electrical products, so the candidate substances mainly come from The list of substances related to material declarations recorded in the IEC 62474 database [2] is not comprehensive. Substances are divided into 3 major categories, which are briefly described below. -- Criterion 1.“Currently regulated” or “explicitly included in relevant national laws or regulations”. The laws or regulations apply to electronic equipment. gas products and take effect on a specific date. -- Criterion 2.Substances or groups of substances that are “for evaluation” or meet Criterion 1, but laws or regulations do not yet provide specific requirements for these substances. The effective date of the entity. -- Criterion 3.“For reference only” or does not meet the requirements of Criterion 1 or Criterion 2.However, for reporting this A substance or group of substances for which there are recognized common market requirements across the industry. In addition to regulated substances, market requirements are also a major consideration in developing test method standards. Examples of market-driven requirements include the requirement for certain chemicals in a product’s supply chain. Although there is no legal obligation for electrical and electronic equipment to meet these initiatives, if they do not meet the requirements In many cases, if these requirements are not met, the supplier’s products may be delisted. Eliminate procurement considerations. The screening process is designed to screen out the majority of substances for consideration, leaving only the “critical few” for further consideration. Given the rapidly changing environment, the screening criteria may or may not be the most appropriate for the substance under consideration. Therefore, caution is required when interpreting the score results. Some judgement is required. The final selection process is designed to be able to consider additional requirements or criteria that were not captured by the initial screening process. In addition, Subjective criteria (relative importance cannot be measured). Due to the changing requirements of the regulatory and market environment, this document does not provide a final selection process. Determine the criteria. Guide to Substance Selection for Assay Development

1 Scope

This document provides guidance on the selection of substances during the development of test method standards and also gives the main sources of candidate substances. Information from the IEC 62474 database. This document is applicable to the substance screening and selection process for other substances under regulatory roadmaps and market requirements.

2 Normative references

This document has no normative references. 3 Terms, definitions and abbreviations 3.1 Terms and Definitions There are no terms or definitions that require definition in this document. 3.2 Abbreviations The following abbreviations apply to this document. CMR carcinogenic, mutagenic or toxic to reproduction CoRAP Community Rolling Action Plan EEE electrical and electronic equipment REACH Registration, Evaluation, Authorization and Restriction of Chemicals of chemicals RoHS Restriction of Hazardous Substances SDO Standards Development Organization SIN replace it now SVHC substances of very high concern

4 Process Flow

To determine their suitability for use in electrical and electronic products, substances listed in the IEC 62474 database have undergone a technical review. Effective initial screening to narrow down the number of substances to be considered for test method development within the standard range. These substances have been evaluated, Substances not included in the IEC 62474 database are also subject to a technical review type of evaluation. Figure 1 shows the chemical Flowchart of the quality selection process. ......

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