Workflow
标准物质
icon
Search documents
《标准物质管理办法》正式公布,“标准”厂商迎来黄金窗口!
仪器信息网· 2026-01-09 10:08
Core Viewpoint - The article discusses the release of the "Standard Material Management Measures" by the State Administration for Market Regulation, marking the most significant revision in 40 years, with a new three-tier management system being implemented [2][3]. Background of the Measures - Standard materials serve as the "ruler" and "weight" in chemical and biological testing activities, acting as key metrological public products and foundational strategic scientific resources. The existing management measures have been in place for nearly 40 years and are no longer suitable for the new demands and technologies emerging in the industry, necessitating a comprehensive revision and elevation to departmental regulations [4]. Key Aspects of the Revision - The revision focuses on four main areas: 1. Clarification of the concept of standard materials, emphasizing their technical characteristics such as uniformity, stability, traceability, and uncertainty [5]. 2. Transition from a two-tier management model to a three-tier model, categorizing standard materials into national benchmark materials, first-level standard materials, and second-level standard materials [5]. 3. Improvement of management systems, specifying the classification criteria for each level of standard materials and standardizing the planning and management of national benchmark materials [5]. 4. Strengthening the responsibilities of relevant entities, requiring certified organizations to ensure production supply, quality traceability, and ongoing management [5]. Transition to a Three-Tier Management Model - The shift to a three-tier management model aims to enhance alignment with other management measures and international standards. This new structure allows for more precise and effective regulation, addressing the significant differences between benchmark standard materials and traditional metrological benchmark devices [7]. Institutional Arrangements for Business Environment Optimization - The measures include: 1. Establishing an administrative approval system for standard materials, delegating the approval authority for second-level standard materials to provincial market regulation departments, thus reducing approval times and costs for enterprises [8]. 2. Introducing a commissioned production system to address the mismatch between research capabilities and production capacity, allowing organizations with core technologies to commission qualified entities for production [8]. Promotion of High-End Standard Material R&D and Technological Innovation - The measures encourage original innovation by facilitating a "green channel" for urgent and unprecedented national benchmark materials and first-level standard materials, guiding resources towards high-end fields [9]. - They also simplify the classification process for internationally recognized standard materials, promoting domestic institutions to align with global standards and integrate into advanced industrial chains [9]. Regulations on Imported Standard Materials - The measures stipulate that imported standard materials must be certified by foreign entities or their designated agents within China, ensuring equal treatment for foreign and domestic enterprises and providing a clear operational pathway for foreign businesses [10][11]. Current Issues in the Standard Material Market - The market faces challenges such as inadequate responsibility among production institutions, the presence of unlicensed low-cost or counterfeit standard materials, and outdated standards remaining in circulation. The new measures address these issues by: 1. Establishing a five-year validity period for classification certificates, ensuring dynamic updates and clear information for regulatory purposes [11]. 2. Reinforcing the responsibilities of certified organizations and requiring compliance from users to enhance product quality [11]. 3. Implementing a comprehensive regulatory mechanism that covers pre-approval, precise regulation during production, and legal enforcement post-incident [12]. Benefits for Standard Material Manufacturers - The measures provide several advantages for manufacturers, including: 1. Clear market entry and qualification pathways, defining classification criteria and application processes for different levels of standard materials [13]. 2. Establishing a tiered management system that enhances market authority and price differentiation for various standard materials [13]. 3. Encouraging innovation through expedited approval processes for urgently needed materials [13]. 4. Allowing commissioned production to optimize resource allocation and facilitate large-scale production [13][14]. 5. Providing a stable market outlook with a five-year certificate validity and renewal mechanism [14]. 6. Establishing legal import and agency channels for standard materials, ensuring compliance and operational clarity for importers [14].
《标准物质管理办法》出台 “标尺”更准 监管更强
Yang Shi Xin Wen· 2026-01-08 10:16
Core Viewpoint - The State Administration for Market Regulation has introduced the "Standard Substance Management Measures," which will take effect on December 1, 2026, to adapt to new requirements and improve the quality and efficiency of standard substance supply [1][5]. Summary by Relevant Sections Revision Aspects - The new measures clarify the concept of standard substances, defining them as materials with uniformity, stability, reliable metrological traceability, and uncertainty, serving as a unified reference for measurement activities [2][6]. - The classification of standard substances has been changed from a two-tier system (primary and secondary) to a three-tier system, including national benchmark substances, primary standard substances, and secondary standard substances [2][6]. - The management system has been improved, with the national benchmark substances planned by the State Administration for Market Regulation, while primary and secondary standard substances will be subject to licensing management [2][7]. - Responsibilities of relevant entities have been strengthened, establishing a system for the commissioned production of standard substances, allowing certified institutions to produce independently or through commission [2][9]. Administrative Approval and Market Environment - The new measures streamline the administrative approval process for secondary standard substances by delegating authority to provincial market regulation departments, significantly reducing approval times and lowering institutional transaction costs for enterprises [7][8]. - A system for commissioned production of standard substances has been established, ensuring that the commissioning party is responsible for the safety, accuracy, and traceability of the standard substances [8][9]. Classification Conditions - National benchmark substances must use benchmark measurement methods and possess the highest metrological characteristics, with technical indicators such as uniformity and stability at the leading level [11]. - Primary standard substances should use benchmark measurement methods or reliable measurement methods from different principles, ensuring reliable metrological traceability [12]. - Secondary standard substances must use primary standard substances for value determination or comparative measurement methods, meeting practical measurement needs [12]. Conditions for Production Units - Units engaged in the production of standard substances must have legal entity status, a quality management system appropriate to the level and type of standard substances produced, and qualified technical and management personnel [13][15]. Penalties for Violations - Penalties for falsifying or misusing standard substance certificates include fines ranging from 30,000 to 100,000 yuan, depending on the severity of the violation [16][17].
市场监管总局:前7个月我国新增标准物质549项 累计逾1.9万项
Yang Shi Wang· 2025-08-07 03:23
Core Insights - The National Standards Material has approved a total of 19,007 items, maintaining China's leading position in international metrology recognition capabilities [1] - From January to July, 549 new national standard materials were approved, representing a year-on-year increase of 56% [1] - The application fields of standard materials are driven by both traditional and emerging sectors, with environmental monitoring and high-end biomedicine being key areas [1] Group 1: Production and Approval Statistics - In the first seven months, 401 items of standard materials were produced by enterprises, accounting for 73% of the total, with a year-on-year growth of 68.5% [2] - Research institutions produced 148 items, making up 27% of the total, with a year-on-year increase of 29.8% [2] - The production of national first-level standard materials is primarily led by research institutions, achieving advanced technical standards [2] Group 2: Regional Development and Focus Areas - The North China region showed a high concentration in the production of standard materials, with 244 items approved, accounting for 44.4% of the total, and a year-on-year growth of 165.2% [2] - Beijing, leveraging its rich research resources, leads in the production of standard materials, particularly in food safety monitoring and steel manufacturing [2] - The collaboration between research institutions and enterprises in North China is enhancing the quantity and quality of standard materials [2] Group 3: Future Directions - The National Standards Administration will continue to strengthen the capacity building of national standard materials and promote the production of urgently needed materials for public welfare and industry [2]
前7个月我国新增标准物质549项 累计逾1.9万项
Yang Shi Wang· 2025-08-07 03:23
Core Insights - The National Standard Material approval has reached 19,007 items, maintaining China's leading position in international metrology recognition [1][2] - From January to July, 549 new national standard materials were approved, representing a 56% year-on-year increase, indicating strong demand in both production and research [1] Group 1: Traditional and Emerging Fields - Traditional fields, particularly environmental monitoring, remain the foundation for standard materials, with 205 items approved from January to July, accounting for 37.3% of the total and a 64% year-on-year increase [1] - Emerging sectors such as high-end biomedicine and new semiconductor manufacturing are also seeing growth, addressing key measurement technology challenges [1] Group 2: Production and Research Dynamics - Enterprises produced 401 standard materials from January to July, making up 73% of the total, with a 68.5% year-on-year increase, all classified as national secondary standard materials [2] - Research institutions produced 148 standard materials, accounting for 27% of the total, with a 29.8% year-on-year increase, including 31 national primary and 117 secondary standard materials [2] Group 3: Regional Concentration and Development - The North China region shows a high concentration in standard material production, with 244 items approved, representing 44.4% of the total and a 165.2% year-on-year increase [2] - Beijing, leveraging its rich research resources, leads in the production of standard materials, particularly in food safety monitoring and steel manufacturing [2] Group 4: Future Directions - The National Market Regulation Administration plans to enhance the capacity for national standard materials, focusing on urgent societal and industrial needs to support high-quality economic development [2]
市场监管总局扩大标准物质行政审批改革试点范围 大幅缩短审批时限
news flash· 2025-07-16 08:03
Core Viewpoint - The National Market Supervision Administration is expanding the pilot program for the administrative approval of national secondary standard substances to enhance measurement capabilities and support high-quality economic development in China [1] Group 1: Administrative Approval Reform - The administrative approval authority for national secondary standard substances will be delegated from the National Market Supervision Administration to provincial market supervision departments in Shanghai, Sichuan, Hunan, and Inner Mongolia [1] - This delegation aims to significantly shorten approval times and respond promptly to market and industry demands for standard substances [1] Group 2: Impact on Enterprises - The reform is expected to accelerate product iteration and market entry for enterprises, reducing institutional transaction costs [1] - It will stimulate market vitality among private enterprises, fostering an environment that encourages innovation and investment [1] Group 3: Industry Development - The initiative is anticipated to attract more upstream and downstream enterprises into the standard substance industry chain [1] - It aims to enhance the efficiency of converting advanced scientific and technological achievements into practical measurement capabilities, improving the self-controllable level of standard substances in China [1] - The reform will address the demand for high-end standard substances necessary for precise measurement activities across various fields [1]
《关于制造业计量创新发展的意见》发布,全面提升我国制造业计量能力
Huan Qiu Wang· 2025-06-15 00:56
Core Viewpoint - The issuance of the "Opinions on the Innovative Development of Measurement in the Manufacturing Industry" by the Ministry of Industry and Information Technology marks a significant milestone in enhancing measurement capabilities for high-quality development in China's manufacturing sector [1][4]. Group 1: Key Objectives and Goals - The document outlines three main areas: strengthening effective supply of measurement in manufacturing, deepening application empowerment, and promoting innovation and upgrading in measurement [4]. - By 2027, the goal is to achieve significant progress in manufacturing measurement, including breakthroughs in over 100 key calibration technologies, revising over 300 industry calibration standards, and developing over 100 sets of measurement instruments and standard substances [4]. - The resilience and safety of the industrial supply chain will be significantly improved, with the aim of cultivating over 50 high-quality instrument enterprises and establishing over 10 high-level calibration service institutions [4]. Group 2: Specific Measures and Implementation - The "Opinions" propose specific measures focusing on emerging fields to address challenges such as "unmeasurable" and "inaccurate" measurements, utilizing methods like "ranking and challenging" to overcome key common technologies [5]. - On the supply side, there will be an acceleration in the research and development of high-end measurement instruments and standard substances, along with the improvement of measurement technical standards [5]. - The document emphasizes the need for enhanced organizational implementation, increased resource investment, industry guidance, and deepened international cooperation to ensure the effective execution of tasks [5].
工信部明确制造业计量领域发展14项重点任务
Xin Hua Cai Jing· 2025-06-13 09:14
Core Viewpoint - The Ministry of Industry and Information Technology (MIIT) has officially released the "Opinions on the Innovation and Development of Measurement in Manufacturing" aimed at enhancing the effective supply of measurement in the manufacturing sector and promoting innovation and upgrades in measurement capabilities [1][2]. Group 1: Key Tasks for Effective Supply of Measurement - The "Opinions" outline six key tasks including breakthroughs in critical measurement technologies, acceleration of high-end measurement instrument development, enhancement of standard material development, improvement of measurement technical specifications, cultivation of quality instrument enterprises, and building a professional talent team in measurement [2]. - Emphasis is placed on innovating value traceability and transmission methods in emerging fields, developing high-precision, integrated, and intelligent measurement instruments, and establishing a quality traceability system for standard materials [2]. Group 2: Innovation and Upgrade in Measurement - The "Opinions" propose the application of advanced technologies such as artificial intelligence, big data, and cloud computing in the measurement field, along with the establishment of a manufacturing measurement database and the promotion of low-energy, low-emission measurement instruments [3]. - By 2027, the goals include achieving significant progress in measurement development, breaking through over 100 key calibration technologies, revising over 300 industry calibration specifications, and cultivating over 50 quality instrument enterprises [3]. Group 3: Implementation and Support - The MIIT plans to strengthen organizational support through enhanced implementation, increased resource investment, industry guidance, and deepening international cooperation [3]. - Collaboration with local industrial and information departments, research institutions, industry associations, and key enterprises will be emphasized to ensure the effective execution of the tasks outlined in the "Opinions" [3].
工信部:到2027年突破100项以上关键计量校准技术,培育50家以上仪器仪表优质企业
news flash· 2025-06-13 02:18
Core Viewpoint - The Ministry of Industry and Information Technology has released opinions on the innovation and development of measurement in the manufacturing industry, aiming for significant advancements by 2027 and continuous improvement by 2030 to support high-quality development in China's manufacturing sector [1][2][3]. Summary by Sections Overall Requirements - The initiative is guided by Xi Jinping's thoughts and aims to enhance the innovation capability of manufacturing measurement, focusing on precision measurement and establishing a robust calibration service system [2]. Key Development Goals - By 2027, the goals include breakthroughs in over 100 key calibration technologies, revision of over 300 industry calibration standards, development of over 100 sets of measuring instruments and standard substances, and the establishment of over 50 quality instrument enterprises [3][4]. Strengthening Effective Supply of Measurement - Focus on overcoming common measurement technology challenges in emerging fields like quantum and AI, and promote military-civilian integration in measurement technology [4]. - Accelerate the development of high-end measuring instruments to meet international standards and enhance reliability and safety [5]. - Develop standard substances across key industries and establish a quality traceability system [6]. Enhancing Measurement Application - Support the establishment of high-level calibration service institutions to provide integrated solutions for precision measurement [8]. - Strengthen legal compliance in measurement standards and ensure proper calibration of measuring instruments [9]. Building Measurement Service Institutions - Systematically develop high-level calibration service institutions to address manufacturing needs and enhance service efficiency [10][11]. Promoting Innovation and Upgrading Measurement - Encourage the integration of advanced technologies like AI and big data in measurement practices to enhance service capabilities [12][13][14]. - Promote green measurement practices to align with low-carbon initiatives [13]. Strengthening Support Measures - Enhance policy coordination and resource investment to support measurement initiatives in manufacturing [14][15]. - Foster international collaboration in measurement technology development and training [16].
2025年中国标准物质行业发展现状、竞争格局及趋势预测
Sou Hu Cai Jing· 2025-05-31 13:52
Group 1 - The core viewpoint of the articles emphasizes the essential role of standard materials in the analytical measurement industry, particularly in calibrating instruments, evaluating measurement methods, and ensuring quality control in production processes [1][6][11] - The upstream segment focuses on the research and development of basic materials and technologies, including high-purity chemicals and biological samples, while the midstream involves the production of standard materials, and the downstream applications span various industries such as pharmaceuticals, food testing, and environmental monitoring [1][8][9] - The domestic standard materials market is projected to reach a total scale of 4.158 billion yuan by 2024, with a compound annual growth rate (CAGR) of 6.67% from 2019 to 2024, driven by sectors closely related to public health and safety [13][14] Group 2 - The domestic standard materials industry has seen rapid development, with an increasing number of local producers aligning with international standards, resulting in improved quality and growth [15] - The competitive landscape consists of three main categories of players: official testing institutions from various countries, international groups with standard materials businesses, and local Chinese companies [15][17] - The report provides a comprehensive analysis of the standard materials industry, including market capacity, industry chain, operational characteristics, profitability, and business models, utilizing various research methodologies [2][25] Group 3 - The report outlines the structure of the standard materials industry chain, highlighting the importance of upstream material supply, midstream production, and downstream applications in various sectors [8][9] - The standard materials market is expected to maintain rapid growth, particularly in areas directly related to public health, such as environmental and food safety, pharmaceuticals, and clinical applications [13][14] - The report includes a detailed analysis of key enterprises in the standard materials sector, such as Tanmo Testing Technology Co., Ltd., which is a leading player in the domestic market with significant revenue from standard materials [18][19]
2025年中国标准物质行业概述、市场规模及整体发展形势研判:新的生产者和国产标准物质的数量持续增加,市场规模仍保持增长[图]
Chan Ye Xin Xi Wang· 2025-04-28 01:33
Core Viewpoint - The standard material market in China is experiencing rapid growth, driven by increasing demand for testing and inspection across various industries, with the market expected to reach 41.58 billion yuan in 2024 and 44.21 billion yuan in 2025 [1][4][6]. Industry Definition and Characteristics - Standard materials are substances with uniform and stable specific characteristics, essential for calibration, measurement method evaluation, and assigning values to materials in fields like chemistry, biology, and environmental science [2][4]. - They are critical tools for ensuring measurement accuracy, comparability, and traceability, serving as benchmarks in scientific services and quality control [2][4]. Current Development Status - The standard material industry is a vital part of the measurement system, with a market size projected to grow from 33.16 billion yuan in 2020 to 41.58 billion yuan in 2024, and further to 44.21 billion yuan in 2025 [4][6]. - The demand for standard materials is expanding due to heightened health awareness and increased inspection needs across various sectors [4][6]. Industry Applications - Standard materials are utilized in environmental monitoring, food safety, pharmaceuticals, and industrial materials, with the environmental and food standard material market expected to account for over 60% of the total market share in 2024 [6][10]. Industry Chain Structure - The upstream of the standard material industry includes suppliers of high-purity chemical reagents, biological standard material raw materials, and precision equipment [8]. - The midstream involves the research and production of standard materials, while the downstream consists of testing and inspection industries, including third-party testing organizations and regulatory bodies [8][10]. Development History - China's standard material industry has evolved significantly, transitioning from reliance on imported materials to developing domestic capabilities, with some products now exported to over 20 countries [12][14]. Competitive Landscape - The market features a mix of international and domestic players, with local companies increasingly closing the quality gap with established international firms [15][16]. - Key domestic companies include Anpel, Tanmo Quality Inspection, and others, which are expanding their product offerings and capabilities [18][19][21]. Future Trends - The domestic standard material market is expected to continue its rapid growth, with an increasing number of producers and improved quality standards [24].