实验室仪器设备管理规范
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最新《实验室仪器设备管理规范》,半年后实施
仪器信息网· 2025-12-26 09:02
Core Viewpoint - The article discusses the implementation of the "Laboratory Instrument and Equipment Management Specifications" by the Guangdong Metrology Association, which will take effect on June 24, 2026. The specifications outline requirements for the acquisition, installation, acceptance, operation, disposal, information management, and risk management of laboratory instruments and equipment. Group 1: Scope and Applicability - The document specifies management requirements for laboratory instruments and equipment, applicable to non-third-party testing or calibration laboratories, with other types of laboratories encouraged to refer to it [3]. Group 2: Acquisition Process - Laboratories must acquire all necessary instruments and equipment through procurement, self-manufacturing, leasing, or borrowing, ensuring independent control and usage rights during the contract period [4][15]. - The acquisition process includes drafting demand documents, conducting preliminary communication and research with suppliers, and preparing procurement documents that include technical and business requirements [16][17][18]. Group 3: Installation and Verification - Laboratories are responsible for confirming installation conditions, ensuring compliance with manufacturer specifications, and documenting the installation process [30][32]. - The installation must be conducted according to the supplier's instructions, and any abnormalities during installation should be recorded and verified with the supplier [32][34]. Group 4: Acceptance Procedures - Acceptance of instruments typically occurs immediately after installation, with personnel required to verify the appearance, specifications, and installation compliance [38][39]. - A detailed operational testing verification plan must be developed to ensure that the instrument's performance meets established technical specifications [40]. Group 5: Operation and Maintenance - Laboratories must maintain a detailed equipment ledger, documenting essential information such as model, serial number, calibration cycle, and maintenance records [49]. - Regular maintenance plans should be established for sensitive and frequently used instruments, with qualified personnel responsible for maintenance tasks [67]. Group 6: Disposal Criteria - Instruments should be considered for disposal if they frequently malfunction, cannot meet performance requirements, or pose safety risks [85][86]. - Software should be disposed of if it is no longer supported by the manufacturer or if maintenance costs exceed its value [88].