Batch requirements for clinical samples
Batch requirements for clinical samples, Total:80 items.
The international standard classification for "Batch requirements for clinical samples" includes: Medical Sciences and health care facilities in general , Laboratory medicine , Diagnostic equipment , Quality management and quality assurance .
The Chinese standard classification for "Batch requirements for clinical samples" includes: Sanitation in general , Medical electronic equipment , Medical apparatus and devices in general , Leather processing and products in general .
Beijing Provincial Standard of the People's Republic of China
- DB11/T 2065-2022 Basic security requirements for clinical biobanks
Professional Standard - Hygiene
- WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
- WS/T 255-2005 Clinical laboratory medicine-Requirements for reference measurement laboratories
- WS/T 406-2012 Analytical quality specifications for routine tests in clinical hematology
Group Standards of the People's Republic of China
- T/WLJC 115-2022 Designof three-dimensional for Machine tool products Synthesize show request of product drawings
- T/CACM 1063~1064-2018 Acupuncture Medicine Clinical Basic Terminology Acupuncture Medicine Clinical General Requirements
- T/SDHCST 002-2023 Test Substance Requirements on the Non-Clinical Studies of the Cell Therapy Medical Products
- T/CADERM 9101-2023 Diagnostic requirements for magnetocardiogram of myocardial ischemia in clinical application
- T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
- T/CSBME 079-2024 Quality acceptance requirements for clinical used PET/CT positron drugs in lung cancer
- T/WLJC 107-2022 Designof three-dimensional for Machine tool products General principles of drawings protract
- T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
- T/CGCPU 028-2023 Requirements for quality control on non gene modified immune cells clinical research
- T/CACM 1064-2018 Acupotomology clinic-General requirements
- T/SSFSIDC 015-2023 Clinical trial data collection requirements
- T/CVMA 121-2023 Energy requirement assessment guidelines for dogs and cats
- T/SHPPA 028-2024 Quality requirements of phage preparations used for clinical therapy
- T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
- T/ZJPA 002-2024 Clinical Research Coordinator (CRC) Training Requirement
- T/ZSA 95-2021 Requirements for quality control on chimeric antigen receptor T cell products clinical research
- T/ZJPA 001-2024 Requirements for Clinical Research Coordinator (CRC) professional ability
- T/CGCPU 017-2021 Quality control requirements for clinical research of CAR-T cell products
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
- GB/T 20470-2006 Requirements of external quality assessment for clinical laboratories
卫生健康委员会
- WS/T 662-2020 Technical requirements for clinical body fluids analysis
Professional Standard - Medicine
- YY 0785-2010 Clinical thermometers—Performance of electrical thermometers for continuous measurement
未注明发布机构
- GJB 1330A-2019 Quality control requirement for military products lotting
- SAE ARP9013/4A-2018 Statistical Product Acceptance Requirements Using Continuous Sampling@ Skip-Lot Sampling@ or Methods for Special Cases
- DIN EN ISO 2588 E:2012-10 Sampling quantity for leather sampling batches (draft)
- WS 533-2017 Clinical nuclear medicine patient protection requirements
国家卫生计生委
- WS/T 494-2017 Guideline for performance characteristics of immunological qualitative test
中华人民共和国国家卫生和计划生育委员会
- WS/T 227-2002 Requirement for the technical procedure manual in clinical laboratory
Professional Standard - Commodity Inspection
- SN/T 0952-2000 Sampling procedures for import and export commodity inspection - Estimation of nonconforming proportion and selection of sample size for isolated lot inspection by attributes
国家市场监督管理总局、中国国家标准化管理委员会
- GB/T 22576.5-2021 Medical laboratories-Requirements for quality and competence- Part 5:Requirements in the field of clinical immunology examination
- GB/T 22576.6-2021 Medical laboratories—Requirements for quality and competence—Part 6: Requirements in the field of clinical microbiological examination
- GB/T 22576.2-2021 Medical laboratories-Requirements for quality and competence- Part 2:Requirements in the field of clinical hematological examination
- GB/T 22576.4-2021 Medical laboratories-Requirements for quality and competence- Part 4:Requirements in the field of clinical chemistry examination
工业和信息化部
- QB/T 1265-2017 Fur. Sampling. Number of items for a gross sample
Professional Standard - Light Industry
- QB/T 3812.3-1999 Leather. Sampling. Number of items for a gross sample
- QB/T 2708-2005 Leather - Sampling - Number of items for a gross sample
Military Standard of the People's Republic of China-General Armament Department
- GJB 1330-1991 Quality control requirements for batch management of military products
未注明发布机构
- DIN EN ISO 2588 E:2012-10 Sampling quantity for leather sampling batches (draft)
- WS 533-2017 Clinical nuclear medicine patient protection requirements
- SAE ARP9013/4A-2018 Statistical Product Acceptance Requirements Using Continuous Sampling@ Skip-Lot Sampling@ or Methods for Special Cases
- GJB 1330A-2019 Quality control requirement for military products lotting
Shanghai Provincial Standard of the People's Republic of China
- DB31/T 687-2013 Basic requirements for clinical cell therapy platform settings
Anhui Provincial Standard of the People's Republic of China
- DB34/T 4796-2024 Quality control standards for comprehensive clinical evaluation of drugs
RU-GOST R
- GOST R 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
- GOST R 53022.4-2008 Medical laboratory technologies. Requirement of quality of clinical laboratory tests. Part 4. Rules for development of requirements to timeliness of laboratory information submitting
- GOST R 57525-2017 Clinical and economic analysis. General requirements
- GOST R 53022.2-2008 Clinical laboratory technologies. Requirements for quility of clinical laboratory tests. Part 2. Assessment of methods analytical reliability (accuracy, censitivity, specificity)
GOST
- GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals
- GOST R 59921.9-2022 Artificial intelligence systems in clinical medicine. Algorithms for data analysis in clinical physiology. Testing methods. General requirements
ZA-SANS
- SANS 5001:1971 Sterility testing: sampling, criteria of compliance of a batch with sterility requirements
International Organization for Standardization (ISO)
- ISO/TR 7553:1987 Fertilizers; Sampling; Minimum mass of increment to be taken to be representative of the total sampling unit
- ISO 7002:1986 Agricultural food products; Layout for a standard method of sampling from a lot
- ISO 2588:2014 Leather - Sampling - Number of items for a gross sample
- ISO 2588:1985 Leather; Sampling; Number of items for a gross sample
AENOR
- UNE 129001:1997 CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.
Society of Automotive Engineers (SAE)
- SAE ARP9013/1-2005 Statistical Product Acceptance Requirements Using Isolated Lot Sampling Methods
- SAE ARP9013/2-2005 Statistical Product Acceptance Requirements Using Attribute or Variable Lot Acceptance Sampling Plans
PL-PKN
- PN C04808-1988 Washing powders Preparation of bulk sample
Korean Agency for Technology and Standards (KATS)
- KS H ISO 7002:2003 Agricultural food products－Layout for a standard method of sampling from a lot
- KS P 8429-2015(2020) General requirements for clinical laboratory automation system information
American Society for Testing and Materials (ASTM)
- ASTM E1466-92(1999) Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
Electronic Components, Assemblies and Materials Association
- ECA TEP140-1974 Proposed Acceptance Sampling Procedures for Small Lots
British Standards Institution (BSI)
- BS EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - General requirements
- BS EN ISO 2588:2014 Leather. Sampling. Number of items for a gross sample
GOSTR
- GOST R 58090-2018 Clinical examination of unproductive animals. General requirements
SAE - SAE International
- SAE ARP9013/1A-2018 Statistical Product Acceptance Requirements Using Isolated Lot Sampling Methods
- SAE ARP9013/4A-2005 Statistical Product Acceptance Requirements Using Continuous Sampling@ Skip-Lot Sampling@ or Methods for Special Cases
Standard Association of Australia （SAA）
- AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements
Association Francaise de Normalisation
- NF G52-044*NF EN ISO 2588:2014 Leather - Sampling - Number of items for a gross sample
- NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
Danish Standards Foundation
- DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
IT-UNI
- EC 1-2020 UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
- UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
US-CLSI
- CLSI MM19-A-2011 Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline
US-AAMI
- ANSI/AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects-Good clinical practice
- ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
SCC
- BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
