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preclinical samples

preclinical samples, Total:165 items.

In the international standard classification, preclinical samples involves: Vocabularies, Laboratory medicine, Medical equipment, Medical sciences and health care facilities in general, Pharmaceutics, Dentistry, Machine tools, Test conditions and procedures in general, Products of the chemical industry, Water quality, Terminology (principles and coordination), Analytical chemistry, Food products in general, Tobacco, tobacco products and related equipment, Geology. Meteorology. Hydrology, Biology. Botany. Zoology, Milk and milk products, Products of the textile industry, Applications of information technology, Microbiology, Quality, Air quality, Environmental protection, Corrosion of metals.

Group Standards of the People's Republic of China, preclinical samples

T/CAV 001-2023 Terms used in vaccine preclinical research
T/CACM 1245-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM anterior uveitis
T/CACM 1165-2019 Clinical guidelines for diagnosis and treatment of proctology in TCM Rectocele
T/CACM 1260-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Premenstrual syndrome
T/CACM 1126-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Premenstrual mental disorder
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CACM 1308-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM Anteriorischemic Optic Neuropathy
T/CNMIA 0012-2020 Clinical Test Assessment of anti-Acne Cosmetics
T/CNMIA 0015-2020 Clinical Test Assessment of Cosmetics for Sensitive Skin
T/CACM 014-2017 Clinical diagnostic criteria of phlegm-damp syndrome in coronary atherosclerotic heart disease
T/SHRH 018-2021 Cosmetics improve the effect of eye contours Clinical evaluation method
T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
T/CGCPU 017-2021 Quality control requirements for clinical research of CAR-T cell products
T/CACM 062-2018 Clinical diagnostic criteria for coronary atherosclerotic heart disease with phlegm and blood stasis syndrome
T/LTIA 12-2021 Method for the collection, transfer, and inactivation of clinically specimens for the COVID-19
T/CACM 1351-2021 Standards for collection, preservation and transportation of fecal microbial samples in clinical trials of TCM
T/SATCM 001-2023 Expert Consensus on Traditional Chinese Medicine Clinical Diagnosis and Treatment of Pediatric Adenoid Hypertrophy with the Characteristic Advantages of Shanghai-style Traditional Chinese Medicine
T/ZSA 95-2021 Requirements for quality control on chimeric antigen receptor T cell products clinical research
T/CACM 1353-2021 Technical guidelines for clinical trial design and evaluation of traditional Chinese medicine in the treatment of carotid atherosclerosis
T/SZGIA 1.4-2017 Detectionofenvironmentalmicroorganismsbasedonhigh-throughputsequencing Part4:Methodologyofdetectingclinicalpathogenicmicroorganism
T/COCIA 9-2020 Clinical method for evaluation of anti-halitosis effect of toothpaste efficacy of oral care products
T/COCIA 10-2020 Clinical method for evaluation of anti-calculus effect of toothpaste efficacy of oral cleaning care products
T/WLJC 115-2022 Designof three-dimensional for Machine tool products Synthesize show request of product drawings
T/SHPPA 023-2023 Long term follow-up study guidance for CAR-T cell therapy products
T/CMBA 013-2021 Specification for hospital in management of clinical application of chimeric antigen receptor T cell marketed products
T/WLJC 107-2022 Designof three-dimensional for Machine tool products General principles of drawings protract
T/WLJC 106-2022 Designof three-dimensional for machine tool products General principles of drawing configure
T/WLJC 108-2022 Designof three-dimensional for Machine tool products General principles of drawings presentation
T/COCIA 8-2020 Clinical method for evaluating the efficacy of toothpaste, an oral cleaning care product, to remove exogenous stains
T/COCIA 13-2021 Clinical method for evaluating the efficacy of bleaching and optical whitening of oral hygiene care products toothpaste

Professional Standard - Hygiene , preclinical samples

WS/T 460-2015 Clinical practice of PSA test in prostatic cancer
WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

American Society for Testing and Materials (ASTM), preclinical samples

ASTM E1466-92(1999) Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
ASTM F2884-21 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
ASTM F2884-12 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
ASTM F2721-09(2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
ASTM F2721-09(2023) Standard Guide for Preclinical in vivo Evaluation in Critical-Size Segmental Bone Defects
ASTM F2721-08 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
ASTM G168-00(2006) Standard Practice for Making and Using Precracked Double Beam Stress Corrosion Specimens
ASTM G168-00(2013) Standard Practice for Making and Using Precracked Double Beam Stress Corrosion Specimens

国家药监局, preclinical samples

YY/T 1679-2021 Guidance for the preclinical evaluation of tissue engineered medical device products in critical size bone defects in the bone
YY/T 1754.1-2020 Preclinical Animal Studies for Medical Devices Part 1: General Requirements
YY/T 1754.2-2020 Medical Device Preclinical Animal Studies Part 2: Induced Diabetic Rat Skin Defect Model

Professional Standard - Agriculture, preclinical samples

农业部1247号公告-6-2009 Guiding principles for preclinical toxicology evaluation tests of veterinary drugs
水产品质量安全检验手册 1.3.2.9-2005 Chapter 1 General Introduction Section 3 Sample Treatment 2. New Technology of Sample Pretreatment (9) Supercritical Fluid Extraction Technology
水产品质量安全检验手册 1.3.1.5-2005 Chapter 1 General Introduction Section 3 Sample Treatment 1. Sample pretreatment method (5) Dialysis method
水产品质量安全检验手册 1.3.1.2-2005 Chapter 1 General Introduction Section 3 Sample Treatment 1. Sample pretreatment method (2) Precipitation method
水产品质量安全检验手册 1.3.1.6-2005 Chapter 1 General Introduction Section 3 Sample Treatment 1. Sample pretreatment method (6) Extraction method
水产品质量安全检验手册 1.3.1.1-2005 Chapter 1 General Introduction Section 3 Sample Treatment 1. Sample pretreatment method (1) Volatility method
水产品质量安全检验手册 1.3.1.4-2005 Chapter 1 General Introduction Section 3 Sample Treatment 1. Sample pretreatment method (4) Adsorption method
水产品质量安全检验手册 1.3.1.3-2005 Chapter 1 General Introduction Section 3 Sample Treatment 1. Sample pretreatment method (3) Distillation method
水产品质量安全检验手册 1.3.2.4-2005 Chapter 1 General Introduction Section 3 Sample Treatment 2. New Technology of Sample Pretreatment (4) Solid Phase Extraction
水产品质量安全检验手册 1.3.2.2-2005 Chapter 1 General Introduction Section 3 Sample Treatment 2. New technology of sample pretreatment (2) Microwave extraction
水产品质量安全检验手册 1.3.2.1-2005 Chapter 1 General Introduction Section 3 Sample Treatment 2. New technology of sample pretreatment (1) Microwave digestion
水产品质量安全检验手册 1.3.1.7-2005 Chapter 1 General Introduction Section 3 Sample Treatment 1. Sample pretreatment method (7) Organic matter destruction method
水产品质量安全检验手册 1.3.2.8-2005 Chapter 1 General Introduction Section 3 Sample Treatment 2. New Technology of Sample Pretreatment (8) Derivatization Technology
水产品质量安全检验手册 1.3.2.6-2005 Chapter 1 General Introduction Section 3 Sample Treatment 2. New Technology of Sample Pretreatment (6) Gel Permeation System
水产品质量安全检验手册 1.3.1.8-2005 Chapter 1 General Introduction Section 3 Sample Treatment 1. Sample pretreatment methods (8) Application of centrifugation technology
水产品质量安全检验手册 1.3.2.7-2005 Chapter 1 General Introduction Section 3 Sample Processing 2. New Technology of Sample Pretreatment (7) Automatic Separation Technology
水产品质量安全检验手册 1.3.2.5-2005 Chapter 1 General Introduction Section 3 Sample Treatment 2. New technology of sample pretreatment (5) Solid phase microextraction technology
水产品质量安全检验手册 1.3.2.3-2005 Chapter 1 General Introduction Section 3 Sample Processing 2. New technology of sample pretreatment (3) Fast solvent extraction technology

Beijing Provincial Standard of the People's Republic of China, preclinical samples

DB11/T 2065-2022 Basic security requirements for clinical biobanks

International Organization for Standardization (ISO), preclinical samples

ISO/TS 22911:2016 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
ISO/TS 22911:2005 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
ISO 18117:2009 Surface chemical analysis - Handling of specimens prior to analysis
ISO 11980:2009 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
ISO 23089-2:2021 Implants for surgery - Pre-clinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
ISO 230-12:2022 Test code for machine tools — Part 12: Accuracy of finished test pieces
ISO/TR 15300:2001 Dentistry - Application of OSI clinical codification to the classification and coding of dental products
ISO/CD 20579-1:2023 Surface chemical analysis — Sample handling, preparation and mounting — Part 1: Documenting and reporting the handling of specimens prior to analysis
ISO/DIS 20579-1:2023 Surface chemical analysis — Sample handling, preparation and mounting — Part 1: Documenting and reporting the handling of specimens prior to analysis
ISO 11980:1997/Cor 1:1998 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations; Technical Corrigendum 1

卫生健康委员会, preclinical samples

WS/T 640-2018 Collection and transportation of samples for clinical microbiology testing
WS/T 404.9-2018 Reference intervals for commonly used clinical biochemical test items Part 9: Serum C-reactive protein, prealbumin, transferrin, β2-microglobulin

Korean Agency for Technology and Standards (KATS), preclinical samples

KS B 4208-2013 specified items for machine tools
KS B 4208-2014 Specified items for machine tools
KS B 4208-1981 specified items for machine tools
KS P ISO TS 22911:2010 Dentistry-Preclinical evaluation of dental implant systems-Animal test methods
KS P ISO TS 22911:2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
KS P 8430-2015(2020) Management and safety requirements for clinical laboratory pre-analytical automation system
KS P ISO TR 15300:2019 Dentistry ― Application of OSI clinical codification to the classification and coding of dental products
KS P ISO 11980-2006(2016) Ophthalmic optics－Contact lenses and contact lens care products－Guidance for clinical investigations
KS P ISO 11980:2006 Ophthalmic optics－Contact lenses and contact lens care products－Guidance for clinical investigations
KS P ISO 11980-2006(2021) Ophthalmic optics－Contact lenses and contact lens care products－Guidance for clinical investigations
KS P ISO TR 15300:2013 Dentistry－Application of OSI clinical codification to the classification and coding of dental products

Professional Standard - Medicine, preclinical samples

YY/T 0522-2009 Dentistry Preclinical evaluation of dental implant systems Animal test methods
YY/T 0268-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 1:Evaluation and test methods selection
YY/T 0127.11-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 2:Biological evaluation test method of dental materials----Pulp capping test
YY/T 1754.3-2023 Preclinical Animal Studies of Medical Devices Part 3: An Animal Incisional Hernia Model for Evaluation of Mesh Histological Response and Biomechanical Properties

KR-KS, preclinical samples

KS P ISO TS 22911-2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
KS P ISO TR 15300-2019 Dentistry ― Application of OSI clinical codification to the classification and coding of dental products

US-CFR-file, preclinical samples

CFR 21-862.1-2013 Food and Drugs. Part862:Clinical chemistry and clinical toxicology devices. Section862.1:Scope.

RU-GOST R, preclinical samples

GOST R 56699-2015 Medicines for medical applications. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. General recommendations
GOST 32893-2014 Perfumery and cosmetics. Methods of evaluation of toxicological and clinical safety indices
GOST R 55041-2012 Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations
GOST 30527-1997 Metal-cutting machines. Checking methods of product specimen working accuracy
GOST R 57106-2016 Products diet therapeutic and preventive nutrition diet. Complexes vitamin-mineral in clinical nutrition. Specification
GOST 25443-1982 Metal-cutting machines. Product specimens for control of working aceuracy. General technical requirements

American National Standards Institute （ANSI), preclinical samples

ANSI/NFPA 1126-2011 Standard for the Use of Pyrotechnics Before a Proximate Audience

British Standards Institution (BSI), preclinical samples

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS ISO 18117:2009 Surface chemical analysis - Handling of specimens prior to analysis
BS ISO 23089-2:2021 Implants for surgery. Pre-clinical mechanical assessment of spinal implants and particular requirements. Spinal intervertebral body fusion devices
BS EN ISO 11980:2009 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
BS EN ISO 11980:2012 Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations
BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
20/30380646 DC BS ISO 23089-2. Implants for surgery. Pre-clinical mechanical assessment of spinal implants and particular requirements. Part 2. Spinal intervertebral body fusion devices
17/30325154 DC BS ISO 20579-2. Surface chemical analysis. Guidelines to sample handling, preparation and mounting. Part 2. Guidelines to preparation and mounting of specimens prior to analysis

European Committee for Standardization (CEN), preclinical samples

EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
CEN/TS 12633:2014 Method of polishing specimens prior to the measurement of slip and skid resistance
EN ISO 7405:1997 Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials ISO 7405: 1997
prEN ISO 11980 rev Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations
EN ISO 11980:2009 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
prEN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
FprEN ISO 20916 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
EN ISO 11980:1997 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Guidance for Clinical Investigations ISO 11980:1997

UY-UNIT, preclinical samples

NORMA 36-P-1947

Association Francaise de Normalisation, preclinical samples

NF S94-801:2007 Vaginal reinforcement implant for stress urinary incontinence and/or pelvic organ prolapse repair surgery through vaginal approach - Pre-clinical and clinical tests.
NF ISO 18117:2009 Analyse chimique des surfaces - Manipulation des échantillons avant analyse
NF G07-204:1984 Textiles. Tests for colour fastness. Specifications for standard adjacent fabric : polyester.
NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
FD S91-016*FD ISO/TR 15300:2002 Dentistry - Application of OSI clinical codification to the classification and coding of dental products
NF ISO 20916:2019 Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude
FD ISO/TR 15300:2002 Art dentaire - Application de la codification clinique OSI au domaine de la classification et du codage des fournitures dentaires
NF EN ISO 11980:2013 Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Directives pour les investigations cliniques
XP P98-346*XP CEN/TS 12633:2016 Method of polishing specimens prior to the measurement of slip and skid resistance
NF G07-205:1984 Textiles. Tests for colour fastness. Specifications for standard adjacent fabric : acrylic.
NF X43-014:2017 Air quality - Ambient air - Determination of total atmospheric deposition - Sampling - Preparation of samples prior analysis
NF T60-166:1994 Produits de protection temporaire contre la corrosion - Méthode de préparation des éprouvettes métalliques pour évaluation des propriétés des produits de protection
NF X43-014:2003 Air quality - Ambient air - Determination of total atmospheric deposition - Sampling - Preparation of samples prior analysis.

水利部, preclinical samples

SL 391-2007 Sample preparation methods for organic analysis

CZ-CSN, preclinical samples

CSN 56 0065-1985 Methods of sample mineralization before the determination of heavy metals content in the foodstuffs

GOSTR, preclinical samples

GOST R 57849-2017 Bee products. Sample preparation for the determination of pesticides chromatographic methods

Professional Standard - Tobacco, preclinical samples

YC/T 145.11-2012 Tobacco flavor.Pretreatment method of complex samples

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, preclinical samples

GB/T 28894-2012 Surface chemical analysis.Handing of specimens prior to analysis
GB/T 30744-2014 The technology specification for the pre-treatment of deep-sea microorganism samples
GB/T 15440-1995 Guidelines for preparing samples for genetoxicity testing of organic pollutants in environment

未注明发布机构, preclinical samples

BS ISO 18117:2009(2015) Surface chemical analysis — Handling of specimens prior to analysis

German Institute for Standardization, preclinical samples

DIN CEN/TS 12633:2014-12*DIN SPEC 5277:2014-12 Method of polishing specimens prior to the measurement of slip and skid resistance; German version CEN/TS 12633:2014
DIN EN ISO 11980:2013-03 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012); German version EN ISO 11980:2012
DIN EN ISO 20916:2021-05 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021 / Note: Date of issue 2021-04-09
DIN 19671-1:1964-05 Soil drilling apparatus for drawing soil samples in agricultural engineering; groove borers, tube borers
DIN 58942-4 Bb.1:2004 Medical microbiology - Culture media - Part 4: Transport systems for specimens containing bacteria - Systems, media and conditions for the transport of selected pathogens in clinical specimens

农业农村部, preclinical samples

NY/T 3051-2016 Standards for handling samples before monitoring raw milk safety indicators

Danish Standards Foundation, preclinical samples

DS/EN ISO 11980:2013 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
DS/ISO 23089-2:2021 Implants for surgery – Pre-clinical mechanical assessment of spinal implants and particular requirements – Part 2: Spinal intervertebral body fusion devices

AT-ON, preclinical samples

OENORM EN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

Professional Standard - Water Conservancy, preclinical samples

SL 391.3-2007 Sample preparation methods for organic analysis.Part 3:Solid-phase extraction(SPE)
SL 391.1-2007 Sample preparation methods for organic analysis.Part 1:liquid-liquid extraction
SL 391.2-2007 Sample preparation methods for organic analysis.Part 2:Soxhlet extraction
SL 391.7-2007 Sample preparation methods for organic analysis.Part 7:Silica gel cleanup
SL 391.9-2007 Sample preparation methods for organic analysis.Part 9:Sulfur cleanup
SL 391.5-2007 Sample preparation methods for organic analysis.Part 5:Alumina cleanup
SL 391.4-2007 Sample preparation methods for organic analysis.Part 4:Accelerated solvent extraction(ASE)
SL 391.8-2007 Sample preparation methods for organic analysis.Part 8:Acid-base partition cleanup
SL 391.6-2007 Sample preparation methods for organic analysis.Part 6:Florisil cleanup
SL 391.10-2007 Sample preparation methods for organic analysis.Part 10:Sulfuric acid/permanganate cleanup

国家市场监督管理总局、中国国家标准化管理委员会, preclinical samples

GB/T 39303-2020 General technical specification for pre-treatment of microorganism samples in wastewater treatment system
GB/T 39304-2020 General technical specification for sample pre-treatment of biological toxicity detection in reclaimed water

Lithuanian Standards Office , preclinical samples

LST EN ISO 11980:2013 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)

AENOR, preclinical samples

UNE-EN ISO 11980:2013 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)

RO-ASRO, preclinical samples

STAS 10542/1-1986 MEAT AND MEAT PRODUCTS Decomposition of test samples prior to determination of metals and arsenic content
STAS 8342/1-1986 MILK AND MILK PRODUCTS.Decomposition of test samples prior to determination of metals and arsenic content

Professional Standard - Commodity Inspection, preclinical samples

SN/T 4401.1-2015 Methods of qualitative and quantitative analysis for drug in clinical sample.Part 1:Ketamine