preclinical model

preclinical model, Total:73 items.

The international standard classification for "preclinical model" includes: Medical equipment in general , Implants for surgery, prosthetics and orthotics , Laboratory medicine .

The Chinese standard classification for "preclinical model" includes: Medical apparatus and devices in general , Extracorporeal circulation, artificial organ and prosthesis device , Sanitation in general .

未注明发布机构

DIN EN ISO 13972 E:2020-11 Health informatics clinical information model characteristics, structure and requirements (draft)
DIN EN ISO 13972:2022 Health informatics - Clinical information models - Characteristics, structures and requirements
ANSI/ADA 1039-2006(2014) Standard Clinical Conceptual Data Model

Group Standards of the People's Republic of China

T/CAV 001-2023 Terms used in vaccine preclinical research
T/CACM 1308-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM Anteriorischemic Optic Neuropathy
T/CACM 1126-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Premenstrual mental disorder
T/CACM 1260-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Premenstrual syndrome
T/CACM 1245-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM anterior uveitis
T/SDHCST 004-2023 Animal Species and Model Selection for Non-clinical Studies of the Cell Therapy Medical Products
T/CACM 1165-2019 Clinical guidelines for diagnosis and treatment of proctology in TCM Rectocele
T/CRHA 066-2024 Meta data model and data quality evaluation specification for clinical research of lymphoma

国家药监局

YY/T 1754.2-2020 Preclinical animal study of medical devices—Part 2:Model of skin defect in induced diabetic rats
YY/T 1679-2021 Tissue engineering medical device products-Bone-Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects
YY/T 1754.1-2020 Preclinical animal study of medical devices—Part 1:General considerations

Professional Standard - Hygiene

WS/T 460-2015 Clinical practice of PSA test in prostatic cancer

Professional Standard - Medicine

YY/T 0522-2009 Dentistry Preclinical evaluation of dental implant systems Animal test methods
YY/T 1754.4-2024 Preclinical animal studies of medical devices Part 4: Acute wound models for evaluating healing-enhancing dressings

Professional Standard - Agriculture

农业部1247号公告-6-2009 Guiding principles for preclinical toxicology evaluation tests of veterinary drugs

SCC

ADA 1039-2006(R2014) Standard Clinical Conceptual Data Model
DANSK DS/ISO/TS 18864:2017 Health informatics – Quality metrics for detailed clinical models
BS PD ISO/TS 18864:2017 Health informatics. Quality metrics for detailed clinical models
DANSK DS/ISO 13972:2022 Health informatics – Clinical information models – Characteristics, structures and requirements
SN-CEN ISO/TS 13972:2015 Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:2015)
NS-EN ISO 13972:2022 Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022)
DIN CEN ISO/TS 13972:2016 Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:2015); English version CEN ISO/TS 13972:2015
DANSK DS/CEN ISO/TS 13972:2015 Health informatics – Detailed clinical models, characteristics and processes (ISO/TS 13972:2015)
DANSK DS/EN ISO 13972:2022 Health informatics – Clinical information models – Characteristics, structures and requirements (ISO 13972:2022)

International Organization for Standardization (ISO)

ISO/TS 18864:2017 Health informatics - Quality metrics for detailed clinical models
ISO/TS 13972:2015 Health informatics - Detailed clinical models, characteristics and processes
ISO 13972:2022 Health informatics — Clinical information models — Characteristics, structures and requirements
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

British Standards Institution (BSI)

PD ISO/TS 18864:2017 Health informatics. Quality metrics for detailed clinical models
BS PD CEN ISO/TS 13972:2015 Health informatics. Detailed clinical models, characteristics and processes
BS EN ISO 13972:2022 Health informatics. Clinical information models. Characteristics, structures and requirements
20/30406205 DC BS EN ISO 13972. Health informatics. Clinical information models. Characteristics, structures and requirements

American Society for Testing and Materials (ASTM)

ASTM E2210-02 Standard Specification for Guideline Elements Model (GEM)-Document Model for Clinical Practice Guidelines
ASTM F2884-12 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
ASTM F2884-21 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 E2210-06 Standard Specification for Guideline Elements Model version 2 (GEM II)-Document Model for Clinical Practice Guidelines
ASTM E2210-12 Standard Specification for Guideline Elements Model version 3 (GEM III)mdash;Document Model for Clinical Practice Guidelines
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

GSO

BH GSO ISO/TS 13972:2022 Health informatics — Detailed clinical models, characteristics and processes
GSO ISO/TS 13972:2021 Health informatics — Detailed clinical models, characteristics and processes
BH GSO ASTM F2884:2022 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
GSO ASTM F2884:2021 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
OS GSO ISO/TS 22911:2015 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
BH GSO ISO/TS 22911:2017 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
GSO ISO/TS 22911:2015 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery

European Committee for Standardization (CEN)

EN ISO/TS 13972:2015 Health informatics - Detailed clinical models@ characteristics and processes
EN ISO 13972:2022 Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022)
CEN ISO/TS 13972:2015 Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:2015)

Association Francaise de Normalisation

NF EN ISO 13972:2022 Health Informatics - Clinical Information Models - Characteristics, Structures and Requirements
NF S97-972*NF EN ISO 13972:2022 Health informatics - Clinical information models - Characteristics, structures and requirements

ES-UNE

UNE-EN ISO 13972:2022 Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022)

SAE - SAE International

SAE EIA-IS-115-2015 CDIF Integrated Meta-model Data Flow Model Subject Area (Interim Standard; Formerly TechAmerica EIA/IS-115)

RU-GOST R

GOST R 53079.2-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model

GOST

GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals

US-FCR

FCR 21 CFR PART 862-2014 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
FCR 21 CFR PART 862-2013 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
FCR 21 CFR PART 862-2015 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

German Institute for Standardization

DIN EN ISO 13972:2022-07 Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022); English version EN ISO 13972:2022

American National Standards Institute （ANSI)

ANSI/ASTM E2210:2012 Specification for Guideline Elements Model Version 2 (GEM II) Document Model for Clinical Practice Guidelines

AT-ON

OENORM EN ISO 13972:2020 Health informatics - Clinical information models - Characteristics, structures and requirements (ISO/DIS 13972:2020)

KR-KS

KS P ISO TS 22911-2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods

Korean Agency for Technology and Standards (KATS)

KS P ISO TS 22911:2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
KS P ISO TS 22911:2010 Dentistry-Preclinical evaluation of dental implant systems-Animal test methods
KS P ISO TS 22911-2020 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