clinically proven clinical

clinically proven clinical, Total:466 items.

The international standard classification for "clinically proven clinical" includes: Medical Sciences and health care facilities in general , Laboratory medicine , Health care technology (Vocabularies) , Birth control. Mechanical contraceptives , Protection against crime , Dental materials , Other services .

The Chinese standard classification for "clinically proven clinical" includes: Sanitation in general , Medical science , Codification , Nutrition sanitation , Basic standards and general methods , Legal medical expert , Pharmaceutical in general , Diagnostic standard for public nuisance diseases , Medical laboratory equipment , Other special devices , Crime judging technology , Stomatologic device, equipment and material , Medical apparatus and devices in general .

Professional Standard - Agriculture

农业部1247号公告-6-2009 Guiding principles for preclinical toxicology evaluation tests of veterinary drugs
CNAS-GL037-2019 Guidelines for performance verification of quantitative assay procedures in clinical chemistry

Professional Standard - Hygiene

WS/T 442-2014 Guideline for clinical laboratory biosafety
WS/T 102-1998 Classification and codes of clinical laboratory tests item
WS/T 225-2024 Collection and processing of blood specimens for clinical chemistry tests
WS/T 225-2002 Collection and processing of blood speciments for clinical chemistry
WS/T 249-2005 Clinical Laboratory Waste Management
WS/T 402-2012 Define and determine the reference intervals in clinical laboratory
WS/T 415-2024 Clinical laboratory quality assessment without external quality assessment
WS/T 427-2013 Nutritional risk screening
WS/T 418-2013 Guidelines for the ion of referral clinical laboratories
WS/T 492-2015 Performance verification of precision and correctness of quantitative determination items in clinical laboratory
WS/T 255-2005 Clinical laboratory medicine-Requirements for reference measurement laboratories
WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
WS/T 492-2016 Verification of performance for precision and trueness of quantitative measurements in clinical laboratories
WS/T 403-2024 Analytical quality standards for common items in clinical chemistry tests
WS/T 422-2013 Clinical application technique specification of hyperbaric oxygen
WS/T 490-2016 Guideline to calibration of clinical chemistry measurement system
WS 392-2012 Clinical application of ventilator
WS/T 227-2024 Requirements for writing standard operating procedures for clinical laboratory tests
WS/T 489-2015 Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
WS/T 406-2024 Quality Standards for Analysis of Common Items in Clinical Blood Tests
WS/T 408-2012 Guide to linearity evaluation of clinical chemistry analyzers
WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
WS/T 251-2005 Guidelines for Clinical Laboratory Safety
WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
WS/T 357-2011 Clinical practice guidelines of bone metabolic markers
WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 489-2016 Laboratory diagnosis of urinary tract infections

Group Standards of the People's Republic of China

T/CAS 819-2024 General technical requirements for clinical laboratory automation system
T/CAAM 014-2015 Evidence-Based Acupuncture Clinical Practice Guidelines: Knee Arthritis
T/CACM 1271-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Headache
T/CACM 1205-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM impotence disease
T/CACM 1313-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM dribbling urinary block
T/CACM 1186-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Comedomastitis
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CACM 1160-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM functional bloating
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CAV 007-2024 Guidelines for site selection of prophylactic vaccine clinical trial
T/CAAM 009-2014 Evidence-based acupuncture clinical practice guidelines: primary dysmenorrhea
T/CACM 1282-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM tremor disease
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CAAM 015-2014 Evidence-based acupuncture clinical practice guidelines: chronic atrophic gastritis
T/CAAM 019-2015 Evidence-based clinical practice guidelines for acupuncture and moxibustion: diabetic peripheral neuropathy
T/CAAM 0017-2019 Evidence-Based Acupuncture Clinical Practice Guidelines: Acupuncture Therapy
T/CADHOH 0006-2024 Specification for clinical diagnosis and treatment of tinnitus
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CAAM 0006-2019 Evidence-based acupuncture and moxibustion clinical practice guidelines hypochondriac pain
T/CACM 1201-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Infantile Malnutrition
T/CACM 1222-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM down-bearing stomachache
T/CACM 015.8-2017 Standards for management of clinical research documents of traditional Chinese medicine
T/CAAM 0013-2019 Evidence-Based Acupuncture Clinical Practice Guidelines: Moxibustion Therapy
T/CACM 1235-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Chilblain
T/CAAM 005-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Migraine
T/CACM 1183-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM hepatic encephalopathy
T/CACM 1524-2023 Guidelins for clinical of body weight management with Chinese medicine
T/CACM 1433-2023 Guidelines for clinical diagnosis and treatment of cervicogenic headache with acupotomy
T/CAAM 016-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Allergic Rhinitis
T/SDAS 848-2024 Clinical application standard of "pulse-emotion correspondence" of systematic sphygmology for pattern differentiation
T/CAAM 0005-2019 Evidence-based acupuncture and moxibustion clinical practice guidelines: fullness
T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
T/CAAM 006-2015 Evidence-based Acupuncture Clinical Practice Guidelines: Cervical Spondylosis
T/SAME 003-2021 Norm for establishment of clinical laboratory of measurement integrity
T/CAV 001-2023 Terms used in vaccine preclinical research
T/CAAM 0007-2019 Evidence-based acupuncture clinical practice guidelines: Pain due to tenosynovitis
T/SDACM 001-2024 Clinical diagnostic criteria for common Traditional Chinese Medicine Symptoms of normal high blood pressure
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/CGSS 008-2019 Clinical application guidelines for laboratory indicators of blood stasis syndrome in senile coronary heart disease
T/CAQI 366-2024 Clinical testing quantitative project method confirmation
T/CAMDI 037-2020 3D printing tantalum metal clinical application standard
T/CAAM 013-2015 Evidence-Based Acupuncture Clinical Practice Guidelines: Frozen Shoulder
T/CACM 1230-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Chronic cough
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
T/CACM 1189-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Varicella
T/CACM 1204-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Lung carbuncle
T/CHSA 008-2019 Evidence-based guidelines for clinical practice of burning mouth syndrome
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
T/CAAM 008-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Low Back Pain
T/CACM 1191-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Mumps
T/NBPIA 007-2021 Classification of hemodialyzer clinical performance
T/CAAM 0007-2022 Guidelines for Acupuncture and Moxibustion Clinical Research Registration
T/CAAM 0014-2019 Evidence-based Acupuncture Clinical Practice Guidelines: Fire Needle Therapy
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CAAM 0009-2019 Evidence-based Acupuncture Clinical Practice Guidelines: Postoperative Urinary Retention
T/CACM 1149-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Abdominal pain
T/CAAM 0012-2019 Evidence-Based Acupuncture Clinical Practice Guidelines: Toothache
T/CAAM 004-2014 Evidence-based clinical practice guidelines for acupuncture and moxibustion: post-stroke pseudobulbar palsy
T/CACM 1336-2020 Development and application specification of clinical diagnostic criteria for traditional Chinese medicine syndrome based on combination of disease and syndrome
T/CAAM 0001-2024 Evidence-Based Acupuncture Clinical Practice Guidelines for Arrhythmias
T/CAAM 0021-2019 Evidence-Based Acupuncture Clinical Practice Guidelines: Electroacupuncture Therapy
T/CAAM 018-2015 Evidence-based acupuncture clinical practice guidelines: primary trigeminal neuralgia
T/CNMIA 0015-2020 Clinical Test Assessment of Cosmetics for Sensitive Skin
T/QDAS 108-2023 Technical specification for mobile intelligent clinical examination platform
T/HNMA 3-2019 MRI Clinical Functional Evaluation Guidelines
T/CGCPU 025-2023 Guideline of contract research organization
T/CSBME 078-2024 Specification for clinical application of handled ultrasound device
T/CACM 1173-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Acute pancreatitis
T/CHSA 010-2023 Operation specification of permanent tooth exaction
T/CACM 1362-2021 Standard for clinical application of traditional Chinese herbal pieces
T/CACM 1199-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM fibroadenoma of breast
T/CAAM 002-2015 Evidence-based acupuncture clinical practice guidelines: Bell's palsy
T/CHSA 007-2019 Evidence-based guidelines for clinical diagnosis and treatment of oral leukoplakia
T/CACM 1164-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Reactive arthritis
T/SAME 001-2022 Management requirements for level II biosafety cabinets in clinical laboratories
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CACM 1214-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Hyperhidrosis in Children
T/CACM 1063-2018 Acupotomology clinic-Basic terminologies
T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
T/CACM 1064-2018 Acupotomology clinic-General requirements
T/CAAM 0002-2023 Evidence-Based Acupuncture Clinical Practice Guidelines for Irritable Bowel Syndrome
T/GDPHA 003-2023 Standard for Sharing Clinical phenotypic data on viral hepatitis
T/CACM 1153-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Sinus
T/CACM 1236-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Pressure Ulcers
T/CAAM 001-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Herpes Zoster
T/CAAM 020-2014 Evidence-based acupuncture clinical practice guidelines: simple obesity
T/CACM 1210-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Neonatal Hyperbilirubinemia
T/CAAM 0015-2019 Evidence-Based Acupuncture Clinical Practice Guidelines: Cupping Therapy
T/CAAM 0016-2019 Evidence-based clinical practice guidelines for acupuncture and moxibustion: pricking and bloodletting therapy
T/CACM 015.12-2017 Chinese medicine clinical research verification standards
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CAAM 0011-2019 Evidence-Based Acupuncture Clinical Practice Guidelines: Ankle Sprains
T/CACM 1304-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Intestinal abscess
T/CRACM 0009-2023 Guidelines for the Clinical Diagnosis and Treatment of Traditional Chinese Medicine for Blood Turbidity Syndrome
T/CACM 1207-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Gynecomastia
T/GDPHA 028-2021 Standard Data Set of Clinical Research on Malignant Tumor Diseases
T/ZJPA 002-2024 Clinical Research Coordinator (CRC) Training Requirement
T/CACM 015.10-2017 Drug Administration Standards for Clinical Research of Traditional Chinese Medicine
T/CACM 1184-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM alcoholic liver disease
T/CACM 1206-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Stone gonorrhea
T/CACM 1063~1064-2018 Acupuncture Medicine Clinical Basic Terminology Acupuncture Medicine Clinical General Requirements
T/CAAM 0003-2023 Evidence-Based Acupuncture Clinical Practice Guidelines for Cognitive Impairment
T/CAAM 007-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Chronic Constipation
T/SDAS 847-2024 Clinical application standard of "pulse-herbs correspondence" of systematic sphygmology for pattern differentiation
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CACM 1227-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM bone rheumatism
T/CACM 1124~1142-2018 Guidelines for clinical diagnosis and treatment of mental illness in traditional Chinese medicine (II)
T/CACM 1178-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Amenorrhea
T/CAAM 012-2014 Evidence-based clinical practice guidelines for acupuncture and moxibustion: bronchial asthma in adults
T/CACM 1247-2019 Guidelines for clinical diagnosis and treatment of surgery in Chinese medicine—Intestinal obstruction
T/CAAM 011-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Insomnia
T/CAAM 0008-2019 Evidence-based clinical practice guidelines for acupuncture and moxibustion: pain caused by varicose veins of lower extremities
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CAAM 0001-2023 Evidence-based guidelines of clinical practice with acupuncture—External humeral epicondylitis
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/CACM 1246-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Polymyositis
T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/SCSKJQYLHH 09-2022 Standard for quality evaluation of clinical nursing teaching
T/CAAM 017-2014 Evidence-based Acupuncture Clinical Practice Guidelines: Sudden Deafness
T/CVMA 65-2021 Technical specification for clinical urinalysis of canine and feline
T/CACM 1376-2022 Chinese medicine clinical practice guideline for idiopathic membranous nephropathy
T/CAAM 0022-2019 Evidence-Based Acupuncture Clinical Practice Guidelines: Acupoint Sticking Therapy
T/CNMIA 0012-2020 Clinical Test Assessment of anti-Acne Cosmetics
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGCPU 025-2022 Guideline of contract research organization
T/GDC 195-2022 Technical specification for clinical blood information system
T/ZSBT 001-2021 Acceptance Standards for clinical blood use management in Zhejiang Province
T/CACM 1169-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM gasp syndrome(Chronic obstructive pulmonary disease and right heart failure)
T/CGDF 00042-2024 Standard for allergic diseases clinical research base construction
T/CAAM 0010-2019 Evidence-based acupuncture and moxibustion clinical practice guidelines: red eyes and pain
T/CAAM 003-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Depression
T/CACM 014-2017 Clinical diagnostic criteria of phlegm-damp syndrome in coronary atherosclerotic heart disease
T/CACM 1266-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Acute viral hepatitis
T/CMEAS 006-2023 Clinical screening standards for secondary hypertension
T/HNMA 1-2019 MRI clinical function evaluation specification
T/CAAM 010-2015 Evidence-Based Acupuncture Clinical Practice Guidelines: Sciatica
T/CACM 1187-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Summer-heat disease
T/CACM 062-2018 Clinical diagnostic criteria for coronary atherosclerotic heart disease with phlegm and blood stasis syndrome
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials

Professional Standard - Certification and Accreditation

RB/T192-2015 Forensic Clinical Examination Standards
RB/T 192-2015 Guideline for clinical forensic examination

司法部

SF/T 0112-2021 Implemental specification of clinical forensic imaging examination
SF/T 0111-2021 Specification of examination in forensic clinical medicine

未注明发布机构

DIN EN 540:1993 Clinical testing of medical devices on humans
DIN EN ISO 14155 E:2018-08 Good Clinical Practice for Clinical Investigation of Medical Devices in Anthropology (Draft)
DIN EN ISO 14155-2 E:2001-08 Clinical Studies of Medical Devices for Human Use Part 2: Clinical Study Protocol (Draft)
ANSI/ADA 1000-2010(2020) Standard Clinical Data Architecture
ANSI/ADA 1039-2006(2014) Standard Clinical Conceptual Data Model
WS 533-2017 Clinical nuclear medicine patient protection requirements
WS/T 514-2017 Establishment and verification of detection capability for clinical laboratory measurement procedures
DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 16751.2-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment - Syndromes
GB 16396-1996 Diagnosis of clinical classification for endemic skeletal fluorosis
GB/T 20469-2006 General guideline of the clinical laboratory design
GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
GB/T 16751.3-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment - Therapeutic methods
GB/T 16751.1-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment - Diseases
GB/T 30224-2013 Clinical Use of Tests for Toxoplasma Gondii
GB/T 42168.1-2022 Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self reports
GB/T 20470-2006 Requirements of external quality assessment for clinical laboratories

Guangdong Provincial Standard of the People's Republic of China

DB44/T 2349-2022 Management specification for clinical medical transportation personnel
DB44/T 2218.4-2019 Traditional Chinese Medicine (Integrated Traditional Chinese and Western Medicine) Clinical Practice Guidelines Formulate and Revise General Principles
DB44/T 2350-2022 Clinical medical transportation operation management specification

中华人民共和国国家卫生和计划生育委员会

WS/T 228-2002 Preliminary evaluation of quantitative clinical laboratory methods
WS/T 222-2002 Guideline for the measurement of catalytic concentration of clinical enzymes
WS/T 496-2017 Quality indicators in clinical laboratories
WS/T 227-2002 Requirement for the technical procedure manual in clinical laboratory
WS/T 497-2017 Performance guideline for clinical laboratory diagnosis of invasive fungal diseases
WS/T 498-2017 Performance guideline for clinical laboratory diagnosis of bacterial diarrhea
WS/T 208-2001 Clinical diagnostic standard for dental fluorosis

Professional Standard - Public Safety Standards

GA/T 1970-2021 Specifications for clinical forensic examination
GA/T 1194-2014 Guideline for forensic clinical examination in sexual assault case

Professional Standard - Medicine

YY/T 1305-2015 Clinical trial guideline for titanium and titanium alloy dental implant
YY/T 0990-2015 Clinical trial guideline for polymer-based dental restorative materials
YY/T 0297-1997 Clinical investigation of medical devices
YY/T 0991-2015 Clinical trial guideline for orthodontic brackets

卫生健康委员会

WS/T 804-2022 Basic technical standard for clinical chemistry laboratory
WS/T 780-2021 Reference intervals of clinical biochemistry tests commonly used for children
WS/T 662-2020 Technical requirements for clinical body fluids analysis
WS/T 641-2018 Internal quality control for quantitative measurement in clinical laboratory
WS/T 640-2018 Specimen collection and transport in clinical microbiology
WS/T 644-2018 Clinical laboratory quality evaluation
WS/T 616-2018 Autoverification of Clinical Laboratory Quantitative Test Results
WS/T 574-2018 Purified reagent water in the clinical laboratory

National Health Commission of the People's Republic of China

WS/T 805-2022 Basic technical standard for clinical microbiology laboratory
WS/T 806-2022 Basic technical standard for clinical hematology and body fluid analysis
WS/T 807-2022 Performance verification of clinical microbial culture, identification and antimicrobial susceptibility testing systems

Fujian Provincial Standard of the People's Republic of China

DB35/T 1033-2010 Protocol for clinical diagnosis of fish cucurbit disease
DB35/T 1985-2021 Primary Liver Cancer Clinical Dataset

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16751.2-2021 Clinic terminology of traditional Chinese medical diagnosis and treatment—Part 2:Syndromes/patterns

未注明发布机构

DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
DIN EN ISO 14155-2 E:2001-08 Clinical Studies of Medical Devices for Human Use Part 2: Clinical Study Protocol (Draft)
ANSI/ADA 1000-2010(2020) Standard Clinical Data Architecture
WS/T 514-2017 Establishment and verification of detection capability for clinical laboratory measurement procedures
DIN EN ISO 14155 E:2018-08 Good Clinical Practice for Clinical Investigation of Medical Devices in Anthropology (Draft)
ANSI/ADA 1039-2006(2014) Standard Clinical Conceptual Data Model
WS 533-2017 Clinical nuclear medicine patient protection requirements
DIN EN 540:1993 Clinical testing of medical devices on humans

Zhejiang Provincial Standard of the People's Republic of China

DB33/T 903-2013 Classification and coding of clinical laboratory test items
DB33/T 855-2011 Clinical disease classification and code

Shanghai Provincial Standard of the People's Republic of China

DB31/T 137-3-1994 Chlorine Standard Solution for Clinical Chemistry
DB31/T 137-13-1994 Total protein standard solution for clinical chemistry
DB31/T 137-1-1994 General rules for standard solutions for clinical chemistry
DB31/T 137-5-1994 Phosphorus standard solution for clinical chemistry
DB31/T 137-7-1994 Uric acid standard solution for clinical chemistry
DB31/T 1076-2018 Regulations on clinical forensic expertise service
DB31/T 137-6-1994 Standard solution of urea nitrogen for clinical chemistry
DB31/T 138-1-1994 General rules for assay kits for clinical chemistry
DB31/T 137-10-1994 Mannitol standard solution for clinical chemistry
DB31/T 137-11-1994 Cholesterol Standard Solution for Clinical Chemistry
DB31/T 137-8-1994 Creatinine standard solution for clinical chemistry
DB31/T 137-4-1994 Calcium Standard Solution for Clinical Chemistry
DB31/T 137-12-1994 Pyruvate standard solution for clinical chemistry
DB31/T 137-2-1994 Potassium and sodium standard solution for clinical chemistry
DB31/T 137-9-1994 Dextrose standard solution for clinical chemistry

Anhui Provincial Standard of the People's Republic of China

DB34/T 4339-2022 Forensic clinical identification service specification

Shanxi Provincial Standard of the People's Republic of China

DB14/T 3065-2024 Medical clinical transportation work specifications

National Metrological Technical Specifications of the People's Republic of China

JJF 1412-2013 Calibration Specification for Clinical Color Change Thermometers
JJF 1644-2017 The Production of Reference Materials for Clinical Enzymology

国家卫生计生委

WS/T 503-2017 Blood culture operating procedures in clinical microbiology laboratories
WS/T 494-2017 Guideline for performance characteristics of immunological qualitative test

Shandong Provincial Standard of the People's Republic of China

DB37/T 3606-2019 Technical regulations for clinical diagnosis and treatment of animal diseases

Beijing Provincial Standard of the People's Republic of China

DB11/T 1794-2020 Technical specifications for clinical blood use in medical institutions
DB11/T 1864-2021 Technical Guidelines for Clinical Nutrition in Medical Institutions

Liaoning Provincial Standard of the People's Republic of China

DB21/T 3842-2023 Pet clinical diagnosis and treatment professional skill level

Jilin Provincial Standard of the People's Republic of China

DB22/T 3225-2021 Technical Specifications for Clinical Ozone Injection Therapy

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc.

ASHRAE NO-94-29-1994 Validation of Pharmaceutical Clinical Supply Laboratories

GSO

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
OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
OS GSO 1647:2002 Methods of testing and verification for Clinical electrical thermometers with maximum device
GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
GSO ISO 19465:2021 Traditional Chinese medicine — Categories of traditional Chinese medicine (TCM) clinical terminological systems
BH GSO ISO 19465:2022 Traditional Chinese medicine — Categories of traditional Chinese medicine (TCM) clinical terminological systems
OS GSO ISO 16037:2009 Rubber condoms for clinical trials – Measurement of physical properties
GSO ISO 29943-1:2021 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
GSO ISO 11953:2015 Dentistry -- Implants -- Clinical performance of hand torque instruments
BH GSO ISO 29943-1:2022 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
OS GSO OIML R115:2010 Clinical electrical thermometers with maximum device
BH GSO ISO 11953:2017 Dentistry -- Implants -- Clinical performance of hand torque instruments

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
FCR AF I44-119-2001 CLINICAL PERFORMANCE IMPROVEMENT
FCR FED H-08-9 CHAP 214-1979 CLINICAL SERVICES ADMINISTRATION
FCR 21 CFR PART 54-2013 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
FCR 21 CFR PART 54-2014 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
FCR 21 CFR PART 54-2015 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
FCR FED H-08-3 316-1-1988 RESEARCH AND CLINICAL LABORATORY GAS AND VACUUM SYSTEMS
FCR FED H-08-5 CHAP 214 TRANSMITTAL NO.135-1983 CLINICAL SERVICES ADMINISTRATION, TRANSMITTAL NO. 135

American Society for Testing and Materials (ASTM)

ASTM F3108-19 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
ASTM F3448-20 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
ASTM F2721-09(2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
ASTM E2045-99 Standard Practice for Detailed Clinical Observations of Test Animals
ASTM E1246-01 Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems
ASTM E2182-02 Standard Specification for Clinical XML DTDs in Healthcare

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 52379-2005 Good clinical practice (GCP)
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 R 53079.3-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 3. Rules for interaction between personnel of clinical departments and personnel of clinical-diagnostic laboratory in medical institutions during fulfillment of clinical
GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
GOST R 56429-2015 Medical devices. Clinical evaluation
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 53022.2-2008 Clinical laboratory technologies. Requirements for quility of clinical laboratory tests. Part 2. Assessment of methods analytical reliability (accuracy, censitivity, specificity)
GOST R 56701-2015 Medicines for medical applications. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals
GOST ISO 16037-2014 Rubber condoms for clinical trials. Determination of physical properties
GOST R 51352-1999 Kits of reagents for clinical laboratory diagnostics. Test methods
GOST R 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications
GOST R 57525-2017 Clinical and economic analysis. General requirements

SCC

CAN/HSO 1003:2023 Clinical Governance
BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
BS ISO 81060-2:2009 Non-invasive sphygmomanometers-Clinical validation of automated measurement type
DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice
AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
AENOR UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
DANSK DS/EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
NS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
BS 691:1961 Clinical maximum thermometers
BS 691:1953 Clinical maximum thermometers
AS 2190:1978 Clinical maximum thermometers
BS 691:1966 Clinical maximum thermometers
BS 691:1936 Clinical maximum thermometers
ADA 1000-2010(R2020) Standard Clinical Data Architecture
DIN EN ISO 14155 E:2018 Draft Document - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2018); German and English version prEN ISO 14155:2018
AS ISO 14155:2002 Clinical investigation of medical devices
AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
AS T33:1966 Specification for clinical maximum thermometers
CAN/CGSB-14.1-M87-1987 Mercury-in-Glass Clinical Thermometers
AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)
DANSK DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
ADA 1039-2006(R2014) Standard Clinical Conceptual Data Model
DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
ANSI Z80.21-2010(R2015) Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
AS 1765:1975 Artificial lighting for clinical observation
ANSI Z80.21-2020 Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
BS EN 21942-1:1992 Dental vocabulary-General and clinical terms
UNE-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
ASTM STP 1008-89 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing

Association Francaise de Normalisation

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S97-045*NF ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
NF S91-154:1995 Clinical evaluation of dental implants.
NF ISO 16037:2002 Préservatifs masculins en caoutchouc destinés aux essais cliniques - Mesurage des propriétés physiques
NF S99-201:1993 Clinical investigation of medical devices for human subjects.

GOST

GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
GOST R 59921.1-2022 Artificial intelligence systems in clinical medicine. Part 1. Clinical evaluation
GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
GOST R 56429-2021 Medical devices. Clinical еvaluation
GOST R 59921.9-2022 Artificial intelligence systems in clinical medicine. Algorithms for data analysis in clinical physiology. Testing methods. General requirements
GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals

US-AAMI

ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ANSI/AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects-Good clinical practice

IT-UNI

UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
EC 1-2020 UNI 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
DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
DS/EN ISO 11953:2010 Dentistry - Implants - Clinical performance of hand torque instruments

Military Standards (MIL-STD)

DOD A-A-51709-1986 THERMOMETER, CLINICAL, HUMAN
DOD A-A-53345-1988 THERMOMETER, CLINICAL, VETERINARY
DOD A-A-54736-1992 THERMOMETER, CLINICAL, HUMAN
DOD A-A-54437-1991 PITCHER, CLINICAL SOLUTIONS (ALUMINUM)
DOD A-A-54861-1993 INDICATOR, CLINICAL CHART HOLDER, METAL
DOD A-A-54778-1993 ANALYZER, CLINICAL CHEMISTRY, DRY
DOD A-A-53656-1988 THERMOMETER, CLINICAL, HUMAN (ELECTRONIC, BATTERY POWERED)

KR-KS

KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P ISO 14155-2019 Clinical investigation of medical devices for human subjects — Good clinical practice
KS M ISO 16037-2018(2023) Rubber condoms for clinical trials — Measurement of physical properties
KS M ISO 16037-2018 Rubber condoms for clinical trials — Measurement of physical properties

International Organization for Standardization (ISO)

ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO 81060-2:2013 Non-invasive sphgmomanometers-Part 2:Clinical investigation of automated measurement type
ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO/TS 22990:2019 Traditional Chinese medicine — Categories of clinical terminological system to support the integration of clinical terms from traditional Chinese medicine and Western medicine
ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
ISO 14155:1996 Clinical investigation of medical devices
ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
ISO 29943-2:2017 Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports
ISO 81060-2:2009/Cor 1:2011 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type; Technical Corrigendum 1
ISO/TR 13128:2012 Health Informatics - Clinical document registry federation
ISO 29943-1:2017 Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports

ES-UNE

UNE-EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

Korean Agency for Technology and Standards (KATS)

KS P ISO 14155:2019 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P 1208-1987 Direct Blood-Pressure Meters for Clinical Use
KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS C 1221-2014 Polygraphs for clinical use
KS C 1222-1989 Clinical electronic spirometers
KS P ISO 14155-2-2019 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS C 1222-2014 Clinical electronic spirometers
KS P 1208-2013 Direct Blood-Pressure Meters for Clinical Use
KS C 1221-1989(2009) Polygraphs for clinical use
KS P 8428-2015(2020) General requirements for clinical laboratory automation system performance
KS P 8428-2020 General requirements for clinical laboratory automation system performance
KS M ISO 16037-2023 Rubber condoms for clinical trials — Measurement of physical properties
KS M ISO 16037:2008 Rubber condoms for clinical trials-Measurement of physical properties
KS M ISO 16037:2018 Rubber condoms for clinical trials — Measurement of physical properties
KS C 1221-1989 Polygraphs for clinical use
KS P 8429-2020 General requirements for clinical laboratory automation system information

AENOR

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE 129001:1997 CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.
UNE 129002:2000 IN Glossary of recommended terms in clinical laboratory sciences.

British Standards Institution (BSI)

BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
24/30467406 DC BS EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
BS ISO 29943-2:2017 Condoms. Guidance on clinical studies. Female condoms, clinical function studies based on self-reports
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice
BS PAS 1616:2016 Healthcare. Provision of clinical services. Specification
BS ISO 29943-1:2017 Condoms. Guidance on clinical studies. Male condoms, clinical function studies based on self-reports
BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects
PAS 1616:2016 Healthcare. Provision of clinical services. Specification

German Institute for Standardization

DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN ISO 14155:2021-05 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
DIN EN ISO 14155:2024 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
DIN EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
DIN 6809-3:1990 Clinical dosimetry; diagnostic radiology
DIN EN ISO 11953:2010-11 Dentistry - Implants - Clinical performance of hand torque instruments (ISO 11953:2010); German version EN ISO 11953:2010

Lithuanian Standards Office

LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

AT-ON

OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
ONORM S 5234-3-2001 Clinical dosimetry - lonization chamber dosimetry
ONORM EN 540-1993 Clinical investigation of medical devices for human subjects
ONORM EN 21942-1-1992 Dental vocabulary - General and clinical terms

AR-IRAM

IRAM 9020-1962 clinical thermometer

US-CLSI

CLSI C28-A3c-2008 Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory
CLSI GP17-A3-2012 Clinical Laboratory Safety; Approved Guideline - Third Edition

PL-PKN

PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)

European Committee for Standardization (CEN)

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)
EN ISO 81060-2:2019 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
EN ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003
EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type
prEN 540-1992 Clinical investigation of medical devices for human subjects
EN ISO 81060-2:2019/A1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)

Japanese Industrial Standards Committee (JISC)

JIS T 1140:1998 Clinical electrical thermometers
JIS T 1170:1987 Clinical electronics spirometers
JIS T 1116:1985 Direct blood-pressure meters for clinical use
JIS T 1309:1986 Polygraphs for clinical use
JIS T 1306:1989 Continuous measuring clinical electrical thermometers
JIS T 1307:1985 Wireless ecg monitors

SE-SIS

SIS 64 41 50-1969 Clinical maximum thermometer

BE-NBN

NBN-EN 540-1993 Clinical investigation of medical devices for human subjects

Indonesia Standards

SNI 16-4941-1998 Enclosed-scale clinical thermometers
SNI ISO 81060-2:2012 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

American National Standards Institute （ANSI)

ANSI/ADA 1000-2010 Standard Clincal Data Architecture
ADA TR 1004-2004 Clinical Software Performance for Dental Practice Software
ANSI/HL7 CMSAPP, R 1-2008 HL7 Clinical Context Management Specification (CCOW) Application Protection Package, Release 1

CN-QIYE

Q/BYYYY 1993-2023 1+X Medical Clinical Guide

VN-TCVN

TCVN 7740-2-2007 Clinical investigation of medical devices for human subjects.Part 2: Clinical investigation plans

IX-EU/EC

MEDDEV 2.12-2-2004 GUIDELINES ON POST MARKET CLINICAL FOLLOW-UP

ZA-SANS

SANS 16037:2003 Rubber condoms for clinical trials - Measurement of physical properties

North Atlantic Treaty Organization Standards Agency

STANAG 2348-1998 BASIC MILITARY HOSPITAL (CLINICAL) RECORDS

US-CFR-file

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

Standard Association of Australia （SAA）

AS 3816:2018 Management of clinical and related wastes
AS 2190:1995 Clinical maximum thermometers - Mercury-in-glass

US-HHS

HHS 21 CFR PART 54 CFR PART 54-2011 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
HHS 21 CFR PART 58-2011 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

Canadian General Standards Board （CGSB)

CAN/CGSB-191.1-2013 Research ethics oversight of biomedical clinical trials
CGSB 191.1-2013-CAN/CGSB-2013 Oversight of research ethics involving biomedical clinical trials

Institute of Electrical and Electronics Engineers (IEEE)

Pre-Standards Workstream Report: Clinical IoT Data Pre-Standards Workstream Report: Clinical IoT Data Validation and Interoperability with Blockchain

RO-ASRO

SR EN 540-1996 Clinical investigation of medical devices for human subjects

IEEE - The Institute of Electrical and Electronics Engineers@ Inc.

IEEE WHITE PAPER-0-2019 Pre‐Standards Workstream Report: Clinical IoT Data Validation and Interoperability with Blockchain

CU-NC

NC 20-25-6-1988 Medical Sciences. Clinical Auxiliary Methods and Means Photometric Determination of Creatinine. Method of Clinical Analyses

GOSTR

GOST R 58090-2018 Clinical examination of unproductive animals. General requirements

NL-NEN

NEN-EN 540-1994 Clinical investigation of medical devices for human subjects

ANSI - American National Standards Institute

Z80.21-2010 Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts (VC)
Z80.21-1992 Ophthalmics-Instruments- General-Purpose Clinical Visual Acuity Charts (VC)

Others: Confirmatory clinical,Confirmatory clinical,clinical validation,clinically proven clinical,clinical validation,clinically proven medicine,confirmatory clinical,Guidelines for Forensic Clinical Examination of Sexual Assault Cases,"Validation of Analytical Performance of Commercial Quantitative Kits in Clinical Laboratories"