Clinical Frontiers

Clinical Frontiers, Total:456 items.

The international standard classification for "Clinical Frontiers" includes: Laboratory medicine , Medical Sciences and health care facilities in general , Implants for surgery, prosthetics and orthotics , Medical equipment in general , Dental materials , Birth control. Mechanical contraceptives , Radiation protection , Other services , Occupational safety. Industrial hygiene .

The Chinese standard classification for "Clinical Frontiers" includes: Sanitation in general , Medical science , Nutrition sanitation , Codification , Legal medical expert , Medical apparatus and devices in general , Extracorporeal circulation, artificial organ and prosthesis device , Stomatologic device, equipment and material , Medical laboratory equipment , Pharmaceutical in general , Diagnostic standard for public nuisance diseases , Other special devices , Radiological sanitation protection .

Group Standards of the People's Republic of China

T/CSCO 2-2022 Standard Datasets for Breast Cancer Clinical Scientific Research
T/CACM 1227-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM bone rheumatism
T/CACM 1185-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Flesh goiter
T/CACM 1128-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Dreaminess
T/HENANPA 004-2022 Specifications for the construction of inpatient clinical pharmacist workstations
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/GDMDMA 0036-2024 Specification for Clinical Medical Device Leasing Services
T/CHSA 010-2023 Operation specification of permanent tooth exaction
T/CADHOH 0006-2024 Specification for clinical diagnosis and treatment of tinnitus
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/NBPIA 010-2023 Clinical Practice Guidelines for Home Hemodialysis
T/CSBME 078-2024 Specification for clinical application of handled ultrasound device
T/CAAM 0007-2022 Guidelines for Acupuncture and Moxibustion Clinical Research Registration
T/CACM 1222-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM down-bearing stomachache
T/CACM 1434-2023 Clinical diagnosis and treatment guide of acupotomy for tarsal tunnel syndrome
T/CACM 1180-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Depression
T/CACM 1437-2023 Clinical guidelines for acupunctomy treatment of knee osteoarthritis
T/CACM 1274-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Dermatomyositis
T/CHSA 008-2019 Evidence-based guidelines for clinical practice of burning mouth syndrome
T/CACM 1312-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Cholelithiasis
T/CACM 1308-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM Anteriorischemic Optic Neuropathy
T/CACM 1153-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Sinus
T/CAQI 366-2024 Clinical testing quantitative project method confirmation
T/CIATCM 073-2020 Basic datasets of clinical paths in Traditional Chinese Medicine
T/CAAM 011-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Insomnia
T/CACM 1178-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Amenorrhea
T/CACM 1368-2021 Clinical practice guideline on traditional Chinese medicine in the treatment of influenza
T/HNMA 3-2019 MRI Clinical Functional Evaluation Guidelines
T/CACM 1271-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Headache
T/CGCPU 001-2015 Guidance for clinical research coordinator profession practice
T/CMEAS 006-2023 Clinical screening standards for secondary hypertension
T/CAAM 0012-2019 Evidence-Based Acupuncture Clinical Practice Guidelines: Toothache
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGDF 00042-2024 Standard for allergic diseases clinical research base construction
T/CVMA 65-2021 Technical specification for clinical urinalysis of canine and feline
T/CACM 1124~1142-2018 Guidelines for clinical diagnosis and treatment of mental illness in traditional Chinese medicine (II)
T/CACM 1204-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Lung carbuncle
T/JX 078-2025 Clinical electroencephalogram examination and reporting standards
T/CACM 1439-2023 Guide to acupotomy for the diagnosis and treatment of carpal tunnel syndrome
T/CACM 1236-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Pressure Ulcers
T/NBPIA 007-2021 Classification of hemodialyzer clinical performance
T/CAV 001-2023 Terms used in vaccine preclinical research
T/CAAM 013-2015 Evidence-Based Acupuncture Clinical Practice Guidelines: Frozen Shoulder
T/CGCPU 025-2022 Guideline of contract research organization
T/CACM 1247-2019 Guidelines for clinical diagnosis and treatment of surgery in Chinese medicine—Intestinal obstruction
T/CAAM 005-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Migraine
T/CACM 1187-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Summer-heat disease
T/CACM 1206-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Stone gonorrhea
T/CACM 1165-2019 Clinical guidelines for diagnosis and treatment of proctology in TCM Rectocele
T/CACM 1228-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM arthralgia with joint deformity
T/NSSQ 072-2024 Specification for Clinical Medical Device Leasing Services
T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CACM 015.12-2017 Chinese medicine clinical research verification standards
T/ZJPA 002-2024 Clinical Research Coordinator (CRC) Training Requirement
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CAAM 0005-2019 Evidence-based acupuncture and moxibustion clinical practice guidelines: fullness
T/CACM 1129-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Dysphoria
T/CIATCM 071-2020 Data element dictionary of clinical pathway of Tradtitional Chinese Medicine
T/CACM 1524-2023 Guidelins for clinical of body weight management with Chinese medicine
T/CACM 1207-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Gynecomastia
T/HNMA 1-2019 MRI clinical function evaluation specification
T/CACM 015.10-2017 Drug Administration Standards for Clinical Research of Traditional Chinese Medicine
T/CACM 1063~1064-2018 Acupuncture Medicine Clinical Basic Terminology Acupuncture Medicine Clinical General Requirements
T/CACM 1292-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Facial Paralysis
T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CHSA 014-2023 Experts consensus on the management of oral erythroplakia
T/SHAAV 001-2020 Clinical physical examination procedure for canine and feline clinic
T/CACM 1263-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Dengue Fever
T/CRHA 067-2024 The guidelines of clinical research telephone-based follow-up
T/CGCPU 025-2023 Guideline of contract research organization
T/CACM 1150-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Headed Carbuncle
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
T/CACM 1223-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM gastroptosis
T/CACM 1210-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Neonatal Hyperbilirubinemia
T/ZSBT 001-2021 Acceptance Standards for clinical blood use management in Zhejiang Province
T/CACM 1149-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Abdominal pain
T/CHSA 093-2025 Clinical technical specifications for rubber dam isolation
T/CATCM 032-2024 Guidelines for the clinical use of traditional Chinese medicine formula granules
T/LXLY 26-2023 Regulation for the application of zero suckback technology in oral treatment
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CACM 1124-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Intracranial tinnitus
T/CADERM 9101-2023 Diagnostic requirements for magnetocardiogram of myocardial ischemia in clinical application
T/CAAM 008-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Low Back Pain
T/CAPA 12-2024 Clinical treatment and long-term management of melasma
T/CAAM 0006-2019 Evidence-based acupuncture and moxibustion clinical practice guidelines hypochondriac pain
T/CACM 1304-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Intestinal abscess
T/CACM 1189-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Varicella
T/CRACM 0009-2023 Guidelines for the Clinical Diagnosis and Treatment of Traditional Chinese Medicine for Blood Turbidity Syndrome
T/CAMDI 037-2020 3D printing tantalum metal clinical application standard
T/CAAM 003-2014 Evidence-Based Acupuncture Clinical Practice Guidelines: Depression
T/NAHIEM 146-2025 General Specifications for Clinical Mass Spectrometry Laboratories
T/CACM 1282-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM tremor disease
T/CACM 1245-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM anterior uveitis
T/CACM 1063-2018 Acupotomology clinic-Basic terminologies
T/CACM 1277-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Burn
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 015.8-2017 Standards for management of clinical research documents of traditional Chinese medicine
T/GDC 195-2022 Technical specification for clinical blood information system
T/CACM 1205-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM impotence disease
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CACM 015.3-2017 Quality Control Standards for Clinical Research of Traditional Chinese Medicine
T/CACM 1433-2023 Guidelines for clinical diagnosis and treatment of cervicogenic headache with acupotomy
T/CEAC 105-2025 TIL Cell Therapy Clinical Application Guidelines
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
T/CACM 1362-2021 Standard for clinical application of traditional Chinese herbal pieces
T/SCSKJQYLHH 09-2022 Standard for quality evaluation of clinical nursing teaching
T/CHSA 007-2019 Evidence-based guidelines for clinical diagnosis and treatment of oral leukoplakia
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CACM 1064-2018 Acupotomology clinic-General requirements
T/CACM 1199-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM fibroadenoma of breast
T/CACM 1194-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Enterobiasis Disease
T/CIATCM 024-2019 Classification and codes of Chinese Medicinals in clinical practice
T/CACM 1313-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM dribbling urinary block
T/CACM 1201-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Infantile Malnutrition
T/CACM 1235-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Chilblain

Professional Standard - Hygiene

WS/T 490-2016 Guideline to calibration of clinical chemistry measurement system
WS/T 644-2018 Clinical laboratory quality evaluation
WS/T 251-2005 Guidelines for Clinical Laboratory Safety
WS/T 228-2002 Preliminary evaluation of quantitative clinical laboratory methods
WS/T 408-2012 Guide to linearity evaluation of clinical chemistry analyzers
WS/T 460-2015 Clinical practice of PSA test in prostatic cancer
WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 496-2017 Quality indicators in clinical laboratories
WS/T 442-2014 Guideline for clinical laboratory biosafety
WS/T 357-2011 Clinical practice guidelines of bone metabolic markers
WS/T 227-2002 Requirement for the technical procedure manual in clinical laboratory
WS 392-2012 Clinical application of ventilator
WS/T 222-2002 Guideline for the measurement of catalytic concentration of clinical enzymes
WS/T 418-2013 Guidelines for the ion of referral clinical laboratories
WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
WS/T 422-2013 Clinical application technique specification of hyperbaric oxygen
WS/T 102-1998 Classification and codes of clinical laboratory tests item
WS/T 804-2022 Basic technical standard for clinical chemistry laboratory
WS/T 208-2001 Clinical diagnostic standard for dental fluorosis
WS/T 662-2020 Technical requirements for clinical body fluids analysis
WS/T 249-2005 Clinical Laboratory Waste Management
WS 533-2017 Clinical nuclear medicine patient protection requirements
WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
WS/T 427-2013 Nutritional risk screening
WS/T 574-2018 Purified reagent water in the clinical laboratory

Professional Standard - Agriculture

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

Professional Standard - Judicatory

SF/T 0111-2021 Specification of examination in forensic clinical medicine
SF/T 0112-2021 Implemental specification of clinical forensic imaging examination
SF/Z JD0103006-2014 Implementation Specification for Forensic Clinical Imaging Examination
SF/Z JD0103003-2011 Specifications for Forensic Clinical Examination

Professional Standard - Certification and Accreditation

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

Professional Standard - Medicine

YY/T 0297-1997 Clinical investigation of medical devices
YY/T 1227-2014 In vitro diagnostic reagent(kit)nomenclature for clinical chemistry
YY/T 1930-2024 Medical Device Clinical Evaluation Terms and Definitions
YY/T 0522-2009 Dentistry Preclinical evaluation of dental implant systems Animal test methods
YY/T 0991-2015 Clinical trial guideline for orthodontic brackets
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

未注明发布机构

CLSI EP37-2018 Supplemental Tables for Interference Testing in Clinical Chemistry
NCCLS LIS3-A-2003 Clinical Laboratory Information System Selection Guide
CLSI EP07-2018 Application of Interference Test in Clinical Chemistry
WFAS 007.8-2023 Clinical Guideline on Acupuncture and Moxibustion for Migraine
WFAS 007.4-2023 Clinical guideline on acupuncture and moxibustion Chronic constipation
WFAS 007.5-2023 Clinical guideline on acupuncture and moxibustion-Allergic rhinitis
NCCLS I6-A-1984 Clinical Laboratory Instrument Service Guide
CLSI C49-2018 Analysis of Body Fluids in Clinical Chemistry
CLSI GP05-A3-2011 Clinical Laboratory Waste Management; Approved Guideline—Third Edition
WFAS 007.2-2023 Clinical guideline on acupuncture and moxibustionSmoking cessation

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 16360-1996 Radiological protection standard for clinical nuclear medicine
GB/T 16751.1-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment - Diseases
GB/T 20469-2006 General guideline of the clinical laboratory design
GB/T 16751.3-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment - Therapeutic methods
GB/T 30224-2013 Clinical Use of Tests for Toxoplasma Gondii
GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
GB 16396-1996 Diagnosis of clinical classification for endemic skeletal fluorosis
GB/T 42168.1-2022 Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self reports

Professional Standard - Public Safety Standards

GA/T 1970-2021 Specifications for clinical forensic examination

Zhejiang Provincial Standard of the People's Republic of China

DB33/T 1333-2023 Integrated clinical information system functional guide
DB33/T 855-2011 Clinical disease classification and code

Shanghai Provincial Standard of the People's Republic of China

DB31/T 137-6-1994 Standard solution of urea nitrogen for clinical chemistry
DB31/T 137-11-1994 Cholesterol Standard Solution for Clinical Chemistry
DB31/T 137-2-1994 Potassium and sodium standard solution for clinical chemistry
DB31/T 137-10-1994 Mannitol standard solution for clinical chemistry
DB31/T 137-3-1994 Chlorine 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 137-9-1994 Dextrose standard solution for clinical chemistry
DB31/T 137-5-1994 Phosphorus standard solution for clinical chemistry
DB31/T 137-13-1994 Total protein standard solution for clinical chemistry
DB31/T 137-12-1994 Pyruvate standard solution for clinical chemistry
DB31/T 138-1-1994 General rules for assay kits for clinical chemistry
DB31/T 1076-2018 Regulations on clinical forensic expertise service
DB31/T 1440-2023 Clinical Research Center Construction and Management Standards
DB31/T 137-7-1994 Uric acid standard solution for clinical chemistry
DB31/T 137-1-1994 General rules for standard solutions for clinical chemistry

Anhui Provincial Standard of the People's Republic of China

DB34/T 5212-2025 Guidelines for Smart Clinical Pharmacy Services
DB34/T 4339-2022 Forensic clinical identification service specification

Fujian Provincial Standard of the People's Republic of China

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

Guangdong Provincial Standard of the People's Republic of China

DB44/T 2218.4-2019 Traditional Chinese Medicine (Integrated Traditional Chinese and Western Medicine) Clinical Practice Guidelines Formulate and Revise General Principles
DB44/T 2552-2024 Ethical review standards for drug clinical trials
DB44/T 2350-2022 Clinical medical transportation operation management specification
DB44/T 2349-2022 Management specification for clinical medical transportation personnel

世界针灸学会联合会World Federation of Acupuncture-Moxibustion Societies

WFAS 009.1-2023 Acupuncture clinical research management standards

Shanxi Provincial Standard of the People's Republic of China

DB14/T 1658-2018 Technical operating procedures for clinical nutrition diagnosis and treatment
DB14/T 3065-2024 Medical clinical transportation work specifications
DB14/T 3071-2024 Quality control specification for clinical use of ventilators

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

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

Beijing Provincial Standard of the People's Republic of China

DB11/T 2065-2022 Basic security requirements for clinical biobanks
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
DB11/T 2226-2024 Clinical research data collection and application specifications

Shandong Provincial Standard of the People's Republic of China

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

Jilin Provincial Standard of the People's Republic of China

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

Liaoning Provincial Standard of the People's Republic of China

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

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4904-2024 Vaccines clinical trial site management standards

National Health Commission of the People's Republic of China

WS/T 805-2022 Basic technical standard for clinical microbiology laboratory

Occupational Health Standard of the People's Republic of China

GBZ 120-2006 Radiological protection standards for clinical nuclear medicine

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 54-2014 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
FCR 21 CFR PART 54-2013 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
FCR 21 CFR PART 54-2015 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
FCR FED H-08-5 CHAP 214 TRANSMITTAL NO.135-1983 CLINICAL SERVICES ADMINISTRATION, TRANSMITTAL NO. 135

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
BH GSO ASTM F2884:2022 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
BH GSO ISO/TS 22911:2017 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
BH GSO ISO 19465:2022 Traditional Chinese medicine — Categories of traditional Chinese medicine (TCM) clinical terminological systems
BH GSO ISO 29943-1:2022 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports

GCC Standardization Organization

GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
GSO ASTM F2884:2021 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
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
GSO ISO/TS 22911:2015 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
GSO ISO 29943-1:2021 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
GSO ISO 29943-2:2021 Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports
GSO ISO/TR 13128:2016 Health Informatics -- Clinical document registry federation

SCC

CAN/HSO 1003:2023 Clinical Governance
AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
OS GSO ISO/TS 22911:2015 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
OS GSO OIML R115:2010 Clinical electrical thermometers with maximum device
OS GSO OIML R7:2010 CLINICAL THERMOMETERS (mercury-in-glass, with maximum device)

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 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 F2721-08 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 E1284-97 Guidelines for the Construction of Clinical Terminology
ASTM STP 1217-1994 Clinical and Laboratory Performance of Bone Plates
ASTM E2182-02 Standard Specification for Clinical XML DTDs in Healthcare

Bureau of Indian Standards

IS/ISO 14155-2011 Clinical Investigation of Medical Devices for Human Subjects-Good Clinical Practice
IS/ISO 29943-2-2017 Condoms Guidance on clinical studies Part 2: Female condoms clinical function studies based on self-reports
IS 15113-2002 Clinical Electrical Thermometers with Maximum Device
IS 3055-1-1994 Clinical thermometers Part 1: solid stem type

British Standards Institution (BSI)

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
08/30116059 DC BS ISO 14155. 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
BS EN ISO 14155:2020+A11:2024 Clinical investigation of medical devices for human subjects. Good clinical practice
24/30506234 DC BS EN ISO 12487 Medical electrical equipment — Clinical performance evaluation of clinical thermometers
BS 691:1966 Clinical maximum thermometers
BS 691:1936 Clinical maximum thermometers
BS 691:1953 Clinical maximum thermometers
BS 691:1961 Clinical maximum thermometers
18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice
BS ISO 29943-1:2017 Condoms. Guidance on clinical studies. Male condoms, clinical function studies based on self-reports
BS EN ISO 14155:2011 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 PAS 1616:2016 Healthcare. Provision of clinical services. Specification
BS EN 21942-1:1992 Dental vocabulary-General and clinical terms
BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects
PAS 1616:2016 Healthcare. Provision of clinical services. Specification
BS ISO 19465:2017 Traditional Chinese medicine. Categories of traditional Chinese medicine (TCM) clinical terminological systems
BS DD CEN/TS 15699:2009 Health informatics — Clinical knowledge resources — Metadata
BS EN ISO 11979-7:2014 Ophthalmic implants. Intraocular lenses. Clinical investigations
BS DD ISO/TS 29585:2010 Health informatics - Deployment of a clinical data warehouse
BS EN ISO 11979-7:2006+A1:2012 Ophthalmic implants. Intraocular lenses. Clinical investigations
BS EN 540:1993 Clinical investigation of medical devices for human subjects
BS ISO/HL7 27932:2009 Data exchange standards. HL7 clinical document architecture, release 2 CD-ROM

Spanish Association for Standardization (UNE)

UNE-EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
AENOR UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
UNE 129001:1997 CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.
UNE-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
UNE 129002:2000 IN Glossary of recommended terms in clinical laboratory sciences.

International Organization for Standardization (ISO)

ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
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 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO/TS 22911:2016 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
ISO 14155:1996 Clinical investigation of medical devices
ISO/TS 22911:2005 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
ISO/TS 23030:2020 Traditional Chinese medicine - Clinical document specification for prescription of traditional Chinese medicine decoction pieces
ISO 29943-2:2017 Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports
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
ISO/CD 12487:2023 Medical electrical equipment — Clinical investigation of clinical thermometers
ISO/TS 29585:2010 Health informatics - Deployment of a clinical data warehouse

Danish Standards Foundation

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
DANSK DS/EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
DANSK DS/ISO/TR 13128:2012 Health Informatics - Clinical document registry federation
DS/EN 540:1993 Clinical investigation of medical devices for human subjects

Korean Agency for Technology and Standards (KATS)

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 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(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 14155-2-2019 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 C 1222-2014 Clinical electronic spirometers
KS C 1221-1989(2009) Polygraphs for clinical use
KS P 1208-2013 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 TS 22911-2020 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 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 8430-2015(2020) Management and safety requirements for clinical laboratory pre-analytical automation system
KS C 1221-1989 Polygraphs for clinical use

Ente Nazionale Italiano di Unificazione

UNI 7792:1977 Clinical thermometers.
EC 1-2011 UNI EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
UNI EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
UNI EN 13503-7:2002 Ophthalmic implants - Intraocular lenses - Clinical investigations
UNI EN 21942-1:1992 Dental vocabulary. General and clinical terms.

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-54778-1993 ANALYZER, CLINICAL CHEMISTRY, DRY
DOD A-A-54861-1993 INDICATOR, CLINICAL CHART HOLDER, METAL
DOD A-A-53656-1988 THERMOMETER, CLINICAL, HUMAN (ELECTRONIC, BATTERY POWERED)
DOD A-A-51827-1987 THERMOMETER, CLINICAL, HUMAN, (DISPOSABLE)
MIL MIL-R-36037B-1967 RACK, DRYING, CLINICAL UTENSILS (NO S/S DOCUMENT)
DOD A-A-54898-1993 THERMOMETER, LIQUID CRYSTAL, CLINICAL, DISPOSABLE

German Institute for Standardization

DIN EN ISO 14155:2020-12 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 E:2018-08 Good Clinical Practice for Clinical Investigation of Medical Devices in Anthropology (Draft)
DIN EN ISO 14155 E:2024-09 Draft Document - 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 14155:2018-08 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
DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
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
DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN ISO 12487 E:2025-01 Draft Document - Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024); German and English version prEN ISO 12487:2024
DIN EN ISO 14155-2 E:2001-08 Clinical Studies of Medical Devices for Human Use Part 2: Clinical Study Protocol (Draft)
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 6809-3:1990-03 Clinical dosimetry; diagnostic radiology
DIN EN ISO 14155/A11:2025-03 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020/A11:2024
DIN EN ISO 14155-2:2009-11 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
DIN 6809-3:1990 Clinical dosimetry; diagnostic radiology
DIN EN ISO 14155:2012-01 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011)
DIN EN ISO 14155-2:2003-09 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
DIN EN 540:1993 Clinical testing of medical devices on humans
DIN CEN/TS 15699:2009 Health informatics - Clinical knowledge resources - Metadata; English version CEN/TS 15699:2009

Standards Norway

NS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
NS-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

AR-IRAM

IRAM 9020-1962 clinical thermometer

Gosstandart of Russia

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 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
GOST R 56429-2021 Medical devices. Clinical еvaluation
GOST R 56429-2015 Medical devices. Clinical evaluation
GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals
GOST R 52379-2005 Good clinical practice (GCP)
GOST R 56699-2015 Medicines for medical applications. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. General recommendations
GOST R 57525-2017 Clinical and economic analysis. General requirements
GOST R 59921.9-2022 Artificial intelligence systems in clinical medicine. Algorithms for data analysis in clinical physiology. Testing methods. General requirements
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 R 57147-2016 Medicine for medical application. Nonclinical evaluation for anticancer pharmaceuticals

SE-SIS

SIS 64 41 50-1969 Clinical maximum thermometer

Association Francaise de Normalisation

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S91-154:1995 Clinical evaluation of dental implants.
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 S99-201:1993 Clinical investigation of medical devices for human subjects.

Standard Association of Australia （SAA）

AS 2190:1978 Clinical maximum thermometers
AS ISO 14155:2002 Clinical investigation of medical devices
AS T33:1966 Specification for clinical maximum thermometers
AS 3816:2018 Management of clinical and related wastes
AS 1765:1975 Artificial lighting for clinical observation
AS 2190:1995 Clinical maximum thermometers - Mercury-in-glass
MP 97-2008 Standards for enterprise-wide clinical information systems

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
JIS T 1140:2014 Clinical electrical thermometers with maximum device

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

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

Swedish Institute for Standards

SS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
SS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

VN-TCVN

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

CN-QIYE

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

European Committee for Standardization (CEN)

EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
prEN ISO 12487 Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024)
prEN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)
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 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003
prEN 540-1992 Clinical investigation of medical devices for human subjects

American National Standards Institute （ANSI)

ANSI/ADA 1000-2010(2020) Standard Clinical Data Architecture
ANSI/ADA 1000-2010 Standard Clincal Data Architecture
ANSI/ADA 1039-2006(2014) Standard Clinical Conceptual Data Model
ANSI/ADA 103-1999(2010) Standard Clinical Conceptual Data Model
ANSI Z80.21-2010(R2015) Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
ANSI Z80.21-2020 Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts

American Dental Association

ADA 1000-2010(R2020) Standard Clinical Data Architecture
ADA 1039-2006(R2014) Standard Clinical Conceptual Data Model
ADA TR 1004-2004 Clinical Software Performance for Dental Practice Software

Indonesia Standards

SNI 16-4941-1998 Enclosed-scale clinical thermometers

PL-PKN

PN-EN ISO 14155-2021-02 E 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 21942-1-1992 Dental vocabulary - General and clinical terms
ONORM EN 540-1993 Clinical investigation of medical devices for human subjects

Lithuanian Standards Office

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

IX-EU/EC

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

Canadian General Standards Board （CGSB)

CAN/CGSB-14.1-M87-1987 Mercury-in-Glass Clinical Thermometers

US-CFR-file

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

North Atlantic Treaty Organization Standards Agency

STANAG 2348-1998 BASIC MILITARY HOSPITAL (CLINICAL) RECORDS

US-HHS

HHS 21 CFR PART 54 CFR PART 54-2011 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

CU-NC

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

BE-NBN

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

RO-ASRO

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

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE)

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

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)

PT-IPQ

NP EN 540-2001 Clinical investigation of medical devices for human subjects