Clinical Diagnostic Medical Devices

Clinical Diagnostic Medical Devices, Total:266 items.

The international standard classification for "Clinical Diagnostic Medical Devices" includes: Medical Sciences and health care facilities in general , Health care technology (Vocabularies) , Laboratory medicine .

The Chinese standard classification for "Clinical Diagnostic Medical Devices" includes: Medical apparatus and devices in general , Pharmaceutical in general , Medical laboratory equipment .

Shanxi Provincial Standard of the People's Republic of China

DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions

Professional Standard - Medicine

YY/T 0297-1997 Clinical investigation of medical devices

Group Standards of the People's Republic of China

T/CACM 1272-2019 Guidelines for clinical diagnosis and treatment of otolaryngology in Chinese medicine—Acute laryngitis
T/CACM 1230-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Chronic cough
T/CACM 1201-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Infantile Malnutrition
T/CACM 1194-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Enterobiasis Disease
T/CACM 1166-2019 Clinical guidelines for diagnosis and treatment of proctology in TCM rectal prolapse
T/CACM 1300-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Ovulation Bleeding
T/CACM 1147-2019 Clinical guidelines for diagnosis and treatment of dermatology in TCM Pemphigus
T/CACM 1219-2019 Guidelines for diagnosis and treatment of spinal orthopedics in Chinese medicine—Thoracic dorsal myofascitis
T/CACM 1183-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM hepatic encephalopathy
T/CACM 1284-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Mental Retardation
T/CACM 1124~1142-2018 Guidelines for clinical diagnosis and treatment of mental illness in traditional Chinese medicine (II)
T/CACM 1180-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Depression
T/CACM 1189-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Varicella
T/CACM 1182-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Aphtha in Children
T/CACM 1278-2019 Clinical guidelines for diagnosis and treatment of dermatology in TCM Tinea pedis
T/CACM 1159-2019 Clinical Guidelines for Diagnosis and Treatment of Orthopedics and Traumatology in Traditional Chinese Medicine Carpal Tunnel Syndrome
T/CACM 1317-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Oculomotor Nerve Palsy
T/CACM 1206-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Stone gonorrhea
T/CACM 1221-2019 Clinical guidelines for diagnosis and treatment in TCM Abnormal glucose regulation
T/CACM 1152-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Heat in lung due to ‘wind-warm’
T/CACM 1184-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM alcoholic liver disease
T/CACM 1190-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM attention deficit hyperactivity disorder
T/CACM 1224-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Ischemic Cardiomyopathy
T/CACM 1188-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM posterior uveitis
T/CACM 1315-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Alzheimer ’s disease
T/CACM 1216-2019 Clinical guidelines for diagnosis and treatment in TCM Diabetic foot
T/CACM 1228-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM arthralgia with joint deformity
T/CACM 1168-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Adenomyosis
T/CACM 1212-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM postpartum urinary retention
T/CACM 1191-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Mumps
T/CACM 1163-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Adult onset Still‵s disease
T/CACM 1270-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Sepsis
T/SAMD 0002-2023 Probes for in-vitro diagnostic medical devices
T/CACM 1149-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Abdominal pain
T/CACM 1249-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Drug-induced Liver Injury
T/CACM 1265-2019 TCM Gynecology Clinical Diagnosis and Treatment Guidelines for Prolonged Menstrual Period
T/CACM 1227-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM bone rheumatism
T/CACM 1292-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Facial Paralysis
T/CACM 1205-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM impotence disease
T/CACM 1129-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Dysphoria
T/CACM 1160-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM functional bloating
T/CACM 1291-2019 Clinical guidelines for diagnosis and treatment of oncology in TCM Malignant Lymphoma
T/CACM 1273-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Acute myocardial infarction
T/CACM 1262-2019 Clinical Guidelines for Diagnosis and Treatment of Orthopedics and Traumatology in Traditional Chinese Medicine Clavicle Fracture
T/CACM 1153-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Sinus
T/CACM 1215-2019 Clinical Guidelines for Diagnosis and Treatment of Orthopedics and Traumatology in Traditional Chinese Medicine fracture of the femoral neck
T/CACM 1260-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Premenstrual syndrome
T/CACM 1202-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Chronic Leg Ulcer
T/CACM 1210-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Neonatal Hyperbilirubinemia
T/CACM 1312-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Cholelithiasis
T/SZZX 014-2023 Probes for in-vitro diagnostic medical devices
T/CACM 1245-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM anterior uveitis
T/CACM 1150-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Headed Carbuncle
T/CACM 1286-2019 Guidelines for clinical diagnosis and treatment of otolaryngology in Chinese medicine—Tinnitus
T/CACM 1157-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Tic Disorders
T/CACM 1174-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Postpartum rheumatism
T/CACM 1199-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM fibroadenoma of breast
T/CACM 1162-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Morning Sickness
T/CACM 1136-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Panic disorder
T/GDACM 0109-2022 the diagnosis and treatment of Insomnia Disorders
T/CACM 1239-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Advanced Menstruation
T/CACM 1307-2019 Guidelines for clinical diagnosis and treatment of pediatrics in Chinese medicine—Autism spectrum disorder
T/CACM 1304-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Intestinal abscess
T/CACM 1234-2019 Guidelines for Clinical Diagnosis and Treatment of Otolaryngology in Traditional Chinese Medicine Nasal Furuncle
T/CACM 1310-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM fever due to internal injury
T/CACM 1217-2019 Clinical guidelines for diagnosis and treatment of oncology in TCM Pancreatic cancer
T/CACM 1185-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Flesh goiter
T/CACM 1220-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Frailty in older adults
T/CACM 1296-2019 Clinical guidelines for diagnosis and treatment of spinal orthopedics in TCM Lumbar Spondylolisthesis
T/CACM 1250-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Urinary Tract Infection in Children
T/CACM 1280-2019 Clinical guidelines for diagnosis and treatment of proctology in TCM Carcinoma of rectum
T/CACM 1193-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Ascariasis Disease
T/CACM 1242-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM GuZhong disease
T/CACM 1209-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM gastric polyps
T/CACM 1288-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM leukorrhea diseases
T/CACM 1165-2019 Clinical guidelines for diagnosis and treatment of proctology in TCM Rectocele
T/CACM 1274-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Dermatomyositis
T/CACM 1154-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Hepatorenal Syndrome
T/CACM 1263-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Dengue Fever
T/CACM 1246-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Polymyositis
T/CACM 1186-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Comedomastitis
T/CRACM 0009-2023 Guidelines for the Clinical Diagnosis and Treatment of Traditional Chinese Medicine for Blood Turbidity Syndrome
T/CACM 1252-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Hematuria in Children
T/CACM 1204-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Lung carbuncle
T/CACM 1282-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM tremor disease
T/CACM 1293-2019 Clinical guidelines for diagnosis and treatment of proctology in TCM Anal cryptitis
T/CACM 1139-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Dysthymia
T/CACM 1207-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Gynecomastia
T/CACM 1151-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Enuresis in Children
T/CACM 1232-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Acute Myocardial Infarction with PCI
T/CACM 1235-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Chilblain
T/CACM 1236-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Pressure Ulcers
T/CACM 1158-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Pediatric Epilepsy
T/CACM 1233-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Ectopic pregnancy
T/CACM 1164-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Reactive arthritis
T/CACM 1269-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Hypomenorrhea
T/CACM 1173-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Acute pancreatitis
T/GDACM 0103-2021 Chinese medicine guidelines for diagnosis and treatment of Parkinson's disease (tremor and spasm disease)
T/CACM 1277-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Burn
T/CACM 1268-2019 TCM Gynecology Clinical Diagnosis and Treatment Guidelines for Premature Ovarian Failure
T/CACM 1200-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Hand-Foot-Mouth Disease
T/CACM 1223-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM gastroptosis
T/CACM 1301-2019 Guidelines for Clinical Diagnosis and Treatment of Otolaryngology in Traditional Chinese Medicine Chronic Pharyngitis
T/CACM 1313-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM dribbling urinary block
T/CACM 1287-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM White Lesions of the Vulva
T/CACM 1290-2019 Clinical Guidelines for Diagnosis and Treatment of Orthopedics and Traumatology in Traditional Chinese Medicine Humeral shaft fractures
T/CACM 1124-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Intracranial tinnitus
T/CACM 1172-2019 Clinical guidelines for diagnosis and treatment of oncology in TCM Cervical Cancer
T/CACM 1314-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Gastritis in Children
T/CACM 1247-2019 Guidelines for clinical diagnosis and treatment of surgery in Chinese medicine—Intestinal obstruction
T/CACM 1214-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Hyperhidrosis in Children
T/CACM 1132-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Manic episode
T/CACM 1138-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Non-organic insomnia
T/CACM 1267-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Hepatic fibrosis
T/CACM 1261-2019 Clinical guidelines for diagnosis and treatment of oncology in TCM Bladder carcinoma
T/CACM 1178-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Amenorrhea
T/CACM 1264-2019 Clinical guidelines for diagnosis and treatment of proctology in TCM Hypertrophy of anal papilla
T/CACM 1271-2019 Guidelines for clinical diagnosis and treatment of internal medicine in Chinese medicine—Headache
T/CACM 1241-2019 Guidelines for clinical diagnosis and treatment of otolaryngology in Chinese medicine—Chronic rhinitis
T/CACM 1306-2019 Clinical guidelines for diagnosis and treatment of dermatology in TCM the wind of four fossae
T/CACM 1369-2021 Guidelines for clinical diagnosis and treatment of high altitude polycythemia in Chinese medicine
T/CACM 1135-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Generalized anxiety disorder
T/CACM 1187-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Summer-heat disease
T/CACM 1131-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- First-episode depression
T/CACM 1176-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Myasthenia gravis
T/CACM 1244-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Mycoplasma pneumoniae pneumonia
T/CACM 1170-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Pulmonary hypertension
T/CACM 1305-2019 Clinical guidelines for diagnosis and treatment of dermatology in TCM systemic scleroderma
T/CACM 1133-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Tic disorder
T/CACM 1208-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Epilepsy
T/CACM 1254-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM chronic biliary tract infection
T/CACM 1128-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Dreaminess
T/CACM 1222-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM down-bearing stomachache
T/CACM 1302-2019 Guidelines for ophthalmology clinical diagnosis and treatment in Chinese medicine—External ophthalmoplegia
T/CACM 1195-2019 Clinical guidelines for Diagnosis and Treatment of Pediatrics in TCM Allergic Rhinitis in Children

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

GB/T 16751.1-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment - Diseases
GB/T 16751.2-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment - Syndromes
GB/T 16751.3-2023 Clinic terminology of traditional Chinese medical diagnosis and treatment—Part 3：Therapeutic methods
GB/T 16751.1-2023 Clinic terminology of traditional Chinese medical diagnosis and treatment—Part 1：Diseases
GB/T 16751.3-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment - Therapeutic methods

未注明发布机构

DIN EN 540:1993 Clinical testing of medical devices on humans
DIN EN ISO 20916 E:2021-05 Good research practices for clinical performance studies of in vitro diagnostic medical devices using human samples (draft)
DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

国家药品监督管理局

YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents

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

Professional Standard - Commodity Inspection

SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for improt - Ultrasonic medical diagnostic and therapy equipment

SCC

AS ISO 14155:2002 Clinical investigation of medical devices
BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
DANSK DS/ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
ISO 14155:2020 Plus Redline 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
DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/ISO 20916:2019 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
DANSK DS/EN ISO 20916:2024 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)
DANSK DS/EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices
BS EN 540:1993 Clinical investigation of medical devices for human subjects
DANSK DS/EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
NS-EN 540:1993 Clinical investigation of medical devices for human subjects
NS-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
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)
AENOR UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
AENOR UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
AENOR UNE-EN 13612/AC:1970 Performance evaluation of in vitro diagnostic medical devices.
BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
AENOR UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
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
DANSK DS/EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NS-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
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 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
AENOR UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
DANSK DS/ISO/TR 18112:2006 Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory requirements for information supplied by the manufacturer
UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

RU-GOST R

GOST R 56429-2015 Medical devices. Clinical evaluation
GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement

GOSTR

GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer
GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic medical devices
GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing

KR-KS

KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS P ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

GSO

BH GSO ISO 15198:2017 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
GSO ISO 15198:2016 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
OS GSO ISO 15198:2016 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
GSO ISO 20916:2021 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
BH GSO EN 13532:2022 General requirements for in vitro diagnostic medical devices for self-testing
GSO EN 13532:2021 General requirements for in vitro diagnostic medical devices for self-testing

Korean Agency for Technology and Standards (KATS)

KS P ISO 15198-2022 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO TR 18112-2020 Clinical laboratory testing and in vitro diagnostic test systems－In vitro diagnostic medical devices for professional use－Summary of regulatory requirements for information supplied by the manufacturer
KS P ISO TR 18112-2009(2014) Clinical laboratory testing and in vitro diagnostic test systems－In vitro diagnostic medical devices for professional use－Summary of regulatory requirements for information supplied by the manufacture
KS P ISO 14155-2-2019 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

European Committee for Standardization (CEN)

prEN 540-1992 Clinical investigation of medical devices for human subjects
EN ISO 20916:2024 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
prEN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
FprEN ISO 20916 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

Association Francaise de Normalisation

NF S99-201:1993 Clinical investigation of medical devices for human subjects.
NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using samples from human subjects - Good study practices
NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF EN ISO 23640:2015 In vitro diagnostic medical devices - Assessment of the stability of in vitro diagnostic reagents
NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing

British Standards Institution (BSI)

BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects
24/30467406 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
18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice

ES-UNE

UNE-EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.

NL-NEN

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

AT-ON

OENORM EN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

Indonesia Standards

SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

Danish Standards Foundation

DS/EN 540:1993 Clinical investigation of medical devices for human subjects
DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice

German Institute for Standardization

DIN EN 13612:2002-08 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
DIN EN ISO 20916:2021-05 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021 / Note: Date of issue 2021-04-09
DIN 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 23640:2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.
DIN EN 13532:2002-08 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

International Organization for Standardization (ISO)

ISO 14155:2011 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 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1

GOST

GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans

DIN

DIN EN ISO 20916:2024 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German version EN ISO 20916:2024

AENOR

UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE-EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

IT-UNI

EC 1-2020 UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice

US-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

VN-TCVN

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

Standard Association of Australia （SAA）

AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements

Lithuanian Standards Office

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

PL-PKN

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