Semi-clinical

Semi-clinical, Total:191 items.

The international standard classification for "Semi-clinical" includes: Medical Sciences and health care facilities in general , Laboratory medicine , Dental materials .

The Chinese standard classification for "Semi-clinical" includes: Medical science , Nutrition sanitation , Sanitation in general , Medical apparatus and devices in general , Stomatologic device, equipment and material , Legal medical expert , Medical laboratory equipment .

Group Standards of the People's Republic of China

T/CGCPU 025-2022 Guideline of contract research organization
T/CACM 1225-2019 Clinical guidelines for diagnosis and treatment of spinal orthopedics in TCM Sacroiliac joint subluxation
T/CACM 1255-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Henoch-Schonlein Purpura Nephritis
T/NBPIA 007-2021 Classification of hemodialyzer clinical performance
T/CACM 015.12-2017 Chinese medicine clinical research verification standards
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CACM 1362-2021 Standard for clinical application of traditional Chinese herbal pieces
T/HNMA 1-2019 MRI clinical function evaluation specification
T/CAAM 0007-2022 Guidelines for Acupuncture and Moxibustion Clinical Research Registration
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CADHOH 0006-2024 Specification for clinical diagnosis and treatment of tinnitus
T/CACM 1063~1064-2018 Acupuncture Medicine Clinical Basic Terminology Acupuncture Medicine Clinical General Requirements
T/CACM 1064-2018 Acupotomology clinic-General requirements
T/CACM 1181-2019 Clinical Guidelines for Diagnosis and Treatment of Orthopedics and Traumatology in Traditional Chinese Medicine Meniscal injury of knee
T/CGCPU 025-2023 Guideline of contract research organization
T/HNMA 3-2019 MRI Clinical Functional Evaluation Guidelines
T/CACM 1063-2018 Acupotomology clinic-Basic terminologies
T/CACM 1524-2023 Guidelins for clinical of body weight management with Chinese medicine

未注明发布机构

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 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
WS 533-2017 Clinical nuclear medicine patient protection requirements
DIN EN ISO 14155 E:2018-08 Good Clinical Practice for Clinical Investigation of Medical Devices in Anthropology (Draft)
ANSI/ADA 1000-2010(2020) Standard Clinical Data Architecture
ANSI/ADA 1039-2006(2014) Standard Clinical Conceptual Data Model

Professional Standard - Hygiene

WS/T 442-2014 Guideline for clinical laboratory biosafety
WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
WS/T 427-2013 Nutritional risk screening
WS/T 249-2005 Clinical Laboratory Waste Management
WS/T 422-2013 Clinical application technique specification of hyperbaric oxygen
WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 251-2005 Guidelines for Clinical Laboratory Safety
WS 392-2012 Clinical application of ventilator

Professional Standard - Certification and Accreditation

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

Professional Standard - Medicine

YY/T 0297-1997 Clinical investigation of medical devices
YY/T 0991-2015 Clinical trial guideline for orthodontic brackets

司法部

SF/T 0111-2021 Specification of examination in forensic clinical medicine

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

GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
GB/T 20469-2006 General guideline of the clinical laboratory design
GB/T 30224-2013 Clinical Use of Tests for Toxoplasma Gondii

Zhejiang Provincial Standard of the People's Republic of China

DB33/T 855-2011 Clinical disease classification and code

中华人民共和国国家卫生和计划生育委员会

WS/T 496-2017 Quality indicators in clinical laboratories

Professional Standard - Public Safety Standards

GA/T 1970-2021 Specifications for clinical forensic examination

Shanghai Provincial Standard of the People's Republic of China

DB31/T 137-3-1994 Chlorine Standard Solution for Clinical Chemistry
DB31/T 137-5-1994 Phosphorus standard solution for clinical chemistry
DB31/T 137-1-1994 General rules for standard solutions for clinical chemistry
DB31/T 137-4-1994 Calcium Standard Solution for Clinical Chemistry
DB31/T 137-8-1994 Creatinine standard solution for clinical chemistry

卫生健康委员会

WS/T 662-2020 Technical requirements for clinical body fluids analysis
WS/T 644-2018 Clinical laboratory quality evaluation
WS/T 574-2018 Purified reagent water in the clinical laboratory

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

Fujian Provincial Standard of the People's Republic of China

DB35/T 1985-2021 Primary Liver Cancer Clinical Dataset

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

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

JJF 1644-2017 The Production of Reference Materials for Clinical Enzymology

未注明发布机构

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 ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
ANSI/ADA 1000-2010(2020) Standard Clinical Data Architecture
DIN EN ISO 14155-2 E:2001-08 Clinical Studies of Medical Devices for Human Use Part 2: Clinical Study Protocol (Draft)

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

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
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

SCC

CAN/HSO 1003:2023 Clinical Governance
BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
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
DANSK DS/EN ISO 14155/AC:2011 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 691:1936 Clinical maximum thermometers
BS 691:1966 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
NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
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)
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
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

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

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

International Organization for Standardization (ISO)

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/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 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO 14155:1996 Clinical investigation of medical devices

ES-UNE

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

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

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(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 ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans

AR-IRAM

IRAM 9020-1962 clinical thermometer

German Institute for Standardization

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

British Standards Institution (BSI)

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 EN ISO 14155:2020 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 PAS 1616:2016 Healthcare. Provision of clinical services. Specification
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 ISO 29943-1:2017 Condoms. Guidance on clinical studies. Male condoms, clinical function studies based on self-reports

GOST

GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
GOST R 59921.1-2022 Artificial intelligence systems in clinical medicine. Part 1. Clinical evaluation
GOST R 56429-2021 Medical devices. Clinical еvaluation
GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans

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.

SE-SIS

SIS 64 41 50-1969 Clinical maximum thermometer

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 ISO 14155-2014 Clinical investigation. Good clinical practice
GOST R 56429-2015 Medical devices. Clinical evaluation
GOST R 52379-2005 Good clinical practice (GCP)
GOST R 57525-2017 Clinical and economic analysis. General requirements

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

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

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

Indonesia Standards

SNI 16-4941-1998 Enclosed-scale clinical thermometers

American National Standards Institute （ANSI)

ANSI/ADA 1000-2010 Standard Clincal Data Architecture

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
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)
prEN 540-1992 Clinical investigation of medical devices for human subjects

HU-MSZT

MSZ 3887-1965 Half-turn milling machine tool radius for lathe processing = 1,6-20
MSZ 3888-1965 Tool radius of semicircular milling machine processed by lathe = 1.6-20

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

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

AENOR

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

PL-PKN

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

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

RO-ASRO

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