production and clinical

production and clinical, Total:180 items.

The international standard classification for "production and clinical" includes: Laboratory medicine , Medical Sciences and health care facilities in general , Radiation protection , Occupational safety. Industrial hygiene , Electronic components in general , Implants for surgery, prosthetics and orthotics .

The Chinese standard classification for "production and clinical" includes: Sanitation in general , Medical science , Nutrition sanitation , Computer application , Radiological sanitation protection , Medical apparatus and devices in general , Legal medical expert , Extracorporeal circulation, artificial organ and prosthesis device .

Professional Standard - Hygiene

WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
WS/T 489-2016 Laboratory diagnosis of urinary tract infections
WS 392-2012 Clinical application of ventilator
WS 363.8-2011 Health data element dictionary—Part 8:Assistant examination
WS/T 442-2014 Guideline for clinical laboratory biosafety
WS/T 427-2013 Nutritional risk screening
WS/T 489-2024 Guidelines for clinical microbiology laboratory testing of urine specimens
WS/T 489-2015 Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
WS/T 251-2005 Guidelines for Clinical Laboratory Safety
WS/T 403-2012 Analytical quality specifications for routine analytes in clinical biochemistry

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

GB 16360-1996 Radiological protection standard for clinical nuclear medicine
GB 16361-1996 Radiological protection standards for the patient in clinical nuclear medicine
GB/T 20469-2006 General guideline of the clinical laboratory design

卫生健康委员会

WS/T 640-2018 Specimen collection and transport in clinical microbiology
WS/T 780-2021 Reference intervals of clinical biochemistry tests commonly used for children

Occupational Health Standard of the People's Republic of China

GBZ 120-2006 Radiological protection standards for clinical nuclear medicine

National Health Commission of the People's Republic of China

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

Beijing Provincial Standard of the People's Republic of China

DB11/T 2065-2022 Basic security requirements for clinical biobanks

Shandong Provincial Standard of the People's Republic of China

DB37/T 3477-2018 Linshu Peanut Production Technical Regulations

Group Standards of the People's Republic of China

T/SAME 001-2022 Management requirements for level II biosafety cabinets in clinical laboratories
T/GDPHA 024-2021 Technical Standard for Property Protection and Exchange of Clinical Research Data
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CGCPU 025-2023 Guideline of contract research organization
T/CACM 1212-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM postpartum urinary retention
T/HNMA 3-2019 MRI Clinical Functional Evaluation Guidelines
T/CSHB 0007-2024 Production process specifications for iron bed frames
T/LYFIA 045-2022 Technique specifications for production of No.1 Lingu millet
T/CACM 1378.2-2022 Technical Specifications for Dispensing Chinese Proprietary Medicines Commonly Used in Clinical Emergency and Critical Care Part 2: Injections
T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
T/LG 002-2022 Linhai Grape Production Technical Regulations
T/CACM 1063~1064-2018 Acupuncture Medicine Clinical Basic Terminology Acupuncture Medicine Clinical General Requirements
T/CACM 1174-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Postpartum rheumatism
T/CGCPU 025-2022 Guideline of contract research organization
T/SDHCST 002-2023 Test Substance Requirements on the Non-Clinical Studies of the Cell Therapy Medical Products

中华人民共和国国家卫生和计划生育委员会

GBZ 120-2002 Radiological protection standard For clinical nuclear medicine
WS/T 496-2017 Quality indicators in clinical laboratories

Jiangxi Provincial Standard of the People's Republic of China

DB36/T 1622-2022 Technical specifications for clinical diagnosis of aquatic animal diseases

国家卫生计生委

WS/T 503-2017 Blood culture operating procedures in clinical microbiology laboratories

Inner Mongolia Provincial Standard of the People's Republic of China

DB15/T 1899-2020 Judgment of primary subclinical ketosis in postpartum dairy cows

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 1000-2010(2020) Standard Clinical Data Architecture
DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

Yunnan Provincial Standard of the People's Republic of China

DB5309/T 69-2022 Lincang City Wogan Production Technical Regulations

Professional Standard - Electron

SJ 20895-2003 Temporary protection demands for electronic product in producing

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

司法部

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

国家药监局

YY/T 1679-2021 Tissue engineering medical device products-Bone-Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects

Zhejiang Provincial Standard of the People's Republic of China

DB33/T 855-2011 Clinical disease classification and code

GOSTR

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

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

GOST

GOST R 56429-2021 Medical devices. Clinical еvaluation
GOST R 59921.9-2022 Artificial intelligence systems in clinical medicine. Algorithms for data analysis in clinical physiology. Testing methods. General requirements
GOST R 57106-2023 Products of dietary medical and dietary preventive nutrition. Vitamin-mineral complexes in clinical nutrition. Specifications
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 ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans

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
BH GSO ISO/TR 15300:2017 Dentistry -- Application of OSI clinical codification to the classification and coding of dental products
GSO ISO/TR 15300:2016 Dentistry -- Application of OSI clinical codification to the classification and coding of dental products
OS GSO ISO/TR 15300:2016 Dentistry -- Application of OSI clinical codification to the classification and coding of dental products
GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
OS GSO ISO 11980:2015 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations

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

British Standards Institution (BSI)

PAS 1616:2016 Healthcare. Provision of clinical services. Specification
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
DD ENV 13728-2001 Health informatics. Clinical analyser interfaces to laboratory information systems
BS EN ISO 11980:2012 Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations

RU-GOST R

GOST R 57106-2016 Products diet therapeutic and preventive nutrition diet. Complexes vitamin-mineral in clinical nutrition. Specification
GOST R 57525-2017 Clinical and economic analysis. General requirements
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 55041-2012 Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations
GOST R 52379-2005 Good clinical practice (GCP)

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/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice
AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
AENOR UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
DANSK DS/EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
NS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
BS 691:1961 Clinical maximum thermometers
BS 691:1953 Clinical maximum thermometers
AS 2190:1978 Clinical maximum thermometers
BS EN 21942-1:1992 Dental vocabulary-General and clinical terms
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)
DANSK DS/EN ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
BS EN ISO 11980:1998 Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations
AS T33:1966 Specification for clinical maximum thermometers

KR-KS

KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P ISO 14155-2019 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P ISO TR 15300-2019 Dentistry ― Application of OSI clinical codification to the classification and coding of dental products

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 11980:1997 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
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/TR 21835:2020 Health informatics — Personal health data generated on a daily basis
ISO 11980:2009 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations

ES-UNE

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

Canadian General Standards Board （CGSB)

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

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)

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 P ISO TR 15300:2019 Dentistry ― Application of OSI clinical codification to the classification and coding of dental products
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 ISO 11980-2006(2016) Ophthalmic optics－Contact lenses and contact lens care products－Guidance for clinical investigations
KS P 1208-2013 Direct Blood-Pressure Meters for Clinical Use
KS C 1221-1989(2009) Polygraphs for clinical use
KS P ISO 11980-2021 Ophthalmic optics－Contact lenses and contact lens care products－Guidance for clinical investigations
KS P ISO 11980:2006 Ophthalmic optics－Contact lenses and contact lens care products－Guidance for clinical investigations
KS P ISO 11980-2006(2021) Ophthalmic optics－Contact lenses and contact lens care products－Guidance for clinical investigations

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 11980:2013-03 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012); German version EN ISO 11980:2012

Association Francaise de Normalisation

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
FD S91-016*FD ISO/TR 15300:2002 Dentistry - Application of OSI clinical codification to the classification and coding of dental products
NF EN ISO 11980:2013 Ophthalmic optics - Contact lenses and contact lens care products - Guidelines for clinical investigations

US-CFR-file

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

SE-SIS

SIS 64 41 50-1969 Clinical maximum thermometer

HU-MSZT

MSZ 6415-1968 Mechanical production products. Lathe equipment

AT-ON

ONORM EN 21942-1-1992 Dental vocabulary - General and clinical terms
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

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

IT-UNI

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

Danish Standards Foundation

DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
DS/EN ISO 11980:2013 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations

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

DIN

DIN EN ISO 11980:1998 Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:1997)

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 11980:2009 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
prEN ISO 11980 rev Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations

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

AENOR

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

CU-NC

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

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)

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