Diagnostic test sample size formula

Diagnostic test sample size formula, Total:88 items.

The international standard classification for "Diagnostic test sample size formula" includes: Radiographic equipment , Medical equipment .

The Chinese standard classification for "Diagnostic test sample size formula" includes: Medical ultrasound, laser, high-frequency instrument and equipment , Medical apparatus and devices in general , Sanitation in general .

Professional Standard - Medicine

YY/T 0704-2008 Ultrasonics - Pulsed Doppler diagnostic system-Test procedures to determine performance
YY/T 1789.6-2023 In vitro diagnostic test systems―Performance evaluation method―Part 6:Precision, diagnostic sensitivity and specificity of qualitative reagents
YY/T 0108-2008 Testing methods for M-mode of ultrasonic diagnostic equipment

未注明发布机构

DIN EN 14252:2004 In-vitro diagnostics – disposable vessels for human specimens with the exception of blood samples; German version EN 14254:2004
DIN 6859-1 E:2020-10 Image quality assurance in diagnostic laboratories - Part 1: Constancy testing of ultrasound equipment for medical diagnosis and monitoring

Group Standards of the People's Republic of China

T/CSBME 024-2021 Reliability test methods for ultrasonic diagnostic equipment
T/CAMDI 125-2024 Reliability test methods for in vitro diagnostic (IVD) medical equipment

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

GB/T 19703-2005 In vitro
GB/T 19702-2005 In vitro
GB/T 15214-2008 Requirements and methods of reliability test for ultrasonic diagnostic equipment

中华人民共和国国家卫生和计划生育委员会

WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits - General guideline

Professional Standard - Agriculture

123兽药典三部-2015 Text Table of Contents Diagnostic Products Agglutination Test Antigen, Positive Serum and Negative Serum for Schistosomiasis japonicum
107兽药产品说明书范本第三册-2013 Diagnostic products Schistosomiasis japonicum agglutination test antigen, positive serum and negative serum instructions

SAE - SAE International

SAE J1979-1994 E/E DIAGNOSTIC TEST MODES
SAE J1979-1996 E/E Diagnostic Test Modes
SAE J1979-2010 E/E Diagnostic Test Modes
SAE J1979-1991 E/E DIAGNOSTIC TEST MODES
SAE J1979-1997 E/E Diagnostic Test Modes
SAE J1979-2007 E/E Diagnostic Test Modes
SAE J1979-2012 E/E Diagnostic Test Modes

SCC

CAN/CGSB-43.125-M90-1990 Packaging of infectious substances and diagnostic specimens
NS-EN 13640:2002 Stability testing of in vitro diagnostic reagents
NS-EN 12287:1999 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials
NS-EN 12286:1998 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures
NS-EN 829:1996 In vitro diagnostic systems — Transport packages for medical and biological specimens — Requirements, tests
DIN 6859-1:2022 Image quality assurance in diagnostic laboratories - Part 1: Constancy testing of ultrasound equipment for medical diagnosis and monitoring
DANSK DS/EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
CAN/CGSB-43.125-1999 Packaging of infectious materials, diagnostic samples, biological products and biomedical waste for transport
NS-EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects
AENOR UNE-EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
DANSK DS/EN 14254:2004 In vitro diagnostic medical devices – Single-use receptacles for the collection of specimens, other than blood, from humans

Society of Automotive Engineers (SAE)

SAE J1979-2014 E/E Diagnostic Test Modes
SAE J1979DA-2010 Digital Annex of E/E Diagnostic Test Modes
SAE J1979-DA-2010 Digital Annex of E/E Diagnostic Test Modes

RU-GOST R

GOST EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
GOST R 27.605-2013 Reliability in technique. Maintainability of equipment. Diagnostic testing
GOST 34243-2017 Telemedicine systems. General requirements for basic safety and essential performance of mobile telemedicine laboratory diagnostic kits

Association Francaise de Normalisation

NF S92-032:2002 Stability testing of in vitro diagnostic reagents.
NF S92-033*NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects.
NF S92-013:1996 In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
NF S92-021*NF EN ISO 17511:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials

British Standards Institution (BSI)

BS EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
BS EN 13640:2002 Stability testing of in vitro diagnostic reagents
BS EN 829:1997 In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements , tests
BS EN 12286:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
BS DD CEN/TS 15053:2005 Non-destructive testing - Recommendations for discontinuities-types in test specimens for examination
BS EN 12286:1999(2001) In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
BS 6548-5:1995 Maintainability of equipment - Guide to diagnostic testing
BS EN ISO 20916:2024 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

European Committee for Standardization (CEN)

EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
EN 829:1996 In Vitro Diagnostic Systems - Transport Packages for Medical and Biological Specimens - Requirements, Tests
prEN 829-1992 In vitro diagnostic systems; transport packages for medical and biological specimens; requirements; tests
PD CEN/TS 15053:2005 Non-destructive testing - Recommendations for discontinuitiestypes in test specimens for examination

Institute of Electrical and Electronics Engineers (IEEE)

IEEE 1522-2004 Trial-use standard for testability and diagnosability characterisics and metrics

American National Standards Institute （ANSI)

ANSI/ASHRAE 87.3-2001 Method of Testing Propeller Fan Vibration-Diagnostic Test Methods

KR-KS

KS P 1975-2018(2023) Protocol for evaluation of precision performance of the quantitative test in in-vitro diagnostic medical laboratory
KS P 1977-2018(2023) Protocol for evaluation of qualitative test performance in in-vitro diagnostic medical laboratory
KS P ISO 17511-2021 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

AT-ON

ONORM EN 829-1996 In vitro diagnostic systems-Transport packages for medical and biological specimens-Requirements,test

German Institute for Standardization

DIN CEN/TS 15053:2005 Non-destructive testing - Recommendations for discontinuities-types in test specimens for examination; German version CEN/TS 15053:2005
DIN V 6868-12:1996 Image quality assurance in X-ray diagnostics - Part 12: Constancy tests for hard copy cameras
DIN EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015
DIN EN ISO 23640:2012 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011
DIN EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
DIN 6859-1:2022-01 Image quality assurance in diagnostic laboratories - Part 1: Constancy testing of ultrasound equipment for medical diagnosis and monitoring
DIN EN 13975:2003-11 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts

CZ-CSN

CSN 85 2115-1982 Medical measuring apparatus for functional diagnostics. Nomenclature of basic indices

Korean Agency for Technology and Standards (KATS)

KS P 1012-2021 Standard materials for the quality control of genetic diagnostic tests of Plasmodium falciparum malaria
KS P 1012-2010(2021) Standard materials for the quality control of genetic diagnostic tests of Plasmodium falciparum malaria
KS P ISO 15193:2010 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Requirements for content and presentation of reference measurement procedures
KS P ISO 15193:2014 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
KS P 2094-2020 Protocol for measurement procedures comparison and bias estimation using patient samples in in-vitro diagnostic medical laboratory
KS P ISO 15194:2010 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Requirements for certified reference materials and the content of supporting documentation
KS P ISO 17511:2010 In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values assigned to calibrators and control materials
KS P ISO 15194:2014 In virto diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
KS P ISO 17511:2021 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
KS P 1977-2023 Protocol for evaluation of qualitative test performance in in-vitro diagnostic medical laboratory

International Organization for Standardization (ISO)

ISO 15193:2002 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
ISO 15194:2002 In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials

Japanese Industrial Standards Committee (JISC)

JIS X 5784:1997 Information technology -- Open Systems Interconnection -- Systems Management: Confidence and diagnostic test categories

AENOR

UNE-EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
UNE-EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

Danish Standards Foundation

DS/ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

GOSTR

GOST R EN 14254-2010 In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans

GSO

GSO ISO 6717:2024 In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood

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