medical molecular biology

medical molecular biology, Total:301 items.

The international standard classification for "medical molecular biology" includes: Medical equipment in general , Laboratory medicine , Health care technology (Vocabularies) , Radiation protection , Microbiology in general , Medical microbiology .

The Chinese standard classification for "medical molecular biology" includes: Medical apparatus and devices in general , Sanitation in general , Radiological sanitation protection , Health quarantine .

未注明发布机构

DIN 58959-2 E:1991-11 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
ANSI/AAMI/ISO 10993-2:2006(2010) Biological evaluation of medical devices— Part 2: Animal welfare requirements
DIN 58942-2:1985 Medical microbiology - Culture media - Part 2: Ready-to-use blood culture systems
DIN 58959-3 E:2013-12 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN EN ISO 10993-18:2009 Biological assessment of medical devices
DIN 58959-2 E:2020-09 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58969-10:1989 Medical microbiology - Diagnostics of infectious diseases in serological and molecular biology - Part 10: Complement fixation test (CFT)
DIN 58943-3 E:2008-05 Medical microbiology - Diagnosis of tuberculosis - Part 3: Detection of mycobacteria by culture methods
DIN 58943-5 E:2008-05 Medical microbiology - Diagnosis of tuberculosis - Part 5: Molecularbiological identification and differentiation of tubercle bacilli
DIN 58959-17 E:2007-04 Medical microbiology - Quality management in medical microbiology - Part 17: Requirements for the use of control strains for the examination of mycobacteria
DIN 58959-20 E:1991-11 Quality management in medical microbiology - Part 20: Requirements for the use of control material for the examination of protozoae and microorganisms of higher order
DIN 58959-17 E:1991-11 Medical microbiology - Quality management in medical microbiology - Part 17: Requirements for the use of control strains for the examination of mycobacteria
DIN 58959-6 Beiblatt 1:1997 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 1: Recommended test organisms for frequently used culture media
DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
DIN 58959-4 E:1991-11 Quality management in medical microbiology - Part 4: Requirements for investigations using light microscopes
DIN 58959-6 E:1991-11 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing
DIN 58959-6 E:2016-12 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing
DIN 58942-4:1986 Medical microbiology - Culture media - Part 4: Transport systems for specimens containing bacteria
DIN 58959-6 Beiblatt 2:1997 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 2: Recommended test organisms for frequently used testing reagents, dyes and biological...
DIN 58943-3:1988 Medical microbiology - Diagnosis of tuberculosis - Part 3: Detection of mycobacteria by culture methods
ANSI/AAMI/ISO TIR10993-19:2006 Biological evaluation of medical devices — Part 19: Physico- chemical, morphological, and topographical characterization of materials
DIN 58959-3 E:1991-11 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58967-20:1989 Medical microbiology and immunology - Diagnostics of infectious diseases and diseases of the immune system in serology and molecular biology - Part 20: General method-specific requirements for immunofluorescence tests (IFT)
DIN 58959-2 E:2006-05 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

Taiwan Provincial Standard of the People's Republic of China

CNS 3820-1975 Classification of Nuclear Science and Technology (Biology and Medical Science)

Professional Standard - Agriculture

129药典四部-2020 1000 molecular biology assays

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

GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23: Tests for irritation
GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials
GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2:Animal welfare requirements
GB/T 42186-2022 Operational specification for cold chain logistics of medical laboratory biological samples
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices

Professional Standard - Medicine

YY/T 1815-2022 Biological evaluation of medical devices-Application for the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

Professional Standard - Hygiene

WS 233-2002 General biosafety standard for microbiological and biomedical laboratories
WS 457-2014 Basic requirements of radiological protection for using unsealed radioactive material in medical and biological laboratory

Professional Standard - Commodity Inspection

SN/T 1862-2007 Standard of biosafety for pathogens test in medical vector laboratory entry-exit ports
SN/T 3457-2012 Criterion on detection of plant virus by molecular biology
SN/T 2965-2011 Criterion on Detection of Plant Pathogenic Fungi by Molecular Biology
SN/T 1630-2005 Rules of risk analysis for imported medical vectors at frontier ports
SN/T 4166-2015 Protocol on proficiency testing for morphological identification of vectors
SN/T 3296-2012 Criterion on detection of plant pathogenic bacteria by molecular biology
SN/T 1415-2004 Control standards for medical vector organisms at frontier ports
SN/T 1146.2-2009 Molecular detection of Tobacco ringspot virus
SN/T 1823-2006 Common drugs and methods of sanitary treatment for medical vectors
SN/T 1597-2005 Control standards for medical vectors in entry-exit vehicles
SN/T 1432-2004 Monitoring codes for medical vector organisms in entry-exit trains

国家质量监督检验检疫总局

SN/T 1146.2-2017 Molecular detection of Tobacco ringspot virus
SN/T 4621-2016 Encoding protocol for medical vectors＇ specimens
SN/T 4710-2016 Technical specifications for identification of medical vectors

国家食品药品监督管理局

YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process

Yunnan Provincial Standard of the People's Republic of China

DB53/T 1167.2-2023 Medical donor pigs for xenotransplantation Part 2: Microbiological and parasitological grading and monitoring

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

Liaoning Provincial Standard of the People's Republic of China

DB21/T 2209-2013 Sponge Species Molecular Biological Identification Technical Regulations

German Institute for Standardization

DIN 58956-10:1986-01 Medical microbiology; medical-microbiological laboratories; safety marking
DIN 58943-5:2011-03 Medical microbiology - Diagnosis of tuberculosis - Part 5: Molecularbiological identification and differentiation of tubercle bacilli; Text in German and English
DIN 58956-2:1986-01 Medical microbiology; medical microbiological laboratories; requirements for equipment
DIN 58956-3:1986-12 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
DIN 58959-3:2014 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58959-3:2014-08 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58956-5:1990 Medical microbiology; medical-microbiological laboratories; hygiene scheme requirements
DIN 58959-2:2021 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58959-17:2011-03 Medical microbiology - Quality management in medical microbiology - Part 17: Requirements for the use of control strains for the examination of mycobacteria; Text in German and English
DIN 58959-2:2021-09 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58969-10:2003 Medical microbiology - Diagnostics of infectious diseases in serological and molecular biology - Part 10: Complement fixation test (CFT)
DIN 58959-6:2019-06 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing
DIN 58959-6 Beiblatt 1:2019-06 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 1: Recommended test organisms for frequently used culture media; Text in German and Eng...
DIN 58942-3:2003-05 Medical microbiology - Culture media - Part 3: Dip slides for microbiological urine analysis
DIN 58959-17:2011 Medical microbiology - Quality management in medical microbiology - Part 17: Requirements for the use of control strains for the examination of mycobacteria; Text in German and English
DIN 58956-2:1986 Medical microbiology; medical microbiological laboratories; requirements for equipment
DIN 58956-10:1986 Medical microbiology; medical-microbiological laboratories; safety marking
DIN 58959-6 Beiblatt 1:2019 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 1: Recommended test organisms for frequently used culture media; Text in German and Englis
DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
DIN 58942-6:2008 Medical microbiology - Culture media - Part 6: Solid chromogenic culture media; Text in German and English
DIN 58956-4:1986 Medical microbiology; medical-microbiological laboratories; waste disposal; safety requirements and testing
DIN 58942-6:2008-01 Medical microbiology - Culture media - Part 6: Solid chromogenic culture media; Text in German and English
DIN 58959-6 Beiblatt 2:2022 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 2: Recommended test organisms for frequently used testing reagents, dyes and biological ma
DIN 58959-6 Beiblatt 2:2022-07 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 2: Recommended test organisms for frequently used testing reagents, dyes and biological...
DIN 58959-6 Beiblatt 2:2021 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 2: Recommended test organisms for frequently used testing reagents, dyes and biological ma
DIN 58967-20:2003 Medical microbiology and immunology - Diagnostics of infectious diseases and diseases of the immune system in serology and molecular biology - Part 20: General method-specific requirements for immunofluorescence tests (IFT)
DIN 58969-44:2005 Medical microbiology - Diagnostics of infectious diseases in serology and molecular biology - Part 44: Immunoblot (IB); Special requirements for the detection of antibodies against Borrelia burgdorferi
DIN 58956-3:1986 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
DIN 58942-2:2004-01 Medical microbiology - Culture media - Part 2: Ready-to-use blood culture systems
DIN 58943-9:2007-11 Medical microbiology - Diagnostics of tuberculosis - Part 9: Phenotypic differentiation of tubercle bacilli; text in German and English
DIN 58943-3:2011-03 Medical microbiology - Diagnosis of tuberculosis - Part 3: Detection of mycobacteria by culture methods; Text in German and English
DIN 58940-1:2002-10 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 1: Terminology
DIN 58959-4:1997 Quality management in medical microbiology - Part 4: Requirements for investigations using light microscopes
DIN 58942-4:2003-05 Medical microbiology - Culture media - Part 4: Transport systems for specimens containing bacteria
DIN 58940-3:2007 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 3: Agar diffusion test; Text in German and English
DIN EN ISO 10993-2:2023-02 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
DIN 58959-4:1997-06 Quality management in medical microbiology - Part 4: Requirements for investigations using light microscopes / Note: To be replaced by DIN 58959-6 Beiblatt 2 (2021-08, t).
DIN 58943-32:2015-05 Medical microbiology - Diagnosis of tuberculosis - Part 32: Detection of mycobacteria by microscopic methods; Text in German and English
DIN 58942-2:2004 Medical microbiology - Culture media - Part 2: Ready-to-use blood culture systems
DIN 58958-1:2008 Medical microbiology - Microbiological urine analysis - Part 1: Rapidly growing bacteria and yeasts which can be cultured aerobically; Text in German and English
DIN EN ISO 10993-17:2024-02 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023
DIN 58943-5:2011 Medical microbiology - Diagnosis of tuberculosis - Part 5: Molecularbiological identification and differentiation of tubercle bacilli; Text in German and English
DIN 58959-20:1997-06 Quality management in medical microbiology - Part 20: Requirements for the use of control material for the examination of protozoae and microorganisms of higher order
DIN 58969-62:2003 Medical microbiology - Diagnosis of infectious diseases in serology and molecular biology - Part 62: Polymerase chain reaction (PCR); Special requirements for the detection of nucleic acid sequences of the mycobacterium tuberculosis complex (MTC)
DIN 58981-1:1984 Medical microbiology; dyes; Azure B thiazine dye

Association Francaise de Normalisation

NF EN ISO 22367:2020 Medical biology laboratories - Application of risk management to medical biology laboratories
XP ISO/TS 17518:2015 Medical biology laboratory - Reagents for staining biological material - Instructions for users
NF S99-501-18:2009 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
XP ISO/TS 10993-19:2022 Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
NF EN ISO 10993-23:2021 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
NF S99-501-23*NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 : tests for irritation
XP ISO/TS 20914:2020 Medical biology laboratories - Practical recommendations for estimating measurement uncertainty
NF EN 60335-2-95:2017 Biological evaluation of medical devices - Part 16: design of toxicokinetic studies of degradation products and leachable substances
NF EN ISO 10993-2:2022 Biological evaluation of medical devices - Part 2: Animal protection requirements
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.

SCC

DIN 58959-1 E:2006 Draft Document - Medical microbiology - Quality management in medical microbiology - Part 1: Requirements for the QM system
DIN 58959-17 E:2007 Draft Document - Medical microbiology - Quality management in medical microbiology - Part 17: Requirements for the use of control strains for the examination of mycobacteria
DIN 58959-6:2019 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing
DIN 58959-6 E:2016 Draft Document - Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing
DIN 58959-2 E:2020 Draft Document - Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58959-6 Supplement 2 E:2021 Draft Document – Medical microbiology – Quality management in medical microbiology – Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 2: Recommended test organisms for frequently used testing reagents, dy...
DIN 58959-6 Supplement 2:2022 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 2: Recommended test organisms for frequently used testing reagents, dyes and biological...
DIN 58967-10 E:2005 Draft Document - Medical microbiology and immunology - Diagnostics of infectious diseases and diseases of the immune system in serology and molecular biology - Part 10: Terms, general requirements for the serological diagnosis
DIN 58943-5 E:2008 Draft Document - Medical microbiology - Diagnosis of tuberculosis - Part 5: Molecular identification and differentiation of tubercle bacilli
BS EN ISO 10993-18:2009 Biological evaluation of medical devices-Chemical characterization of materials
BS EN ISO 10993-18:2005 Biological evaluation of medical devices-Chemical characterization of materials
DIN 58959-6 Supplement 1:2019 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 1: Recommended test organisms for frequently used culture media; Text in German and Eng...
DIN 58967-50 E:2007 Draft Document - Medical microbiology and immunology - Diagnostics of infectious deseases and deseases of the immune system in serology and molecular biology - Part 50: Agglutination reactions; Terms, general method-specific requirements
MIL MIL-DTL-3628/110B-2019 Badge, Occupational, Biomedical Sciences Officer, U.S. Air Force
MIL MIL-DTL-3628/110A-2014 Badge, Occupational, Biomedical Sciences Officer, U.S. Air Force
DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
DIN 58967-60 E:2005 Draft Document - Medical microbiology and immunology - Diagnostics of infectious diseases and diseases of the immune system in serology and molecular biology - Part 60: Polymerase chain reaction (PCR); Terminology, general method-specific requirements
DANSK DS/ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BS PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BS 4851:1972 Specification for medical specimen containers for haematology and biochemistry
DANSK DS/EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
AAMI/ISO 10993-16:1997(R2009) Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
BS 6242:1982 Specification for single use unlabelled medical specimen containers for haematology and biochemistry
MIL MIL-PRF-32497-2014 Refrigerator, Biomedical, for Surface Ships
BS EN ISO 10993-2:1998 Biological evaluation of medical devices-Animal welfare requirements
CAN/CSA-ISO 10993.2-1997(R2006) Biological evaluation of medical devices - Part 2: Animal welfare requirements
CAN/CSA-ISO 10993.2-1997(C2006) Biological evaluation of medical devices - Part 2: Animal protection requirements
DANSK DS/ISO 10993-2:2022 Biological evaluation of medical devices – Part 2: Animal welfare requirements
MIL MIL-DTL-3628/110-1996 BADGE, OCCUPATIONAL, BIOMEDICAL SCIENCES OFFICER, AIR FORCE (SUPERSEDING MIL-I-3575/55D)
AAMI/ISO 10993-2:1993 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements
SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
SN-ISO/TS 10993-19:2006 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
DIN 58959-9 E:2022 Draft Document - Medical microbiology - Quality management in medical microbiology - Part 9: Requirements for handling, storage and performance testing of culture media, testing reagents, dyes, biological materials, ready-to-use tests, test kits and im...
SN-ISO/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
BS PD ISO/TR 15499:2012 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
BS PAS 84:2008 Regenerative medicine. Glossary
BS DD ISO/TS 10993-19:2006 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
DANSK DS/ISO/TR 15499:2016 Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
DANSK DS/EN ISO 10993-2:2006 Biological evaluation of medical devices – Part 2: Animal welfare requirements
DANSK DS/ISO/TS 10993-19:2020 Biological evaluation of medical devices – Part 19: Physico-chemical, morphological and topographical characterization of materials
SN-ISO/TR 15499:2012 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
BS PD ISO/TS 10993-19:2020 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
DIN EN 80003-4 E:2014 Draft Document - Quantities and units - Quantities for e-health - Part 4: Biology (IEC 25/485/CD:2014)
NS-EN ISO 10993-18:2009 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)
CAN/CSA-ISO 10993.9-98:1998 Biological evaluation of medical devices - Part 9: Degradation of materials related to biological testing
CAN/CSA-ISO 10993-1-01:2001 Biological evaluation of medical devices - Part 1: Evaluation and Testing
NS-EN ISO 10993-18:2005 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)
AWWA ACE99446 Advances in the Toxicological Assessment of Disinfection By-Products in Rodent and Fish Biomedical Models
UNE-EN ISO 10993-18:2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
DIN 58943 Supplement 1:2003 Medical microbiology - Diagnosis of tuberculosis - Guidance for the specialized use of methods of detection
BS EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
DIN 58958-1 E:2002 Draft Document - Medical microbiology - Microbiological urine analysis - Part 1: Rapidly growing bacteria and yeasts which can be cultured aerobically
BS 4851:1982 Specification for single use labelled medical specimen containers for haematology and biochemistry

International Organization for Standardization (ISO)

ISO/CD 10993-1.2:2023 Biological evaluation of medical devices
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-8:2000 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO 10993-2:2022 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-2:1992 Biological evaluation of medical devices; part 2: animal welfare requirements
ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

British Standards Institution (BSI)

BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS 5213:1975 Specification for medical specimen containers for microbiology
21/30379304 DC BS EN ISO 10993-17. Biological evaluation of medical devices - Part 17. Toxicological risk assessment of medical device constituents
PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
16/30323845 DC BS ISO 13484. Molecular biomarker analysis. General requirements for molecular biology analysis for detection and identification of plant pests
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-18:2020 Biological evaluation of medical devices Part 18 : Chemical characterization of medical device materials within a risk management process
BS 1000[57]:1979 Universal Decimal Classification - English full edition - Biological sciences in general - Virology - Microbiology
BS ISO 80000-9:2009 Quantities and units - Physical chemistry and molecular physics
BS ISO 31-8:1992 Quantities and units - Physical chemistry and molecular physics
BS EN ISO 10993-16:2017(2020) Biological evaluation of medical devices Part 16 : Toxicokinetic study design for degradation products and leachables
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process

U.S. Military Regulations and Norms

ARMY MIL-DTL-3628/110 VALID NOTICE 3-2013 Badge, Occupational, Biomedical Sciences Officer, Air Force

VDI - Verein Deutscher Ingenieure

VDI 5701-2018 Biomaterials in medicine - Classification@ requirements@ and applications
VDI 5701-2016 Biomaterials in medicine - classification@requirements and applications

TH-TISI

TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials
TIS 2395.1-2008 Biological evaluation of medical devices.part 1: evaluation and testing
TIS 2395.2-2008 Biological evaluation of medical devices.part 2: animal welfare requirements

VN-TCVN

TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
TCVN 7391-2-2005 Biological evaluation of medical devices.Part 2: Animal welfare requirements
TCVN 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing

RU-GOST R

GOST ISO/TS 10993-19-2011 Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R ISO 11138-2-2000 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization
GOST ISO 11138-2-2012 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization
GOST R 57343-2016 Forensic molecular genetic analysis. Terms and definitions
GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R 52770-2007 Medical products. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 10993.16-1999 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 14199-2016 Health informatics. Information models. Biomedical Research Integrated Do-main Group (BRIDG) Model
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST 31576-2012 Evaluation of biological hazard of medical dental materials and articles. Classification and sampling
GOST R 51758-2001 Nutrient media for veterinary purposes. Methods of biological testing

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-19:2009 Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO TS 21726-2023 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
KS P ISO 10993-18:2009 Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20:2009 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20-2019 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-2-2021 Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2-2010(2021) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2-2010(2016) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-8:2007 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-8:2002 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-19-2009(2019) Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO TS 10993-19:2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-2:2010 Biological evaluation of medical devices-Part 2:Animal welfare requirements
KS P ISO TR 15499-2021 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
KS P ISO 10993-16:2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables

GOST

GOST 34833-2022 Wildlife forensics molecular genetic examination. Terms and definitions
GOST R ISO/TS 10993-19-2009 Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

Standard Association of Australia （SAA）

ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc.

ASHRAE REFRIGERATION IP CH 49-2010 BIOMEDICAL APPLICATIONS OF CRYOGENIC REFRIGERATION
ASHRAE REFRIGERATION SI CH 40-2002 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION SI CH 39-1994 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION IP CH 40-1998 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION SI CH 40-2006 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION SI CH 40-1998 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION IP CH 39-1994 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION IP CH 40-2002 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION IP CH 40-2006 BIOMEDICAL APPLICATIONS OF CRYOGENIC REFRIGERATION

GSO

OS GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
BH GSO ISO 10993-18:2017 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
GSO ISO/TS 21726:2021 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BH GSO ISO/TS 21726:2022 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BH GSO ISO 10993-2:2017 Biological evaluation of medical devices -- Part 2: Animal welfare requirements
OS GSO ISO/TS 10993-19:2016 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
BH GSO ISO/TS 10993-20:2017 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
OS GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
GSO ISO/TR 15499:2016 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
OS GSO ISO/TR 15499:2016 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
GSO ISO/TS 10993-19:2016 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
BH GSO ISO/TS 10993-19:2017 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
GSO ISO 17516:2015 Cosmetics -- Microbiology -- Microbiological limits
GSO ISO 10993-23:2024 Biological evaluation of medical devices — Part 23: Tests for irritation

ES-AENOR

UNE 20-666-1990 Electronic glossary. Medical Radiology and Radiation Physics

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

ASHRAE REFRIGERATION SI CH 49-2010 BIOMEDICAL APPLICATIONS OF CRYOGENIC REFRIGERATION

European Committee for Standardization (CEN)

EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
EN ISO 10993-8:2000 Biological Evaluation of Medical Devices - Part 8: Selection and Qualification of Reference Materials for Biological Tests ISO 10993-8:2000
FprEN ISO 10993-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/FDIS 10993-17:2023)
EN ISO 10993-17:2023 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

American Society for Testing and Materials (ASTM)

ASTM F665-98 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM F665-09 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application

CEN - European Committee for Standardization

EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
EN ISO 10993-16:2009 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

GOSTR

GOST 18996-1980 Medical analyzers of biological liquids. Terms and definitions
GOST R 52770-2020 Medical devices. Evaluation system of biological effects. Part 1. General requirements for biological safety

DIN

DIN 58959-9:2022 Medical microbiology - Quality management in medical microbiology - Part 9: Requirements for handling, storage and performance testing of culture media, testing reagents, dyes, biological materials, ready-to-use tests, test kits and immunological test ...
DIN EN ISO 10993-17:2024 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

SE-SIS

SIS SEN 01 02 70-1964 Electrotechnical vocabulary Electrobiology

PT-IPQ

NP EN ISO 10993-13:2000 Biological evaluation of medical devices Part 13:Identification and quantification of degradation products from polymeric medical devices(ISO 10993-13-1998)

IN-BIS

IS 3998-1982 cup normative medicine

Canadian Standards Association (CSA)

CSA ISO-10993.2-97-CAN/CSA:1997 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements

KR-KS

KS P ISO 10993-8-2002 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO TS 10993-19-2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-16-2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables

American National Standards Institute （ANSI)

AAMI/ISO TIR10993-20:2006(R2021) Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
AAMI/ISO TIR10993-19:2020 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials

US-FCR

FCR 21 CFR PART 890-2015 PHYSICAL MEDICINE DEVICES
FCR 21 CFR PART 890-2014 PHYSICAL MEDICINE DEVICES
FCR 21 CFR PART 890-2013 PHYSICAL MEDICINE DEVICES

PH-BPS

PNS ISO 10993-2:2021 Biological evaluation of medical devices - Part 2: Animal welfare requirements

US-AAMI

ANSI/AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process
ANSI/AAMI/ISO 10993-16:2017 Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables

AENOR

UNE-EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

Danish Standards Foundation

DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation

ZA-SANS

SANS 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing