Biomedical Summit Fund

Biomedical Summit Fund, Total:272 items.

The international standard classification for "Biomedical Summit Fund" includes: Radiation protection , Health care technology (Vocabularies) , Medical equipment in general , Biology. Botany. Zoology , Medical microbiology , Laboratory medicine , Microbiology in general .

The Chinese standard classification for "Biomedical Summit Fund" includes: Radiological sanitation protection , Sanitation in general , Medical apparatus and devices in general , Medical science , Medical sanitary products , Health quarantine , Legal medical expert .

未注明发布机构

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 58959-2 E:2020-09 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
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 58959-3 E:1991-11 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58959-2 E:2006-05 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58959-3 E:2013-12 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
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 58959-9 E:1991-11 Quality management in medical microbiology - Part 9: Requirements for the use of control strains for testing culture media
DIN 58959-9:2022-12 Quality management in medical microbiology - Part 9: Requirements for the use of control strains for testing culture media
DIN 58942-5:1990 Medical microbiology - Culture media - Part 5: Requirements and selection of culture media for the diagnostic of stool specimen
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
ANSI/AAMI/ISO 10993-2:2006(2010) Biological evaluation of medical devices— Part 2: Animal welfare requirements
DIN 58959-2 E:1991-11 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58942-2:1985 Medical microbiology - Culture media - Part 2: Ready-to-use blood culture systems
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 58959-9 E:2022-04 Quality management in medical microbiology - Part 9: Requirements for the use of control strains for testing culture media
DIN 58942-4:1986 Medical microbiology - Culture media - Part 4: Transport systems for specimens containing bacteria
ANSI/AAMI/ISO 10993-15:2019 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-15:2000/Cor 1:2001 Biologicalevaluation of medical devices - Part 15: Identificationand quantification of degradation products from metals and alloys
DIN EN ISO 10993-18:2009 Biological assessment of medical devices
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...

Professional Standard - Hygiene

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

Shanghai Provincial Standard of the People's Republic of China

DB31/T 60.1-1991 Basic Requirements for Medical Inspection Report Form
DB31/T 899-2015 Code of Ethics Review for Biomedical Research Involving Humans

Taiwan Provincial Standard of the People's Republic of China

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

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

GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2:Animal welfare requirements
GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials
GB/T 16175-1996 Organic silicon material for medical use-Biological evaluation test methods
GB/T 42186-2022 Operational specification for cold chain logistics of medical laboratory biological samples
GB/T 42465-2023 Basic dataset of biological material information in Chinese Medicine
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

国家质量监督检验检疫总局

SN/T 4621-2016 Encoding protocol for medical vectors＇ specimens
SN/T 4710-2016 Technical specifications for identification of medical vectors

Professional Standard - Commodity Inspection

SN/T 1597-2005 Control standards for medical vectors in entry-exit vehicles
SN/T 1560-2005 Codes of surveillance for the medical vectors organisms at entry-exit vessels
SN/T 1553-2005 Codes of surveillance for vector-bonds in entry-exit aircrafts
SN/T 1434-2004 Control standards for medical vector organisms in entry-exit trains
SN/T 2788-2011 Requirement of Preserving and Transporting the Medical Vector Specimens
SN/T 1415-2004 Control standards for medical vector organisms at frontier ports
SN/T 1422-2004 Control standards for medical vector organisms in entry-exit airplane
SN/T 1596-2005 Codes of surveillance for medical vectors in entry-exit vehicles
SN/T 1862-2007 Standard of biosafety for pathogens test in medical vector laboratory entry-exit ports
SN/T 1432-2004 Monitoring codes for medical vector organisms in entry-exit trains
SN/T 1423-2004 Control standards for medical vector organisms in entry-exit ships
SN/T 1823-2006 Common drugs and methods of sanitary treatment for medical vectors
SN/T 4166-2015 Protocol on proficiency testing for morphological identification of vectors

Group Standards of the People's Republic of China

T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CMBA 023-2024 Requirements for construction and management of biomedical research laboratories
T/CSBM 0010-2021 Hydroxyapatite nanopowder for biomedical applications
T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating：Sample preparation

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
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration

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

工业和信息化部

HG/T 5350-2018 Biochemical reagent-Tris(hydroxymethyl)aminomethane

Professional Standard - Judicatory

SF/T 0134-2023 Technical specification for nucleic acid extraction of forensic biological sample

Anhui Provincial Standard of the People's Republic of China

DB34/T 4793-2024 Ethical review standards for biomedical research involving human beings

Guangdong Provincial Standard of the People's Republic of China

DB4403/T 86-2020 Code of Ethics Review for Biomedical Research Involving Humans

Hunan Provincial Standard of the People's Republic of China

DB43/T 2561-2023 Code of Ethics Review for Biomedical Research Involving Humans

German Institute for Standardization

DIN 58956-10:1986-01 Medical microbiology; medical-microbiological laboratories; safety marking
DIN 58942-6:2008 Medical microbiology - Culture media - Part 6: Solid chromogenic culture media; Text in German and English
DIN 58956-3:1986-12 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
DIN 58942-6:2008-01 Medical microbiology - Culture media - Part 6: Solid chromogenic culture media; Text in German and English
DIN 58956-2:1986-01 Medical microbiology; medical microbiological laboratories; requirements for equipment
DIN 58942-3:2003-05 Medical microbiology - Culture media - Part 3: Dip slides for microbiological urine analysis
DIN 58956-5:1990 Medical microbiology; medical-microbiological laboratories; hygiene scheme requirements
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 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 58942-2:2004-01 Medical microbiology - Culture media - Part 2: Ready-to-use blood culture systems
DIN EN 12322:1999-06 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media; German version EN 12322:1999
DIN 58956-4:1986 Medical microbiology; medical-microbiological laboratories; waste disposal; safety requirements and testing
DIN 58959-2:2021 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58942-4:2003-05 Medical microbiology - Culture media - Part 4: Transport systems for specimens containing bacteria
DIN 58959-2:2021-09 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58956-3:1986 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
DIN 58942-2:2004 Medical microbiology - Culture media - Part 2: Ready-to-use blood culture systems
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 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 58942-5:2005-04 Medical microbiology - Culture media - Part 5: Requirements and selection of culture media for the diagnostic of stool specimen
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 58959-17:2011 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 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 58942-5:2005 Medical microbiology - Culture media - Part 5: Requirements and selection of culture media for the diagnostic of stool specimen
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 EN ISO 10993-15:2023-07 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023
DIN 58959-9:1997 Quality management in medical microbiology - Part 9: Requirements for the use of control strains for testing culture media
DIN EN ISO 10993-15:2023 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
DIN 58981-1:1984 Medical microbiology; dyes; Azure B thiazine dye
DIN-Fachbericht 53:2000 Biotechnology-Microorganisms - Report on the criteria used to classify Group I genetically modified microorganisms; German version CR 13426
DIN 58959 Bb.1:1997 Quality management in medical microbiology - Overview and index
DIN EN ISO 10993-15:2018 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018); German and English version prEN ISO 10993-15:2018
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 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

Association Francaise de Normalisation

NF EN ISO 22367:2020 Medical biology laboratories - Application of risk management to medical biology laboratories
NF EN 12322/A1:2002 In vitro diagnostic medical devices - Microbiology culture media - Performance criteria for culture media
NF EN 12322:1999 In vitro diagnostic medical devices - Microbiology culture media - Performance criteria for culture media
XP ISO/TS 17518:2015 Medical biology laboratory - Reagents for staining biological material - Instructions for users
NF EN ISO 10993-15:2009 Biological assessment of medical devices - Part 15: identification and quantification of degradation products from metals and alloys
NF S99-501-15*NF EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15 : identification and quantification of degradation products from metals and alloys
NF S94-071:2013 Materials for surgical implants - Determination of surface finish of coatings used for biomedical applications
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF S91-224:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.

RU-GOST R

GOST R 51758-2001 Nutrient media for veterinary purposes. Methods of biological testing
GOST R 57647-2017 Medicines for medical applications. Pharmacogenomics. Biomarkers
GOST ISO 10993-15-2011 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST R ISO 10993-15-2001 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
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 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 ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
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

SCC

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 58959-1 E:2006 Draft Document - Medical microbiology - Quality management in medical microbiology - Part 1: Requirements for the QM system
AENOR UNE-EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
NS-EN 12322:1999 In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media
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 58959-6 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...
AAMI/ISO 10993-15:2019 Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys
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...
BS EN ISO 10993-18:2009 Biological evaluation of medical devices-Chemical 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...
DANSK DS/ISO 10993-15:2023 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
BS EN ISO 10993-18:2005 Biological evaluation of medical devices-Chemical characterization of materials
DANSK DS/EN ISO 10993-15:2009 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
BS EN ISO 10993-2:1998 Biological evaluation of medical devices-Animal welfare requirements
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
MIL MIL-DTL-3628/110A-2014 Badge, Occupational, Biomedical Sciences Officer, U.S. Air Force
MIL MIL-DTL-3628/110B-2019 Badge, Occupational, Biomedical Sciences Officer, U.S. Air Force
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
MIL MIL-PRF-32497-2014 Refrigerator, Biomedical, for Surface Ships
BS 4851:1972 Specification for medical specimen containers for haematology and biochemistry
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
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 5736-1:1979 Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test
BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
BS 5736-1:1989 Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test
UNE-EN ISO 10993-15:2001 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys. (ISO 10993-15:2000)
CAN/CGSB 43.125-1999 Packaging of Infectious Substances, Diagnostic Specimens, Biological Products and Biomedical Waste for Transport
NS-EN ISO 10993-15:2023 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
BS EN ISO 10993-12:2009 Biological evaluation of medical devices-Sample preparation and reference 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 EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
NS-EN ISO 10993-15:2000 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
SN-ISO/TR 15499:2012 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
NS-EN ISO 10993-15:2009 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
AENOR UNE-EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
BS EN ISO 10993-12:1997 Biological evaluation of medical devices-Sample preparation and reference materials
ASQ TR1-2012 Best quality practices for biomedical research in drug development
BS EN ISO 10993-11:1996 Biological evaluation of medical devices-Tests for systemic toxicity
BS EN ISO 10993-11:2006 Biological evaluation of medical devices-Tests for systemic toxicity
DANSK DS/ISO/TR 15499:2016 Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
CAN/CGSB-43.125-1999 Packaging of infectious materials, diagnostic samples, biological products and biomedical waste for transport
BS EN ISO 10993-13:2009 Biological evaluation of medical devices-Identification and quantification of degradation products from polymeric medical devices
AAMI/ISO 10993-16:1997(R2009) Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
CAN/CSA-ISO 10993.2-1997(R2006) Biological evaluation of medical devices - Part 2: Animal welfare requirements
BS PAS 84:2008 Regenerative medicine. Glossary
DANSK DS/ISO 10993-2:2022 Biological evaluation of medical devices – Part 2: Animal welfare requirements
DIN 58959-9 Supplement 1:1997 Quality management in medical microbiology - Part 9: Requirements for the use of control strains for testing culture media; control strains for commonly used culture media
CAN/CSA-ISO 10993.2-1997(C2006) Biological evaluation of medical devices - Part 2: Animal protection 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
BS DD ISO/TS 10993-19:2006 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
BS PD ISO/TS 10993-19:2020 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
AS ISO 10993.10:2002 Biological evaluation of medical devices - Tests for irritation and sensitization
CAN/CSA-ISO 10993.9-98:1998 Biological evaluation of medical devices - Part 9: Degradation of materials related to biological testing

Lithuanian Standards Office

LST EN 12322-2000 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

International Organization for Standardization (ISO)

ISO/CD 10993-1.2:2023 Biological evaluation of medical devices
ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-15:2019 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO 10993-8:2000 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO/CD 23691:2006 Microbiology of the food chain — Determination and use of cardinal values
ISO/TR 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

Danish Standards Foundation

DS/EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
DS/EN 12322/A1:2002 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
DS/EN ISO 1567:1995 Dentistry- Denture base polymers
DS/ISO/TS 22456:2021 Sterilization of healthcare products – Microbiological methods – Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

GOSTR

GOST R EN 12322-2010 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
GOST 34310-2017 Biological medicine remedies for veterinary use. Methods for determination of mertiolyt, phenol, formaldehyde
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

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

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

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 ...

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

ASHRAE REFRIGERATION SI CH 49-2010 BIOMEDICAL APPLICATIONS OF CRYOGENIC REFRIGERATION
ASHRAE REF SI CH 40-2002 Biomedical Applications of Cryogenic Refrigeration(ASHRAE Handbook, Refrigeration, SI Edition

U.S. Military Regulations and Norms

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

GSO

GSO ISO 10993-15:2016 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
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
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/TR 15499:2016 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
BH GSO ISO 10993-2:2017 Biological evaluation of medical devices -- Part 2: Animal welfare requirements
GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
OS 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

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-15-2006(2016) Biological evaluation of medical devices－Part 15：Identification and quantification ofdegradation products from metals and alloys
KS P ISO 10993-15:2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
KS P ISO 10993-15:2006 Biological evaluation of medical devices－Part 15：Identification and quantification ofdegradation products from metals and alloys
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 TR 15499-2021 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
KS P ISO 7405:2014 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 10993-2-2010(2016) 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 10993-2-2021 Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 7405:2010 Dentistry-Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 10993-19:2009 Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials

TH-TISI

TIS 2395.15-2008 Biological evaluation of medical devices.part 15: identification and quantification of degradation products from metals and alloys
TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials

KR-KS

KS P ISO 10993-15-2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys

British Standards Institution (BSI)

BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
BS 5213:1975 Specification for medical specimen containers for microbiology
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 10993-13:1999 Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices
PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
18/30354781 DC BS EN ISO 10993-15. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices. Ethylene oxide sterilization residuals
BS EN ISO 10993-12:2004 Biological evaluation of medical devices - Sample preparation and reference materials
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-10:2023 Biological evaluation of medical devices. Tests for skin sensitization

American National Standards Institute （ANSI)

BS EN ISO 10993-15:2023 Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys (British Standard)

American Society for Testing and Materials (ASTM)

ASTM F624-98a Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
ASTM F624-98ae1 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
ASTM F665-09 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM F665-98 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application

VDI - Verein Deutscher Ingenieure

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

AENOR

UNE-EN 12322:1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES. CULTURE MEDIA FOR MICROBIOLOGY. PERFORMANCE CRITERIA FOR CULTURE MEDIA.
UNE-EN 12322/A1:2002 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media.
UNE-EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

CN-STDBOOK

图书 3-9473 Compilation of Common Standards for Microbiology and Biomedical Laboratories (Part 1) (Second Edition)
图书 3-9474 Compilation of Common Standards for Microbiology and Biomedical Laboratories (Part 2) (Second Edition)

VN-TCVN

TCVN 7391-15-2007 Biological evaluation of medical devices.Part 15: Identification and quantification of degradation products from metals and alloys
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

US-AAMI

ANSI/AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process

Canadian General Standards Board （CGSB)

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

European Committee for Standardization (CEN)

EN ISO 10993-15:2023 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
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)
FprEN ISO 10993-15 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/FDIS 10993-15:2019)
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

North Atlantic Treaty Organization Standards Agency

STANAG 2478-2006 MEDICAL SUPPORT PLANNING FOR NUCLEAR, BIOLOGICAL AND CHEMICAL ENVIRONMENTS

Standard Association of Australia （SAA）

ISO/IEC 14496-4:2004/AMD17:2007 Amendment 17 — Information technology — Coding of audio-visual objects — Part 4: Conformance testing — Advanced text and 2D graphics conformance
ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

CEN - European Committee for Standardization

EN ISO 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

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)

Canadian Standards Association (CSA)

CSA ISO-10993.2-97-CAN/CSA:1997 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements
CSA PLUS 15189-2005 The essential principles of the ISO 15189:2003 standard A practical guide for the implementation of the ISO 15189:2003 standard in medical biology analysis laboratories

Others: