Frontiers in Biomedical Engineering

Frontiers in Biomedical Engineering, Total:346 items.

The international standard classification for "Frontiers in Biomedical Engineering" includes: Medical equipment in general , Microbiology in general , Health care technology (Vocabularies) , Radiation protection , Public buildings .

The Chinese standard classification for "Frontiers in Biomedical Engineering" includes: Medical apparatus and devices in general , Health quarantine , Sanitation in general , Radiological sanitation protection , Stomatologic device, equipment and material , Residential and public building engineering .

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

未注明发布机构

DIN 58959-3 E:2013-12 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58959-3 E:1991-11 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 EN ISO 10993-18:2009 Biological assessment of medical devices
DIN 58729 E:2015-04 Production in optical engineering - Ball seats
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 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 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 58959-2 E:2006-05 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN EN ISO 10993-18 E:2018-09 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials during risk management (draft)
VDI 4250 Blatt-1 E:2022-09 Bioaerosols and biological agents Assessment of source-related ambient air measurements in the scope of environmental health Effects of bioaerosol pollution on human health
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 58959-17 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 EN ISO 9241-394 E:2021-11 Ergonomics of human-computer interaction Part 394: Ergonomic requirements to reduce the adverse biomedical effects of visually induced motion sickness during viewing of electronic images (Draft)
ANSI/AAMI/ISO 10993-1:2018 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
DIN 58729 E:2015-10 Production in optical engineering - Ball seats
ANSI/AAMI/ISO 10993-13:2010(2014) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
DIN 58959-2 E:1991-11 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens

Group Standards of the People's Republic of China

T/SZDT 006-2023 Guidelines for vector control work along municipal roads
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices

Professional Standard - Commodity Inspection

SN/T 1553-2005 Codes of surveillance for vector-bonds in entry-exit aircrafts
SN/T 1596-2005 Codes of surveillance for medical vectors in entry-exit vehicles
SN/T 1415-2004 Control standards for medical vector organisms at frontier ports
SN/T 4166-2015 Protocol on proficiency testing for morphological identification of vectors
SN/T 1432-2004 Monitoring codes for medical vector organisms in entry-exit trains
SN/T 1862-2007 Standard of biosafety for pathogens test in medical vector laboratory entry-exit ports
SN/T 1560-2005 Codes of surveillance for the medical vectors organisms at entry-exit vessels
SN/T 1876-2007 Rules of collecting making and preserving for specimen of medical vectors
SN/T 1823-2006 Common drugs and methods of sanitary treatment for medical vectors
SN/T 2750-2010 Collection of medical vector on entry-exit vehicle

Military Standard of the People's Republic of China-General Armament Department

GJB 2969A-2011 Terminology for discipline of space medico-engineering
GJB 2969-1997 Aerospace Medical Engineering Terminology

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

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

GB/T 42186-2022 Operational specification for cold chain logistics of medical laboratory biological samples
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Professional Standard - Medicine

YY/T 0127.11-2001 Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Part 2: Biological evaluation test method of dental materials - Pulp capping test
YY/T 0268-2001 Dentistry--Preclinical evaluation of biocompatibility of medical devices used in dentistry--Part 1:Evaluation and test methods selevtion
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 1754.3-2023 Preclinical Animal Studies of Medical Devices Part 3: An Animal Incisional Hernia Model for Evaluation of Mesh Histological Response and Biomechanical Properties
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration

Taiwan Provincial Standard of the People's Republic of China

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

国家质量监督检验检疫总局

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

Professional Standard - Environmental Protection

HJ 228-2021 Technical specifications for centralized treatment engineering of chemical disinfection on medical waste
HJ/T 228-2006 Technical specification for chemical disinfection centralized treatment engineering on medical waste (on trial)
HJ/T 228-2005 Technical specifications for chemical disinfection centralized treatment engineering on medical waste (on trial)

Hunan Provincial Standard of the People's Republic of China

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

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

Shanghai Provincial Standard of the People's Republic of China

DB31/T 899-2015 Code of Ethics Review for Biomedical Research Involving Humans

Shandong Provincial Standard of the People's Republic of China

DB37/T 5163-2020 Technical regulations for identification and evaluation of existing buildings (structures) along urban rail transit projects

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

GB/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

GSO

GSO ISO 17516:2015 Cosmetics -- Microbiology -- Microbiological limits
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
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
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
BH GSO ISO 10993-13:2017 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
OS GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
OS GSO ISO 10993-1:2020 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

ACI - American Concrete Institute

ACI SP-278 CD-2011 Frontiers in the Use of Polymers in Concrete

German Institute for Standardization

DIN 58956-2:1986-01 Medical microbiology; medical microbiological laboratories; requirements for equipment
DIN 58956-10:1986-01 Medical microbiology; medical-microbiological laboratories; safety marking
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 58956-4:1986 Medical microbiology; medical-microbiological laboratories; waste disposal; safety requirements and testing
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 58956-2:1986 Medical microbiology; medical microbiological laboratories; requirements for equipment
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 58956-10:1986 Medical microbiology; medical-microbiological laboratories; safety marking
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 58956-3:1986 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
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 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
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 58959-17:2011 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 58959-2:2021-09 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58722-1:2009-02 Production in optical engineering - Definitions related to production in optical engineering - Part 1: Processes
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 58942-3:2003-05 Medical microbiology - Culture media - Part 3: Dip slides for microbiological urine analysis
DIN EN ISO 9241-394:2023-08 Ergonomics of human-system interaction - Part 394: Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images (ISO 9241-394:2020); German version EN ISO 9241-394:2022
DIN 58750-1:2013-01 Production in optical engineering - Test of polishing agents for optical engineering - Part 1: Physical and colloidal properties
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 9241-394:2023 Ergonomics of human-system interaction - Part 394: Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images (ISO 9241-394:2020)
DIN EN ISO 10993-18:2021-03 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020 / Note: To be amended by DIN EN ISO 10993-18/A1 (2021-10).
DIN 58722-2:2001-10 Production in optical engineering - Terms relating to production in optical engineering - Part 2: Equipment
DIN 58729:2016-03 Production in optical engineering - Ball seats
DIN EN ISO 10993-18:2023-11 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023

Japanese Industrial Standards Committee (JISC)

JIS K 3610:1992 Technical terms for biological engineering (biochemistry)
JIS K 3600:1989 Technical terms for biotechnology

Association Francaise de Normalisation

NF EN ISO 22367:2020 Medical biology laboratories - Application of risk management to medical biology laboratories
NF EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: chemical characterization of medical device materials within a risk management process
NF S99-501-18*NF EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process
XP ISO/TS 17518:2015 Medical biology laboratory - Reagents for staining biological material - Instructions for users
NF X42-051:1988 BIOTECHNOLOGY. GUIDE OF GOOD PRACTICES FOR INDUSTRIAL PRODUCTION OF CHEMICALS AND BIOLOGICAL PRODUCTS FROM PATHOGENIC MICROORGANISMS.
NF EN ISO 15195:2019 Medical biology - Requirements for the competence of calibration laboratories using reference measurement procedures
NF V08-602:2011 Microbiology of food and animal feeding stuffs - Enumeration of spores from food products before appertization process by colony counts.
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF S99-501-18:2009 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
NF V08-250:2010 Microbiology of food and animal feeding stuffs - Heat treatments prior to the enumeration or to the detection of bacterial spores
XP ISO/TS 20914:2020 Medical biology laboratories - Practical recommendations for estimating measurement uncertainty
NF S99-501-13*NF EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices

American Society for Testing and Materials (ASTM)

ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
ASTM F2064-00 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
ASTM F2064-00(2006)e1 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
ASTM F2064-14 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F2027-08 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F2103-01(2007) Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F2103-11 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F2064-00(2006) Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
ASTM F2103-01 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F3515-21 Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM E3354-22 Standard Guide for Application of Molecular Biological Tools to Assess Biological Processes at Contaminated Sites
ASTM F2103-01(2007)e2 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F665-98 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM F2103-01(2007)e1 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F665-09 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM E3072-24 Standard Terminology for Industrial Biotechnology and Synthetic Biology
ASTM F665-98(2003) Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application

International Organization for Standardization (ISO)

ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO/TR 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO/CD 10993-1.2:2023 Biological evaluation of medical devices
ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
ISO 7405:1997 Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials
ISO 10993-8:2000 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
ISO 19610:2017 Traditional Chinese medicine - General requirements for industrial manufacturing process of red ginseng (Panax ginseng C.A. Meyer)
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO 10993-2:2022 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO/TS 10993-19:2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
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 21726:2019 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13:1998 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO/CD 10993-1:2011 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

British Standards Institution (BSI)

PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS 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 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 9241-394:2022 Ergonomics of human-system interaction - Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images
BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
BS EN ISO 10993-18:2020 Biological evaluation of medical devices Part 18 : Chemical characterization of medical device materials within a risk management process
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 10993-1:2009 Biological evaluation of medical devices - Evaluation and testing within a risk management process
BS EN ISO 10993-23:2021 Biological evaluation of medical devices. Evaluation and testing within a risk management process
BS ISO 9241-394:2020 Ergonomics ofhuman - system interaction Part 394 : Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images
BS EN ISO 10993-13:1999 Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 10993-1:2020 Biological evaluation of medical devices. Evaluation and testing 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
19/30361626 DC BS ISO 9241-394. Ergonomics of human-system interaction. Part 394. Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS 70000:2017 Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence
18/30358832 DC BS EN ISO 10993-18. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process
BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
BS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices. Ethylene oxide sterilization residuals
BS EN ISO 10993-16:2010 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 10993-12:2004 Biological evaluation of medical devices - Sample preparation and reference materials
BS 5213:1975 Specification for medical specimen containers for microbiology
BS EN ISO 10993-10:2023 Biological evaluation of medical devices. Tests for skin sensitization
PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
21/30439273 DC BS EN ISO 10993-18 AMD1. Biological evaluation of medical devices - Part 18. Chemical characterization of medical device materials within a risk management process
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
PD 6597-1996 Biotechnology. Microorganisms. Examination of the various existing lists of plant pathogens and production of a report
BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
PD CEN ISO/TR 12296:2013 Ergonomics. Manual handling of people in the healthcare sector
BS EN ISO 10993-14:2009 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
BS EN ISO 10993-17:2009 Biological evaluation of medical devices. Establishment of allowable limits for leachable substances

SCC

BS PD 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
DANSK DS/ISO/TR 15499:2016 Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
SN-ISO/TR 15499:2012 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
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 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 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 58959-1 E:2006 Draft Document - Medical microbiology - Quality management in medical microbiology - Part 1: Requirements for the QM system
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...
MIL MIL-PRF-32497-2014 Refrigerator, Biomedical, for Surface Ships
DANSK DS/ISO 9241-394:2020 Ergonomics of human-system interaction – Part 394: Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images
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 58959-17 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 58959-2 E:2020 Draft Document - Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
AWWA JAW52374 Journal AWWA — AOP/Biofilm Processes for DOX Precursors
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
DANSK DS/ISO 10993-18:2020 Biologisk vurdering af medicinsk udstyr – Del 18: Kemisk karakterisering af materialer til medicinsk udstyr inden for rammerne af en risikostyringsproces
DANSK DS/ISO 10993-18/AMD 1:2020 Biologisk vurdering af medicinsk udstyr – Del 18: Kemisk karakterisering af materialer til medicinsk udstyr inden for rammerne af en risikostyringsproces
BS EN ISO 10993-18:2005 Biological evaluation of medical devices-Chemical characterization of materials
DANSK DS/EN ISO 9241-394:2022 Ergonomics of human-system interaction – Part 394: Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images (ISO 9241-394:2020)
BS EN ISO 10993-18:2009 Biological evaluation of medical devices-Chemical characterization of materials
NS-EN ISO 9241-394:2022 Ergonomics of human-system interaction - Part 394: Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images (ISO 9241-394:2020)
BS EN ISO 10993-13:2009 Biological evaluation of medical devices-Identification and quantification of degradation products from polymeric medical devices
CAN/CGSB 43.125-1999 Packaging of Infectious Substances, Diagnostic Specimens, Biological Products and Biomedical Waste for Transport
AENOR UNE-EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
BS DD ISO/TS 10993-19:2006 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
NS-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)
ASQ TR1-2012 Best quality practices for biomedical research in drug development
DIN EN ISO 9241-394 E:2021 Draft Document – Ergonomics of human-system interaction – Part 394: Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images (ISO 9241-394:2020); German and English version...
DANSK DS/EN ISO 10993-18/A1:2020 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
BS PD ISO/TS 10993-19:2020 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-2:1998 Biological evaluation of medical devices-Animal welfare requirements
BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
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
CAN/CGSB-43.125-1999 Packaging of infectious materials, diagnostic samples, biological products and biomedical waste for transport
DANSK DS/EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
AWWA ACE99446 Advances in the Toxicological Assessment of Disinfection By-Products in Rodent and Fish Biomedical Models
CAN/CSA-ISO 10993.9-98:1998 Biological evaluation of medical devices - Part 9: Degradation of materials related to biological testing
BS EN ISO 10993-16:2009 Biological evaluation of medical devices-Toxicokinetic study design for degradation products and leachables
BS 4851:1972 Specification for medical specimen containers for haematology and biochemistry
CAN/CGSB 43.125-2003 Conception et fabrication des emballages destinés au transport des matières infectieuses, des échantillons de diagnostic, des produits biologiques et des déchets biomédicaux
DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
DANSK DS/EN ISO 10993-2:2006 Biological evaluation of medical devices – Part 2: Animal welfare requirements
DIN EN ISO 10993-18 E:2018 Draft Document - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO/DIS 10993-18:2018); German and English version prEN ISO 10993-18:2018
DANSK DS/EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
DIN 58750-1 E:2012 Draft Document - Production in optical engineering - Test of polishing agents for optical engineering - Part 1: Physical and colloidal properties
VDI 4250 BLATT 1-2014 Bioaerosols and biological agents — Environmental medical assessment of bioaerosol emissions — Effects of microbial air pollution on humans
BS 5736-1:1989 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
CAN/CSA-ISO 10993-13-00:2000 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
BS 5736-1:1979 Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test
DANSK DS/EN ISO 10993-1/AC:2010 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
DANSK DS/EN ISO 10993-1:2020 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
DANSK DS/ISO 10993-1:2020 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
BS PD CEN ISO/TR 12296:2013 Ergonomics. Manual handling of people in the healthcare sector
AAMI/ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
BS PD ISO/TR 12296:2012 Ergonomics. Manual handling of people in the healthcare sector

Korean Agency for Technology and Standards (KATS)

KS P ISO TR 15499-2021 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
KS A 5552-2002 ERGONOMICS-ANTHROPOMETIC AND BIOMECHANIC MEASUREMENTS
KS P ISO TS 20993-2009(2014) Biological evaluation of medical devices－Guidance on a risk－management process
KS P ISO TS 20993-2020 Biological evaluation of medical devices－Guidance on a risk－management process
KS P ISO 10993-18:2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process
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 10993-20:2009 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
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 Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
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 10993-2:2010 Biological evaluation of medical devices-Part 2:Animal welfare requirements
KS J 0014-2010(2021) Bioindustry－Preparation of standard operating procedure and its application for bioindustrial process
KS P ISO 10993-13:2007 Biological evaluation of medical devices－Part 13：Identification and quantification of degradation products from polymeric medical devices
KS J 0020-2010 Production system policy in biopharmaceutical production based on Good Manufacturing Practice
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 10993-13-2023 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
KS P ISO TR 37137:2019 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
KS J 0014-2010(2015) Bioindustry－Preparation of standard operating procedure and its application for bioindustrial process

US-AAMI

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

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 40-2002 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 40-2006 BIOMEDICAL APPLICATIONS OF CRYOGENIC REFRIGERATION

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

YU-JUS

JUS U.F2.010-1978 Final Work in Building. Specificatioru for Frontside works

RU-GOST R

GOST R 56699-2015 Medicines for medical applications. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. General recommendations
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 11138-2-2012 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization
GOST R ISO 11138-2-2000 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 R 57647-2017 Medicines for medical applications. Pharmacogenomics. Biomarkers
GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 11138-3-2012 Sterilization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
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 10993.7-1999 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing

ES-UNE

UNE-EN ISO 9241-394:2022 Ergonomics of human-system interaction - Part 394: Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images (ISO 9241-394:2020) (Endorsed by Asociación Española de Normal...
UNE-EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
UNE-EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

IT-UNI

UNI EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
UNI EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

KR-KS

KS P ISO 10993-18-2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process
KS P ISO TS 22911-2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
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 TR 37137-2019 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants

American National Standards Institute （ANSI)

AAMI TIR18:1997 Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers-Part 1: Radiated radio-frequency electromagnetic energy, 1ed
ANSI/AAMI HE75-2009 Human factors engineering - Design of medical devices

US-FCR

FCR COE EM 1110-2-1414-1989 WATER LEVELS AND WAVE HEIGHTS FOR COASTAL ENGINEERING DESIGN

U.S. Military Regulations and Norms

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

European Committee for Standardization (CEN)

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)
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
EN ISO 7405:1997 Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials ISO 7405: 1997
EN ISO 10993-18:2020/prA1 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
EN ISO/TR 12296:2013 Ergonomics - Manual handling of people in the healthcare sector
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)

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
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

PL-PKN

PN-EN ISO 10993-18-2020-11 E Biological evaluation of medical devices -- Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

ZA-SANS

SANS 7218:1996 Microbiology of food and animal feeding stuffs - General rules for microbiological examinations

AT-ON

OENORM EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
ONORM EN 73-1989 Wood preservatives; accelerated ageing oftreated wood prior to biological testing; evaporative ageing procedure

GOST

GOST R 59787-2021 Medical laboratories. Requirements for collection, transport, receipt, and handling of biological material
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

GOSTR

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 33871-2016 Biological medicine remedies for veterinary use. Vaccines against viral diseases of animals. Method of determination of activity

North Atlantic Treaty Organization Standards Agency

STANAG 2478-2006 MEDICAL SUPPORT PLANNING FOR NUCLEAR, BIOLOGICAL AND CHEMICAL ENVIRONMENTS
STANAG 1446-2005 NATO STANADARD OPERATING PROCEDURES FOR THE OPERATION OF ADVANCED AND FORWARD LOGISTIC SITES - ALP-4.1 SUPP 1

VDI - Verein Deutscher Ingenieure

VDI 5701-2016 Biomaterials in medicine - classification@requirements and applications
VDI 5701-2018 Biomaterials in medicine - Classification@ requirements@ and applications
VDI 4250 Blatt 1-2011 Bioaerosols and biological agents - Risk assessment of source-related ambient air measurements in the scope of environmental health - Effects of bioaerosol pollution on human health
VDI 4250 Blatt 1-2009 Bioaerosols and biological agents - Risk assessment of source related ambient air measurements in the scope of environmental health - Effects of bioaerosol pollution on human health

Canadian General Standards Board （CGSB)

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

CH-SNV

SN 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)

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)

IAEA - International Atomic Energy Agency

WS-G-2.7-2005 Management of Waste from the Use of Radioactive Material in Medicine@ Industry@ Agriculture@ Research and Education

Standard Association of Australia （SAA）

AS ISO 10993.17:2004 Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
HB 1-1994 Technical drawing for students
AS ISO 10993.11:2002/Amdt 1:2005 Biological evaluation of medical devices Systemic toxicity testing
AS 5013.14:2004 Food microbiology - Microbiology of food and animal feeding stuffs - General rules for microbiological examinations
HB 2.2-2003 Australian Standards for civil engineering students - Structural engineering

SE-SIS

SIS SEN 47 10 02-1973 Interference from R.F. equipment for industrial, scientific and medical purposes

PH-BPS

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

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)

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 Petroleum Institute (API)

API RP 2Z-2005(2020) Recommended Practice for Preproduction Qualification for Steel Plates for Offshore Structures

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