Application of bioreactors in biomedicine

Application of bioreactors in biomedicine, Total:201 items.

The international standard classification for "Application of bioreactors in biomedicine" includes: Environmental protection , Sewage water , Microbiology of water , Other equipment for the chemical industry , Alarm and warning systems , Protection against crime , Medical equipment in general , Environmental management , Water quality , Medical equipment , Product and company certification. Conformity assessment , Other standards related to water quality .

The Chinese standard classification for "Application of bioreactors in biomedicine" includes: Environmental protection equipment , Permissible standards for discharging into treatment structures , Separating machinery , Non-metal chemical machinery equipment , Guard and alarm system , Medical apparatus and devices in general , Standardization and quality management , Water supply and draining instrument and equipment , Standardization and Quality Management , Outdoor water supply and draining engineering .

Group Standards of the People's Republic of China

T/CECS 1543-2024 Technical specification for wastewater treatment using horizontal flow biofilm reactors
T/ZZB 0937-2019 Single-use bioreactor
T/ZZB 2831-2022 Membrane biological reaction integrated domestic sewage treatment equipment
T/CAQI 61-2018 Biological treatment equipment for sewage and wastewater—Aerobic circulating biological expansion bed reactor
T/QME 0011-2023 Evaluation criteria for scientific and technological achievements in the bio-pharmaceutical field
T/NIFA 18-2023 Technical guideline for the application of financial distributed ledger technology in the field of anti-money laundering
T/QDAS 114-2023 Technical specifications for membrane bioreactor operation and maintenance
T/QGCML 4355-2024 Constant temperature reactor for bio-enzyme production
T/CECS 1356-2023 Technical regulations for reaction-precipitation integrated loop bioreactor
T/CAQI 59-2018 Biological treatment of sewage and wastewater—Technical specification for moving bed biofilm reactor system engineering
T/ZGM 004-2021 Assessment requirements for forerunner standards-membrane bioreactor cassettes
T/CAQI 21-2016 Biological-enhanced treatment of wastewater —Up-flow integrative biological reactor
T/CAQI 22-2016 Biological-enhanced pretreatment of wastewater—High-efficiency catalytic reactor
T/ZPP 058-2023 Membrane-Bioreactor Technical Regulations

Professional Standard - Agriculture

CNAS-CL03-A001-2019 Description of the application of the accreditation criteria for proficiency testing providers in the field of microbiology
CNAS-CI01-A009-2023 The Application of Inspection Institution Ability Accreditation Criteria in the Field of Logistics Safety and Cargo Transportation Inspection
301药典四部-2015 3600 Specific Biological Raw Materials - Animals 3605 Bacterial Biochemical Reaction Medium
1773药典化学药和生物制品卷-2010 Chapter 29 Pediatric Drugs Section 1 Drug Application in Neonates 2. Calculation of Drug Dose in Neonates
1772药典化学药和生物制品卷-2010 Chapter 29 Pediatric Drugs Section 1 Drug Application in Newborns 1. Pharmacokinetic characteristics of newborns
CNAS-RL01-2019 Explanation on the Application of Testing and Calibration Laboratory Competence Accreditation Criteria in the Field of Microbiological Testing
CNAS-CL01-A001-2022 Explanation on the Application of Testing and Calibration Laboratory Competence Accreditation Criteria in the Field of Microbiological Testing
CNAS-CL01-A001-2018 Explanation on the Application of Testing and Calibration Laboratory Competence Accreditation Criteria in the Field of Microbiological Testing
350药典三部-2020 Specific Biological Raw Materials - Animal 3605 Bacterial Biochemical Reaction Medium

未注明发布机构

DIN EN ISO 20836 E:2020-02 Polymerase chain reaction for detection of microorganisms in food chain microbiology (draft)
ANSI/AWWA B130-2023 Membrane Bioreactor Systems
AS 4031:1992(R1996) Non-reusable containers for the collection of sharp medical items used in health care areas
ASTM RR-E35-1008 2013 E2871-Test Method for Determining Disinfectant Efficacy Against Biofilm Grown in the CDC Biofilm Reactor Using the Single Tube Method
VDI 3957 Blatt-10 E:2022-05 Biological measuring techniques for the determi- nation and evaluation of effects of air pollutants on plants (biomonitoring) – Use of active bio- monitoring methods in the vicinity of emission sources

工业和信息化部

JB/T 20206-2022 Temperature control device for biopharmaceutical reaction process

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 33898-2017 General technical specification for membrane bioreactor

Shanxi Provincial Standard of the People's Republic of China

DB14/T 2164-2020 Guidelines for the Application of Biometric Identification Technology in the Field of Public Security

Professional Standard - Chemical Industry

HG/T 3917-2006 Membrane bioreactor equipment for wastewater treatment

Professional Standard - Recommended Standards for Engineering Construction

CECS 152-2003 Technical specification for application of integrative submerged membrane bioreactor for wastewater treatment
CECS 152-2003（条文说明） Technical specification for application of integrative submerged membrane bioreactor for wastewater treatment

Professional Standard - Light Industry

QB/T 5966.2-2023 Intelligent manufacturing in biological fermentation industry — Part 2: Intelligent bioreactor

Professional Standard - Public Safety Standards

GA 1802.1-2022 Requirements for counter-terrorism in the field of biosafety-Part 1:High-level pathogenic microorganism laboratories
GA 1802.2-2022 Requirements for counter-terrorism in the field of biosafety-Part 2:Preservation centers for pathogenic microorganisms
GA 1802.3-2022 Requirements for counter-terrorism in the field of biosafety-Part 3:Vaccine production institutions with high biosafety risk

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

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

GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation
GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6:Tests for local effects after implantation
GB/T 42281-2022 Hollow fiber membrane module of membrane aerated biofilm reactor
GB/Z 40824-2021 Environmental management—Guide on life cycle assessment for electrical and electronic equipment

Jilin Provincial Standard of the People's Republic of China

DB22/T 1862-2013 Hygienic protection norms for the application of antineoplastic drugs

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

中国国家认证认可监督管理委员会

RB/T 209-2017 Implementation guidelines for laboratory proficiency testing in the field of medical vectors

Guangdong Provincial Standard of the People's Republic of China

DB44/T 1658-2015 Membrane bioreactor and ultraviolet disinfection equipment for water treatment

Professional Standard - Environmental Protection

HJ 2527-2012 Technical requirement for environmental protection products membrane bioreactor

Professional Standard - Ocean

HY/T 168.3-2013 Design code for domestic seawater post-treatment-Part 3:MBR process

Liaoning Provincial Standard of the People's Republic of China

DB21/T 2302-2014 Technical specification for straw bioreactor in open field

RU-GOST R

GOST R 57688-2017 Medicines for medical applications. Stability testing of biotechnological/biological medications
GOST R 57679-2017 Medicines for medical applications. Investigation bioequivalence of medications
GOST R 57647-2017 Medicines for medical applications. Pharmacogenomics. Biomarkers
GOST R 57689-2017 Medicines for medical applications. Detection of toxicity to reproduction and male reproductivity
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST 31928-2013 Probiotics medicine remedies for veterinary use. Methods for determination of the probiotics microorganisms
GOST R 56140-2014 Medicine biological remedies for veterinary use. Polymerase chain reaction for the Mycoplasma DNA detection
GOST R 55291-2012 Probiotic medicine remedies for veterinary use. Methods of microbiological analysis

SCC

AWWA PATH56561 Application of Surrogate Microorganisms for UV Reactor Validation
AWWA B130-2018 Membrane Bioreactor Systems
VDI 3478 BLATT 2-2008 Biological exhaust gas purification — bio trickle bed reactors
AWWA WQTC52990 Membrane Bioreactors for Water Recycling
VDI 3478 BLATT 2-2008 Biological exhaust gas purification — bio trickle bed reactors
AWWA MTC69741 Application of Membrane Bioreactors for a Gulf Coast Water Reclamation Facility
AWWA MTC57674 Enhanced Biological Phosphorus Removal (EBPR) in Membrane Bioreactors (MBR)
AWWA WQTC64079 Exploration of Membrane Bioreactor Use for DBP Control
AWWA SOURCES59239 Wastewater Membrane Bioreactors — An Emerging Technology for the Development of a Reclaimed Water Supply
NS-EN 13311-4:2001 Biotechnology — Performance criteria for vessels — Part 4: Bioreactors
AWWA MTC57585 In-building Membrane Bioreactors for Wastewater Treatment
DANSK DS/EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors
BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from medical devices
AWWA WQTC58870 Integrated Bioreactor-Membrane Systems for Organics Removal
AWWA WQTC71616 Changes in Microbial Communities in Drinking Water Treatment Bioreactors upon Phosphorus Addition
SN-CEN/TR 15897:2018 Submerged Membrane Bioreactor (MBR) technology
SN-CWA 15897:2008 Submerged Membrane Bioreactor (MBR) Technology
BS PD CEN/TR 15897:2018 Submerged Membrane Bioreactor (MBR) technology
AWWA ACE56277 Membrane Biofilm Reactors for Removal of Perchlorate
AWWA WQTC57158 Removal of Perchlorate with Membrane Biofilm Reactors
AWWA JAW48547 Journal AWWA — Using a Membrane Bioreactor to Reclaim Wastewater
AWWA MTC64597 Treatment of Dilute Wastewater Using an Anaerobic Membrane Bioreactor
AWWA REUSE52114 Feasibility of the Membrane Bioreactor Process for Water Reclamation
AWWA ACE58189 A Better Way to do Membrane Bioreactors: Study of a Novel Hybrid Sorption-Membrane-Bioreactor Process for Concurrent Removal of Ammonia, Iron and Manganese
AWWA WQTC52925 Optimizing Biodegradable Organic Carbon Removal From Drinking Water Using a Membrane Bioreactor Process
AWWA ACE63077 Microbial Bromate Reduction in a Hydrogen-Based, Membrane Biofilm Reactor: Inhibitory Mechanisms
AWWA ACE58244 Biodegradation of Methyl tert-Butyl Ether Using an Innovative Biomass Concentrator Reactor
AWWA WKICO66046 Characterizing the Microbial Community for a Bioreactor Treating Perchlorate-Contaminated Groundwater
AWWA MTC64549 Indirect Potable Reuse Using Membrane Bioreactors and Reverse Osmosis
VDI 4075 BLATT 1-2014 Production-integrated environmental protection (PIUS) — basics and scope of application
AWWA MTC61119 Planning and Design for a Large Membrane Bioreactor System
AWWA MTC57635 Procurement of Membrane Equipment: Differences between Water Treatment and Membrane Bioreactor (MBR) Applications
AWWA ACE58108 Perchlorate Removal Using an Innovative Membrane Biofilm Reactor
BS EN ISO 10993-10:2009 Biological evaluation of medical devices-Tests for irritation and delayed-type hypersensitivity
AWWA WQTC71391 Modeling Bioreactors for Drinking Water Treatment: Attachment and Detachment of Bacteria to Carrier Media
AWWA WQTC64178 Novel Bioreactor for Perchlorate Removal Using Elemental Sulfur
AWWA MTC61178 Membrane Bioreactor for Pilot Studies in the Arctic Alaska
BS EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives-Application of risk management
AWWA ACE70555 GAC Biofilters in Retrofit Applications for Removal of Organic Contaminants
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
AWWA REUSE52113 Using a Membrane Bioreactor/Reverse Osmosis System for Indirect Potable Reuse
AWWA JAW39584 Journal AWWA — Membrane Bioreactor: A New Treatment Tool
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
AWWA MTC53836 Drinking Water Denitrification Using Hollow Fiber Membrane Bioreactors
AWWA SOURCES55668 Membrane Bio-Reactor Pilot Study: Michelson Water Reclamation Plant (MWRP)
AWWA ACE56260 Hydrogenotrophic Denitrification Using a Dead End Hollow Fiber Membrane Bioreactor
AENOR UNE 166005 IN:2012 R&D&i management: Application guide of UNE 166002 Standard to the capital goods sector.
AWWA MTC57632 Membrane Bioreactor Evaluation for Water Reuse in Seattle, Washington
AWWA MTC61196 Universal Design of a Submerged Hollow Fiber Membrane System for a Membrane Bioreactor
VDI 4230 BLATT 3-2009 Biological methods for detecting the effects of air pollution (bioindication) — Passive biomonitoring with bird eggs as accumulation and reaction indicators
NS-EN 12255-7:2002 Wastewater treatment plants — Part 7: Biological fixed-film reactors
AWWA MTC57673 Parameters Influencing Filterability of Activated Sludge in Membrane Bioreactors
DANSK DS/EN 12255-7:2002 Wastewater treatment plants - Part 7: Biological fixed-film reactors
AENOR UNE-EN 12255-7:2003 Wastewater treatment plants - Part 7: Biological fixed-film reactors.
AWWA ACE68714 Turbocharging Membrane Bioreactor Performance with Integrated Adsorptive Treatment
AWWA WKICO66056 Simultaneous Bio-reduction of Multiple Oxidized Contaminants in Groundwater Using a Hydrogen-based Membrane Biofilm Reactor (MBfR)
AWWA QTC97148 Bioreactors for the Rapid Determination of Biodegradable Dissolved Organic Carbon (BDOC) in Drinking Water: Feed Mode Impact
AWWA ACE65372 Biotechnology and Nanotechnology in the Water Sector

American National Standards Institute （ANSI)

ANSI/AWWA B130-2013 Membrane Bioreactor

British Standards Institution (BSI)

BS EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Bioreactors
BS CWA 15897:2008 Submerged membrane bioreactor (MBR) technology
BS DD ISO/TS 22224:2009 Health informatics - Electronic reporting of adverse drug reactions
BS EN 12255-7:2002 Wastewater treatment plants. Biological fixed-film reactors
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

American Water Works Association (AWWA)

ANSI/AWWA B130-2018 Membrane Bioreactor Systems
AWWA B130-2013 Membrane Bioreactor Systems (First Edition)

BSI

AWWA B130-2023 Membrane Bioreactor Systems

Association Francaise de Normalisation

NF X42-070:1989 BIOTECHNOLOGY. GUIDE OF GOOD PRACTICES FOR RESEARCH AND DEVELOPMENT IN THE FIELD OF USE OF MICROORGANISMS AND OF SUPERIOR ORGANISM CELLS.
NF EN ISO 22367:2020 Medical biology laboratories - Application of risk management to medical biology laboratories
NF X42-102:1988 Biotechnologies - Bioreactors - Help sheet for drafting specifications
X42-102:1988 Biotechnology. Bioreactors. Data sheet for the drafting of a contract bill.
NF X42-137*NF EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Part 4 : bioreactors.
NF EN 13311-4:2001 Biotechnology - Vessel performance criteria - Part 4: bioreactors
NF X42-100:1987 BIOTECHNOLOGY. BIOREACTORS. DEFINITIONS AND CLASSIFICATION.
NF X42-073:1990 BIOTECHNOLOGY. CODE OF GOOD PRATICE FOR GREENHOUSE RESEARCH AND TESTING IN THE FIELD OF MICROORGANISMS NON-PATHOGENIC TO MAN.
NF EN 12255-7:2002 Stations d'épuration - Partie 7 : réacteurs biologiques à cultures fixées
NF P16-700-7*NF EN 12255-7:2002 Wastewater treatment plants - Part 7 : biological fixed-film reactors.

VDI - Verein Deutscher Ingenieure

VDI 3478 Blatt 2-2005 Biological waste gas purification - Biological trickle bed reactors
VDI 3478-1996 Biological waste gas purification - Bioscrubbers and trickle bed reactors
VDI 3478-1994 Biological waste gas purification - Bioscrubbers and trickle bed reactors
VDI 4075 Blatt 1-2013 Cleaner production (PIUS) - Basic principles and area of application
VDI 5701-2018 Biomaterials in medicine - Classification@ requirements@ and applications
VDI 5701-2016 Biomaterials in medicine - classification@requirements and applications

Standard Association of Australia （SAA）

AS 4031:1992 Non-reusable containers for the collection of sharp medical items used in health care areas

American Society for Testing and Materials (ASTM)

ASTM F1481-94(2001) Standard Guide for Ecological Considerations for the Use of Bioremediation in Oil Spill Response-Sand and Gravel Beaches
ASTM E2562-22 Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow using CDC Biofilm Reactor
ASTM E2562-17 Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow using CDC Biofilm Reactor
ASTM E2871-12 Standard Test Method for Evaluating Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm Grown in CDC Biofilm Reactor using Single Tube Method
ASTM E2871-21 Standard Test Method for Determining Disinfectant Efficacy Against Biofilm Grown in the CDC Biofilm Reactor Using the Single Tube Method
ASTM E2871-19 Standard Test Method for Determining Disinfectant Efficacy Against Biofilm Grown in the CDC Biofilm Reactor Using the Single Tube Method
ASTM F1904-23 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo

AENOR

UNE-EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors.
UNE 77104:2014 Bioassay for the characterization of the ecotoxicity of oil pollution response products by the bioluminescent bacterium Vibrio fischeri
UNE-EN 12255-7:2003 Wastewater treatment plants - Part 7: Biological fixed-film reactors.

German Institute for Standardization

DIN EN 13311-4:2001-06 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors; German version EN 13311-4:2001
DIN EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors; German version EN 13311-4:2001
DIN CEN/TR 15897:2020-09 Submerged Membrane Bioreactor (MBR) technology; English version CEN/TR 15897:2018
DIN EN ISO 22174:2022-11 Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection and quantification of microorganisms - General requirements and definitions (ISO/DIS 22174:2022); German and English version prEN ISO 22174:2022 / Note: Date of issue 20...
DIN EN 12255-7:2002-04 Wastewater treatment plants - Part 7: Biological fixed-film reactors; German version EN 12255-7:2002

European Committee for Standardization (CEN)

EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors
EN ISO 20836:2021 Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection of microorganisms - Thermal performance testing of thermal cyclers (ISO 20836:2021)

Lithuanian Standards Office

LST EN 13311-4-2002 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors
LST EN 12255-7-2002 Wastewater treatment plants - Part 7: Biological fixed-film reactors

Danish Standards Foundation

DS/EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors
DS/CWA 15897:2009 Submerged Membrane Bioreactor (MBR) Technology
DS/EN 12255-7:2002 Wastewater treatment plants - Part 7: Biological fixed-film reactors

GOSTR

GOST R 58357-2019 Medicine biological remedies for veterinary use. Detection and identification of the causative agent of Marek's disease by means of polymerase chain reaction
GOST R ISO 22442-1-2011 Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management

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 IP CH 40-2006 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

ES-UNE

UNE-CEN/TR 15897:2018 Submerged Membrane Bioreactor (MBR) Technology (Endorsed by Asociación Española de Normalización in February of 2019.)

CEN - European Committee for Standardization

PD CEN/TR 15897:2018 Submerged Membrane Bioreactor (MBR) technology
EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
EN ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

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

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

ISA - International Society of Automation

ISA AUTOMTN APPL BIO-PHARM-2008 Automation Applications in Bio-Pharmaceuticals

ET-QSAE

ES 544-2000 Microbiological testing of antibiotics for medicinal, medicinal and crude pharmaceutical products

International Organization for Standardization (ISO)

ISO 10993-6:1994 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 20836:2021 Microbiology of the food chain — Polymerase chain reaction (PCR) for the detection of microorganisms — Thermal performance testing of thermal cyclers
ISO/TS 21726:2019 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

TH-TISI

TIS 2395.6-2008 Biological evaluation of medical devices.part 6: tests for local effects after implantation
TIS 2395.10-2008 Biological evaluation of medical devices.part 10: tests for irritation and delayed-type hypersensitivity

Association of German Mechanical Engineers

VDI 4075 Blatt 1-2005 Cleaner production (PIUS) - Basic principles and area of application

IN-BIS

IS 12572 Pt.5-1988 Guidelines for Biohazard Evaluation of Medical Devices Part 5 Test Method for Intradermal Reactivity of Medical Device Extracts

VN-TCVN

TCVN 7391-6-2007 Biological evaluation of medical devices.Part 6: Tests for local effects after implantation

GOST

GOST ISO/TS 21726-2021 Medical devices. Evaluation system of biological effects. Application of the threshold of toxicological concern for assessing biocompatibility of medical device constituents
GOST R 70621-2022 Conformity assessment. Application of ISO/IEC 17021-1 in the field of medical device quality management systems (ISO 13485)

GSO

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

Korean Agency for Technology and Standards (KATS)

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

HU-MSZT

MSZ 17010-1972 Medicinal plants, antiseptic grass for doctors

ZA-SANS

SANS 10993-10:2004 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity

GB-REG

REG NASA-LLIS-0945-2001 Lessons Learned ?Unexpected reactions in chemical mixtures during storage

BE-NBN

NBN EN 30993-6-1995 Biological evaluation of medical devices - Part 6 : Tests for local effects after implantation (ISO 10993-6:1994)

Others: