ZH
RU
ES

Regenerative Medicine and Cell Therapy

Regenerative Medicine and Cell Therapy, Total:104 items.

In the international standard classification, Regenerative Medicine and Cell Therapy involves: Vocabularies, Medical sciences and health care facilities in general, Medical equipment, Dentistry, Laboratory medicine, Microbiology, Biology. Botany. Zoology, Sterilization and disinfection, Pharmaceutics.

British Standards Institution (BSI), Regenerative Medicine and Cell Therapy

BS PAS 84:2012 Cell therapy and regenerative medicine. Glossary
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
BS ISO 19090:2018 Tissue-engineered medical products. Bioactive ceramics. Method to measure cell migration in porous materials
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
20/30369896 DC BS ISO 23033. Biotechnology. Analytical methods. General guidelines for the characterization and testing of cellular therapeutic products
BS ISO 23033:2021 Biotechnology. Analytical methods. General requirements and considerations for the testing and characterization of cellular therapeutic products
BS EN ISO 11290-1+A1:1997 Microbiology of food and animal feeding stuffs. Horizontal method for the detection and enumeration of Listeria monocytogenes. Detection method
BS EN ISO 11290-1:1996+A1:2004 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Detection method
BS EN ISO 10993-16:1997 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
BS EN ISO 11290-1:2017 Microbiology of the food chain. Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. Detection method
BS PD 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
BS EN ISO 11290-2:2017 Microbiology of the food chain. Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. Enumeration method

RU-GOST R, Regenerative Medicine and Cell Therapy

GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST R 52770-2007 Medical products. Safety requirements. Methods of sanitation-chemical and toxicological tests

Danish Standards Foundation, Regenerative Medicine and Cell Therapy

DS/EN 30993-5:1994 Biological evaluation of medical devices-Part 5:Tests for cytotoxicity-in vitro methods
DS/ISO 23033:2021 Biotechnology – Analytical methods – General requirements and considerations for the testing and characterization of cellular therapeutic products
DS/EN ISO 11290-2:1998 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 2: Enumeration method
DS/EN ISO 11290-1:1997 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 1: Detection method
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

International Organization for Standardization (ISO), Regenerative Medicine and Cell Therapy

ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO/TR 10993-55:2023 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
ISO 13022:2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices
ISO 19090:2018 Tissue-engineered medical products - Bioactive ceramics - Method to measure cell migration in porous materials
ISO 23033:2021 Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products
ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO 11737-3:2004 Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data
ISO 11290-2:1998 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 2: Enumeration method
ISO 11290-1:1996 Microbiology of food and animal feeding stuffs - Horizontal method for detection and enumeration of Listeria monocytogenes - Part 1: Detection method
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
ISO 11290-2:2017 Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 2: Enumeration method
ISO 11290-1:2017 Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 1: Detection method

VN-TCVN, Regenerative Medicine and Cell Therapy

TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity
TCVN 7700-1-2007 Microbiology of food and animal feeding stuffs.Horizontal method for the detection and enumeration of Listeria monocytogenes.Part 1: Detection method
TCVN 7700-2-2007 Microbiology of food and animal feeding stuffs.Horizontal method for the detection and enumeration of Listeria monocytogenes.Part 2: Enumeration method

TH-TISI, Regenerative Medicine and Cell Therapy

TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity
TIS 2279.3-2006 Sterilization of medical devices.microbiological methods.part 3: guidance on evaluation and interpretation of bioburden data

ZA-SANS, Regenerative Medicine and Cell Therapy

SANS 10993-5:2003 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

American National Standards Institute （ANSI), Regenerative Medicine and Cell Therapy

ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Regenerative Medicine and Cell Therapy

GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests
GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices

Association Francaise de Normalisation, Regenerative Medicine and Cell Therapy

NF EN ISO 10993-5:2010 Évaluation biologique des dispositifs médicaux - Partie 5 : essais concernant la cytotoxicité in vitro
NF S99-501-5*NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
NF S99-505:1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 5 : TESTS FOR CYTOTOXICITY : IN VITRO METHODS. (EUROPEAN STANDARD EN 30993-5).
NF C74-329:1990 Medical electrical equipment. Part 2 : particular safety requirements for separation of cells and plasma monitors by centrifugation.
NF V08-055:1997 Microbiology of food and animal feeding stuffs. Detection of Listeria monocytogenes. Routine method.
NF V08-028-2*NF EN ISO 11290-2:2017 Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 2 : enumeration method
NF V08-028-1*NF EN ISO 11290-1:2017 Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 1 : detection method
NF EN ISO 11290-1:2017 Microbiologie de la chaîne alimentaire - Méthode horizontale pour la recherche et le dénombrement de Listeria monocytogenes et Listeria spp. - Partie 1 : méthode de recherche
NF EN ISO 11290-2:2017 Microbiologie de la chaîne alimentaire - Méthode horizontale pour la recherche et le dénombrement de Listeria monocytogenes et de Listeria spp. - Partie 2 : méthode de dénombrement

German Institute for Standardization, Regenerative Medicine and Cell Therapy

DIN EN ISO 10993-5:2009-10 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
DIN ISO 13022:2014 Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
DIN 58940-1:2002 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 1: Terminology
DIN 58962-3:1996 Medical microbiology - Diagnosis of infections of the lower respiratory tract - Part 3: Cultural examination for the detection of bacteria and fungi
DIN 58940-8:2002 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 8: Microdilution; General method-specific requirements
DIN 58959-6 Bb.1:1997 Quality management in medical microbiology - Part 6: Requirements for control strains; examples for production and preservation of bacteria used as stock cultures and working cultures
DIN EN ISO 11290-2:2005 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 2: Enumeration method (ISO 11290-2:1998 + AMD1:2004); German version EN ISO 11290-2:1998 + A1:2004
DIN EN ISO 11290-1:2005 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 1: Detection method (ISO 11290-1:1996 + AMD 1:2004); German version EN ISO 11290-1:1996 + A1:2004
DIN EN ISO 11290-2:2017-09 Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 2: Enumeration method (ISO 11290-2:2017); German version EN ISO 11290-2:2017
DIN EN ISO 11290-1:2017-09 Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 1: Detection method (ISO 11290-1:2017); German version EN ISO 11290-1:2017

PH-BPS, Regenerative Medicine and Cell Therapy

PNS ISO 10993-5:2021 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Korean Agency for Technology and Standards (KATS), Regenerative Medicine and Cell Therapy

KS P ISO 10993-5:2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20:2009 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS J ISO 11290-2-2007(2012) Microbiology of food and animal feeding stuffs－Horizontal method for the detection and enumeration of Listeria monocytogenes－Part 2：Enumeration method
KS J ISO 11290-1-2007(2012) Microbiology of food and animal feeding stuffs－Horizontal method for the detection and enumeration of Listeria monocytogenes－Part 1：Detection method
KS J ISO 11290-1:2007 Microbiology of food and animal feeding stuffs-Horizontal method for the detection and enumeration of Listeria monocytogenes-Part 1:Detection method
KS J ISO 11290-2:2007 Microbiology of food and animal feeding stuffs－Horizontal method for the detection and enumeration of Listeria monocytogenes－Part 2：Enumeration method

KR-KS, Regenerative Medicine and Cell Therapy

KS P ISO 10993-5-2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

国家药监局, Regenerative Medicine and Cell Therapy

YY/T 1688-2021 Blastocyst cell staining and counting methods for medical devices used in human assisted reproductive technology
YY/T 1744-2020 Method for measuring cell migration in bioactive ceramic porous materials for tissue engineering medical device products

RO-ASRO, Regenerative Medicine and Cell Therapy

STAS SR EN 30993-5-1996 Biological evaluation of medical devices -Part 5: Tests for cytotoxicity: in vitro methods

Professional Standard - Medicine, Regenerative Medicine and Cell Therapy

YY/T 0993-2015 Biological evaluation of medical devices.Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay)
YY/T 0127.18-2016 Biological evaluation of medical devices used in dentistry.Part 18:Dentine barrier cytotoxicity test
YY/T 0127.17-2014 Biological evaluation of medical devices used in dentistry.Part 17: Mouse lymphoma cells (TK) gene mutation test
YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
YY/T 0127.9-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Cytotxicity tests .Agar diffusion test and filter diffusion test
YY/T 0127.16-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method In Vitro mammalian chromosome aberration test

AENOR, Regenerative Medicine and Cell Therapy

UNE-EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
UNE-EN ISO 11290-2:2000 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 2: Enumeration method (ISO 11290-2:1998)
UNE-EN ISO 11290-1:1997 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 1: Detection method (ISO 11290-1:1996)

未注明发布机构, Regenerative Medicine and Cell Therapy

YY 0127.9-2009 Biological Evaluation of Oral Medical Devices Unit 2: Test Methods Cytotoxicity Test: Agar Diffusion Method and Filter Diffusion Method

BE-NBN, Regenerative Medicine and Cell Therapy

NBN-EN 30993-5-1994 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - in vitro methods (ISO 10993-5:1992)

American Society for Testing and Materials (ASTM), Regenerative Medicine and Cell Therapy

ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products

European Committee for Standardization (CEN), Regenerative Medicine and Cell Therapy

EN 30993-5:1994 Biological Evaluation of Medical Devices - Part 5: Tests for Cytotoxicity : In Vitro Methods (ISO 10993-5 : 1992) ISO 10993-5:1992; Superseded by EN ISO 10993-5:1999
EN ISO 11290-1:2017 Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 1: Detection method

GOSTR, Regenerative Medicine and Cell Therapy

GOST R 52770-2020 Medical devices. Evaluation system of biological effects. Part 1. General requirements for biological safety

Indonesia Standards, Regenerative Medicine and Cell Therapy

SNI ISO 11290-1:2012 Mikrobiologi bahan pangan dan pakan - Metode horizontal untuk deteksi dan enumerasi Listeria monocytogenes - Bagian 1: Metode deteksi

Standard Association of Australia （SAA）, Regenerative Medicine and Cell Therapy

AS 5013.24.2:2020 Food microbiology, Method 24.2: Microbiology of the food chain — Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. — Enumeration method (ISO 11290-2:2017, MOD)
AS 5013.24.1:2020 Food microbiology, Method 24.1: Microbiology of the food chain — Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. — Detection method (ISO 11290-1:2017, MOD)
AS 5013.24.2:2009 Food microbiology Method 24.2: Microbiology of food and animal feeding stuffs—Horizontal method for the detection and enumeration of Listeria monocytogenes—Enumeration method (ISO 11290-2:1998, MOD)

Lithuanian Standards Office , Regenerative Medicine and Cell Therapy

LST EN ISO 11290-2:2000 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 2: Enumeration method (ISO 11290-2:1998)
LST EN ISO 11290-1:2003 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 1: Detection method (ISO 11290-1:1996)

ES-UNE, Regenerative Medicine and Cell Therapy

UNE-EN ISO 11290-2:2018 Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 2: Enumeration method (ISO 11290-2:2017)
UNE-EN ISO 11290-1:2018 Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 1: Detection method (ISO 11290-1:2017)

PL-PKN, Regenerative Medicine and Cell Therapy

PN-EN ISO 11290-1-2017-07 P Microbiology of the food chain--Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp.-- Part 1: Detection method (ISO 11290-1:2017)

NZ-SNZ, Regenerative Medicine and Cell Therapy

AS/NZS 1766.2.16.1:1998 Food Microbiology Method 2.16.1: Examination for Specific Organisms - Food and Animal Feeding Stuffs - Horizontal Method for the Detection and Enumeration of Listeria Monocytogenes - Detection Method (ISO 11290-1: 1996)