Biomedical Inorganic Materials

Biomedical Inorganic Materials, Total:165 items.

The international standard classification for "Biomedical Inorganic Materials" includes: Medical microbiology , Laboratory medicine , Medical equipment in general , Surgical instruments and materials .

The Chinese standard classification for "Biomedical Inorganic Materials" includes: Medical sanitary products , Medical apparatus and devices in general , Legal medical expert .

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

GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials
GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
GB/T 16175-1996 Organic silicon material for medical use-Biological evaluation test methods
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials

Group Standards of the People's Republic of China

T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CSTE 0012-2020 Inorganic modified biodegradable material and product Part 1: Pellet
T/CAMPA 001-2020 Organic-inorganic compound （complex） fertilizer containing microbial inoculants

国家食品药品监督管理局

YY/T 1532-2017 Biological evaluation of medical devices—Nanomaterials—Hemolysis test

Professional Standard - Medicine

YY/T 1295-2015 Biological evaluation of medical devices―Nanomaterial:Endotoxin test

未注明发布机构

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)
DIN EN ISO 10993-12:2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ANSI/AAMI/ISO TIR10993-19:2006 Biological evaluation of medical devices — Part 19: Physico- chemical, morphological, and topographical characterization of materials
DIN EN ISO 10993-18:2009 Biological assessment of medical devices
DIN 58959-10 E:1991-11 Quality management in medical microbiology - Part 10: Requirements for the use of control strains for testing reagents, dyes and biological materials
DIN 58959-20 E:1991-11 Quality management in medical microbiology - Part 20: Requirements for the use of control material for the examination of protozoae and microorganisms of higher order
DIN 58959-3 E:2013-12 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms

Professional Standard - Judicatory

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

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 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

SCC

BS EN ISO 10993-18:2005 Biological evaluation of medical devices-Chemical characterization of materials
BS EN ISO 10993-18:2009 Biological evaluation of medical devices-Chemical characterization of materials
BS PD ISO/TR 10993-22:2017 Biological evaluation of medical devices-Guidance on nanomaterials
DANSK DS/ISO/TS 17518:2015 Medical laboratories - Reagents for staining biological material - Guidance for users
CAN/CGSB-43.125-1999 Packaging of infectious materials, diagnostic samples, biological products and biomedical waste for transport
BS DD ISO/TS 10993-19:2006 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
AS ISO 10993.12:2002 Biological evaluation of medical devices - Sample preparation and reference materials
DANSK DS/EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
BS PD ISO/TS 10993-19:2020 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
CAN/CSA-ISO 10993.9-98:1998 Biological evaluation of medical devices - Part 9: Degradation of materials related to biological testing
DANSK DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials
SN-ISO/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
SN-ISO/TS 10993-19:2006 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
DANSK DS/ISO/TS 10993-19:2020 Biological evaluation of medical devices – Part 19: Physico-chemical, morphological and topographical characterization of materials
NS-EN ISO 10993-18:2009 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)
NS-EN ISO 10993-18:2005 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)
UNE-EN ISO 10993-18:2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
DIN 58959-9 E:2022 Draft Document - Medical microbiology - Quality management in medical microbiology - Part 9: Requirements for handling, storage and performance testing of culture media, testing reagents, dyes, biological materials, ready-to-use tests, test kits and im...
AAMI/ISO 10993-12:2002 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
AAMI/ISO 10993-12:2007 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
AAMI/ISO 10993-12:2012 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
AAMI/ISO TIR10993-19:2006 Biological evaluation of medical devices - Part 19: Physio-chemical, morphological and topographical characterization of materials [Historical]
BS PD ISO/TS 17518:2015 Medical laboratories. Reagents for staining biological material. Guidance for users
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...
BS 6242:1982 Specification for single use unlabelled medical specimen containers for haematology and biochemistry
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
NS-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)
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
ASTM STP 1173-94 Biomaterials' Mechanical Properties
BS 5828:1989 Methods for biological assessment of dental materials
AENOR UNE-EN ISO 10993-8:2001 Biological evaluation of medical devices. Part 8: Selection and qualification of reference materials for biological assays. (ISO 10993-8:2000)

Association Francaise de Normalisation

XP ISO/TS 17518:2015 Medical biology laboratory - Reagents for staining biological material - Instructions for users
XP S92-042*XP ISO/TS 17518:2015 Medical Laboratories - Reagents for staining biological material - Guidance for users
NF S99-518:2005 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
NF S99-501-18:2009 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
FD S99-501-22*FD ISO/TR 10993-22:2017 Biological evaluation of medical devices - Part 22 : guidance on nanomaterials
FD ISO/TR 10993-22:2017 Biological evaluation of medical devices - Part 22: guidance on nanomaterials
XP ISO/TS 10993-19:2022 Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
NF EN ISO 22367:2020 Medical biology laboratories - Application of risk management to medical biology laboratories
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
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
NF S94-071:2013 Materials for surgical implants - Determination of surface finish of coatings used for biomedical applications
NF S94-072:1998 Materials for surgical implants. Determination of tensile adherence of phosphocalcic coatings for biomedical applications.

VDI - Verein Deutscher Ingenieure

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

TH-TISI

TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials

VN-TCVN

TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials

British Standards Institution (BSI)

PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-12:2007 Biological evaluation of medical devices - Sample preparation and reference materials
BS EN ISO 10993-12:2021 Biological evaluation of medical devices. Sample preparation and reference materials
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-12:2012 Biological evaluation of medical devices. Sample preparation and reference materials
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 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 17518:2015 Medical laboratories. Reagents for staining biological material. Guidance for users

GSO

GSO ISO/TS 17518:2024 Medical laboratories — Reagents for staining biological material — Guidance for users
OS GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
BH GSO ISO 10993-18:2017 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
BH GSO ISO/TR 10993-22:2022 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
GSO ISO/TR 10993-22:2021 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
OS GSO ISO/TS 10993-19:2016 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
GSO ISO/TS 10993-19:2016 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
BH GSO ISO/TS 10993-19:2017 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials

Korean Agency for Technology and Standards (KATS)

KS P ISO TS 17518:2018 Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
KS P ISO TS 17518-2023 Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 10993-18:2009 Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 10993-19:2009 Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO TR 10993-22:2020 Biological evaluation of medical devices —Part 22: Guidance on nanomaterials
KS P ISO 10993-8:2007 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-8:2002 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-19-2009(2019) Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO TS 10993-19:2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-18:2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process

RU-GOST R

GOST R 59722-2021 Medical laboratories. Reagents for staining biological material. Guidance for users
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
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 31576-2012 Evaluation of biological hazard of medical dental materials and articles. Classification and sampling
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST ISO 10993-12-2015 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

International Organization for Standardization (ISO)

ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TR 10993-22:2017 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
ISO/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TR 7405:1984 Biological evaluation of dental materials
ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

KR-KS

KS P ISO TS 17518-2018 Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
KS P ISO TS 17518-2018(2023) Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
KS P ISO TR 10993-22-2020 Biological evaluation of medical devices —Part 22: Guidance on nanomaterials
KS P ISO 10993-8-2002 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO TS 10993-19-2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-18-2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process

European Committee for Standardization (CEN)

EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
EN ISO 10993-18:2020/prA1:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021)

CEN - European Committee for Standardization

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

German Institute for Standardization

DIN 58956-10:1986-01 Medical microbiology; medical-microbiological laboratories; safety marking
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 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 58956-3:1986-12 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
DIN 58956-2:1986-01 Medical microbiology; medical microbiological laboratories; requirements for equipment
DIN EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005
DIN 58981-1:1984 Medical microbiology; dyes; Azure B thiazine dye
DIN 58959-20:1997-06 Quality management in medical microbiology - Part 20: Requirements for the use of control material for the examination of protozoae and microorganisms of higher order
DIN EN ISO 10993-12:2021-08 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021
DIN 58956-5:1990 Medical microbiology; medical-microbiological laboratories; hygiene scheme requirements
DIN 58956-2:1986 Medical microbiology; medical microbiological laboratories; requirements for equipment
DIN 58956-10:1986 Medical microbiology; medical-microbiological laboratories; safety marking
DIN 58981-2:1985 Medical microbiology; dyes; xanthene dye, fluorescein derivate eosin Y (=G)
DIN 58959-10 Bb.1:1997 Quality management in medical microbiology - Part 10: Requirements for the use of control strains for testing reagents, dyes and biological materials; control strains for commonly used materials
DIN 58959-3:2014 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58959-10:1997 Quality management in medical microbiology - Part 10: Requirements for the use of control strains for testing reagents, dyes and biological materials
DIN 58981-3:1985 Medical microbiology; dyes; thionin thiazine dye
DIN 58959-3:2014-08 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms

Danish Standards Foundation

DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials

GOSTR

GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials

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
GOST R ISO 10993-18-2009 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials

American National Standards Institute （ANSI)

ANSI/AAMI BE83-2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
AAMI/ISO TIR10993-19:2020 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials

DIN

DIN 58959-9:2022 Medical microbiology - Quality management in medical microbiology - Part 9: Requirements for handling, storage and performance testing of culture media, testing reagents, dyes, biological materials, ready-to-use tests, test kits and immunological test ...

American Society for Testing and Materials (ASTM)

ASTM E1287-89(1999) Standard Practice for Aseptic Sampling of Biological Materials
ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
ASTM F665-09 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM F665-98 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM F2027-08 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for 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

AENOR

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

U.S. Military Regulations and Norms

ARMY MIL-E-51420 A VALID NOTICE 1-1989 EDGESEAL MATERIAL, CHEMICAL-BIOLOGICAL FILTER
ARMY MIL-E-51420 A NOTICE 2-1996 EDGESEAL MATERIAL, CHEMICAL-BIOLOGICAL FILTER
ARMY MIL-E-51420 A-1983 EDGESEAL MATERIAL, CHEMICAL-BIOLOGICAL FILTER
ARMY MIL-E-51420 A (1)-1991 EDGESEAL MATERIAL, CHEMICAL-BIOLOGICAL FILTER

ES-UNE

UNE-EN ISO 10993-12:2022 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
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)

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

US-AAMI

ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials