Medical device raw material selection

Medical device raw material selection, Total:111 items.

The international standard classification for "Medical device raw material selection" includes: Medical equipment in general , Sterilization and disinfection in general .

The Chinese standard classification for "Medical device raw material selection" includes: Medical apparatus and devices in general , General requirements on medical devices , Public medical equipment .

未注明发布机构

ANSI/AAMI/ISO 16142-1:2016 Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
DIN 13145 E:2008-09 Medical instruments - Mallet of plastic material
ANSI/AAMI/ISO TIR16142:2005 Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices ANSI/AAMI/ISO TIR16142:2005 Technical Information Report
DIN 13173 E:2022-08 Medical instruments - Dressing forceps
DIN 13173 E:2016-07 Medical instruments - Dressing forceps

Professional Standard - Medicine

YY/T 0466.2-2015 Medical devices―Symbols to be used with medical device labels, labelling,and information to be supplied―Part 2:Symbol development,selection and validation
YY/T 1463-2016 Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sites
YY/T 0467-2016 Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices

Taiwan Provincial Standard of the People's Republic of China

CNS 14393.8-2005 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
CNS 14393-8-2005 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood

Group Standards of the People's Republic of China

T/CAMDI 106-2023 Guidelines for the control of polymeric materials for use in medical devices

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

GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

Danish Standards Foundation

DS/ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
DS/EN 30993-4:1994 Biological evaluation of medical devices. Part 4: Selection of tests for interactions with blood
DS/ISO 15223-2:2011 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation

SCC

DANSK DS/ISO/TR 16142:2006 Medical devices – Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
AAMI/ISO TIR16142:2005 Medical devices- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
BS PD ISO/TR 16142:2006 Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
BS EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
DANSK DS/ISO 16142-2:2017 Medical devices – Recognized essential principles of safety and performance of medical devices – Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
AAMI/ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
DANSK DS/ISO 16142-1:2016 Medical devices – Recognized essential principles of safety and performance of medical devices – Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standard...
BS PD ISO/TR 10993-22:2017 Biological evaluation of medical devices-Guidance on nanomaterials
DIN 13145 E:2008 Draft Document - Medical instruments - Mallet of plastic material
NS-EN 1641:1996 Dentistry — Medical devices for dentistry — Materials
DANSK DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
NS-EN 1641:2009 Dentistry — Medical devices for dentistry — Materials
CAN/CSA-ISO 10993-1-98:1998 Biological evaluation of medical devices - Part 1: Guidelines for the selection of tests
NS-EN 1641:2004 Dentistry — Medical devices for dentistry — Materials
UNE-EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
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)
AS ISO 10993.4:2002 Biological evaluation of medical devices - Selection of tests for interactions with blood
BS EN 30993-4:1994 Biological evaluation of medical devices-Selection of tests for interactions with blood
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)
BS 5736-1:1979 Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test
BS 5736-1:1989 Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test
DIN EN 1641 E:2008 Draft Document - Dentistry - Medical devices for dentistry - Materials; German version prEN 1641:2008
08/30184612 DC BS EN 1641. Dentistry. Medical devices for dentistry. Materials
AAMI/ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
DANSK DS/ISO 15223-2:2011 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
08/30154605 DC BS ISO 15223-2. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 2. Symbol development, selection and validation

Korean Agency for Technology and Standards (KATS)

KS P ISO TR 16142-2007(2012) Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO TR 16142-2019 Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO 16142-2:2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
KS P ISO 16142-1:2019 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medic
KS P ISO TR 16142:2007 Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO 15223-2:2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

British Standards Institution (BSI)

BS EN ISO 10993-8:2001 Biological evaluation of medical devices - Selection and qualification of reference materials for biological tests
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of s...
BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BS EN ISO 10993-4:2009 Biological evaluation of medical devices - Selection of tests for interactions with blood
BS EN ISO 10993-4:2017 Biological evaluation of medical devices. Selection of tests for interactions with blood
BS EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
BS EN ISO 10993-4:2002 Biological evaluation of medical devices - Selection of tests for interactions with blood
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
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 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process

GSO

GSO ISO 16142-2:2021 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BH GSO ISO 16142-2:2022 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
GSO ISO 16142-1:2021 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
BH GSO ISO 16142-1:2022 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standard...
GSO ASTM F2901:2021 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
BH GSO ASTM F2901:2023 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
GSO ASTM F2901:2022 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
BH GSO ISO 15223-2:2017 Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ANSI/AAMI TIR39:2009(R2022) Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices

International Organization for Standardization (ISO)

ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO/TR 16142:1999 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 10993-1:1992 Biological evaluation of medical devices; part 1: guidance on selection of tests

KR-KS

KS P ISO 16142-1-2019 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medic
KS P ISO 16142-2-2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
KS P ISO 15223-2-2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE-AR-E 2750-200-2013 Approach to the classification of medical devices and the selection of conformity assessment procedures

GOSTR

GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood

RU-GOST R

GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R ISO 10993.4-1999 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
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 ISO/TR 16142-2008 Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

German Institute for Standardization

DIN EN 1641:2010-02 Dentistry - Medical devices for dentistry - Materials; German version EN 1641:2009
DIN 58298:2005 Medical instruments - Materials, finish and testing
DIN 58298:2010 Medical instruments - Materials, finish and testing
DIN 13173:2023-03 Medical instruments - Dressing forceps
DIN 13145:2010 Medical instruments - Mallet of plastic material
DIN 13173:2005 Medical instruments - Dressing forceps
DIN 13145:1979 Medical instruments; mallet of plastic material
DIN 13173:2016 Medical instruments - Dressing forceps
DIN 96160:2011 Medical instruments - Wire guide

Association Francaise de Normalisation

NF S99-501:1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 1 : GUIDANCE ON SELECTION OF TESTS. (EUROPEAN STANDARD EN 30993-1).
NF ISO 15223-2:2010 Medical devices - Symbols for use with labels, labeling and information requirements relating to medical devices - Part 2: development, selection and validation of symbols

Lithuanian Standards Office

LST EN 1641-2010 Dentistry - Medical devices for dentistry - Materials

DIN

DIN EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
DIN 13173:2023 Medical instruments - Dressing forceps

AENOR

UNE-EN 1641:2010 Dentistry - Medical devices for dentistry - Materials

GOST

GOST ISO 10993-12-2023 Medical devices. Biological evaluation of medical devices. Part 12. Selection and preparation of samples for research

CEN - European Committee for Standardization

EN 1641:2004 Dentistry - Medical devices for dentistry - Materials

European Committee for Standardization (CEN)

EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
EN 1641:1996 Dentistry - Medical Devices for Dentistry - Materials

American Society for Testing and Materials (ASTM)

ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

VN-TCVN

TCVN 7391-4-2005 Biological evaluation of medical devices.Part 4: Selection of test for interactions with blood

Canadian Standards Association (CSA)

CSA ISO-10993.4-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 4: Choix Des Essais Concernant Les Interactions Avec Le Sang

TH-TISI

TIS 2395.4-2008 Biological evaluation of medical devices.part 4: selection of tests for interactions with blood

Others: Medical Device Raw Materials,Medical Device Raw Materials,Medical Device Raw Material Requirements,Medical Device Raw Material Requirements