Alloy prosthesis implanted for the first time

Alloy prosthesis implanted for the first time, Total:79 items.

The international standard classification for "Alloy prosthesis implanted for the first time" includes: Implants for surgery, prosthetics and orthotics , Diagnostic equipment .

The Chinese standard classification for "Alloy prosthesis implanted for the first time" includes: Orthopedic devices , Medical optical instrument and endoscope .

Group Standards of the People's Republic of China

T/GDMRS 001-2023 Implant for surgery—Total hip joint prostheses—Additive manufacturing titanium alloy femoral stems
T/CSBM 0003-2021 Additive manufacturing of titanium alloy acetabular cup for surgical implant total hip prosthesis

Professional Standard - Medicine

YY 0117.1-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part1:Ti6Al4V titanium alloy forgings
YY 0117.3-1993 Implants for surgery - Forgings, castings for bone joint prostheses - Cobalt chromium molybdenum castings
YY 0117.1-2005 Implants for surgery - Forgings, castings for bone joint prostheses - Ti6Al4V titanium alloy forgings
YY 0117.2-1993 Implants for surger-Forgings castings for bone joint prostheses - ZTiAl5V4 titanium alloy castings
YY 0117.2-2024 Implants for surgery - Forgings, castings for bone joint prostheses - Part 2: ZTi6Al4V titanium alloy castings
YY 0117.1-1993 Implants for surgery - Forgings, castings for bone joint prostheses - TC4 titanium alloy forgings
YY 0117.3-2005 Implants for surgery-Forgings, castings for bone joint prostheses Cobalt chromium molybdenum alloy castings
YY/T 0963-2014 Joint replacement implants―Shoulder prostheses
YY 0118-2016 Joint replacement implants - Hip joint prostheses
YY 0117.2-2005 Implants for surgery-Forgings, castings for bone joint prostheses-ZTi6Al4V titanium alloy castings
YY 0117.3-2024 Implants for surgery - Forgings, castings for bone joint prostheses - Part 3: Cobalt chromium molybdenum alloy castings
YY 0502-2016 Joint replacement implants―Knee joint prostheses

国家药监局

YY/T 0500-2021 Cardiovascular implants and extracorporeal systems-vascular prostheses-tubular vascular grafts and vascular patches

American Society for Testing and Materials (ASTM)

ASTM F703-18(2022) Standard Specification for Implantable Breast Prostheses
ASTM F2068-15 Standard Specification for Femoral Prostheses—Metallic Implants
ASTM F2068-03 Standard Specification for Femoral Prostheses8212;Metallic Implants
ASTM F2068-09 Standard Specification for Femoral Prostheses8212;Metallic Implants
ASTM F2068-01 Standard Specification for Femoral Prostheses8212;Metallic Implants
ASTM F2068-01e1 Standard Specification for Femoral Prostheses8212;Metallic Implants
ASTM F2068-00 Standard Specification for Femoral Prostheses8212;Metallic Implants
ASTM F2051-00(2022) Standard Specification for Implantable Saline-Filled Breast Prostheses
ASTM F703-18 Standard Specification for Implantable Breast Prostheses
ASTM F2051-00 Standard Specification for Implantable Saline Filled Breast Prosthesis
ASTM F2051-00(2006) Standard Specification for Implantable Saline Filled Breast Prosthesis
ASTM F2051-00(2014) Standard Specification for Implantable Saline Filled Breast Prosthesis

International Organization for Standardization (ISO)

ISO 7198:1998 Cardiovascular implants - Tubular vascular prostheses
ISO 5840:1984 Implants for surgery — Cardiovascular implants — Cardiac valve prostheses
ISO/TS 15539:2000 Cardiovascular implants - Endovascular prostheses
ISO 5840:2005 Cardiovascular implants - Cardiac valve prostheses
ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 5840:1996 Cardiovascular implants - Cardiac valve prostheses
ISO 5840-3:2021 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
ISO 5840-2:2021 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches

British Standards Institution (BSI)

BS EN ISO 5840-3:2013 Cardiovascular implants. Cardiac valve prostheses. Heart valve substitutes implanted by transcatheter technique
BS EN ISO 5840-3:2021 Cardiovascular implants. Cardiac valve prostheses. Heart valve substitutes implanted by transcatheter techniques
BS EN ISO 5840-2:2015 Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes
BS EN ISO 5840-2:2021 Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes
BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices. Endovascular prostheses
BS EN ISO 5840-1:2015 Cardiovascular implants. Cardiac valve prostheses. General requirements
BS EN ISO 5840-1:2021 Cardiovascular implants. Cardiac valve prostheses. General requirements
BS EN ISO 25539-1:2009 Cardiovascular implants - Endovascular devices - Endovascular prostheses
BS ISO 14243-2:2010 Implants for surgery. Wear of total knee-joint prostheses. Methods of measurement

Danish Standards Foundation

DS/ISO/TS 15539:2001 Cardiovascular implants - Endovascular prostheses
DS/EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses

Korean Agency for Technology and Standards (KATS)

KS P ISO 15539-2007(2012) Cardiovascular implants－Endovascular prostheses
KS P ISO 5840-2007(2012) Cardiovascular implants－Cardiac valve prostheses
KS P ISO TR 9325:2013 Implants for surgery－Partial and total hip joint prostheses－Recommendations for simulators for evaluation of hip joint prostheses
KS P ISO 5840-2:2019 Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

Standard Association of Australia （SAA）

AS ISO 15539:2003(R2014) Cardiovascular Implants Endovascular Prostheses

SCC

DANSK DS/EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses
BS EN ISO 5840:2005 Cardiovascular implants. Cardiac valve prostheses
CAN/CSA-ISO 5840-1998(R2002) Cardiovascular implants - Cardiac valve prostheses
NS-EN ISO 5840:2009 Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005)
AENOR UNE-EN ISO 5840:2009 Cardiovascular implants. Heart valve prostheses. (ISO 5840:2005)
NS-EN ISO 5840:2005 Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005)
UNE-EN ISO 5840:2007 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
BS 3531-13:1983 Surgical implants-Specification for bearing surfaces of hip joint prostheses
BS ISO 25539-1:2003 Cardiovascular implants. Endovascular devices. Endovascular prostheses

GSO

OS GSO ISO 7198:2016 Cardiovascular implants -- Tubular vascular prostheses
BH GSO ISO 7198:2017 Cardiovascular implants -- Tubular vascular prostheses
GSO ASTM F703:2021 Standard Specification for Implantable Breast Prostheses
BH GSO ASTM F703:2022 Standard Specification for Implantable Breast Prostheses
BH GSO ISO 5840:2015 Cardiovascular implants -- Cardiac valve prostheses
GSO ISO 7198:2016 Cardiovascular implants -- Tubular vascular prostheses
OS GSO ISO 5840:2014 Cardiovascular implants -- Cardiac valve prostheses

Association Francaise de Normalisation

NF S94-200-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: heart valve substitutes implanted by transcatheter techniques

Lithuanian Standards Office

LST EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

AENOR

UNE-EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

RU-GOST R

GOST R ISO 7206-4-2005 Implants for surgery. Partial and total hip joint prostheses. Part 4. Determination of endurance properties of stemmed femoral components
GOST R 53000-2008 Implantable mammary prostheses. General technical requirements. Test methods

BR-ABNT

ABNT NBR 15721-2016 Orthopedic implant - Prostheses for finger total joint - Requirements for elastomeric flexible hinge finger

European Committee for Standardization (CEN)

EN ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
EN ISO 5840-2:2021 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)

KR-KS

KS P ISO 5840-2-2019 Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

German Institute for Standardization

DIN 19401:2014 Dentistry - Vocabulary of process chain from DVT to CAD/CAM for implantprosthetic restorations

Others: Alloy prosthesis implanted for the first time