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Committee

Committee:

CTN 91 - Implants for surgery

Secretary:
FENIN - FEDERACIÓN ESPAÑOLA DE EMPRESAS DE TECNOLOGÍA SANITARIA
Field of Activity:
Standardization of:

Specific materials both basic and composite for implants for surgery and standardization of the required instrumentation for its implantation, covering terminology, specifications and test methods.

Excluding:

Materials and surgical instruments which are within the scope of other committees.

Note: Implants for surgery are meant objects or devices which are surgically implanted in the body either temporarily or permanently for diagnostic or therapeutic purposes.
International Relations:

ISO/TC 150  Implants for surgery

CEN/CLC/JTC 16  CEN/CENELEC Joint Working Group on Active Implantable Medical Devices

CEN/TC 285  Non-active surgical implants

Standards developed by the committee: CTN 91: 139

UNE-EN ISO 9713:2009

Status: ANULADA2022-03-01

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

UNE-EN ISO 16672:2016

Status: ANULADA2021-11-01

Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)

UNE-EN ISO 16061:2015

Status: ANULADA2021-10-13

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)

UNE-EN ISO 25539-2:2013

Status: ANULADA2021-04-28

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)

UNE-EN ISO 11979-5:2007

Status: ANULADA2021-04-28

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)

UNE-EN ISO 5840-1:2016

Status: ANULADA2021-03-01

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)

UNE-EN ISO 5840-2:2016

Status: ANULADA2021-03-01

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

UNE-EN ISO 5840-3:2013

Status: ANULADA2021-03-01

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)

UNE-EN 12006-2:1998+A1:2009

Status: ANULADA2020-04-01

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

UNE-EN ISO 16054:2002

Status: ANULADA2020-03-25

Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000)

UNE-EN ISO 25539-1:2009 V2

Status: ANULADA2020-03-16

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

UNE-EN ISO 25539-1:2009 V2/AC:2011

Status: ANULADA2020-03-16

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

UNE-EN ISO 11979-1:2013

Status: ANULADA2019-10-23

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)

UNE-EN ISO 5840:2009

Status: ANULADA2018-10-01

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

UNE-EN ISO 14607:2009

Status: ANULADA2018-08-01

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

UNE-EN ISO 11979-10:2007

Status: ANULADA2018-06-01

Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006)

UNE-EN ISO 11979-10:2007/A1:2014

Status: ANULADA2018-06-01

Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006/Amd 1:2014)

UNE-EN ISO 11979-7:2015

Status: ANULADA2018-06-01

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014)

UNE-EN ISO 11979-9:2007

Status: ANULADA2018-06-01

Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006)

UNE-EN ISO 11979-9:2007/A1:2014

Status: ANULADA2018-06-01

Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006/Amd 1:2014)