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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 11979-1:2007

Status: ANULADA / 2013-03-20

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2006)

UNE-EN ISO 14602:2010

Status: ANULADA / 2012-02-22

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

UNE-EN ISO 7439:2009

Status: ANULADA / 2011-12-28

Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)

UNE-EN 14299:2004

Status: ANULADA / 2011-10-01

Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents

UNE-EN 12006-3:1999+A1:2009

Status: ANULADA / 2011-04-19

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

UNE-EN ISO 14602:2009

Status: ANULADA / 2010-09-15

Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

UNE-EN ISO 15798:2002

Status: ANULADA / 2010-07-14

Ophthalmic implants - Ophthalmic viscosurgical devices. (ISO 15798:2001)

UNE-EN ISO 15798:2002/AC:2005

Status: ANULADA / 2010-07-14

Ophthalmic implants - Ophthalmic viscosurgical devices. (ISO 15798:2001/Cor.1:2003)

UNE-EN ISO 7439:2002

Status: ANULADA / 2010-03-22

Cooper-bearing intra-uterine contraceptive devices. Requirements, tests. (ISO 7439:2002)

UNE-EN ISO 5840:2007

Status: ANULADA / 2010-03-22

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

UNE-EN ISO 9713:2004

Status: ANULADA / 2010-03-22

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

UNE-EN ISO 7197:2007

Status: ANULADA / 2010-03-22

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006)

UNE-EN ISO 7197:2007/AC:2008

Status: ANULADA / 2010-03-22

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006/Cor 1:2007)

UNE-EN ISO 11979-8:2007

Status: ANULADA / 2010-03-22

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

UNE-EN ISO 21535:2008

Status: ANULADA / 2010-03-22

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)

UNE-EN ISO 21536:2008

Status: ANULADA / 2010-03-22

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)

UNE-EN ISO 21534:2008

Status: ANULADA / 2010-03-22

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

UNE-EN ISO 14607:2007

Status: ANULADA / 2010-03-22

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

UNE-EN ISO 14602:1999

Status: ANULADA / 2010-03-22

NON-ACTIVE SURGICAL IMPLANTS. IMPLANTS FOR OSTEOSYNTHESIS. PARTICULAR REQUIREMENTS (ISO 14602:1998)

UNE-EN ISO 14630:2008

Status: ANULADA / 2010-03-22

Non-active surgical implants - General requirements (ISO 14630:2008)