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 11979-8:2015

Status: ANULADA /  2017-07-26

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011)

UNE-EN ISO 16672:2003

Status: ANULADA /  2016-01-20

Ophthalmic implants - Ocular endotamponades (ISO 16672:2003)

UNE-EN ISO 16671:2004

Status: ANULADA /  2016-01-20

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)

UNE-EN ISO 16061:2010

Status: ANULADA /  2015-09-16

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)

UNE-EN ISO 7439:2011

Status: ANULADA /  2015-06-17

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2011)

UNE-EN ISO 11979-6:2008

Status: ANULADA /  2015-05-13

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2007)

UNE-EN ISO 11979-7:2007

Status: ANULADA /  2015-05-13

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)

UNE-EN ISO 11979-7:2007/A1:2012

Status: ANULADA /  2015-05-13

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations - Amendment 1 (ISO 11979-7:2006/Amd 1:2012)

UNE-EN ISO 11979-2:2000

Status: ANULADA /  2015-05-06

OPHTALMIC IMPLANTS. INTRAOCULAR LENSES. PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:1999)

UNE-EN ISO 11979-8:2009

Status: ANULADA /  2015-03-11

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

UNE-EN ISO 11979-8:2009/A1:2011

Status: ANULADA /  2015-03-11

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements - Amendment 1 (ISO 11979-8:2006/Amd 1:2011)

UNE-EN ISO 15798:2010

Status: ANULADA /  2014-03-19

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)

UNE 91300:1993

Status: ANULADA /  2014-01-16

MECHANICAL CONTRACEPTIVE. INTRAUTERINE DEVICES.

UNE 91110:1990

Status: ANULADA /  2014-01-16

IMPLANTS FOR SURGERY. METALLIC MATERIALS. STAINLESS STEEL

UNE-EN ISO 11979-3:2007

Status: ANULADA /  2013-07-24

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2006)

UNE-EN ISO 25539-1:2009

Status: ANULADA /  2013-07-18

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

UNE-EN ISO 25539-2:2009 V2

Status: ANULADA /  2013-07-10

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

UNE-EN ISO 25539-2:2009 V2/AC:2011

Status: ANULADA /  2013-07-10

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

UNE-EN ISO 25539-2:2009

Status: ANULADA /  2013-07-10

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

UNE-EN ISO 14630:2009

Status: ANULADA /  2013-06-19

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

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