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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 12006-2:1998

Status: ANULADA / 2010-03-22

NON-ACTIVE SURGICAL IMPLANTS. PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS. PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS.

UNE-EN 12006-3:1999

Status: ANULADA / 2010-03-22

NON ACTIVE SURGICAL IMPLANTS. PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS. PART 3: ENDOVASCULAR DEVICES.

UNE-EN ISO 16061:2009

Status: ANULADA / 2010-01-13

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)

UNE-EN 12011:1998

Status: ANULADA / 2009-06-24

INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS. GENERAL REQUIREMENTS.

UNE-EN ISO 11979-4:2001

Status: ANULADA / 2009-05-13

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information. (ISO 11979-4:2000)

UNE-EN ISO 14630:2005

Status: ANULADA / 2008-07-09

Non-active surgical implants - General requirements (ISO 14630:2005)

UNE-EN 12563:1999

Status: ANULADA / 2008-03-26

NON ACTIVE SURGICAL IMPLANTS. JOINT REPLACEMENT IMPLANTS. SPECIFIC REQUIREMENTS FOR HIP JOINT REPLACEMENT IMPLANTS.

UNE-EN 12564:1999

Status: ANULADA / 2008-03-26

NON ACTIVE SURGICAL IMPLANTS. JOINT REPLACEMENT IMPLANTS. SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS.

UNE-EN 12010:1998

Status: ANULADA / 2008-03-26

NON-ACTIVE SURGICAL IMPLANTS. JOINT REPLACEMENT IMPLANTS. PARTICULAR REQUIREMENTS.

UNE-EN 13503-6:2003

Status: ANULADA / 2008-01-30

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability. (ISO 11979-6:2002,modified)

UNE-EN 12180:2000

Status: ANULADA / 2007-09-19

Non-active surgical implants. Body contouring implants. Specific requirements for mammary implants.

UNE-EN ISO 11979-1:2000

Status: ANULADA / 2007-05-16

OPHTHALMIC IMPLANTS. INTRAOCULAR LENSES. PART 1: VOCABULARY (ISO 11979-1:1999)

UNE-EN 13503-3:2001

Status: ANULADA / 2007-05-16

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods. (ISO 11979-3:1999, modified)

UNE-EN 13503-5:2001

Status: ANULADA / 2007-05-16

Ophthalmic implants. Intraocular lenses. Part 5: Biocompatibility. (ISO 11979-5:1999, modified)

UNE-EN 13503-7:2002

Status: ANULADA / 2007-05-16

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2001, modified)

UNE-EN 13503-8:2000

Status: ANULADA / 2007-02-28

OPHTHALMIC IMPLANTS. INTRAOCULAR LENSES. PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:1999, MODIFIED)

UNE-EN ISO 5840:2005 (Ratificada)

Status: ANULADA / 2007-01-24

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) (Endorsed by AENOR in August of 2006.)

UNE-EN 12006-1:2000

Status: ANULADA / 2006-08-01

NON ACTIVE SURGICAL IMPLANTS. PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS. PART 1: HEART VALVE SUBSTITUTES.

UNE-EN ISO 14630:1998

Status: ANULADA / 2005-12-21

NON-ACTIVE SURGICAL IMPLANTS. GENERAL REQUIREMENTS. (ISO 14630:1997).

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