BIOCOMPATIBILIDAD- VALIDACION

Dr. Andrs Ozols

Grupo de Biomateriales para Prtesis
Instituto de Ingeniera Biomdica (IIBM)
Instituto de Tecnologas y Ciencias de la Ingeniera (INTECIN)
Facultad de Ingeniera de la Universidad de Buenos Aires

PROGRAMA DE SEGUNDA ESPECIALIDAD EN PRODUCTOS SANITARIOS

MATERIALES BIOMDICOS Y DISPOSITIVOS MDICOS: BIOMATERIALES
FACULTAD DE FARMACIA Y BIOQUMICA
UNIVERSIDAD NACIONAL MAYOR DE SAN
MARCOS
Lima PerD R . A . O Z O L S
Diciembre 2015

Normas para la Validacin de Dispositivos Mdicos

La

International

Organization

for

Standardization

)ISO)

http://www.iso.org/iso/home.html
La American Society of Testng and Measuring (ASTM) son los entes que
desarrollan las normas de validacin de dispositivos mdicos.

DR. A. OZOLS

Cmo desarrollar normas

ISO?

Un estndar ISO es desarrollado por un panel de expertos, dentro de

un comit tcnico.

Una vez se ha establecido la necesidad de una norma, estos expertos

se renen para discutir y negociar un proyecto de norma.

Tan pronto como un proyecto se ha desarrollado es compartido con

los miembros de la ISO , que se les pide hacer comentarios y votar en
ella.

Si se llega a un consenso el proyecto se convierte en una norma ISO.

Si no hay consenso se realizan ms enmiendas.

Las enmiendas futuras se presentan en ms ediciones actualizadas

de la norma.
DR. A. OZOLS

Principios Clave en la Elaboracin de Normas

1. Las normas ISO responden a una necesidad en el mercado
ISO no decide cundo debe desarrollar un nuevo estndar, sino que
responde a una peticin de la industria o de otras partes interesadas,
como los grupos de consumidores. Tpicamente, un sector de la
industria o grupo comunica la necesidad de una norma a su miembro
nacional, que se pone en contacto con ISO. Los datos de contacto de
los miembros nacionales se pueden encontrar en la lista de
miembros.

DR. A. OZOLS

Principios Clave en la Elaboracin de Normas

2. Las normas ISO se basan en la opinin de expertos mundial
Las normas ISO son desarrolladas por grupos de expertos de todo el
mundo, que forman parte de grupos ms grandes, llamados comits
tcnicos. Estos expertos negocian todos los aspectos de la norma,
incluyendo su alcance, definiciones clave y contenido. Los detalles se
pueden encontrar en la lista de los comits tcnicos.

DR. A. OZOLS

Principios Clave en la Elaboracin de Normas

3. Las normas ISO son desarrolladas a travs de un proceso de mltiples
partes interesadas
Los comits tcnicos estn formados por expertos de la industria en
cuestin, sino tambin de las asociaciones de consumidores,
instituciones acadmicas, organizaciones no gubernamentales y el
gobierno. Leer ms acerca de quien desarrolla las normas ISO.
4. Las normas ISO se basan en el consenso
El desarrollo de las normas ISO es un enfoque basado en el consenso y
los comentarios de todos los interesados se tienen en cuenta
DR. A. OZOLS

Elaboracin de Normas
1- Una nueva norma es propuesta
como relevante a un comit
tcnico

Si
propuesta
aceptada

es

3- El primer borrador de trabajo es

compartido con el comit tcnico y
con la ISO

2- El grupo de trabajo de expertos

inicia la discusin para preparar un
borrador de trabajo tcnico
Si el consenso es alcanzado
con la comisin tcnica
4- El borrador compartido con todos
los miembros de la ISO nacional ,
quienes son invitados a hacer
comentarios

Si la norma es aprobada por

votacin de los miembros
5- El borrador final es enviado a
todos los miembros de la ISO

6- Norma Internacional ISO

DR. A. OZOLS

Los Comits Tcnicos

La lista de los comits tcnicos de ISO proporciona informacin
bsica para cada comit tcnico (TC), que se enumeran en orden
numrico, siguiendo el orden en el que se establecieron.
Por ejemplo, TC 1 centrado en roscas de tornillos fue creado en
1947 y el TC 269 en aplicaciones ferroviarias se cre en 2012.
En cambio, el TC 150, Implantes para Ciruga es el ms vinculado
con los biomateriales.

DR. A. OZOLS

Committee

Title

ISO/IEC JTC 1

Information technology

ISO/IEC JPC 2

Joint Project Committee - Energy efficiency and renewable energy sources - Common
terminology

ISO/TC 1

Screw threads

ISO/TC 2

Fasteners

ISO/TC 4

Rolling bearings

ISO/TC 5

Ferrous metal pipes and metallic fittings

ISO/TC 6

Paper, board and pulps

ISO/TC 8

Ships and marine technology

ISO/TC 10

Technical product documentation

ISO/TC 11

Boilers and pressure vessels - STANDBY

ISO/TC 12

Quantities and units

ISO/TC 14

Shafts for machinery and accessories

ISO/TC 17

Steel

ISO/TC 18

Zinc and zinc alloys - STANDBY

ISO/TC 19

Preferred numbers - STANDBY

ISO/TC 20

Aircraft and space vehicles

ISO/TC 21

Equipment for fire protection and fire fighting

ISO/TC 22

Road vehicles

ISO/TC 23

Tractors and machinery for agriculture and forestry

ISO/TC 24

Particle characterization including sieving

ISO/TC 25

Cast irons and pig irons

ISO/TC 26

Copper and copper alloys

ISO/TC 27

Solid mineral fuels

ISO/TC 28

Petroleum products and related products of synthetic or biological origin

ISO/TC 29

Small tools

ISO/TC 30

Measurement of fluid flow in closed conduits

ISO/TC 31

Tyres, rims and valves

ISO/TC 33

Refractories

ISO/TC 34

Food products

ISO/TC 35

Paints and varnishes

DR. A. OZOLS

ISO/TC 37

Terminology and other language and content resources

ISO/TC 38

Textiles

ISO/TC 39

Machine tools

ISO/TC 41

Pulleys and belts (including veebelts)

ISO/TC 42

Photography

ISO/TC 43

Acoustics

ISO/TC 44

Welding and allied processes

ISO/TC 45

Rubber and rubber products

ISO/TC 46

Information and documentation

ISO/TC 47

Chemistry

ISO/TC 48

Laboratory equipment

ISO/TC 51

Pallets for unit load method of materials handling

ISO/TC 52

Light gauge metal containers

ISO/TC 54

Essential oils

ISO/TC 58

Gas cylinders

ISO/TC 59

Buildings and civil engineering works

ISO/TC 60

Gears

ISO/TC 61

Plastics

ISO/TC 63

Glass containers

ISO/TC 67

Materials, equipment and offshore structures for petroleum, petrochemical and natural gas
industries

ISO/TC 68

Financial services

ISO/TC 69

Applications of statistical methods

ISO/TC 70

Internal combustion engines

ISO/TC 71

Concrete, reinforced concrete and pre-stressed concrete

ISO/TC 72

Textile machinery and accessories

ISO/TC 74

Cement and lime

ISO/TC 76
ISO/TC 77

Transfusion, infusion and injection, and blood processing equipment for medical and
pharmaceutical use
DR. A. OZOLS
Products in fibre reinforced cement

ISO/TC 79

Light metals and their alloys

ISO/TC 82

Mining

ISO/TC 83

Sports and other recreational facilities and equipment

ISO/TC 84

Devices for administration of medicinal products and catheters

ISO/TC 85

Nuclear energy, nuclear technologies, and radiological protection

ISO/TC 86

Refrigeration and air-conditioning

ISO/TC 87

Cork

ISO/TC 89

Wood-based panels

ISO/TC 91

Surface active agents

ISO/TC 92

Fire safety

ISO/TC 93

Starch (including derivatives and by-products)

ISO/TC 94

Personal safety -- Protective clothing and equipment

ISO/TC 96

Cranes

ISO/TC 98

Bases for design of structures

ISO/TC 100

Chains and chain sprockets for power transmission and conveyors

ISO/TC 101

Continuous mechanical handling equipment - STANDBY

ISO/TC 102

Iron ore and direct reduced iron

ISO/TC 104

Freight containers

ISO/TC 105

Steel wire ropes

ISO/TC 106

Dentistry

ISO/TC 107

Metallic and other inorganic coatings

ISO/TC 108

Mechanical vibration, shock and condition monitoring

ISO/TC 109

Oil and gas burners

ISO/TC 110

Industrial trucks

ISO/TC 111

Round steel link chains, chain slings, components and accessories

ISO/TC 112

Vacuum technology

ISO/TC 113

Hydrometry

ISO/TC 114

Horology

ISO/TC 115

Pumps

ISO/TC 117

Fans

ISO/TC 118

DR. A. OZOLS
Compressors and pneumatic tools, machines and equipment

ISO/TC 119

Powder metallurgy

ISO/TC 120

Leather

ISO/TC 121

Anaesthetic and respiratory equipment

ISO/TC 122

Packaging

ISO/TC 123

Plain bearings

ISO/TC 126

Tobacco and tobacco products

ISO/TC 127

Earth-moving machinery

ISO/TC 130

Graphic technology

ISO/TC 131

Fluid power systems

ISO/TC 132

Ferroalloys

ISO/TC 133

Clothing sizing systems - size designation, size measurement methods and digital fittings

ISO/TC 134

Fertilizers and soil conditioners

ISO/TC 135

Non-destructive testing

ISO/TC 136

Furniture

ISO/TC 137

Footwear sizing designations and marking systems

ISO/TC 138

Plastics pipes, fittings and valves for the transport of fluids

ISO/TC 142

Cleaning equipment for air and other gases

ISO/TC 145

Graphical symbols

ISO/TC 146

Air quality

ISO/TC 147

Water quality

ISO/TC 148

Sewing machines

ISO/TC 149

Cycles

ISO/TC 150

Implants for surgery

ISO/TC 153

Valves

ISO/TC 154

Processes, data elements and documents in commerce, industry and administration

ISO/TC 155

Nickel and nickel alloys

ISO/TC 156

Corrosion of metals and alloys

ISO/TC 157

Non-systemic contraceptives and STI barrier prophylactics

ISO/TC 158

Analysis of gases

ISO/TC 159

Ergonomics

ISO/TC 160

Glass in building

DR. A. OZOLS

ISO/TC 197

Hydrogen technologies

ISO/TC 198

Sterilization of health care products

ISO/TC 199

Safety of machinery

ISO/TC 201

Surface chemical analysis

ISO/TC 202

Microbeam analysis

ISO/TC 204

Intelligent transport systems

ISO/TC 205

Building environment design

ISO/TC 206

Fine ceramics

ISO/TC 207

Environmental management

ISO/TC 208

Thermal turbines for industrial application (steam turbines, gas expansion

turbines) - STANDBY

ISO/TC 209

Cleanrooms and associated controlled environments

ISO/TC 210

Quality management and corresponding general aspects for medical devices

ISO/TC 211

Geographic information/Geomatics

ISO/TC 212

Clinical laboratory testing and in vitro diagnostic test systems

ISO/TC 213

Dimensional and geometrical product specifications and verification

ISO/TC 214

Elevating work platforms

ISO/TC 215

Health informatics

ISO/TC 216

Footwear

ISO/TC 217

Cosmetics

ISO/TC 218

Timber

ISO/TC 219

Floor coverings

ISO/TC 220

Cryogenic vessels

ISO/TC 221

Geosynthetics

ISO/TC 222

Personal financial planning - STANDBY

ISO/TC 224

Service activities relating to drinking water supply systems and wastewater

systems - Quality criteria of the service and performance indicators

ISO/TC 225

Market, opinion and social research

ISO/TC 226

Materials for the production of primary aluminium

ISO/TC 227

Springs

ISO/TC 228

Tourism and related services

ISO/TC 229

Nanotechnologies

DR. A. OZOLS

ISO/TC 232

Learning services outside formal education

ISO/TC 234

Fisheries and aquaculture

ISO/TC 238

Solid biofuels

ISO/TC 241

Road traffic safety management systems

ISO/TC 242

Energy Management

ISO/TC 244

Industrial furnaces and associated processing equipment

ISO/PC 245

Cross-border trade of second-hand goods

ISO/PC 248

Sustainability criteria for bioenergy

ISO/TC 249

Traditional chinese medicine

ISO/TC 251

Asset management

ISO/PC 252

Natural gas fuelling stations for vehicles

ISO/TC 254

Safety of amusement rides and amusement devices

ISO/TC 255

Biogas

ISO/TC 256

Pigments, dyestuffs and extenders

ISO/TC 257

Evaluation of energy savings

ISO/TC 258

Project, programme and portfolio management

ISO/TC 260

Human resource management

ISO/TC 261

Additive manufacturing

ISO/TC 262

Risk management

ISO/TC 263

Coalbed methane (CBM)

ISO/TC 264

Fireworks

ISO/TC 265

Carbon dioxide capture, transportation, and geological storage

ISO/TC 266

Biomimetics

ISO/TC 267

Facilities management

ISO/TC 268

Sustainable development in communities

ISO/TC 269

Railway applications

ISO/TC 270

Plastics and rubber machines

ISO/TC 272

Forensic sciences

ISO/PC 273

Customer contact centres

ISO/TC 274

Light and lighting

ISO/TC 275

Sludge recovery, recycling, treatment and disposal

DR. A. OZOLS

ISO/TC 276

Biotechnology

ISO/PC 277

Sustainable procurement

ISO/PC 278

Anti-bribery management systems

ISO/TC 279

Innovation management

ISO/PC 280

Management Consultancy

ISO/TC 281

Fine Bubble Technology

ISO/TC 282

Water re-use

ISO/PC 283

Occupational health and safety management systems

ISO/TC 285

Clean cookstoves and clean cooking solutions

ISO/PC 286

Collaborative business relationship management -- Framework

ISO/PC 287

Chain of custody of wood and wood-based products

ISO/PC 288

Educational organizations management systems - Requirements with guidance for use

ISO/TC 289

Brand evaluation

ISO/TC 290

Online reputation

ISO/TC 291

Domestic gas cooking appliances

ISO/TC 292

Security and resilience

ISO/TC 293

Feed machinery

ISO/PC 294

Guidance on unit pricing

ISO/PC 295

Audit data collection

ISO/TC 296

Bamboo and rattan

ISO/TC 297

Waste management, recycling and road operation service

ISO/TC 298

Rare earth

ISO/TC 299

Robots and robotic devices (officially starting on the 2016-01-01)

ISO/TC 300

Solid recovered fuels

DR. A. OZOLS

Normas de Implantes Quirrgicos (Comit Tcnico 150)

Alcance:
Normalizacin en el campo de los implantes para de la ciruga

y la

instrumentacin requerida, que cubre la terminologa, las especificaciones

y mtodos de pruebas para todos los tipos de implantes, y para los
materiales bsicos y compuestos utilizados en su fabricacin y aplicacin.
Objetos o dispositivos que se implantan quirrgicamente en el cuerpo, ya
sea temporal o permanente, con fines de diagnstico o teraputicos.
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_tc_browse.ht
m?commid=53058&published=on&includesc=true
DR. A. OZOLS

Standard and/or project

ISO 5841-2:2014
Implants for surgery -- Cardiac pacemakers -- Part 2: Reporting of clinical performance of
populations of pulse generators or leads
ISO 16061:2015
Instrumentation for use in association with non-active surgical implants -- General
requirements
ISO 5840-2:2015
Cardiovascular implants -- Cardiac valve prostheses -- Part 2: Surgically implanted heart valve
substitutes
ISO 5837-1:1985
Implants for surgery -- Intramedullary nailing systems -- Part 1: Intramedullary nails with
cloverleaf or V-shaped cross-section
ISO 9713:2002
Neurosurgical implants -- Self-closing intracranial aneurysm clips
ISO 14949:2001
Implants for surgery -- Two-part addition-cure silicone elastomers
ISO 5836:1988
Implants for surgery -- Metal bone plates -- Holes corresponding to screws with asymmetrical
DR. A. OZOLS
thread and spherical under-surface

ISO 14708-7:2013

Implants for surgery -- Active implantable medical devices -- Part 7: Particular

requirements for cochlear implant systems
ISO 5834-5:2005
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 5:
Morphology assessment method
ISO 5832-9:2007
Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless
steel
ISO 5834-2:2011
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 2: Moulded
forms
ISO 5840-3:2013
Cardiovascular implants -- Cardiac valve prostheses -- Part 3: Heart valve
substitutes implanted by transcatheter techniques
ISO 5841-3:2013
Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1)
for implantable pacemakers
DR. A. OZOLS

ISO 7198:1998
Cardiovascular implants -- Tubular vascular prostheses
ISO 7207-2:2011
Implants for surgery -- Components for partial and total knee joint prostheses -- Part
2: Articulating surfaces made of metal, ceramic and plastics materials
ISO 8637:2010/Amd 1:2013
Revision to Figure 2 -- Main fitting dimensions of dialysis fluid inlet and outlet ports
ISO 9268:1988
Implants for surgery -- Metal bone screws with conical under-surface of head -Dimensions
ISO 11663:2014
Quality of dialysis fluid for haemodialysis and related therapies
ISO 12189:2008
Implants for surgery -- Mechanical testing of implantable spinal devices -- Fatigue
test method for spinal implant assemblies using an anterior support
ISO 12417-1:2015
Cardiovascular implants and extracorporeal systems -- Vascular device-drug
combination products -- Part 1: General requirements
DR. A. OZOLS

ISO 12891-1:2015
Retrieval and analysis of surgical implants -- Part 1: Retrieval and handling
ISO 13779-4:2002
Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion
strength
ISO 13959:2014
Water for haemodialysis and related therapies
ISO 14242-2:2000
Implants for surgery -- Wear of total hip-joint prostheses -- Part 2: Methods of
measurement
ISO 15675:2009
Cardiovascular implants and artificial organs -- Cardiopulmonary bypass systems -Arterial blood line filters
ISO 15676:2005
Cardiovascular implants and artificial organs -- Requirements for single-use tubing
packs for cardiopulmonary bypass and extracorporeal membrane oxygenation
(ECMO)
ISO 15814:1999
D R . on
A . Opolylactide
ZOLS
Implants for surgery -- Copolymers and blends based
-- In vitro
degradation testing degradation testing

ISO 16054:2000
Implants for surgery -- Minimum data sets for surgical implants
ISO 16087:2013
Implants for surgery -- Roentgen stereophotogrammetric analysis for the
assessment of migration of orthopaedic implants
ISO/TR 16379:2014
Tissue-engineered medical products -- Evaluation of anisotropic structure of
articular cartilage using DT (Diffusion Tensor)-MR Imaging
ISO 25539-1:2003/Amd 1:2005
Test methods
ISO 5832-1:2007/Cor 1:2008
ISO 5832-4:2014
Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum
casting alloy
ISO 5832-8:1997
Implants for surgery -- Metallic materials -- Part 8: Wrought cobalt-nickel-chromiummolybdenum- tungsten-iron alloy
DR. A. OZOLS

ISO 5832-12:2007/Cor 1:2008

ISO 5835:1991
Implants for surgery -- Metal bone screws with hexagonal drive connection,
spherical under-surface of head, asymmetrical thread -- Dimensions
ISO 5838-1:2013
Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General
requirements
ISO 7197:2006/Cor 1:2007
ISO 7206-2:2011
Implants for surgery -- Partial and total hip joint prostheses -- Part 2: Articulating
surfaces made of metallic, ceramic and plastics materials
ISO 7206-6:2013
Implants for surgery -- Partial and total hip joint prostheses -- Part 6: Endurance
properties testing and performance requirements of neck region of stemmed
femoral components
ISO 8637:2010
Cardiovascular implants and extracorporeal systems -- Haemodialysers,
haemodiafilters, haemofilters and haemoconcentrators
DR. A. OZOLS

ISO 8828:2014
Implants for surgery -- Guidance on care and handling of orthopaedic implants
ISO 9583:1993
Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of
metallic surgical implants
ISO 9584:1993
Implants for surgery -- Non-destructive testing -- Radiographic examination of cast
metallic surgical implants
ISO 9585:1990
Implants for surgery -- Determination of bending strength and stiffness of bone
plates
ISO/TR 9586:1988
Implants for surgery -- Usage of terms "valgus" and "varus" in orthopaedic surgery
ISO 9714-1:2012
Orthopaedic drilling instruments -- Part 1: Drill bits, taps and countersink cutters
ISO 11318:2002
Cardiac defibrillators -- Connector assembly DF-1 for implantable defibrillators -Dimensions and test requirements
DR. A. OZOLS

ISO 13179-1:2014
Implants for surgery -- Plasma-sprayed unalloyed titanium coatings on metallic surgical
implants -- Part 1: General requirements
ISO 13958:2014
Concentrates for haemodialysis and related therapies
ISO 14708-5:2010
Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support
devices
ISO 14708-6:2010
Implants for surgery -- Active implantable medical devices -- Part 6: Particular
requirements for active implantable medical devices intended to treat tachyarrhythmia
(including implantable defibrillators)
ISO 14879-1:2000
Implants for surgery -- Total knee-joint prostheses -- Part 1: Determination of endurance
properties of knee tibial trays
ISO 15142-1:2003
Implants for surgery -- Metal intramedullary nailing systems -- Part 1: Intramedullary nails
ISO 15142-2:2003
Implants for surgery -- Metal intramedullary nailing systems -- Part 2: Locking components
DR. A. OZOLS

ISO 15674:2009
Cardiovascular implants and artificial organs -- Hard-shell cardiotomy/venous
reservoir systems (with/without filter) and soft venous reservoir bags
ISO 17853:2011
Wear of implant materials -- Polymer and metal wear particles -- Isolation and
characterization
ISO 23500:2014
Guidance for the preparation and quality management of fluids for haemodialysis
and related therapies
ISO 5832-1:2007
Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel
ISO 5832-2:1999
Implants for surgery -- Metallic materials -- Part 2: Unalloyed titanium
ISO 5832-3:1996
Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4vanadium alloy
DR. A. OZOLS

ISO 5832-5:2005
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungstennickel alloy
ISO 5832-6:1997
Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromiummolybdenum alloy
ISO 5832-7:1994
Implants for surgery -- Metallic materials -- Part 7: Forgeable and cold-formed cobaltchromium-nickel-molybdenum-iron alloy
ISO 5832-11:2014
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7niobium alloy
ISO 5832-12:2007
Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromiummolybdenum alloy
ISO 5832-14:2007
Implants for surgery -- Metallic materials -- Part 14: Wrought titanium 15-molybdenum 5zirconium 3-aluminium alloy
ISO 5833:2002
Implants for surgery -- Acrylic resin cements

DR. A. OZOLS

ISO 5834-1:2005
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 1: Powder
form
ISO 5834-1:2005/Cor 1:2007
ISO 5834-3:2005
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 3:
Accelerated ageing methods
ISO 5834-4:2005
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 4: Oxidation
index measurement method
ISO 5838-2:1991
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -Dimensions
ISO 5838-3:1993
Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
ISO 5840-1:2015
Cardiovascular implants -- Cardiac valve prostheses -- Part 1: General requirements
DR. A. OZOLS

ISO 6474-1:2010
Implants for surgery -- Ceramic materials -- Part 1: Ceramic materials based on high
purity alumina
ISO 6474-2:2012
Implants for surgery -- Ceramic materials -- Part 2: Composite materials based on a
high-purity alumina matrix with zirconia reinforcement
ISO 6475:1989
Implants for surgery -- Metal bone screws with asymmetrical thread and spherical
under-surface -- Mechanical requirements and test methods
ISO 7197:2006
Neurosurgical implants -- Sterile, single-use hydrocephalus shunts and components
ISO 7199:2009
Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators)
ISO 7199:2009/Amd 1:2012
Clarifications for test methodologies, labelling, and sampling schedule
ISO 7206-1:2008
Implants for surgery -- Partial and total hip joint prostheses -- Part 1: Classification
and designation of dimensions
DR. A. OZOLS

ISO 7206-4:2010
Implants for surgery -- Partial and total hip joint prostheses -- Part 4: Determination of
endurance properties and performance of stemmed femoral components
ISO 7206-10:2003
Implants for surgery -- Partial and total hip-joint prostheses -- Part 10: Determination of
resistance to static load of modular femoral heads
ISO 7207-1:2007
Implants for surgery -- Components for partial and total knee joint prostheses -- Part 1:
Classification, definitions and designation of dimensions
ISO 8319-1:1996
Orthopaedic instruments -- Drive connections -- Part 1: Keys for use with screws with
hexagon socket heads
ISO 8319-2:1986
Orthopaedic instruments -- Drive connections -- Part 2: Screwdrivers for single slot head
screws, screws with cruciate slot and cross-recessed head screws
ISO 8615:1991
Implants for surgery -- Fixation devices for use in the ends of the femur in adults
ISO 8638:2010
Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for
DR. A. OZOLS
haemodialysers, haemodiafilters and haemofilters

ISO 8827:1988
Implants for surgery -- Staples with parallel legs for orthopaedic use -- General
requirements
ISO 9269:1988
Implants for surgery -- Metal bone plates -- Holes and slots corresponding to screws
with conical under-surface
ISO 10334:1994
Implants for surgery -- Malleable wires for use as sutures and other surgical
applications
ISO/TS 10974:2012
Assessment of the safety of magnetic resonance imaging for patients with an active
implantable medical device
ISO 11658:2012
Cardiovascular implants and extracorporeal systems -- Blood/tissue contact surface
modifications for extracorporeal perfusion systems
ISO 12891-2:2014
Retrieval and analysis of surgical implants -- Part 2: Analysis of retrieved surgical
implants
DR. A. OZOLS

ISO 13175-3:2012
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and betatricalcium phosphate bone substitutes
ISO 13356:2015
Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal
zirconia (Y-TZP)
ISO 13779-1:2008
Implants for surgery -- Hydroxyapatite -- Part 1: Ceramic hydroxyapatite
ISO 13779-2:2008
Implants for surgery -- Hydroxyapatite -- Part 2: Coatings of hydroxyapatite
ISO 13779-3:2008
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and
characterization of crystallinity and phase purity
ISO 13779-6:2015
Implants for surgery -- Hydroxyapatite -- Part 6: Powders
ISO 13781:1997
Poly(L-lactide) resins and fabricated forms for surgical implants -- In vitro
degradation testing
DR. A. OZOLS

ISO 13782:1996
Implants for surgery -- Metallic materials -- Unalloyed tantalum for surgical implant
applications
ISO 13960:2010
Cardiovascular implants and extracorporeal systems -- Plasmafilters
ISO 14117:2012
Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for
implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac
resynchronization devices
ISO 14242-1:2014
Implants for surgery -- Wear of total hip-joint prostheses -- Part 1: Loading and displacement
parameters for wear-testing machines and corresponding environmental conditions for test
ISO 14242-3:2009
Implants for surgery -- Wear of total hip-joint prostheses -- Part 3: Loading and displacement
parameters for orbital bearing type wear testing machines and corresponding
environmental conditions for test
ISO 14243-1:2009
Implants for surgery -- Wear of total knee-joint prostheses -- Part 1: Loading and
displacement parameters for wear-testing machines with load control and
D R . corresponding
A. OZOLS
environmental conditions for test

ISO 14243-2:2009
Implants for surgery -- Wear of total knee-joint prostheses -- Part 2: Methods of
measurement
ISO 14243-3:2014
Implants for surgery -- Wear of total knee-joint prostheses -- Part 3: Loading and
displacement parameters for wear-testing machines with displacement control and
corresponding environmental conditions for test
ISO/TR 14283:2004
Implants for surgery -- Fundamental principles
ISO 14602:2010
Non-active surgical implants -- Implants for osteosynthesis -- Particular
requirements
ISO 14607:2007
Non-active surgical implants -- Mammary implants -- Particular requirements
ISO 14630:2012
Non-active surgical implants -- General requirements
ISO 14708-1:2014
Implants for surgery -- Active implantable medical devices -- Part 1: General
A. OZOLS
requirements for safety, marking and for information to be provided DbyR . the
manufacturer

ISO 14708-2:2012
Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac
pacemakers
ISO 14708-3:2008
Implants for surgery -- Active implantable medical devices -- Part 3: Implantable
neurostimulators
ISO 14708-4:2008
Implants for surgery -- Active implantable medical devices -- Part 4: Implantable
infusion pumps
ISO 15142-3:2003
Implants for surgery -- Metal intramedullary nailing systems -- Part 3: Connection
devices and reamer diameter measurements
ISO 15309:2013
Implants for surgery -- Differential scanning calorimetry of poly ether ether ketone
(PEEK) polymers and compounds for use in implantable medical devices
ISO 15374:1998
Implants for surgery -- Requirements for production of forgings
DR. A. OZOLS

ISO 16402:2008
Implants for surgery -- Acrylic resin cement -- Flexural fatigue testing of acrylic resin
cements used in orthopaedics
ISO 16428:2005
Implants for surgery -- Test solutions and environmental conditions for static and
dynamic corrosion tests on implantable materials and medical devices
ISO 16429:2004
Implants for surgery -- Measurements of open-circuit potential to assess corrosion
behaviour of metallic implantable materials and medical devices over extended time
periods
ISO/TS 17137:2014
Cardiovascular implants and extracorporeal systems -- Cardiovascular absorbable
implants
ISO 18192-1:2011
Implants for surgery -- Wear of total intervertebral spinal disc prostheses -- Part 1:
Loading and displacement parameters for wear testing and corresponding
environmental conditions for test
ISO 18192-2:2010
Implants for surgery -- Wear of total intervertebral spinal disc prostheses -- Part 2:
DR. A. OZOLS
Nucleus replacements

ISO 20160:2006
Implants for surgery -- Metallic materials -- Classification of microstructures for
alpha+beta titanium alloy bars
ISO 21534:2007
Non-active surgical implants -- Joint replacement implants -- Particular requirements
ISO 21535:2007
Non-active surgical implants -- Joint replacement implants -- Specific requirements
for hip-joint replacement implants
ISO 21536:2007
Non-active surgical implants -- Joint replacement implants -- Specific requirements
for knee-joint replacement implants
ISO 21536:2007/Amd 1:2014
ISO 23317:2014
Implants for surgery -- In vitro evaluation for apatite-forming ability of implant
materials
ISO/TS 23810:2012
Cardiovascular implants and artificial organs -- Checklist for preoperative
extracorporeal circulation equipment setup
DR. A.

OZOLS

ISO 25539-1:2003
Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses
ISO 25539-2:2012
Cardiovascular implants -- Endovascular devices -- Part 2: Vascular stents
ISO 25539-3:2011
Cardiovascular implants -- Endovascular devices -- Part 3: Vena cava filters
ISO 26722:2014
Water treatment equipment for haemodialysis applications and related therapies
ISO 27185:2012
Cardiac rhythm management devices -- Symbols to be used with cardiac rhythm
management device labels, and information to be supplied -- General requirements
ISO 27186:2010
Active implantable medical devices -- Four-pole connector system for implantable
cardiac rhythm management devices - Dimensional and test requirements
IEC/TR 62653:2013
Guidelines for the safe use of medical products in dialysis treatment
DR. A. OZOLS

BIOCOMPATIBILIDAD

DR. A. OZOLS

La respuesta biolgica a los materiales

Debe realizarse el estudio de los eventos a escala molecular y celular

que siguen al contacto con los fluidos y tejidos, tanto en in vitro,
como in vivo, desde el contacto inicial hasta la culminacin eventual
de la respuesta.
La biocompatibilidad
La capacidad de un material para responder en forma apropiada
para una aplicacin especfica en el organismo
(D.F. Williams, Biomaterials Science: An Introduction to Materials in Medicine, 2nd ed.,
B.D. Ratner et al., eds., Elsevier, NY 2004)
DR. A. OZOLS

39

ENSAYOS DE BIOCOMPATIBILIDAD

Citotoxicidad.

Toxicidad aguda, sub-crnica, y crnica.

Irritacin de la piel, ojos, y surperficies mucosas.

Sensibilidad.

Hemo-compatibilidad.

Efecto de corto plazo ulteriores a la implantacin.

Geno-toxicidad.

Carcino-genicidad.

Efectos sobre la reproduccin, incluyendo los de desarrollo.

DR. A.
OZOLS

40

Normas sobre la Validacin Biolgica y Clnica

El Comit Tcnico TC 194 Evaluacin biolgica y la clnica de los
dispositivos mdicos
Trata la normalizacin de la evaluacin biolgica y clnica de los
materiales y dispositivos mdicos y dentales, junto con la normalizacin
de los mtodos de ensayo biolgicos aplicables a esos materiales y
dispositivos, as como los principios de buena prctica clnica en las
investigaciones clnicas en humanos de estos dispositivos.
http://www.iso.org/iso/home/standards_development/list_of_iso_technic
al_committees/iso_technical_committee.htm?commid=54508
DR. A. OZOLS

ISO 10993-1:2009
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management
process
ISO 10993-1:2009/Cor 1:2010
ISO 10993-2:2006
Biological evaluation of medical devices -- Part 2: Animal welfare requirements
ISO 10993-3:2014
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity
ISO 10993-4:2002
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
ISO 10993-4:2002/Amd 1:2006
ISO 10993-5:2009
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993-6:2007
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
ISO 10993-7:2008
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
DR. A. OZOLS

ISO 10993-7:2008/Cor 1:2009

ISO 10993-9:2009
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of
potential degradation products
ISO 10993-10:2010
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2006
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
ISO 10993-12:2012
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
ISO 10993-13:2010
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation
products from polymeric medical devices
ISO 10993-14:2001
Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation
products from ceramics
ISO 10993-15:2000
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation
products from metals and alloys
DR. A. OZOLS

ISO 10993-16:2010
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products
and leachables
ISO 10993-17:2002
Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable
substances
ISO 10993-18:2005
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical
characterization of materials
ISO/TS 10993-20:2006
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology
testing of medical devices
ISO/TR 10993-33:2015
Biological evaluation of medical devices -- Part 33: Guidance on tests to evaluate genotoxicity -Supplement to ISO 10993-3
ISO 13022:2012
Medical products containing viable human cells -- Application of risk management and requirements
for processing practices
DR. A. OZOLS
ISO 14155:2011
Clinical investigation of medical devices for human subjects -- Good clinical practice

ISO 14155:2011/Cor 1:2011

ISO/TR 15499:2012
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation
within a risk management process
ISO 22442-1:2015
Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk
management
ISO 22442-2:2015
Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing,
collection and handling
ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the
elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE)
agents
ISO/TR 22442-4:2010
Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for
elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and
validation assays for those processes
ISO/TR 37137:2014
Cardiovascular biological evaluation of medical devices -- Guidance for absorbable
D R . A . Oimplants
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ISO 10993-1: 2009 Evaluacin biolgica de productos

sanitarios. Parte 1: Evaluacin y pruebas dentro de un
proceso de gestin de riesgos
Los principios generales que rigen la evaluacin biolgica de dispositivos
mdicos dentro de un proceso de gestin de riesgos;
La categorizacin general de los dispositivos basados en la naturaleza y
duracin de su contacto con el cuerpo;
La evaluacin de los datos pertinentes de todas las fuentes existentes;
La identificacin de falta de datos en el anlisis de riesgo sobre la base de los
datos disponibles;
La identificacin de datos adicionales establece necesario analizar la
seguridad biolgica del dispositivo mdico;
La evaluacin de la seguridad biolgica del dispositivo mdico.
DR. A. OZOLS