Biomedical Engineering Reference
In-Depth Information
Table 4.2 Pacing, ICD, and neuromodulation system components arranged by most
common material, tissue interface, and relevant standard(s). (Note: Lead conductor
materials (e.g., MP35N) and internal can components generally do not contact
tissue and are not listed)
Components
Selected
Primary
Applicable standards
materials
tissue
contacts
Pacemaker
Titanium
Subcutaneous
ISO 10993
pulse
and muscle
ISO 14708-1 (CEN EN 45502-1)
generator
ISO 14708-2
ISO 14708-3
CENELEC EN 45502-2-1
ISO 14708-6 (CENELEC EN
45502-2-2)
Guidance for Industry (12)
Connector
Polyether
Subcutaneous
ISO 5841-3 (IS-1)
module of
polyurethane
and muscle
ISO 11318 (DF1)
pulse
(rigid, e.g.,
ISO 27186 (IS4)
generator
75D)
ISO 10993
Adhesives
Silicone or
Subcutaneous
ISO 10993
polyurethane
and muscle
ISO 14708-1 (CEN EN 45502-1)
ISO 14708-2
ISO 14708-3
CENELEC EN 45502-2-1
ISO 14708-6 (CENELEC EN
45502-2-2)
Guidance for Industry (12)
Lead
Polyether
Subcutaneous
ISO 10993
connector
polyurethane
and muscle
ISO 14708-1 (CEN EN 45502-1)
ISO 14708-2
ISO 14708-3
CENELEC EN 45502-2-1
ISO 14708-6 (CENELEC EN
45502-2-2)
Guidance for Industry (12)
Lead
Silicone or
Subcutaneous
ISO 10993
insulation
polyether
and muscle,
ISO 14708-1 (CEN EN 45502-1)
polyurethane
venous tissue,
ISO 14708-2
blood, cardiac
ISO 14708-3
tissues
CENELEC EN 45502-2-1
ISO 14708-6 (CENELEC EN
45502-2-2)
Guidance for Industry (12)
Lead
Titanium
Blood, cardiac
ISO 10993
electrode
nitride,
tissues
ISO 14708-1 (CEN EN 45502-1)
platinum,
ISO 14708-2
platinum^
ISO 14708-3
iridium alloys,
CENELEC EN 45502-2-1
or activated
ISO 14708-6 (CENELEC EN
carbon
45502-2-2)
Guidance for Industry (12)
