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Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Document Number: ISO 14708-1:2000
File Size: 289 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section
File Size: 289 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price:
$156.00
Product Details
This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices.
The tests that are specified in this part of ISO 14708 are type tests intended to be carried out on samples of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.
This part of ISO 14708 is applicable not only to active implantable medical devices that are electrically powered, but also to those powered by other energy sources (for example gas pressure or springs).
This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices (see 3.3).
Other parts of this product are listed below:
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
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