For implantable medical device manufacturers, the ISO 14708 series is essential. Now the ISO 14708-1, “Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer,” has been updated. The new 2nd Edition is a technical revision of the original release in 2000 (which is now cancelled). It’s the first in the series and covers the general requirements for active implantable medical devices in terms of basic safety.
The standard has 24 specific requirement clauses that generally cover all implantable medical devices. First, the general requirements are spelled out. These include such things as software, related non-implantable parts, data security, risk management and mis-connection. Then, more specific areas are addressed. Packaging, information, marking, etc., are also covered since the mis-use of devices can be as harmful as device failures.
Harmful effects for both the patient and for the device are considered in this document. What kinds of factors could be harmful? Well, patients could be harmed by radiation, unintended biological effects, electricity and a number of other concerns. The device itself can be affected by heat, atmospheric pressure changes, electrical fields and the use of defibrillators, electrostatic discharge and so on.
Your standard addresses all of these factors in order to confirm that you have considered all risk factors your device may face. Additionally, two Annexes cover general guidance and the relationship between the ISO 14708-1 and ISO/TR 14283, “Implants for surgery – Fundamental principles.” A 28-item bibliography finishes the publication.
You’ll also want to review this new edition if you use any of the other parts of the ISO 14708 series, since they provide additional information for specific device types. Here’s the list of the additional topics they cover:
- ISO 14708-2, Part 2: Cardiac pacemakers
- ISO 14708-3, Part 3: Implantable neurostimulators
- ISO 14708-4, Part 4: Implantable infusion pumps
- ISO 14708-5, Part 5: Circulatory support devices
- ISO 14708-6, Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
- ISO 14708-7, Part 7: Particular requirements for cochlear implant systems
When it’s time to order your new edition, you’ll want to get it from an authorized ISO dealer like Document Center Inc. You can order at our web store at www.document-center.com, with options for either paper or pdf delivery. If you’d rather, you can choose multi-user access by contacting our staff and setting up a Standards Online subscription for your company. We’ve been providing standards and supporting services to our customers since 1982. Make us your Standards Experts!
