ISO 14708-1:2000-11

Inhalt (en)

• Foreword
• Introduction
• Scope
• Normative references
• Terms and definitions
• Symbols and abbreviated terms
• General requirements for non-implantable parts
• Requirements for particular active implantable medical devices
• General arrangement of the packaging
• General markings for active implantable medical devices
• Markings on the sales packaging
• Construction of the sales packaging
• Markings on the sterile pack
• Construction of the non-reusable pack
• Markings on the active implantable medical device
• Protection from unintentional biological effects caused by the active implantable medical device
• Protection from harm to the patient or user caused by external physical features of the active implantable medical device
• Protection from harm to the patient caused by electricity
• Protection from harm to the patient caused by heat
• Protection from ionizing radiation released or emitted from the active implantable medical device
• Protection from unintended effects caused by the device
• Protection of the device from damage caused by external defibrillators
• Protection of the device from changes caused by high-power electrical fields applied directly to the patient
• Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
• Protection of the active implantable medical device from mechanical forces
• Protection of the active implantable medical device from damage caused by electrostatic discharge
• Protection of the active implantable medical device from damage caused by atmospheric pressure changes
• Protection of the active implantable medical device from damage caused by temperature changes
• Protection of the active implantable medical device from electromagnetic non-ionizing radiation
• Accompanying documentation
• Relationship between the fundamental principles in and the clauses of this part of (informative)
• Relationship between the clauses of this part of and the fundamental principles listed in Annex A (informative)
• Rationale (informative) Unterkapitel anzeigen Unterkapitel ausblenden

  • Introduction
  • General
  • Notes on specific clauses and subclauses
• Bibliography