AS ISO 14155.1-2004
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Clinical investigations of medical devices for human subjects - General requirements
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
30-06-2017
English
27-07-2004
Important note : All end users must be registered with an Account prior to user licenses being assigned.Specifies procedures for the conduct and performance of clinical investigations of medical devices. Not applicable to in vitro diagnostic medical devices. Identical with and reproduced from ISO 14155-1:2003.
| Committee |
HE-012
|
| DocumentType |
Standard
|
| ISBN |
0 7337 6169 0
|
| Pages |
21
|
| PublisherName |
Standards Australia
|
| Status |
Withdrawn
|
| Supersedes |
This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to- protect human subjects,- ensure the scientific conduct of the clinical investigation,- assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.This part of ISO 14155a) specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.
| Standards | Relationship |
| ISO 14155-1:2003 | Identical |
First published as AS ISO 14155-2002.
Revised and redesignated as AS ISO 14155.1-2004.
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