ISO/TR 18112:2006
$55.25
Clinical laboratory testing and in vitro diagnostic test systems — In vitro diagnostic medical devices for professional use — Summary of regulatory requirements for information supplied by the manufacturer
| Published By | Publication Date | Number of Pages |
| ISO | 2006-01 | 128 |
ISO/TR 18112:2006 summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use.
Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use.
Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included.
Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison.
IVD medical devices for self-testing are excluded.
Related products
-
IEEE ISO IEC 9945 2009
Information technology Portable Operating System Interface (POSIX) Base Specifications, Issue 7 Published By Publication Date…
-
IEEE P1003.1:2024 Edition
IEEE Draft Standard for Information Technology–Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 8 Published…
-
IEEE 1003.1-2024
IEEE/Open Group Standard for Information Technology–Portable Operating System Interface (POSIX™) Base Specifications, Issue 8 (Published)…
-
IEEE 9945-2009
IEEE/ISO/IEC International Standard – Information technology Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 7…
-
ASHRAE Fundamentals Handbook IP 2013
2013 ASHRAE Handbook – Fundamentals – IP Edition Published By Publication Date Number of Pages…
-
IEEE 1003.1-2024
IEEE/Open Group Standard for Information Technology–Portable Operating System Interface (POSIX™) Base Specifications, Issue 8 (Published)…
-
IEEE 1003.1 2008
Standard for Information Technology – Portable Operating System Interface (POSIX(R)) Published By Publication Date Number…
-
IEEE 1003.1-2008
IEEE Standard for Information Technology – Portable Operating System Interface (POSIX(TM)) Published By Publication Date…
-
IEEE 1003.1-2017
IEEE Standard for Information Technology–Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 7 (Superseded) Published…
-
IEEE/OpenGroup 1003.1 2017:2018 Edition
IEEE Standard for Information Technology–Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 7 Published By…
-
IEEE OpenGroup 1003.1 2017:2018 Edition
IEEE Standard for Information Technology–Portable Operating System Interface (POSIX(R)) Base Specifications, Issue 7 Published By…
-
BICSI TDMM 15 v1 2024
BICSI Telecommunications Distribution Methods Manual (TDMM), 15th Edition Published By Publication Date Number of Pages…
-
IEEE 1003.1-2017
IEEE Standard for Information Technology–Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 7 Published By…
-
IEEE 1003.1-2017(Redline)
IEEE Standard for Information Technology–Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 7 (Redline) Published…
-
IEEE/ISO/IEC 9945 2009
IEEE/ISO/IEC International Standard – Information technology Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 7…
-
IEEE 1003.1-2024
IEEE/Open Group Standard for Information Technology–Portable Operating System Interface (POSIX™) Base Specifications, Issue 8 (Published)…
-
IEEE 1003.1-2017
IEEE Standard for Information Technology–Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 7 Published By…
-
IEEE 1003.1-2017
IEEE Standard for Information Technology–Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 7 (Superseded Redline)…
-
ISO/IEC 25066:2016
Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Common…
-
IEEE 1003.1-2017
IEEE Standard for Information Technology–Portable Operating System Interface (POSIX(TM)) Base Specifications, Issue 7 (Approved Draft)…
