ISO/TR 18112:2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 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
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
15-02-2019
English
13-01-2006
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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.
| DocumentType |
Technical Report
|
| Pages |
120
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| Standards | Relationship |
| NEN NPR ISO/TR 18112 : 2006 | Identical |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| CFR 16(PTS1000-END) : 0 | COMMERCIAL PRACTICES - FEDERAL TRADE COMMISSION - CONSUMER PRODUCT SAFETY COMMISSION |
| EN 376 : 2002 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| CFR 42(PTS430-END) : OCT 2010 | PUBLIC HEALTH - HEALTH CARE FINANCING ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| CFR 29(PT1910.1000 TO END) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| CFR 21(PTS600-799) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 600-799 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.