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ISO/TR 18112:2006

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

15-02-2019

Language(s)

English

Published date

13-01-2006

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Withdrawn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

EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
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

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