ISO/TR 18112:2006

Withdrawn

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 , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

02-15-2019

Language(s)

English

Published date

01-13-2006

Publisher

International Organization for Standardization

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Status	Withdrawn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