Low prices! Originals & Translations! Save your budget and time!
ONLINENORMS: Online Standards Store
Click View Shopping Cart
  1. Home
  2. DANSK
  3. DANSK DS/ISO/TR 18112 PDF

DANSK DS/ISO/TR 18112 PDF

DANSK DS/ISO/TR 18112 PDF

Name:
DANSK DS/ISO/TR 18112 PDF

Published Date:
02/23/2006

Status:
[ Withdrawn ]

Description:

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

Publisher:
Dansk Standard

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$47.4
Need Help?
SAME AS ISO/TR 18112 * W/D NO S/S

This Technical Report 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.


Edition : 06
File Size : 1 file , 1.2 MB
Number of Pages : 130
Product Code(s) : DS-121, DS-121
Published : 02/23/2006

History

Related products

DANSK DS/EN ISO 18183-1
DANSK DS/EN ISO 18183-1
Published Date: 04/11/2024
Geometrical product specifications (GPS) – Partition – Part 1: Vocabulary and basic concepts (ISO 18183-1:2024)
$19.2
DANSK DS/EN IEC 62541-4
DANSK DS/EN IEC 62541-4
Published Date: 09/21/2020
OPC Unified Architecture – Part 4: Services
$47.7
DANSK DS/EN ISO 10079-1
DANSK DS/EN ISO 10079-1
Published Date: 04/04/2022
Medical suction equipment – Part 1: Electrically powered suction equipment (ISO 10079-1:2022)
$13.2
DANSK DSF/PREN 81-22
DANSK DSF/PREN 81-22
Published Date:
Safety rules for the construction and installation of lifts – Lifts for the transport of persons and goods – Part 22: Passenger and goods passenger lifts with inclined travel path
$30.3

Best-Selling Products

AAMI/IEC 601219E
AAMI/IEC 601219E
Published Date: 03/27/2012
Erratum for Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators
Free Download
AAMI/IEC 601220E
AAMI/IEC 601220E
Published Date: 03/27/2012
Erratum for Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators
Free Download
AAMI/IEC 60601-1-12:2016/A1:2021
AAMI/IEC 60601-1-12:2016/A1:2021
Published Date: 03/20/2022
Amendment 1, Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performan - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
$38.7
AAMI/IEC 60601-1-12:2016 & A1:2021
AAMI/IEC 60601-1-12:2016 & A1:2021
Published Date: 08/22/2022
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment CONSOLIDATED EDITION
$85.2
AAMI/IEC 60601-1-12:2016
AAMI/IEC 60601-1-12:2016
Published Date: 10/06/2016
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performan - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
$82.5
AAMI/IEC 60601-1-2:2007/(R)2012
AAMI/IEC 60601-1-2:2007/(R)2012
Published Date: 05/15/2007
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
$56.1