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BS EN ISO 18113-2:2011

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use

Available format(s)

Hardcopy , PDF

Superseded date

12-06-2024

Superseded by

BS EN ISO 18113-2:2024

Language(s)

English

Published date

31-01-2012

€231.38
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Content of the outer container label
6 Content of the immediate container label
7 Content of the instructions for use
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of the EU
         Directive 98/79/EC on "in vitro Diagnostic Medical
         Devices"

Describes requirements for information supplied by the manufacturer of IVD reagents for professional use.

Committee
CH/212
DevelopmentNote
Supersedes BS EN 375 and 06/30146515 DC. (02/2010)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

This part of ISO18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of ISO18113 can also be applied to accessories. This part of ISO18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO18113 does not apply to IVD instruments or equipment, IVD reagents for self-testing.

Standards Relationship
ISO 18113-2:2009 Identical
EN ISO 18113-2:2011 Identical

ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
CLSI GP10 A : 1ED 95(R2001) ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
ISO 18153:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
CLSI C28 A2 : 2ED 2000 HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008 Symbols for use in the labelling of medical devices

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