BS EN ISO 18113-4:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 self-testing
Hardcopy , PDF
12-06-2024
English
31-01-2012
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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 self-testing.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes BS EN 376 and 06/30146522 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Superseded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 self-testing. 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 self-testing. 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 professional use.
| Standards | Relationship |
| ISO 18113-4:2009 | Identical |
| EN ISO 18113-4:2011 | Identical |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| EN 376 : 2002 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| CLSI GP10 A : 1ED 95(R2001) | ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS |
| CLSI C28 A2 : 2ED 2000 | HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 18113-5:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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