BS EN ISO 18113-5:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 instruments 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 Essential requirements
5 Labels and marking
6 Elements of the instructions for use
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 instruments for self-testing.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes BS EN 592 and 06/30146526 DC. (02/2010)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
This part of ISO18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO18113 can also be applied to accessories. This part of ISO18113 does not apply to instructions for instrument servicing or repair, IVD reagents, including calibrators and control materials for use in control of the reagent, IVD instruments for professional use.
| Standards | Relationship |
| EN ISO 18113-5:2011 | Identical |
| ISO 18113-5:2009 | Identical |
| IEC 61326-2-6:2012 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| EN 592 : 2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| 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 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - 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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