ISO 18113-2:2009
Withdrawn
Withdrawn
View Superseded by
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
Available format(s)
Hardcopy , PDF
Language(s)
English, French, Russian
Published date
12-09-2009
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.
| Committee |
ISO/TC 212
|
| DevelopmentNote |
Supersedes ISO/DIS 18113-2. (12/2009)
|
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| NF EN ISO 18113-2 : 2012 | Identical |
| NBN EN ISO 18113-2 : 2011 | Identical |
| NEN EN ISO 18113-2 : 2011 | Identical |
| NS EN ISO 18113-2 : 2011 | Identical |
| I.S. EN ISO 18113-2:2011 | Identical |
| PN EN ISO 18113-2 : 2011 | Identical |
| SAC GB/T 29791-2 : 2013 | Identical |
| SS-EN ISO 18113-2 : 2011 | Identical |
| GOST R ISO 18113-2 : 2015 | Identical |
| BS EN ISO 18113-2:2011 | Identical |
| DIN EN ISO 18113-2:2013-01 | Identical |
| EN ISO 18113-2:2011 | Identical |
| BS EN ISO 18113-2:2009 | Equivalent |
| I.S. EN ISO 18113-2:2009 | Equivalent |
| DS EN ISO 18113-2 : 2011 | Identical |
| BS EN ISO 18113-2:2009 | Identical |
| UNE-EN ISO 18113-2:2010 | Identical |
| UNE-EN ISO 18113-2:2012 | Identical |
| PD ISO/TS 17518:2015 | Medical laboratories. Reagents for staining biological material. Guidance for users |
| BS EN ISO 18113-3:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use |
| DIN EN ISO 18113-3:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
| ISO/TS 17518:2015 | Medical laboratories — Reagents for staining biological material — Guidance for users |
| EN ISO 19001:2013 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013) |
| 15/30325469 DC : 0 | BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| PD ISO/TS 17822-1:2014 | <i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions |
| ANSI/AAMI/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/TS 17822-1:2014 | In vitro diagnostic test systems — Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens — Part 1: General requirements, terms and definitions |
| BS EN ISO 19001:2013 | In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| 10/30228700 DC : 0 | BS EN ISO 19001 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY |
| I.S. EN ISO 19001:2013 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY (ISO 19001:2013) |
| DIN EN ISO 15223-1:2015-08 (Draft) | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
| BS EN ISO 15223-1:2016 | Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements |
| I.S. EN 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 15223-1:2016, CORRECTED VERSION 2017-03) |
| 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 19001:2013 | In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| ISO 18113-3:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use |
| 06/30146518 DC : 0 | BS ISO 18113-3 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
| DIN EN ISO 19001:2013-07 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY (ISO 19001:2013) |
| I.S. EN ISO 18113-3:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009) |
| CEI UNI EN ISO 15223-1:2022-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements |
| CEI UNI EN ISO 15223-1 : 2018 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| UNE-EN ISO 15223-1:2017 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03) |
| UNE-EN ISO 19001:2013 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013) |
| UNE-EN ISO 18113-3:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| AS ISO 22367:2021 | Medical laboratories - Application of risk management to medical laboratories |
| 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 |
Summarise
US$96.00
Excluding Tax where applicable
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.