ISO 18113-5:2009
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
10-06-2022
Superseded by
Language(s)
English, French, Russian
Published date
12-09-2009
Important note : All end users must be registered with an Account prior to user licenses being assigned.
ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.
| DevelopmentNote |
Supersedes ISO/DIS 18113-5. (12/2009)
|
| DocumentType |
Standard
|
| Pages |
8
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| NF EN ISO 18113-5 : 2012 | Identical |
| NBN EN ISO 18113-5 : 2011 | Identical |
| NEN EN ISO 18113-5 : 2011 | Identical |
| NS EN ISO 18113-5 : 2011 | Identical |
| I.S. EN ISO 18113-5:2011 | Identical |
| PN EN ISO 18113-5 : 2011 | Identical |
| SAC GB/T 29791-5 : 2013 | Identical |
| SN EN ISO 18113-5:2012 | Identical |
| UNI EN ISO 18113-5 : 2012 | Identical |
| UNE-EN ISO 18113-5:2012 | Identical |
| BS EN ISO 18113-5:2011 | Identical |
| EN ISO 18113-5:2011 | Identical |
| DIN EN ISO 18113-5:2013-01 | Identical |
| DS EN ISO 18113-5 : 2011 | Identical |
| ONORM EN ISO 18113-5 : 2012 | Identical |
| BS EN ISO 18113-5:2009 | Identical |
| UNE-EN ISO 18113-5:2010 | Identical |
| CSA ISO 15197 : 2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| DIN EN ISO 18113-4:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| 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 |
| BS ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| BS EN ISO 18113-4:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing |
| BIS IS/ISO 15197 : 2013 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEM FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| UNI EN ISO 18113-4 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| BS EN 61010-2-101:2017 | Safety requirements for electrical equipment for measurement, control and laboratory use Particular requirements for in vitro diagnostic (IVD) medical equipment |
| 06/30146522 DC : 0 | BS ISO 18113-4 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| UNE-EN ISO 18113-4:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| 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 |
| I.S. EN 61010-2-101:2017 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| BS EN ISO 22870:2016 | Point-of-care testing (POCT). Requirements for quality and competence |
| I.S. EN ISO 15197:2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
| ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| BS EN ISO 15197:2015 | In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| EN ISO 22870:2016 | Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) |
| 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) |
| 11/30208525 DC : 0 | BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| I.S. EN ISO 18113-4:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009) |
| 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) |
| I.S. EN ISO 22870:2016 | POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 22870:2016) |
| ISO 15223-1:2016 | 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) |
| ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing |
| ISO 22870:2016 | Point-of-care testing (POCT) — Requirements for quality and competence |
| EN ISO 15197:2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
| CEI EN 61010-2-101 : 2003 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| PREN ISO 15197 : DRAFT 2011 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| DIN EN ISO 15197:2015-12 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
| UNE-EN ISO 15197:2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
| EN 61010-2-101:2017 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
| UNE-EN ISO 22870:2017 | Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) |
| CSA C22.2 No. 61010.2.101 : 2015 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| 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 |
| AS ISO 22367:2021 | Medical laboratories - Application of risk management to medical laboratories |
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.