ISO 23640:2011
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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English, French
29-11-2011
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ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.
ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:
- the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;
- the establishment of stability of the IVD reagent in use after the first opening of the primary container;
- the monitoring of stability of IVD reagents already placed on the market;
- the verification of stability specifications after modifications of the IVD reagent that might affect stability.
| Committee |
ISO/TC 212
|
| DevelopmentNote |
Supersedes ISO/DIS 23640. (12/2011)
|
| DocumentType |
Standard
|
| Pages |
7
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| GOST R ISO 23640 : 2015 | Identical |
| NF EN ISO 23640 : 2015 | Identical |
| NBN EN ISO 23640 : 2015 | Identical |
| NEN EN ISO 23640 : 2015 | Identical |
| NS EN ISO 23640 : 2015 | Identical |
| I.S. EN ISO 23640:2015 | Identical |
| I.S. EN ISO 23640:2011 | Identical |
| PN EN ISO 23640 : 2015 | Identical |
| SN EN ISO 23640:2015 | Identical |
| UNI EN ISO 23640 : 2013 | Identical |
| UNI EN ISO 23640 : 2012 | Identical |
| SS-EN ISO 23640:2015 | Identical |
| UNE-EN ISO 23640:2015 | Identical |
| UNE-EN ISO 23640:2012 | Identical |
| BS EN ISO 23640:2015 | Identical |
| BS EN ISO 23640:2011 | Identical |
| EN ISO 23640:2015 | Identical |
| DIN EN ISO 23640:2015-12 | Identical |
| DIN EN ISO 23640:2012-03 | Identical |
| UNE-EN ISO 23640:2013 | Identical |
| CSA ISO 15197 : 2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| BIS IS/ISO 15197 : 2013 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEM FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| 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 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| 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 |
| 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 |
| 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) |
| 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 15197:2015 | 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) |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| EN 13640:2002 | Stability testing of in vitro diagnostic reagents |
| CLSI EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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