EN 13532:2002
Current
The latest, up-to-date edition.
General requirements for in vitro diagnostic medical devices for self-testing
17-04-2002
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design criteria
5 Markings and information supplied by the manufacturer
6 Performance evaluation
7 User verification
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Bibliography
This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing.
| Committee |
CEN/TC 140
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| NBN EN 13532 : 2002 | Identical |
| UNI EN 13532 : 2002 | Identical |
| DIN EN 13532:2002-08 | Identical |
| PN EN 13532 : 2006 | Identical |
| BS EN 13532:2002 | Identical |
| NF EN 13532 : 2002 | Identical |
| UNE-EN 13532:2002 | Identical |
| NEN EN 13532 : 2002 | Identical |
| SN EN 13532 : 2002 | Identical |
| GOST R EN 13532 : 2010 | Identical |
| NS EN 13532 : 1ED 2002 | Identical |
| I.S. EN 13532:2002 | Identical |
| 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 |
| 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 22870:2016 | POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 22870:2016) |
| BS EN ISO 22870:2016 | Point-of-care testing (POCT). Requirements for quality and competence |
| EN ISO 22870:2016 | Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) |
| 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 |
| 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 22870:2016 | Point-of-care testing (POCT) — Requirements for quality and competence |
| 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 |
| 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 |
| PREN ISO 15197 : DRAFT 2011 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| UNE-EN ISO 22870:2017 | Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) |
| EN 1658 : 1996 | REQUIREMENTS FOR MARKING OF IN VITRO DIAGNOSTIC INSTRUMENTS |
| EN 1441 : 1997 | MEDICAL DEVICES - RISK ANALYSIS |
| EN 592 : 2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| EN 61326:1997/A3:2003 | |
| EN 376 : 2002 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN 61010-1:2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
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