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EN 13532:2002

Current
Current

The latest, up-to-date edition.

General requirements for in vitro diagnostic medical devices for self-testing
Published date

17-04-2002

Publisher

Comite Europeen de Normalisation

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 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
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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