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EN 13641:2002

Current

Current

The latest, up-to-date edition.

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

Published date

08-05-2002

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements related to design and manufacture
5 Information supplied by the manufacturer
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

This standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection. The standard does not apply to the following:- instruments and specimen receptacles;NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment is addressed in other relevant International and/or European Standards. - general aspects of workers' protection;- transportation of infectious goods;- disposal measures.NOTE 2 Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.

Committee
CEN/TC 140
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
NS EN 13641 : 1ED 2002 Identical
NBN EN 13641 : 2002 Identical
UNI EN 13641 : 2003 Identical
UNE-EN 13641:2002 Identical
DIN EN 13641:2002-08 Identical
I.S. EN 13641:2002 Identical
NF EN 13641 : 2002 Identical
GOST R EN 13641 : 2010 Identical
BS EN 13641:2002 Identical
SN EN 13641 : 2002 Identical
NEN EN 13641 : 2002 Identical
PN EN 13641 : 2006 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
CSA Z15190 : 2005 : R2010 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
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
ISO 15190:2003 Medical laboratories Requirements for safety
BS ISO 15190:2003 Medical laboratories. Requirements for safety
CSA Z15190 : 2005 : R2015 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
CSA Z15190 : 2005 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
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

EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
89/686/EEC : 1989 AMD 5 2012 COUNCIL DIRECTIVE OF 21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT
EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
CLSI GP17 A : 1ED 96 CLINICAL LABORATORY SAFETY

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