EN 13641:2002
Current
The latest, up-to-date edition.
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
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 |
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.