BS EN 13641:2002 - Elimination or reduction of risk of infection related to in vitro diagnostic reagents

BS EN 13641:2002

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

Status : Confirmed, Current   Published : May 2002
Conformity to regulation : Designated

Format
PDF

Format
HARDCOPY



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.




Standard NumberBS EN 13641:2002
TitleElimination or reduction of risk of infection related to in vitro diagnostic reagents
StatusConfirmed, Current
Publication Date27 May 2002
Conformity to regulationDesignated
Confirm Date20 February 2020
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
International RelationshipsEN 13641:2002
Draft Superseded By99/564177 DC
DescriptorsBiotechnology, Biochemical methods of analysis, Diagnosis (medical), Medical sciences, Biological hazards, Chemical analysis and testing
ICS11.100.10
Title in FrenchElimination ou reduction du risque d'infection relatif aux reactifs de diagnostic in vitro
Title in GermanEliminierung oder Herabsetzung des von Reagenzien f r in-vitro- diagnostische Untersuchungen ausgehenden Infektionsrisikos
CommitteeCH/212
ISBN0 580 39780 7
PublisherBSI
FormatA4
DeliveryYes
Pages12
File Size279 KB
Price£112.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


BSOL

Access, view and download standards with multiple user access, across multiple sites with BSOL


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Customers who bought this product also bought

  • BS EN 13612:2002
    Performance evaluation of in vitro diagnostic medical devices
  • BS EN 13975:2003
    Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
  • BS EN ISO 18113-2:2011
    In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
  • BS EN ISO 18113-1:2011
    In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements