BS EN 13975:2003 - Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects – BSI British Standards

BS EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

Status : Confirmed, Current   Published : March 2003
Conformity to regulation : Designated

Format
PDF

Format
HARDCOPY



BS EN 13975:2003 specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body.

Two different provisions are addressed:

a) verification by testing attributes and/or variables on a statistical basis

b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control.

This European standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.




Standard NumberBS EN 13975:2003
TitleSampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
StatusConfirmed, Current
Publication Date28 March 2003
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 13975:2003
DescriptorsAcceptance (approval), Clinical investigation instruments, Medical equipment, Homogeneity, Statistical methods of analysis, Diagnosis (medical), Certification (approval), Approval testing, Quality assurance, Sampling methods, Statistics, Process control
ICS11.100.10
Title in FrenchProcedures d'echantillonnage utilisees pour l'acceptation des essais des dispositifs medicaux de diagnostic in vitro. Aspects statistiques
Title in GermanProbenahmeverfahren fuer die Annahmepruefung von In-vitro- Diagnostika. Statistische Aspekte
CommitteeCH/212
ISBN0 580 41510 4
PublisherBSI
FormatA4
DeliveryYes
Pages16
File Size296 KB
Price£134.00


 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 13641:2002
    Elimination or reduction of risk of infection related to in vitro diagnostic reagents
  • BS EN 14136:2004
    Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
  • BS EN ISO 18113-1:2011
    In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements