iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN 928:1995

(Main)

In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

This European Standard provides guidance on the implementation of EN 29001 and EN 46001 and of EN 29002 and EN 46002 as applied to the manufacturer of IVDs. It is aimed at affording a better understanding of the standards themselves as well as assistance in its use, either implementing or evaluating such a quality system. The guidance given is not intended to be exhaustive, but to highlight important aspects to which attention should be drawn.  The adoption of systems other than those described in this European Standard is not to be regarded as a non-compliance with EN 29001 and EN 29002 and/or the particular requirements in EN 46001 and EN 46002.

In-vitro-Diagnostik/Diagnostika - Leitfaden für die Anwendung von EN 29001 und EN 46001 sowie EN 29002 und EN 46002 für Medizinprodukte für die In-vitro-Diagnose

Diese europäische Norm ist ein Leitfaden für die Anwendung der Normen EN 29001und EN 46001 sowie EN 29002 und EN 46002 bei der Herstellung von Medizinprodukten für die In-vitro Diagnose. Er soll dazu beitragen, diese Normen besser zu verstehen und ihre Anwendung sowohl bei der Einrichtung als auch bei der Bewertung eines Qualitätssicherungssystems zu erleichtern. Es ist nicht beabsichtigt, in dem vorliegenden Leitfaden alle Aspekte erschöpfend zu behandeln, vielmehr soll die Aufmerksamkeit auf Schwerpunkte gelenkt werden.

Systèmes d'analyses médicales in vitro - Guide d'application des EN 29001 et EN 46001, et EN 29002 et EN 46002 pour les dispositifs médicaux de diagnostic in vitro

Cette norme européenne donne des conseils pour l'application des normes EN 29001et EN 46001, et EN 29002 et EN 46002 dans la fabrication des DIV. Elle a pour but de permettre une meilleure compréhension de la norme elle-même, aussi bien que d'aider dans son utilisation, que ce soit en réalisant ou en évaluant un telsystème. Les conseils fournis ne sont pas exhaustifs mais mettent en lumière lesaspects importants sur lesquels l'attention devrait être attirée.

Diagnostični sistemi in vitro - Navodila za uporabo EN 29001 in EN 46001 ter EN 29002 in EN 46002 za diagnostične medicinske pripomočke

General Information

Status
Withdrawn
Publication Date
01-Nov-1995
Withdrawal Date
07-Jun-2005
ICS
11.100 - Laboratory medicine
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 2 - Quality systems for IVD MDs
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
08-Jun-2005
Completion Date
08-Jun-2005
Directive
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN 928:2000 - In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

Buy Standard

EN 928:2000EN 928:2000
PreviousNext
Standard
EN 928:2000
English language
15 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 928:2000
01-januar-2000
'LDJQRVWLþQLVLVWHPLLQYLWUR1DYRGLOD]DXSRUDER(1LQ(1WHU(1
LQ(1]DGLDJQRVWLþQHPHGLFLQVNHSULSRPRþNH
In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001
and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
In-vitro-Diagnostik/Diagnostika - Leitfaden für die Anwendung von EN 29001 und EN
46001 sowie EN 29002 und EN 46002 für Medizinprodukte für die In-vitro-Diagnose
Systemes d'analyses médicales in vitro - Guide d'application des EN 29001 et EN
46001, et EN 29002 et EN 46002 pour les dispositifs médicaux de diagnostic in vitro
Ta slovenski standard je istoveten z: EN 928:1995
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN 928:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 928:2000

---------------------- Page: 2 ----------------------

SIST EN 928:2000

---------------------- P
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 17511:2021(Main)
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
SIST EN ISO 17511:2021

This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).
All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.
NOTE 1      Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.
This document is applicable to:
a)   all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales.
b)   IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.
c)   RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).
d)   IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.
e)   IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).
This document is not applicable to:
a)   calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand;
b)   control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;
c)   control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;
d)   properties reported as nominal scales and ordinal scales, where no magnitude is involved.
NOTE 2  Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.
NOTE 3

  • Standard
    68 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    60 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 20776-1:2020(Main)
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12)
SIST EN ISO 20776-1:2020

This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    25 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 15195:2019(Main)
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
SIST EN ISO 15195:2019

This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE       Requirements for medical laboratories are specified in ISO 15189[1].

  • Standard
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 14136:2004(Main)
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
SIST EN 14136:2004

This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:
- scheme design and organisation;
- identification of procedures (IVD MDs) used by the participant;
- classification and evaluation of data.
NOTE   External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs.
This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 18153:2003(Main)
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
SIST EN ISO 18153:2003

ISO 18153:2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes.
The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.
The following subjects are outside the scope of ISO 18153:2003: requirements for the design or selection of a reference measurement procedure; quantities involving mass of enzyme or immunoreactivity of enzymes; control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; properties involving nominal and ordinal scales.

  • Standard
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13975:2003(Main)
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
SIST EN 13975:2003

This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EU 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 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
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13612:2002/AC:2002(Corrigendum)
Performance evaluation of in vitro diagnostic medical devices
SIST EN 13612:2002/AC:2003

TC - Modifications in 2.6, 2.14, 4.5, Annex ZA and Bibliography

  • Corrigendum
    3 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13641:2002(Main)
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
SIST EN 13641:2002

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
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13532:2002(Main)
General requirements for in vitro diagnostic medical devices for self-testing
SIST EN 13532:2002

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.

  • Standard
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13612:2002(Main)
Performance evaluation of in vitro diagnostic medical devices
SIST EN 13612:2002

This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.
NOTE   For a selection of publications on specific evaluation plans see Bibliography.
Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs.
In particular, this standard applies to IVD MDs to
- show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer,
- establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to
- satisfy the requirements of a quality system for design validation.

  • Standard
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day