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

DIN EN 13641:2002-08 (D/E)
Eliminierung oder Herabsetzung des von Reagenzien für in-vitro-diagnostische Untersuchungen ausgehenden Infektionsrisikos; Deutsche Fassung EN 13641:2002, Text in Deutsch und Englisch
Elimination or reduction of risk of infection related to in vitro diagnostic reagents ; German version EN 13641:2002, German and English texts
Inhalt Seite
Vorwort ……………………………………………………………………………………………………………………………………….. 2
Einleitung ………………………………………………………………………………………………………………………………………. 2
1 Anwendungsbereich …………………………………………………………………………………………………………. 3
2 Normative Verweisungen ………………………………………………………………………………………………….. 3
3 Begriffe …………………………………………………………………………………………………………………………….. 4
4 Anforderungen bezüglich des Designs ……………………………………………………………………………… 4
4.1 Allgemeines ……………………………………………………………………………………………………………………… 4
4.2 Verwendung infektiöser biologischer Materialien oder potentiell infektiöser biologischer Materialien ………………………………………………………………………………………………………………………. 5
4.3 Spezifikationen für Rohmaterialien ……………………………………………………………………………………. 5
4.3.1 Allgemeines ……………………………………………………………………………………………………………………… 5
4.3.2 Anforderung an die Beschaffung ………………………………………………………………………………………. 5
4.3.3 Anforderungen an die Prüfung ………………………………………………………………………………………….. 6
4.4 Herstellungsverfahren ………………………………………………………………………………………………………. 6
5 Vom Hersteller bereitgestellte Informationen …………………………………………………………………….. 7
Anhang ZA (informativ) Abschnitte in dieser Europäischen Norm, die grundlegende Anforderungen oder andere Vorgaben von EG-Richtlinien betreffen ………………………………… 8
Literaturhinweise ……………………………………………………………………………………………………………………………. 9

Foreword ……………………………………………………………………………………………………………………………………….. 2
Introduction ……………………………………………………………………………………………………………………………………. 2
1 Scope ……………………………………………………………………………………………………………………………….. 3
2 Normative references ………………………………………………………………………………………………………… 3
3 Terms and definitions ……………………………………………………………………………………………………….. 4
4 Requirements related to design and ………………………………………………………………………………….. 4
4.1 General …………………………………………………………………………………………………………………………….. 4
4.2 Use of infectious biological materials or potentially infectious biological materials ……………. 5
4.3 Raw material specifications ………………………………………………………………………………………………. 5
4.3.1 General …………………………………………………………………………………………………………………………….. 5
4.3.2 Sourcing requirements ……………………………………………………………………………………………………… 5
4.3.3 Testing requirements ………………………………………………………………………………………………………… 6
4.4 Manufacturing process ……………………………………………………………………………………………………… 6

5 Information supplied by the manufacturer ………………………………………………………………………… 7
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EC Directives ……………………………………………………………………………………. 8
Bibliography ………………………………………………………………………………………………………………………………….. 9

Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Abstract

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

DIN EN ISO 14971:2013-04 (E)
Medical devices – Application of risk management to medical devices (ISO
14971:2007, Corrected version 2007-10 -01)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Terms and definitions …………………………………………………………………………………………………….. 5
3 General requirements for risk management ……………………………………………………………………. 9
3.1 Risk management process ……………………………………………………………………………………………… 9
3.2 Management responsibilities ………………………………………………………………………………………… 11
3.3 Qualification of personnel …………………………………………………………………………………………….. 11
3.4 Risk management plan …………………………………………………………………………………………………. 11
3.5 Risk management file …………………………………………………………………………………………………… 12
4 Risk analysis ………………………………………………………………………………………………………………… 12
4.1 Risk analysis process …………………………………………………………………………………………………… 12
4.2 Intended use and identification of characteristics related to the safety of the medical
device ………………………………………………………………………………………………………………………….. 13
4.3 Identification of hazards ……………………………………………………………………………………………….. 13
4.4 Estimation of the risk(s) for each hazardous situation …………………………………………………… 13
5 Risk evaluation …………………………………………………………………………………………………………….. 14
6 Risk control ………………………………………………………………………………………………………………….. 15
6.1 Risk reduction ……………………………………………………………………………………………………………… 15
6.2 Risk control option analysis …………………………………………………………………………………………. 15
6.3 Implementation of risk control measure(s) ……………………………………………………………………. 15
6.4 Residual risk evaluation ……………………………………………………………………………………………….. 16
6.5 Risk/benefit analysis …………………………………………………………………………………………………….. 16
6.6 Risks arising from risk control measures ……………………………………………………………………… 16
6.7 Completeness of risk control ………………………………………………………………………………………… 16
7 Evaluation of overall residual risk acceptability …………………………………………………………….. 17
8 Risk management report ………………………………………………………………………………………………. 17
9 Production and post-production information ………………………………………………………………… 17
Annex A (informative) Rationale for requirements ………………………………………………………………………… 19
Annex B (informative) Overview of the risk management process for medical devices ………………….. 27
Annex C (informative) Questions that can be used to identify medical device characteristics that
could impact on safety …………………………………………………………………………………………………. 29
Annex D (informative) Risk concepts applied to medical devices ………………………………………………….. 36
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous
situations …………………………………………………………………………………………………………………….. 53

Annex F (informative) Risk management plan …………………………………………………………………………………. 58
Annex G (informative) Information on risk management techniques………………………………………………… 60
Annex H (informative) Guidance on risk management for in vitro diagnostic medical devices………….. 64
Annex I (informative) Guidance on risk analysis process for biological hazards………………………………. 80
Annex J (informative) Information for safety and information about residual risk …………………………….. 82
Annex ZA (informative) Relationship between this European Standard and Requirements of
EU Directive 93/42/EEC on Medical Devices …………………………………………………………………………………….
Annex ZB (informative) Relationship between this European Standard and Requirements of
EU Directive 90/385/EEC on Active Implantable Medical Devices ……………………………………………………..
Annex ZC (informative) Relationship between this European Standard and Requirements of
EU Directive 98/79/EC on In Vitro Diagnostic Medical Devices …………………………………………………………
Bibliography …………………………………………………………………………………………………………………………………..