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 …………………………………………………………………………………………………………………………………..

Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2007)

Abstract

 

ISO 22442-1:2007 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. ISO 22442-1:2007 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:

• contamination by bacteria, moulds or yeasts;
• contamination by viruses;
• contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
• material responsible for undesired pyrogenic, immunological or toxicological reactions.

DIN EN ISO 22442-1:2008-03 (E)
Medical devices utilizing animal tissues and their derivatives – Part 1: Application of
risk management (I SO 22442-1:2007)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..6
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Risk management process ………………………………………………………………………………………………7
4.1 General …………………………………………………………………………………………………………………………..7
4.2 Risk analysis …………………………………………………………………………………………………………………..8
4.3 Risk evaluation ……………………………………………………………………………………………………………….9
4.4 Risk control …………………………………………………………………………………………………………………….9
4.5 Evaluation of overall residual risk acceptability ……………………………………………………………..11
4.6 Production and post-production information system ……………………………………………………..11
Annex A (informative) Guidance an the application of this part of ISO 22442 …………………………………12
Annex B (informative) Graphical representation of part of the risk management process formedical
devices utilizing animal material ……………………………………………………………………………………13
Annex C (normative) Special requirements for some animal materials considering the risk
management for TSE agents ………………………………………………………………………………………….15
Annex D (informative) Information relevant to the management of TSE risk …………………………………..20
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC as amended by Commission Directive
2003/32/EC ……………………………………………………………………………………………………………………28
Bibliography …………………………………………………………………………………………………………………………………29

Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)

Abstract

 

ISO 22442-2:2007 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin, other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1.

DIN EN ISO 22442-2:2008-03 (E)
Medical devices utilizing animal tissues and their derivatives – Part 2: Cont rols on
sourcing, collection and handling (ISO 22442-2:2007)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 General requirements ……………………………………………………………………………………………………..6
4.1 General …………………………………………………………………………………………………………………………..6
4.2 Quality System elements …………………………………………………………………………………………………6
4.3 Procedures ……………………………………………………………………………………………………………………..7
4.4 Personnel ……………………………………………………………………………………………………………………….7
4.5 Current regulatory requirements and guidance ……………………………………………………………….8
5 Sourcing …………………………………………………………………………………………………………………………8
5.1 General …………………………………………………………………………………………………………………………..8
5.2 Species and strain …………………………………………………………………………………………………………..8
5.3 Geography ……………………………………………………………………………………………………………………..8
5.4 Inspection ………………………………………………………………………………………………………………………8
5.5 Certification ……………………………………………………………………………………………………………………9
5.6 Traceability …………………………………………………………………………………………………………………….9
6 Collection ……………………………………………………………………………………………………………………….9
7 Handling ……………………………………………………………………………………………………………………….10
8 Storage and transport ……………………………………………………………………………………………………10
Annex A (normative) Additional requirements relating to the application of this part of ISO 22442 to
bovine-sourced materials ………………………………………………………………………………………………11
Annex B (informative) Certification and attestation ……………………………………………………………………….17
Annex C (informative) Veterinary services …………………………………………………………………………………….19
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC as amended by Commission Directive
2003/32/EC ……………………………………………………………………………………………………………………20
Bibliography …………………………………………………………………………………………………………………………………21

Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)

Abstract

 

ISO 22442-3:2007 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.

DIN EN ISO 22442-3:2008-03 (E)
Medical devi ces utilizing animal tissues and their derivatives – Part 3: Validation of
the elimination and/or inactivation of viruses and transmissible spongiform
encephalopathy (TSE) agents (ISO 22442-3:2007)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 General requirements ……………………………………………………………………………………………………..7
4.1 Risk management ……………………………………………………………………………………………………………7
4.2 Sourcing and manufacturing process ……………………………………………………………………………..7
4.3 General requirements related to validation ………………………………………………………………………7
5 Literature review ……………………………………………………………………………………………………………..8
5.1 Conduct of the literature review ………………………………………………………………………………………8
5.2 Application of literature review output …………………………………………………………………………….8
5.3 Viruses …………………………………………………………………………………………………………………………..8
5.4 TSE agents ……………………………………………………………………………………………………………………..8
6 Elimination and/or inactivation study of viruses and TSE agents ……………………………………..9
6.1 General …………………………………………………………………………………………………………………………..9
6.2 Protocol ………………………………………………………………………………………………………………………….9
6.3 Conduct of the study …………………………………………………………………………………………………….10
6.4 Interpretation of data …………………………………………………………………………………………………….10
7 Final report ……………………………………………………………………………………………………………………10
8 Review of final report …………………………………………………………………………………………………….10
9 Routine monitoring and control of critical process parameters ………………………………………10
Annex A (normative) Requirements related to literature review ……………………………………………………..11
Annex B (informative) Guidance on the elimination and/or inactivation study for viruses ………………15
Annex C (informative) Guidance on the elimination and/or inactivation study for TSE agents ………..20
Annex D (informative) Guidance on scaling down …………………………………………………………………………21
Annex E (informative) Statistical evaluation of virus titres and reduction factors and assessment of
their validity ………………………………………………………………………………………………………………….22
Annex F (informative) Calculation of reduction factors ………………………………………………………………….24
Annex G (informative) Probability of detection of agents at low concentrations …………………………….23

Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC as amended by Commission Directive
2003/32/EC …………………………………………………………………………………………………………………… 25
Bibliography ……………………………………………………………………………………………………………………………….. 26