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Standard

DIN EN ISO 13485

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Product image - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012

Publication date: 2012-11

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translation: English
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Product image - Medical devices - Quality mmanagements systems - Requirements for regulatory purpose

Medical devices - Quality mmanagements systems - Requirements for regulatory purpose

Publication date: 2004-07-30

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Product image - Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004); German version CEN ISO/TR 14969:2005

Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004); German version CEN ISO/TR 14969:2005

Publication date: 2005-10

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Draft standard

DIN EN 285 [NEW]

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Product image - Sterilization - Steam sterilizers - Large sterilizers; German version prEN 285:2013

Sterilization - Steam sterilizers - Large sterilizers; German version prEN 285:2013

Publication date: 2013-05

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Draft standard

DIN EN 13060

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Product image - Small steam sterilizers; German version prEN 13060:2012

Small steam sterilizers; German version prEN 13060:2012

Publication date: 2012-06

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Standard

SN EN ISO 13485

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Product image - Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009) incl. EN ISO 13485/AC:2012

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009) incl. EN ISO 13485/AC:2012

Publication date: 2012-09

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Standard

BS EN ISO 13485

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Product image - Medical devices. Quality management systems. Requirements for regulatory purposes

Medical devices. Quality management systems. Requirements for regulatory purposes

Publication date: 2012-03-31

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Product image - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor 1:2009) (consolidated version)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor 1:2009) (consolidated version)

Publication date: 2012-11-01

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Standard

UNE-EN ISO 13485

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Product image - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

Publication date: 2012-05-23

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nach DIN EN ISO 13485:2012 unter Berücksichtigung der DIN EN ISO 14971:2012 - Mit CD-ROM

Mit dieser Musterdokumentation erhalten Hersteller und Anwender von Medizinprodukten eine solide Grundlage für den Aufbau bzw. die Pflege des eigenen QM-Systems: die Anforderungen aus... Read abstract

Publication date: 2013

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Original: German
 
 
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