11.040.01 : Medical equipment in general

UNE-EN 46003:2000

UNE-EN 46003:2000

Superseded Historical

QUALITY SYSTEMS. MEDICAL DEVICES. PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003

€60.00

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UNE-EN ISO 15225:2000

UNE-EN ISO 15225:2000

Superseded Historical

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange. (ISO 15225:2000)

€69.00

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UNE-EN ISO 13485:2001

UNE-EN ISO 13485:2001

Superseded Historical

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001. (ISO 13485:1996)

€60.00

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UNE-EN 980/A2:2002

UNE-EN 980/A2:2002

Superseded Historical

Graphical symbols for use in the labelling of medical devices.

€26.00

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UNE-EN 60601-1-2:2002

UNE-EN 60601-1-2:2002

Superseded Historical

Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.

€133.00

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UNE-EN 13718-2:2003

UNE-EN 13718-2:2003

Superseded Historical

Air, water and difficult terrain ambulances. Part 2: Operational and technical requirements for the continuity of patient care.

€74.00

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UNE-EN ISO 13485:2004 ERRATUM

UNE-EN ISO 13485:2004 ERRATUM

Superseded Historical

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

€0.00

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UNE-CEN ISO/TR 14969:2006 IN

UNE-CEN ISO/TR 14969:2006 IN

Superseded Historical

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

€131.00

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UNE-EN 60601-1-2:2002/A1:2006

UNE-EN 60601-1-2:2002/A1:2006

Superseded Historical

Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2001/A1:2004)

€71.00

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UNE-EN ISO 13485:2004 ERRATUM:2007

UNE-EN ISO 13485:2004 ERRATUM:2007

Superseded Historical

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

€0.00

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UNE-EN 60601-1-2:2008

UNE-EN 60601-1-2:2008

Superseded Historical

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

€140.00

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UNE-EN 980:2008

UNE-EN 980:2008

Superseded Historical

Symbols for use in the labelling of medical devices

€81.00

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UNE-EN 13718-2:2009

UNE-EN 13718-2:2009

Superseded Historical

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements of air ambulances.

€79.00

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UNE-EN ISO 11197:2009

UNE-EN ISO 11197:2009

Superseded Historical

Medical supply units (ISO 11197:2004)

€98.00

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UNE-EN ISO 10993-11:2009

UNE-EN ISO 10993-11:2009

Superseded Historical

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

€81.00

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