11.040.01 : Medical equipment in general

UNE-EN 60601-1-6:2005

UNE-EN 60601-1-6:2005

Superseded Historical

Medical electrical equipment -- Part 1-6: General requirements for safety - Collateral standard: Usability

€126.00

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UNE-EN ISO 11197:2005

UNE-EN ISO 11197:2005

Superseded Historical

Medical supply units. (ISO 11197:2004)

€96.00

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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Superseded Historical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 ISO 15225:2000/A2:2006

UNE-EN ISO 15225:2000/A2:2006

Superseded Historical

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)

€28.00

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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Superseded Historical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-EN ISO 15225/A1:2004

UNE-EN ISO 15225/A1:2004

Superseded Historical

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1 (ISO 15225:2000/A1:2004)

€28.00

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UNE-EN ISO 13485:2004

UNE-EN ISO 13485:2004

Superseded Historical

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

€117.00

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NF ISO 17664-2, S98-116-2 (08/2021)

NF ISO 17664-2, S98-116-2 (08/2021)

Withdrawn Most Recent

Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif - Partie 2 : dispositifs médicaux non critiques

€91.33

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NF EN ISO 10993-23/A1, S99-501-23/A1 (08/2025)

NF EN ISO 10993-23/A1, S99-501-23/A1 (08/2025)

Active Most Recent

Évaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation - Amendement 1: Modèles supplémentaires d'épiderme humain reconstruit in vitro

€59.00

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DIN EN ISO 16571:2024-09

DIN EN ISO 16571:2024-09

Active Most Recent

Systems for evacuation of plume generated by medical devices (ISO 16571:2024); German version EN ISO 16571:2024

€140.00

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UNE-EN ISO 10993-2:1998

UNE-EN ISO 10993-2:1998

Superseded Historical

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 2: ANIMAL WELFARE REQUIREMENTS. (ISO 10993-2:1992).

€58.00

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UNE-EN ISO 10993-7:1996

UNE-EN ISO 10993-7:1996

Superseded Historical

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATIONN RESIDUALS. (ISO 10993-7:1995).

€106.00

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UNE-EN ISO 10993-7:1996 ERRATUM

UNE-EN ISO 10993-7:1996 ERRATUM

Superseded Historical

BIOLOGICAL EVAULATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS. (ISO 10993-7:1995).

€0.00

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UNE-EN ISO 10993-10:1996

UNE-EN ISO 10993-10:1996

Superseded Historical

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 10: TESTS FOR IRRITATION AND SENSIBILIZATION. (ISO 10993-10:1995).

€98.00

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UNE-EN ISO 10993-11:1996

UNE-EN ISO 10993-11:1996

Superseded Historical

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 11: TESTS FOR SYSTEMIC TOXICITY. (ISO 10993-11:1993).

€69.00

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