11.040.01 : Medical equipment in general

UNE-EN ISO 10993-16:2009

UNE-EN ISO 10993-16:2009

Superseded Historical

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

€62.00

View more
UNE-EN 60601-1-2:2008 CORR:2010

UNE-EN 60601-1-2:2008 CORR:2010

Superseded Historical

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

€0.00

View more
UNE-EN ISO 15225:2010

UNE-EN ISO 15225:2010

Superseded Historical

Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)

€72.00

View more
UNE-EN ISO 15223-1:2013

UNE-EN ISO 15223-1:2013

Superseded Historical

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

€77.00

View more
UNE-EN ISO 13485:2013

UNE-EN ISO 13485:2013

Superseded Historical

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

€129.00

View more
UNE-EN ISO 13485:2016

UNE-EN ISO 13485:2016

Superseded Historical

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

€115.00

View more
UNE-EN ISO 15225:2016

UNE-EN ISO 15225:2016

Withdrawn Most Recent

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

€69.00

View more
UNE-EN ISO 13485:2016/AC:2017

UNE-EN ISO 13485:2016/AC:2017

Superseded Historical

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

€0.00

View more
UNE-EN ISO 15378:2018/A1:2024

UNE-EN ISO 15378:2018/A1:2024

Active Most Recent

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)

This product is not for sale, please contact us for more information

View more
UNE 20615/1C:1980

UNE 20615/1C:1980

Superseded Historical

MEDICAL ISOLATING TRANSFORMERS AND CONTROL MONITORING DEVICE

€64.00

View more
UNE-EN 60601-1/A2:1996

UNE-EN 60601-1/A2:1996

Superseded Historical

Medical electrical equipment - Part 1: General requirements for safety

€105.00

View more
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

View more
UNE-EN 980/A1:2000

UNE-EN 980/A1:2000

Superseded Historical

GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES.

€26.00

View more
UNE-EN 980:2004

UNE-EN 980:2004

Superseded Historical

Graphical symbols for use in the labelling of medical devices

€75.00

View more
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

View more