11.040.01 : Medical equipment in general

VDI/VDE 2426 Blatt 3:2000-05

VDI/VDE 2426 Blatt 3:2000-05

Superseded Historical

Catalogues in maintenance and management of medical devices - Fault catalogues

€28.15

View more
VDI/VDE 2426 Blatt 4:2000-05

VDI/VDE 2426 Blatt 4:2000-05

Superseded Historical

Catalogues in maintenance and management of medical devices - Maintenance measures

€28.15

View more
ASTM F2901-19

ASTM F2901-19

Active Most Recent

Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

€65.00

View more
ASTM F3357-19

ASTM F3357-19

Active Most Recent

Standard Guide for Designing Reusable Medical Devices for Cleanability

€65.00

View more
UNE-EN 62304:2007/A1:2016

UNE-EN 62304:2007/A1:2016

Active Most Recent

Medical device software - Software life-cycle processes

€96.00

View more
UNE-EN ISO 10993-16:2018

UNE-EN ISO 10993-16:2018

Active Most Recent

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

€73.00

View more
UNE-EN ISO 13485:2018

UNE-EN ISO 13485:2018

Active Most Recent

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

€123.00

View more
UNE-EN ISO 15378:2018

UNE-EN ISO 15378:2018

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) (ISO 15378:2017)

€134.00

View more
UNE-EN ISO 10993-11:2018

UNE-EN ISO 10993-11:2018

Active Most Recent

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

€96.00

View more
UNE-EN 13718-1:2015+A1:2020

UNE-EN 13718-1:2015+A1:2020

Active Most Recent

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

€69.00

View more
UNE-EN 13718-2:2015+A1:2020

UNE-EN 13718-2:2015+A1:2020

Active Most Recent

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

€89.00

View more
UNE-EN ISO 14155:2021

UNE-EN ISO 14155:2021

Active Most Recent

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

€139.00

View more
UNE-EN ISO 15223-1:2022

UNE-EN ISO 15223-1:2022

Active Most Recent

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

€118.00

View more
UNE-EN ISO 10993-7:2009/A1:2022

UNE-EN ISO 10993-7:2009/A1:2022

Active Most Recent

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

€53.00

View more
UNE-EN ISO 13485:2018/A11:2022

UNE-EN ISO 13485:2018/A11:2022

Active Most Recent

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

€76.00

View more