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Technical rule [CURRENT]

ISO/TR 20416

Medical devices - Post-market surveillance for manufacturers
Edition 2020-07

Pre-standard

ISO/TS 20914

Medical laboratories - Practical guidance for the estimation of measurement uncertainty
Edition 2019-07

Pre-standard

ISO/TS 23128

Medical devices - Transfusion set and blood bag compatibility test method
Edition 2019-12

Pre-standard

BS DD ENV 13609-2

Healthcare informatics. Messages for maintenance of supporting information in healthcare systems. Updating of medical laboratory-specific information
Edition 2000-08-15

Standards [CURRENT]

NF S99-170

Maintenance of medical devices - Quality management system for the maintenance of medical devices and the management of risks associated with their use
Edition 2013-05-17

Standards [CURRENT]

OENORM EN ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
Edition 2010-10-01

Standards [CURRENT]

OEVE/OENORM EN 45502-2-2

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
Edition 2008-12-01

Standards [CURRENT]

NF S99-171

Maintenance of medical devices - Model and definition for establishment and management of the medical device security, quality and maintenance register (RSQM)
Edition 2006-07-01

Standards [CURRENT]

OEVE/OENORM EN 45502-2-1

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Edition 2004-11-01

Standards [CURRENT]

SN EN 45502-2-1 (FR)

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Edition 2003-12

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