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Standards [CURRENT]

ISO 11608-6

Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems
Edition 2022-04

Standards [CURRENT]

ISO/HL7 27953-1

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting
Edition 2011-12

Standards [CURRENT]

UNE-EN ISO 8871-1

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)
Edition 2005-03-30

Standards [CURRENT]

UNE-EN ISO 8871-3

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)
Edition 2004-12-10

Standards [CURRENT]

UNE-EN ISO 8871-4

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
Edition 2007-05-16

Standards [CURRENT]

UNE-EN ISO 20776-2

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices (ISO 20776-2:2007)
Edition 2008-01-16

Standards [CURRENT]

UNE-EN 17229

Fitness centres - Requirements for centre amenities and operation - Operational and managerial requirements
Edition 2021-01-27

Standards [CURRENT]

UNE-EN ISO 8871-3/A1

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)
Edition 2019-12-04

Standards [CURRENT]

UNE-EN ISO 20776-2

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)
Edition 2022-09-21

Standards [CURRENT]

UNE-EN ISO 11608-3

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022) (Endorsed by Asociación Española de Normalización in July of 2022.)
Edition 2022-07-01

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