Standards ISO - International Organization for Standardization - Page 279

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
(Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 1: Exigences relatives aux matériaux, aux systemes de barriere stérile et aux systemes d´emballage)

Standard published on 31.1.2019

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
(Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 1: Exigences relatives aux matériaux, aux systemes de barriere stérile et aux systemes d´emballage — Amendement 1: Application de la gestion des risques)

Change published on 13.9.2023

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
(Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage)

Standard published on 31.1.2019

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
(Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage — Amendement 1: Application de la gestion des risques)

Change published on 13.9.2023

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
(Systemes d´injection a aiguille pour usage médical — Exigences et méthodes d´essai — Partie 1: Systemes d´injection a aiguille)

Standard published on 7.4.2022

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1
(Systemes d´injection a aiguille pour usage médical — Exigences et méthodes d´essai — Partie 1: Systemes d´injection a aiguille — Amendement 1)

Change published on 24.4.2026

Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles
(Systemes d´injection a aiguille pour usage médical — Exigences et méthodes d´essai — Partie 2: Aiguilles a deux extrémités pour stylos-injecteurs)

Standard published on 7.4.2022

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
(Systemes d´injection a aiguille pour usage médical — Exigences et méthodes d´essai — Partie 3: Conteneurs et chemins de fluide intégrés)

Standard published on 7.4.2022

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1
(Systemes d´injection a aiguille pour usage médical — Exigences et méthodes d´essai — Partie 3: Conteneurs et chemins de fluide intégrés — Amendement 1)

Change published on 17.4.2026

Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
(Systemes d´injection a aiguille pour usage médical — Exigences et méthodes d’essai — Partie 4: Systemes d´injection a aiguille contenant de l´électronique)

Standard published on 7.4.2022