Tecnología Médica
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ISO/CD 8871-5 - Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
07/09/2023 -
Status: Under development
ISO/FDIS 23217 - Injection systems for self-administration by paediatric patients — Guidelines for design
17/08/2023 -
Status: Under development
ISO/DIS 1135-4 - Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
14/08/2023 -
Status: Under development
ISO/DIS 1135-5 - Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
14/08/2023 -
Status: Under development
ISO/FDIS 10555-7 - Intravascular catheters — Sterile and single-use catheters — Part 7: Peripherally inserted central catheters
14/08/2023 -
Status: Under development
ISO 15747:2018 - Plastic containers for intravenous injections
26/07/2023 -
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document is applicable to plastic...
ISO 8362-1:2018 - Injection containers and accessories — Part 1: Injection vials made of glass tubing
26/07/2023 -
This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the...
ISO 10555-3:2013 - Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
25/07/2023 -
ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.
ISO 10555-5:2013 - Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
25/07/2023 -
ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended...
ISO 20698:2018 - Catheter systems for neuraxial application — Sterile and single-use catheters and accessories
24/07/2023 -
This document specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications.
This document specifies requirements for intended...
ISO/DIS 8362-2 - Injection containers and accessories — Part 2: Closures for injection vials
03/07/2023 -
Status: Under development
ISO/DIS 10555-8 - Intravascular catheters — Sterile and single-use catheters — Part 8: Catheters for extracorporeal blood treatment
21/06/2023 -
Status: Under development
ISO/CD 8362-2 - Injection containers and accessories — Part 2: Closures for injection vials
21/06/2023 -
Status: Under development
ISO/FDIS 10555-1 - Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
12/06/2023 -
Status: Under development
ISO/FDIS 10555-4 - Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
12/06/2023 -
Status: Under development
ISO 20697:2018 - Sterile drainage catheters and accessory devices for single use
18/04/2023 -
This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter...
ISO 18250-3:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications
18/04/2023 -
This document specifies dimensions and requirements for the design and functional performance of connectors intended to be used on enteral reservoirs.
This document does not specify the...
ISO 15010:1998 - Disposable hanging devices for transfusion and infusion bottles — Requirements and test methods
17/04/2023 -
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
ISO/DIS 23217.2 - Injection systems for self-administration by paediatric patients — Guidelines for design
23/02/2023 -
Status: Under development
