This International Standard applies to sterilized, single-use transfer devices for pharmaceutical preparations.
EN ISO 22413:2013 Referenced Document
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15747:2010 Plastic containers for intravenous injections
ISO 15759:2005 Medical infusion equipment - Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 7864:1993 Sterile hypodermic needles for single use
ISO 8362-1:2009 Injection containers and accessories - Part 1: Injection vials made of glass tubing
ISO 8362-2:2008 Injection containers and accessories - Part 2: Closures for injection vials
ISO 8362-3:2001 Injection containers and accessories - Part 3: Aluminium caps for injection vials
ISO 8362-4:2011 Injection containers and accessories - Part 4: Injection vials made of moulded glass
ISO 8362-5:2008 Injection containers and accessories - Part 5: Freeze drying closures for injection vials
ISO 8362-6:2010 Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials
ISO 8362-7:2006 Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
ISO 8536-10:2004 Infusion equipment for medical use - Part 10: Accessories for fluid lines for use with pressure infusion equipment
ISO 8536-11:2004 Infusion equipment for medical use - Part 11: Infusion filters for use with pressure infusion equipment
ISO 8536-12:2007 Infusion equipment for medical use - Part 12: Check valves
ISO 8536-1:2011 Infusion equipment for medical use - Part 1: Infusion glass bottles
ISO 8536-2:2010 Infusion equipment for medical use - Part 2: Closures for infusion bottles
ISO 8536-3:2009 Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles
ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 8536-5:2004 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
ISO 8536-6:2009 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
ISO 8536-7:2009 Infusion equipment for medical use - Part 7: Caps made of aluminium-plastics combinations for infusion bottles
ISO 8536-8:2004 Infusion equipment for medical usePart 8:Infusion equipment for use with pressure infusion apparatus*， 2013-02-08 Update
ISO 8536-9:2004 Infusion equipment for medical usePart 9:Fluid lines for use with pressure infusion equipment*， 2013-02-08 Update
EN ISO 22413:2013 history
2021EN ISO 22413:2021 Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
2013EN ISO 22413:2013 Transfer sets for pharmaceutical preparations - Requirements and test methods
2011EN ISO 22413:2011 Transfer sets for pharmaceutical preparations - Requirements and test methods