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Standardization · SIS/TK 330

Förbrukningsmaterial inom sjukvården

Kommittén för Förbrukningsmaterial inom sjukvården hanterar produkter så som medicinska handskar, skydd mot stick- och skärskador, injektionsmaterial, kopplingar och katetrar som används inom alla typer av hälso- och sjukvård. Kommittén arbetar för att säkerställa produkternas medicintekniska funktion och underlätta vid upphandling.

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Kommittén arbetar främst för att säkerställa produkternas medicintekniska funktion för säker användning, samt utveckla rationella tillverkningsrutiner som ger industriell effektivitet.

Produkterna kan vara enkla, men också högt kvalificerade. De flesta produkter är massproducerade engångsartiklar, sterila eller osterila. På nästan alla förbrukningsartiklar ställs höga krav ifråga om säkerhet och funktion. Förbrukningsartiklarna ska vara riskfria för patienter och personal och om möjligt fungera tillsammans med produkter av annat fabrikat.

More information about the committèes work:

Now working on 59 standards
ISO 24166-3, Snap-on Bottles for Metering Pumps - Part 3: Plastic
ISO 24166-2, Snap-on Bottles for Metering Pumps - Part 2: Moulded Glass
ISO 24166-1, Snap-on Bottles for Metering Pumps - Part 1: Tubing Glass
EN ISO 8871-2, Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO/DIS 8871-2:2019)
ISO 11040-4:2015/Amd 1, Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling - Amendment 1
ISO 8536-15, Infusion equipment for medical use - Part 15: Light-resistant infusion sets for single use
ISO 24075, Determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices
ISO 24072, Aerosol Bacterial Retention Test Method for Air-inlet on Infusion Sets
ISO 11608-6, Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems
ISO 11608-5, Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated or device-driven features
ISO 11608-4, Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
ISO 11608-3, Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
EN ISO 8871-3:2004/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)
ISO 7886-2, Sterile hypodermic syringes for single use - Part2: Syringes for use with power-driven syringe pumps
ISO 8871-2, Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
EN ISO 7199:2017/A1, Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/DAM 1:2018)
EN ISO 3826-1, Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO/DIS 3826-1:2018)
ISO 3826-1, Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers
EN ISO 8536-4, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO/DIS 8536-4:2018)
ISO 8536-4, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
EN ISO 80601-2-56:2017/A1, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/DAM 1:2018)
ISO 13926-3, Pen systems - Part 3: Seals for pen-injectors for medical use
ISO 28620, Medical devices - Non-electrically driven portable infusion devices
ISO/TR 23128, Medical devices - Blood Transfusion Set Closure Piercing Device (Spike) Insertion Force Test - General procedure
EN ISO 81060-2, Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO/FDIS 81060-2:2018)
ISO 8871-3:2003/Amd 1, Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1
ISO 22740, Devices incorporating small-bore connectors- recommended colour allocation for each application
EN ISO 23500-5, Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/FDIS 23500-5:2018)
EN ISO 23500-4, Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/FDIS 23500-4:2018)
EN ISO 23500-3, Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/FDIS 23500-3:2018)
EN ISO 23500-2, Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO/FDIS 23500-2:2018)
EN ISO 23500-1, Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO/FDIS 23500-1:2018)
ISO 6717, In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
EN ISO 80369-3:2016/A2, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 2 (ISO 80369-3:2016/DAmd 2:2017)
EN ISO 80369-3:2016/A1, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/DAmd 1:2017)
ISO 23907-2, Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers
EN ISO 7886-3, Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO/DIS 7886-3:2016)
ISO 6710, Single-use containers for venous blood specimen collection
ISO 80369-3:2016/Amd 2, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 2
ISO 21882, Sterile packaging of ready for filling vials
ISO 21881, Sterile packaging of ready for filling cartridges
EN ISO 8637-1, Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/FDIS 8637-1:2017)
ISO 20695, Enteral feeding systems - Design and testing
ISO 20069, Guidance for assessment and evaluation of changes to drug delivery systems
ISO 7886-3, Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
EN ISO 11608-4, Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)
ISO 11608-2, Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
ISO 11608-1, Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
EN ISO 20695, Enteral feeding systems - Design and testing (ISO/DIS 20695:2018)
EN ISO 80369-2, Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications
ISO 18250-6, Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6: Neural applications
EN ISO 20698-1, Catheter systems for neuraxial application - Sterile and single use catheters and accessories - Part 1: General requirements and test methods
ISO 23907, Sharps injury protection - Requirements and test methods - Sharps containers
EN 13726-5, Non-active medical devices - Test methods for primary wound dressings - Part 5: Bacterial barrier properties
ISO/TR 19727, Medical devices - Pump tube spallation test - General procedure
EN ISO 8638:2013, Approval of NWIP on overtaking ISO 8638:2010 as EN ISO standard via UAP
EN , Test methods for microbial wound dressings
EN 455-3:2015/A1, Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 16756, Antimicrobial wound dressings - Requirements and test methods
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Published 104 standards
SS-EN ISO 7886-4:2019
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)
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SS-EN ISO 15747:2019
Plastic containers for intravenous injections (ISO 15747:2018)
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SS-EN ISO 23907-1:2019
Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps containers (ISO 23907-1:2019)
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SS-EN ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
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SS-EN ISO 80601-2-56:2017
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)
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SS-EN ISO 80369-7:2017
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016)
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SS-EN ISO 1135-3:2017
Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
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SS-EN ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
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SS-EN ISO 7199:2017
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
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SS-EN ISO 8871-5:2016
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
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SS-EN ISO 8536-13:2016
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
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SS-EN ISO 6009:2016
Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
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SS-EN ISO 9626:2016
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
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SS-EN ISO 7864:2016
Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
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SS-ISO 11040-4:2016
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015, IDT)
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SS-EN ISO 8537:2016
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
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SS-EN ISO 80369-6:2016
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016)
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SS-EN ISO 8362-5:2016
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
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SS-EN ISO 8362-1:2010/A1:2016
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009/Amd 1:2015)
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SS-EN ISO 1135-5:2016
Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
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SS-EN ISO 1135-4:2016
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
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SS-EN ISO 26722:2015
Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014)
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SS-EN ISO 13959:2015
Water for haemodialysis and related therapies (ISO 13959:2014)
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SS-EN ISO 13958:2015
Concentrates for haemodialysis and related therapies (ISO 13958:2014)
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SS-EN ISO 11663:2015
Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
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SS-EN ISO 8362-2:2015
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
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SS-EN ISO 23500:2015
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)
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SS-EN ISO 3826-4:2015
Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
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SS-EN ISO 8536-11:2015
Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)
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SS-EN ISO 8536-10:2015
Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
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SS-EN ISO 8536-9:2015
Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)
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SS-EN ISO 8536-8:2015
Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
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SS-EN ISO 80369-20:2015
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
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SS-EN 455-2:2015
Medical gloves for single use - Part 2: Requirements and testing for physical properties
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SS-EN 455-3:2015
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
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SS-EN ISO 11608-1:2015
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
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SS-EN ISO 11070:2014
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
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SS-EN ISO 8871-2:2005/A1:2014
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
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SS-EN ISO 81060-2:2014
Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
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SS-EN ISO 8637:2014
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
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SS-EN ISO 10555-5:2013
Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)
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SS-EN ISO 10555-4:2013
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
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SS-EN ISO 10555-3:2013
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)
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SS-EN ISO 10555-1:2013
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2013-07-01)
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SS-EN ISO 23908:2013
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
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SS-EN ISO 8536-4:2013/A1:2013
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010/Amd 1:2013)
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SS-EN ISO 8536-4:2013
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)
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SS-EN ISO 22413:2013
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
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SS-EN ISO 8536-5:2013
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)
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SS-EN ISO 3826-1:2013
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
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SS-EN ISO 20072:2013
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
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SS-EN ISO 11608-5:2012
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
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SS-EN ISO 11608-3:2012
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
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SS-EN ISO 81060-1:2012
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
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SS-EN ISO 11608-2:2012
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
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SS-EN ISO 8362-4:2011
Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011)
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SS-EN ISO 8536-1:2011
Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)
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SS-EN ISO 8362-6:2011
Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010)
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SS-EN ISO 8362-7:2010
Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006)
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SS-EN ISO 9187-2:2010
Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)
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SS-EN ISO 9187-1:2010
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)
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SS-EN 1060-3+A2:2010
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
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SS-EN ISO 8536-2:2010
Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)
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SS-EN ISO 8362-1:2010
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009)
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SS-EN ISO 7886-3:2009
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
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SS-EN ISO 21649:2009
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
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SS-EN 12470-2+A1:2009
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
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SS-EN 12470-1+A1:2009
Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
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SS-EN 455-4:2009
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
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SS-EN ISO 8536-3:2009
Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009)
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SS-EN ISO 3826-2:2008
Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)
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SS-EN ISO 3826-3:2007
Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)
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SS-EN ISO 11608-4:2007
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
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SS-EN ISO 8871-4:2006
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
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SS-EN ISO 21171:2006
Medical gloves - Determination of removable surface powder (ISO 21171:2006)
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SS-EN ISO 8871-3:2005
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003)
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SS-EN ISO 8871-2:2005
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)
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SS-EN 13726-4
Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
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SS-EN 13726-3
Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
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SS-EN 13726-6
Non-active medical devices - Test methods for primary wound dressings - Part 6: Odour control
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SS-EN ISO 8362-3
Injection containers and accessories - Part 3: Aluminium caps for injection vials (ISO 8362-3:2001)
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SS-EN 13868
Catheters - Test methods for kinking of single lumen catheters and medical tubing
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SS-EN 13726-2
Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
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SS-EN 13726-1
Test methods for primary wound dressings - Part 1: Aspects of absorbency
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SS-EN 455-1
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
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SS-EN 1615
Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
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SS-EN 1644-2
Test methods for nonwoven compresses for medical use - Part 2: Finished compresses
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SS-EN 1616/A1
Sterile urethral catheters for single use
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SS-EN 12439
Sterile rectal catheters for single use
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SS-EN ISO 7886-2
Sterile hypodermic syringes for single use - Part2: Syringes for use with power-driven syringe pumps (ISO 7886-2:1996)
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SS-EN ISO 10555-2
Sterile, single-use intravascular catheters - Part 2: Angiographic catheters (ISO 10555-2:1996)
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SS-EN 1644-1
Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture ofcompresses
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SS-EN 1618
Catheters other than intravascular catheters - Test methods for common properties
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SS-EN 1707
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
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SS-EN ISO 11070:2014/A1:2018
Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)
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SS-EN ISO 20696:2018
Sterile urethral catheters for single use (ISO 20696:2018)
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SS-EN ISO 10555-1:2013/A1:2017
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements - Amendment 1 (ISO 10555-1:2013/Amd 1:2017)
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SS-EN ISO 11608-7:2017
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
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SS-EN ISO 10555-6:2017
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
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SS-EN ISO 8536-14:2018
Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)
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SS-EN ISO 15378:2017
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
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SS-EN ISO 8637-2:2018
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
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SIS-CEN/TR 16953:2018
Medical gloves for single use - Guidance for selection
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SS-EN ISO 7886-1:2018
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2016)
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Working group 5 workgroups
SIS/TK 330/AG 01, "Non-wovens" och förband
SIS/TK 330/AG 03, Medicinska handskar
SIS/TK 330/AG 04, Medicintekniska produkter för provtagning och administration av läkemedel
SIS/TK 330/AG 06, Transfusions-, injektions- och infusionsutrustning samt primärförpackningar
SIS/TK 330/AG 09, CEN TC 205, ISO TC 210 JWG 4, ISO TC 210 WG 5
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Participants 15 companies and organizations
Abigo Medical AB, Askim
AstraZeneca AB R&D, Mölndal
Becton Dickinson AB, Stockholm
Dentsply IH AB, Mölndal
Landsorganisationen i Sverige LO, Stockholm
Mölnlycke Health Care AB, Göteborg
NeoMed, Inc, Woodstock
Nestle Health Science, Stockholm
Nutricia Nordica AB, Solna
Q-Med AB, Uppsala
Region Kronoberg, Centrallasarettet, Växjö
Region Skåne, Malmö
SHL Group AB, Nacka Strand
Skånes Universitetssjukhus (SUS), Malmö
Vygon (Sweden) AB, Skellefteå
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International participation 26 international committees
ISO/TC 210/AHG, Ad-hoc group for ISO 22740
ISO/TC 210/JWG 4, Joint ISO/TC 210-IEC/SC 62D: Small bore connectors
ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
ISO/TC 76/WG 1, Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment
ISO/TC 76/WG 2, Rigid container systems and related accessories for parenterals and injectables
ISO/TC 76/WG 4, Elastomeric parts and components and related secondary packaging components
ISO/TC 76/WG 6, Primary packaging materials for medical products
ISO/TC 84, Devices for administration of medicinal products and catheters
ISO/TC 84/WG 11, Syringes
ISO/TC 84/WG 13, On-body delivery systems
ISO/TC 84/WG 14, Needle-based injection system (NIS) - Electrotechnical requirements and test methods
ISO/TC 84/WG 15, Device Change Management
ISO/TC 84/WG 16, Drug delivery system requirements for paediatrics and other demographics
ISO/TC 84/WG 3, Needle-based injection systems - Injector, container and pen needle
ISO/TC 84/WG 8, Sharps containers
ISO/TC 84/WG 9, Catheters
CEN/CLC/JTC 3, Quality management and corresponding general aspects for medical devices
CEN/CLC/TC 3/WG 2, Small bore connectors
CEN/SS S02, Transfusion equipment - Förbrukningsmaterial
CEN/SS S03, Syringes - Förbrukningsmaterial
CEN/SS S99, Health environment and medical equipment - Undetermined
CEN/TC 205, Non-active medical devices
CEN/TC 205/WG 14, Surgical clothing and drapes used as medical devices in health care facilities - Performance requirements and test methods
CEN/TC 205/WG 15, Wound dressings
CEN/TC 205/WG 16, Catheters
CEN/TC 205/WG 3, Medical gloves - Förbrukningsmaterial
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Financing
Arbetet styrs och finansieras av de organisationer som deltar i kommittén. Projektavgiften beror på arbetsform och omfattning, samt antal deltagare.
Att delta i kommittén

Påverka nationellt och internationellt

Kommittén skapar ett forum för svenskt inflytande genom aktiv medverkan i den europeiska standardiseringsorganisationen, CEN och den globala standardiseringsorganisationen, ISO. Eftersom standarderna ofta är kopplade till internationella regelverk, som t.ex. EU-förordningar, underlättar dessa vid både tillverkning, inköp och användande av produkterna. Standardiseringsarbetet säkerställer därmed att produkterna tillverkas efter samstämmiga krav, som kan hänvisas till vid upphandlingar. Ett arbete som skapar fri rörlighet och konkurrens av produkter mellan länder, vilket stödjer den svenska exportmarknaden.

Ett värdefullt arbete

I kommittén samlas expertkunskap genom representanter från tillverkare, anbudsgivare, köpare, brukare eller övriga inom branschen. Standardiseringsarbetet ger deltagarna djupare insikt om standardernas krav och hur man arbetar med dessa, vilket underlättar diskussion med olika parter inom branschen. Deltagarna är med och påverkar framtidens standarder, vilket också leder till nya insikter och tidig information som kan omsättas i den egna verksamhetsutvecklingen. 

Vill du vara med i kommittén?

Du är välkommen att delta i SIS tekniska kommitté för Förbrukningsmaterial inom sjukvården. Du som jobbar med tillverkning, upphandlingar, köpare, brukare eller med annat inom branschen. Om du är intresserad av att delta, kan du kontakta oss så berättar vi mer om arbetet.

Årsberättelse 2017

Årsberättelse 2017 TK 330 SIS.pdf

Subjects

Health care technology Medical equipment General Transfusion, infusion and injection equipment Syringes, needles and catheters

Årsrapport 2016 SIS/TK 330

Årsrapport 2016 SIS/TK 330

Contact

If you have questions or want to know more about the SIS standardization activities? Please contact us.

Jenny Acaralp

Jenny Acaralp
Project manager
08-55552057
jenny.acaralp@sis.se

Mattis Rundgren

Mattis Rundgren
Project assistant
08-55552056
mattis.rundgren@sis.se

Related

Standards
SS-EN 60601-1-9 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
SS-EN 60598-2-25 Luminaires - Part 2: Particular requirements - Section 25: Luminaires for use in clinical areas of hospitals and health care buildings
SS-EN ISO 7886-1:2018 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2016)
SIS, Swedish Standards Institute
Box 45443, SE-104 31 Stockholm
Sweden
+46 8-555 520 00
info@sis.se

Visiting address: Solnavägen 1E, 113 65 Stockholm.
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