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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.

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
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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

Subjects

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