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.


Webinar om fördelen att standardisera

 

Den 16 december 2020 höll vi ett webinar om Hälsa, vård och omsorg - Varför standardisera? Tema på det första är samhällsnytta, kvalitetssäkring och innovation om du missade tillfället.  Nästa webinar är 4 februari 2021. Välkommen att anmäla dig här>> 

 

 

More information about the committèes work:

Now working on 50 standards
EN 16756, Antimicrobial wound dressings - Requirements and test methods
EN ISO 8638:2013, Approval of NWIP on overtaking ISO 8638:2010 as EN ISO standard via UAP
ISO/TR 19727, Medical devices - Pump tube spallation test - General procedure
EN 13726-5, Non-active medical devices - Test methods for primary wound dressings - Part 5: Bacterial barrier properties
ISO 23907, Sharps injury protection - Requirements and test methods - Sharps containers
EN ISO 20698-1, Catheter systems for neuraxial application - Sterile and single use catheters and accessories - Part 1: General requirements and test methods
EN ISO 80369-2, Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications
ISO 11608-1, Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
ISO 11608-2, Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
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)
EN 455-3:2015/A1, Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
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 6710, Single-use containers for venous blood specimen collection
EN ISO 7886-3, Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO/DIS 7886-3:2016)
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)
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)
ISO 6717, In vitro diagnostic medical devices — Single-use containers for the collection of specimens, other than blood, from humans
ISO 22740, Devices incorporating small-bore connectors- recommended colour allocation for each application
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 8536-4, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 11608-3, Needle-based injection systems for medical use — Requirements and test methods — Part 3: NIS containers and integrated fluid paths
ISO 11608-4, Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
ISO 11608-5, Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
ISO 11608-6, Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
ISO 24072, Aerosol Bacterial Retention Test Method for Air-inlet on Infusion Sets
ISO 24075, Determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices
ISO 8536-15, Infusion equipment for medical use - Part 15: Light-resistant infusion sets for single use
ISO 11040-4:2015/Amd 1, Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling - Amendment 1
ISO 24166-1, Snap-on Bottles for Metering Pumps — Part 1: Tubing Glass
ISO 24166-2, Snap-on Bottles for Metering Pumps — Part 2: Moulded Glass
ISO 24166-3, Snap-on Bottles for Metering Pumps — Part 3: Plastic
ISO/TS 23128, Medical devices - Transfusion set and blood bag compatibility test method
EN ISO 8536-12, Infusion equipment for medical use - Part 12: Check valves for single use (ISO/FDIS 8536-12:2020)
ISO 80369-2, Small bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for breathing systems and driving gases applications
EN ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications (ISO/DIS 80369-7:2019)
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications
ISO 3749, Glass syringes — Determination of extractable Tungsten
EN ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for breathing systems and driving gases applications
EN ISO 81060-3, Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO/DIS 81060-3:2019)
EN ISO 11608-1, Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO/DIS 11608-1:2020)
ISO 8536-12, Infusion equipment for medical use — Part 12: Check valves for single use
ISO 22413, Transfer sets for pharmaceutical preparations - Requirements and test methods
EN ISO 11608-2, Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO/DIS 11608-2:2020)
EN ISO 11608-3, Needle-based injection systems for medical use - Requirements and test methods - Part 3: NIS containers and integrated fluid paths (ISO/DIS 11608-3:2020)
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 11608-4:2020)
EN ISO 11608-5, Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/DIS 11608-5:2020)
EN ISO 22413, Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO/DIS 22413:2020)
ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
ISO 23217, Needle-based injection systems intended for self-administration by paediatric patients — Guidance for design
ISO 8872, Aluminium caps for transfusion, infusion and injection bottles — General requirements and test methods
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Published 109 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 11 companies and organizations
Abigo Medical AB, ASKIM
Becton Dickinson Sweden AB, STOCKHOLM
Dentsply IH AB, MÖLNDAL
Hallands sjukhus Halmstad, Halmstad
Mölnlycke Health Care AB, GÖTEBORG
NeoMed Inc, Woodstock
Nestlé Health Science, STOCKHOLM
Q-Med AB, UPPSALA
SHL Group AB, NACKA STRAND
Skånes Universitetssjukhus (SUS), Malmö
Vygon SA, Ecouen
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International participation 23 international committees
ISO/TC 210, Quality management and corresponding general aspects for medical devices
ISO/TC 210/JWG 4, Joint ISO/TC 210 - IEC/SC 62D WG: Small bore connectors
ISO/TC 210/WG 5, Connectors for reservoir delivery systems
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 84, Devices for administration of medicinal products and catheters
ISO/TC 84/JWG 18, Joint ISO/TC 84 - ISO/TC 76: "Sterile blood sample collection needles for single use"
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 17, Specification and demonstration of reliability of single-use drug delivery systems
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/TC 205, Non-active medical devices
CEN/TC 205/WG 15, Wound dressings
CEN/TC 205/WG 16, Catheters
CEN/TC 205/WG 3, Medical gloves
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Att delta i kommittén

Subjects

Health care technology (11) Medical equipment (11.040) General (11.040.01) Transfusion, infusion and injection equipment (11.040.20) Syringes, needles and catheters (11.040.25)


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Contact

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

Jenny Acaralp
Project manager
jenny.acaralp@sis.se

Mats-Göran Rundgren
Project assistant
mattis.rundgren@sis.se