Standardization · SIS/TK 330

Förbrukningsmaterial inom sjukvården

Förbrukningsmaterial används varje dag i vården och måste fungera säkert och tillförlitligt. Genom standardisering skapas gemensamma krav som bidrar till patientsäkerhet, effektiv upphandling och produkter som fungerar tillsammans. TK 330 utvecklar standarder för medicinska förbrukningsprodukter som används inom hälso- och sjukvården.

Kommittén arbetar med standardisering av medicinska förbrukningsprodukter som används inom hälso- och sjukvården. Området omfattar bland annat medicinska handskar, injektionsmaterial, katetrar, kopplingar samt produkter för skydd mot stick- och skärskador.

Varför standardisering?

Förbrukningsprodukter används dagligen i vården och måste uppfylla höga krav på säkerhet, kvalitet och funktion. Standarder bidrar till säkrare produkter för patienter och vårdpersonal samt underlättar upphandling och samverkan mellan produkter från olika tillverkare.

Delta i arbetet

Kommittén samlar representanter från vård, myndigheter, industri, forskning och andra intressenter. Som deltagare får du möjlighet att påverka framtida standarder, följa utvecklingen inom området och bidra med din expertis.

Kommitténs arbete

TK 330 deltar i ett omfattande europeiskt och internationellt standardiseringsarbete inom medicinska förbrukningsprodukter. SIS innehar även sekretariatet för CEN/TC 205/WG 15 Wound Dressings, vilket ger svenska intressenter goda möjligheter att följa och påverka utvecklingen av europeiska standarder inom området.

More information about the committèes work:

Verksamhetsplan

Verksamhetsplan 2026

Published 123 standards

SS-EN ISO 80369-1:2026
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements (ISO 80369-1:2025, IDT)

SS-EN ISO 12487:2026
Medical electrical equipment — Clinical performance evaluation of clinical thermometers (ISO 12487:2026, IDT)

SS-EN ISO 15747:2026
Plastic containers for intravenous injections (ISO 15747:2026, IDT)

SS-EN ISO 11608-1:2022/A1:2026
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1 (ISO 11608-1:2022/Amd 1:2026, IDT)

SS-EN ISO 11608-3:2022/A1:2026
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1 (ISO 11608-3:2022/Amd 1:2026, IDT)

SS-EN ISO 1135-4:2025
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2025, IDT)

SS-EN ISO 1135-5:2025
Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2025, IDT)

SS-EN ISO 23908:2025
Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration — Requirements and test methods (ISO 23908:2024, IDT)

SS-EN 455-5:2025
Medical gloves for single use — Part 5: Extractable chemical residues

SS-EN ISO 8536-16:2025
Infusion equipment for medical use — Part 16: Infusion sets for single use with volumetric infusion controllers (ISO 8536-16:2025, IDT)

SS-EN ISO 80369-6:2025
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO 80369-6:2025)

SS-EN ISO 8871-5:2025
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing (ISO 8871-5:2024, IDT)

SS-ISO 11040-4:2025
Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2024, IDT)

SS-EN ISO 80369-20:2025
Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods (ISO 80369‑20:2024, IDT)

SS-EN ISO 15378:2017/A1:2024
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) — Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024, IDT)

SS-EN 455-1:2020+A2:2024
Medical gloves for single use — Part 1: Requirements and testing for freedom of holes

SS-EN ISO 7199:2024
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) (ISO 7199:2024, IDT)

SS-EN ISO 23500-2:2024
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024, IDT)

SS-EN ISO 80369-2:2024
Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications (ISO 80369-2:2024, IDT)

SS-EN ISO 23500-1:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements (ISO 23500-1:2024, IDT)

SS-EN ISO 8536-13:2024
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024)

SS-EN ISO 8362-2:2024
Injection containers and accessories — Part 2: Closures for injection vials (ISO 8362-2:2024, IDT)

SS-EN ISO 23500-3:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024, IDT)

SS-EN ISO 23500-5:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024, IDT)

SS-EN ISO 23500-4:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024, IDT)

SS-EN 455-2:2024
Medical gloves for single use — Part 2: Requirements and testing for physical properties

SS-EN ISO 8637-2:2024
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2023, IDT)

SS-EN 17854:2024
Antimicrobial wound dressings — Requirements and test method

SS-EN ISO 81060-2:2019/A2:2024
Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 2 (ISO 81060 2:2018/Amd 2:2023, IDT)

SS-EN ISO 10555-1:2024
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)

SS-EN ISO 10555-4:2024
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)

SS-EN 455-3:2023
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

SS-EN 13726:2023
Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility

SS-EN ISO 24072:2023
Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023)

SS-EN ISO 3826-1:2019/A1:2023
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)

SS-EN ISO 11608-5:2023
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)

SS-EN ISO 8536-15:2022/A1:2023
Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023)

SS-EN ISO 8536-2:2023
Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)

SS-EN ISO 21649:2023
Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)

SS-EN ISO 81060-3:2023
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)

SS-EN ISO 80369-3:2016/A1:2022
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)

SS-EN ISO 8872:2022
Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and test methods (ISO 8872:2022)

SS-EN ISO 8362-2:2015/A1:2022
Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)

SS-EN ISO 8536-3:2009/A1:2022
Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:2009/Amd 1:2022)

SS-EN ISO 11608-3:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)

SS-EN ISO 11608-2:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)

SS-EN ISO 11608-1:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)

SS-EN ISO 11608-4:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)

SS-ISO 11040-8:2022
Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016, IDT)

SS-EN ISO 8536-15:2022
Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)

SS-EN ISO 22413:2021
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)

SS-EN ISO 80369-7:2021
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)

SS-EN ISO 8536-12:2021
Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

SS-EN ISO 81060-2:2019/A1:2020
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)

SS-EN ISO 8871-2:2020
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)

SS-EN ISO 7886-3:2020
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)

SS-EN ISO 7886-2:2020
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)

SS-EN ISO 80601-2-56:2017/A1:2020
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/Amd 1:2018)

SS-EN ISO 8637-1:2020
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

SS-EN ISO 20695:2020
Enteral feeding systems - Design and testing (ISO 20695:2020)

SS-EN ISO 8536-4:2020
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

SS-EN ISO 81060-2:2019
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)

SS-EN ISO 10555-6:2017/A1:2019
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)

SS-EN ISO 3826-1:2019
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)

SS-EN ISO 8362-1:2019
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2018)

SS-EN ISO 8871-3:2005/A1:2019
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)

SS-EN ISO 7886-4:2019
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)

SS-EN ISO 23907-1:2019
Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps containers (ISO 23907-1:2019)

SS-EN ISO 23907-1:2019
Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps containers (ISO 23907-1:2019)

SS-EN ISO 20697:2018
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018)

SS-EN ISO 20696:2018
Sterile urethral catheters for single use (ISO 20696:2018)

SS-EN ISO 11070:2014/A1:2018
Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

SS-EN ISO 7886-1:2018
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2016)

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)

SIS-CEN/TR 16953:2018
Medical gloves for single use - Guidance for selection

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)

SS-EN ISO 10555-6:2017
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)

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)

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)

SS-EN ISO 1135-3:2017
Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)

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)

SS-EN ISO 6009:2016
Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)

SS-EN ISO 9626:2016
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

SS-EN ISO 7864:2016
Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

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)

SS-EN ISO 8537:2016
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

SS-EN ISO 8362-5:2016
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)

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)

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)

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)

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)

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)

SS-EN ISO 11070:2014
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)

SS-EN ISO 10555-5:2013
Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)

SS-EN ISO 10555-3:2013
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)

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)

SS-EN ISO 20072:2013
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)

SS-EN ISO 81060-1:2012
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

SS 872400:2012
Medical compression hosiery - Requirements and test methods

SS-EN ISO 8536-1:2011
Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)

SS-EN ISO 8362-4:2011
Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011)

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)

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)

SS-EN ISO 9187-1:2010
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)

SS-EN ISO 9187-2:2010
Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)

SS-EN 1060-3+A2:2010
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

SS-EN 455-4:2009
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

SS-EN 12470-2+A1:2009
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

SS-EN 12470-1+A1:2009
Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device

SS-EN ISO 8536-3:2009
Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009)

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)

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)

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)

SS-EN ISO 21171:2006
Medical gloves - Determination of removable surface powder (ISO 21171:2006)

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)

SS-EN ISO 8362-3
Injection containers and accessories - Part 3: Aluminium caps for injection vials (ISO 8362-3:2001)

SS-EN 13868
Catheters - Test methods for kinking of single lumen catheters and medical tubing

SS-EN 1615
Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing

SS-EN 1644-2
Test methods for nonwoven compresses for medical use - Part 2: Finished compresses

SS-EN 12439
Sterile rectal catheters for single use

SS-EN ISO 10555-2
Sterile, single-use intravascular catheters - Part 2: Angiographic catheters (ISO 10555-2:1996)

SS-EN 1644-1
Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture ofcompresses

SS-EN 1707
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings

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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 8 companies and organizations

Abigo Medical AB, Mölndal

Abigo Medical AB, Göteborg

Hallands sjukhus Halmstad, Halmstad

Landsorganisationen i Sverige LO, Stockholm

Mölnlycke Health Care AB, Mölndal

Region Halland, Halmstad

SHL Medical AB, Nacka Strand

Wellspect AB, Mölndal

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International participation 24 international committees

SIS/TK 330/AG 01, "Non-wovens" och förband:

CEN/TC 205, Non-active medical devices

CEN/TC 205/WG 15, Wound dressings

SIS/TK 330/AG 03, Medicinska handskar:

CEN/TC 205, Non-active medical devices

CEN/TC 205/WG 3, Medical gloves

SIS/TK 330/AG 04, Medicintekniska produkter för provtagning och administration av läkemedel:

CEN/TC 205, Non-active medical devices

ISO/TC 84, Devices for administration of medicinal products and catheters

ISO/TC 84/WG 10, Needles

ISO/TC 84/WG 11, Syringes

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 injury protection

ISO/TC 84/WG 9, Catheters

SIS/TK 330/AG 06, Transfusions-, injektions- och infusionsutrustning samt primärförpackningar:

CEN/TC 205, Non-active medical devices

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/WG 9, Catheters

SIS/TK 330/AG 09, CEN TC 205, ISO TC 210 JWG 4, ISO TC 210 WG 5:

CEN/CLC/JTC 3, Quality management and corresponding general aspects for medical devices

CEN/TC 205, Non-active medical devices

ISO/TC 210, Quality management and corresponding general aspects for products with a health purpose including 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

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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.

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)

För dig som är kommittédeltagare

Klicka här för att ta dig till kommitténs digitala arbetsyta.

Hur du som deltagare kan berätta om standardisering

Information om utbildningar, regelverk och ordlista inom standardisering.

Så kan du förankra standardiseringsarbetet i din organisation

Nyttiga länkar för kommittédeltagare

CEN & ISO Meetings
ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
ISO/TC 84 - Devices for administration of medicinal products and catheters
ISO/TC 210 - Quality management and corresponding general aspects for medical devices

CEN/TC 205 - Non-active medical devices

Kommittén bidrar bland annat till de här tre målen:

Läs mer om de globala målen här >

SIS Webinar

Hälsa, vård och omsorg – Varför standardisera?

Del 1 – Samhällsnytta, Kvalitetssäkring och innovation

Del 2 – Patientsäkerhet, lagkrav och nya initiativ.

Webinar 27 april 2021 - Nyttan med standarder- hur kan vi använda standarder vid upphandling

Webinar 27 april 2021 - Nyttan med standarder- hur kan vi använda standarder vid upphandling

Hur kan standarder bidra till ökad patientsäkerhet, kvalitet, kostnadseffektivitet och samhällsnytta?

Deltagare i standardiseringskommittéerna TK 330 Förbrukningsmaterial inom sjukvården och TK 595 Trycksårsprevention berättar om hur standarder kan göra nytta i ditt arbete med upphandling.

De produktområden som berörs i webinaret är medicinska handskar, förband och tryckavlastande madrasser.

Se webinaret genom att klicka här

Följ oss på vår LinkedIn, Hälsa, vård och omsorg SIS

Följ oss på vår LinkedIn, Hälsa, vård och omsorg SIS

Contact

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

Paulo Cruz Nunez
Project manager
paulo.cruz.nunez@sis.se

Jenny Aromaa
Vice project manager
jenny.aromaa@sis.se

Mattis Rundgren
Project coordinator
mattis.rundgren@sis.se