Standardization · SIS/TK 349

Rengöring, desinfektion och sterilisering

När vi kommer i kontakt med sjukvården förutsätter vi att instrumenten är rengjorda och sterila, och så ska det naturligtvis vara. Kommittén skapar förutsättningar för en säker sjukvård genom att arbeta fram standarder för bland annat steriliseringsprocesser som effektivt förhindrar smitta och ökar patientsäkerheten.

Kommittén för rengöring, desinfektion och sterilisering är med och aktivt påverkar innehåll och riktlinjer för framtida standarder, både globalt och nationellt. Standarderna syftar till att skapa säkra produkter och processer där alla delar av rengöring, desinfektion och sterilisering effektivt förhindrar att smitta och infektioner sprids.

Arbetet resulterar i standarder som gör det möjligt för vårdgivare, tillverkare, leverantörer och myndighet att enas om gemensamma krav för tillverkning och användande av medicintekniska produkter. Detta bidrar till ökad patientsäkerhet och samordning inom vården.

More information about the committèes work:

Now working on 63 standards
ISO 11138-6, Sterilization of health care products - Biological Indicators - Part 6: Biological indicators for hydrogen peroxide vapour sterilization processes
ISO 16342, Sterilization of health care products - Method for validation of a biological indicator incubation period
EN ISO 15424, Sterilization of medical devices - low temperatur steam and formaldehyde - Requirements for development , validation and routine control of a sterilization process for medical devices
ISO 17210, Test method to demonstrate the suitability of a medical device simulator during steam sterilization - Medical device simulator testing
, Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method and requirements (phase 2, step 2)
SIS-TR 600, -
SIS HB 600-7, . . .
ISO/TS 19572, Sterilization of health care products — Guidance on the application of ISO14937 to the sterilization of medical devices using Ethylene Oxide in a flexible sterilization chamber
ISO 15883-5, Washer-disinfectors — Part 5: Test methods for demonstrating cleaning efficacy of washer-disinfectors
ISO 13408-1, Aseptic processing of health care products - Part 1: General requirements
ISO 11140-6, Sterilization of health care products - Chemical indicators - Part 6: Class 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
ISO 11138-1, Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-3, Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
ISO 11138-4, Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
ISO 11138-5, Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
EN ISO 15883-5, Washer disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO/DIS 15883-5:2019)
EN 17180, Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing
EN ISO 16342, Biological indicators — Method for validation of incubation
ISO/TS 11137-4, Sterilization of health care products - Radiation - Part 4: Guidance on process control
CEN/TC 216 N 933, Quantitative test method for the evaluation of virucidal activity on non-porous surfaces with mechanical action in the medical area (4-field test) — Test method and requirements (phase 2, step 2)
SS 150000, General requirements for distribution logistics of medical devices with specified cleanliness level within health care organization
ISO/TS 21387, Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
ISO 11138-6, Sterilization of health care products - Biological indicators - Part 6: Biological indicators for hydrogen peroxide sterilization processes
EN 16437/A1, Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action - Test method and requirements
ISO 14161, Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
ISO 13408-6, Aseptic processing of health care products - Part 6: Isolator systems
ISO/TS 22421, Sterilization of health care products - Common requirements for sterilizers forterminal sterilization of medical devices in health care facilities
ISO/TS 22456, Sterilization of healthcare products - Microbiological Methods- Guidance on conducting bioburden determinations and tests of sterility for tissue-based products
ISO 11138-5/Amd1, Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
EN , Quantitative surface test for the evaluation of residual antimicrobial ( bactericidal and/or yeasticidal) efficacy of liquid chemical disinfectan ts on hard non-porous surfaces. Test method
EN 13697:2015, Chemical disinfectants and antiseptics — Quantitative non-porous surface test for the evaluation of bactericidal and/or yeasticidal and/or fungicidal activity of chemical disinfectants used in medical area — Part rev: Test method and requirements without mechanical action (phase 2, step 2)
ISO 22913, Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Medical devices not intended for direct patient contact
ISO 22441, Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO/FDIS 11607-1:2018)
EN ISO 11607-2, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/FDIS 11607-2:2018)
ISO 11138-7, Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
ISO PRF 14160, Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
EN ISO 14160, Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO/DIS 14160:2018)
EN 17272, Chemical disinfectants and antiseptics - Methods of airborne room disinfection by automated process - Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities
EN 285:2015/A1:2018, Sterilization - Steam sterilizers - Large sterilizers
EN ISO 18362, Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016)
EN 14222, Stainless steel shell boilers
EN 17430, Chemical disinfectants and antiseptics - Hygienic handrub virucidal - Test method and requirements (phase 2/step 2)
EN 13623, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems - Test method and requirements (phase 2, step 1)
, Quantitative carrier test method for the evaluation of sporicidal activity of chemical disinfectants on hard non-porous surfaces in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 2)
, Chemical disinfectants and antiseptics - Quantitative suspension test method for the evaluation of virucidal activity of chemical disinfectants and antiseptics in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
, Quantitative carrier test method for the evaluation of virucidal activity of chemical disinfectants on hard non-porous surfaces in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 2)
ISO 11138-8, Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
EN ISO 22441, Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 22913, Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Medical devices not intended for direct patient contact
EN ISO 11737-2, Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/FDIS 11737-2:2019)
EN 13624, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
ISO 17665, Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-3, Sterilization of medical devices - Microbiological methods - Part 3: Bacterial endotoxin testing
ISO 11737-1:2018/Amd 1, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1
EN 12353, Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
ISO/TS 16775, Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
CEN ISO/TS 16775, Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
EN ISO 13408-6, Aseptic processing of health care products - Part 6: Isolator systems (ISO/DIS 13408-6:2019)
EN 17387, Chemical disinfectants and antiseptics — Quantitative non-porous surface test for the evaluation of bactericidal and/or yeasticidal and/or fungicidal activity of chemical disinfectants used in medical area — Part rev: Test method and requirements without mechanical action (phase 2, step 2)
EN ISO 11737-1:2018/A1, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/DAM 1:2019)
EN 556-1 prA1, Sterilization of medical devices - Requirements for medical devices to be designated "sterile" - Part: 1 Reqiurements for terminally sterilized medical devices
SIS-TR 57, Handbok för grundläggande rekommendationer för lagerhållning, hantering och transport av sterila medicintekniska produkter inom hälso- och sjukvård, tandvård, djursjukvård och yrkesmässig hygienisk verksamhet
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Published 107 standards
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Working group 1 workgroups
SIS/TK 349/AG 03, Lagerhållning och logistik inom vården
Participants 18 companies and organizations
Akademiska sjukhuset Klinisk mikrobiologi och vårdhygien, Uppsala
Arctic Paper Munkedals AB, Munkedal
B. Braun Medical AB, Danderyd
BillerudKorsnäs Sweden AB, Skärblacka
Bjerking AB, Uppsala
Danderyds Sjukhus AB, Stockholm
Falu lasarett, Falun
Getinge Disinfection AB, Växjö
Getinge Sterilization AB, Getinge
Getinge Sverige AB, Getinge
Johnson & Johnson AB, Solna
Q-Med AB, Uppsala
Region Värmland, Karlstad
SUS, Malmö
Tiohundra AB, Norrtälje
Universitetssjukhuset Örebro, ÖREBRO
W & H Nordic AB, Täby
YrkesAkademin YH AB, Orsa
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International participation 28 international committees
ISO/TC 198, Sterilization of health care products
ISO/TC 198/WG 1, Industrial ethylene oxide sterilization
ISO/TC 198/WG 11, General criteria for sterilization processes and sterilizing equipment
ISO/TC 198/WG 12, Information for reprocessing of resterilizable devices
ISO/TC 198/WG 13, Washer-disinfectors
ISO/TC 198/WG 15, Assurance of sterility
ISO/TC 198/WG 16, Vaporized hydrogen peroxide sterilization
ISO/TC 198/WG 2, Radiation sterilization
ISO/TC 198/WG 3, Moist heat sterilization
ISO/TC 198/WG 4, Biological indicators
ISO/TC 198/WG 5, Terminology
ISO/TC 198/WG 6, Chemical indicators
ISO/TC 198/WG 7, Packaging
ISO/TC 198/WG 8, Microbiological methods
ISO/TC 198/WG 9, Aseptic processing
CEN/TC 102, Sterilizers and associated equipment for processing of medical devices
CEN/TC 102/WG 4, Packaging
CEN/TC 102/WG 5, Steam sterilizers
CEN/TC 102/WG 6, Low temperature sterilizers
CEN/TC 102/WG 7, Biological and chemical indicators
CEN/TC 102/WG 8, Washer-disinfectors
CEN/TC 204, Sterilization of medical devices
CEN/TC 204/WG 6, Microbiological quality of processed medical devices
CEN/TC 216, Chemical disinfectants and antiseptics
CEN/TC 216/WG 1, Human medicine
CEN/TC 216/WG 2, Veterinary use
CEN/TC 216/WG 3, Food hygiene and domestic and institutional use
CEN/TC 216/WG 5, Strategy Group
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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.
Information om kommittearbetet
Aktuella remisser att kommentera på
Europeiskt sekreteratiat för CEN/TC102/WG 6
Årsberättelse 2018

Subjects

Health care technology (11) Sterilization and disinfection (11.080)


Illustation av leveranskontroll, exempel ur SS 8760015:2017

Figur A1 i bilaga A i SS 8760015:2017 ger exempel på transportskador och åtgärder för dessa som kan ske vid leverans. Denna finns tillgänglig att ladda ner kostnadsfritt.

Contact

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

Anna Sjögren
Project manager
08-55552087
anna.sjogren@sis.se

Ulla Hihldor
Project assistant
+46855552018
ulla.hihldor@sis.se