Standardization · SIS/TK 340

Biologisk säkerhet för medicintekniska produkter

Kirurgiska implantat används för att ersätta kroppsdelar samt för att förstärka, stötta och stabilisera olika funktioner i kroppen. Biologisk säkerhet innebär att de medicintekniska produkter som kommer i direktkontakt med kroppen ska vara oskadliga för människan.

Kommitténs arbete omfattar standarder för biologisk säkerhet och biokompatibilitet, kirurgiska implantat, kliniska prövningar samt klinisk utvärdering av medicintekniska produkter.

Målet är att ge både patient och personal säkra produkter genom att ta fram standarder med relevanta krav för olika typer av implantat samt provningsmetoder för alla kategorier av medicintekniska produkter som kommer i kontakt med människokroppen.

Standarderna utgör också en central del för att produkterna skall godkännas för marknadsföring i Europa, USA och övriga världen.

Standarderna för biologisk säkerhet beskriver olika typer av provningsmetoder för att bl.a. fastställa att en produkt inte är toxisk, carcinogen, påverkar reproduktionen, ger upphov till allergier eller ger lokala oönskade reaktioner. Detta gäller såväl engångsartiklar som infusionsaggregat och kanyler som mer kvalificerade produkter som kirurgiska implantat, anestesiutrustningar och djurvävnad.

More information about the committèes work:

Verksamhetsplan Verksamhetsplan

Verksamhetsplan 2026

Published 66 standards

SS-EN ISO 10993-7:2026
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026, IDT)

SS-EN ISO 10993-6:2026
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2026, IDT)

SS-EN ISO 14155:2026
Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2026, IDT)

SS-EN ISO 10993-1:2025
Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025, IDT)

SS-EN ISO 10993-17:2023/A1:2025
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1 (ISO 10993-17:2023/Amd 1:2025, IDT)

SS-EN ISO 10993-12:2021/A1:2025
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1 (ISO 10993-12:2021/Amd 1:2024, IDT)

SS-EN ISO 14607:2025
Non-active surgical implants — Mammary implants — Particular requirements (ISO/FDIS 14607:2024, IDT)

SS EN ISO 10993-23:2021/A1:2025
Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd1:2025. IDT)

SS-EN ISO 10993-5:2009/A11:2025
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009/A11:2025)

SS-EN ISO 5840-1:2021/A1:2025
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements — Amendment 1 (ISO 5840-1:2021/AMD 1:2024, IDT)

SS-EN ISO 5840-3:2021/A1:2025
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques — Amendment 1 (ISO 5840 3:2021/AMD 1:2024, IDT)

SS-EN ISO 5840-2:2021/A1:2025
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1 (ISO 5840-2:2021/AMD 1:2024, IDT)

SS-EN ISO 14630:2025
Non-active surgical implants — General requirements (ISO 14630:2024, IDT)

SS-EN ISO 7197:2025
Neurosurgical implants — Sterile, single-use hydrocephalus shunts (ISO 7197:2024, IDT)

SS-EN ISO 10993-4:2017+A1:2025
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 (ISO 10993-4:2017/Amd 1, IDT)

SS-EN ISO 21535:2024
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2024, IDT)

SS-EN ISO 21536:2024
Non-active surgical implants — Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2024, IDT)

SS-EN ISO 25539-3:2024
Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters (ISO 25539-3:2023, IDT)

SS-EN ISO 5832-1:2024
Implants for surgery — Metallic materials — Part 1: Wrought stainless steel (ISO 5832-1:2024, IDT)

SS-EN ISO 5832-7:2024
Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024, IDT)

SIS-ISO/TS 10993-19:2024
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials (ISO/TS 10993-19:2020, IDT)

SS-EN ISO 12417-1:2024
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements (ISO 12417-1:2024, IDT)

SS-EN ISO 10993-17:2024
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023, IDT)

SS-EN ISO 10993-18:2020/A1:2023
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)

SS-EN ISO 10993-15:2023
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

SS-EN ISO 7439:2023
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)

SS-EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

SS-EN ISO 10993-2:2022
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

SS-EN ISO 14708-7:2022
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)

SS-EN ISO 14708-5:2022
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)

SS-EN ISO 14708-3:2022
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)

SS-EN ISO 14708-2:2022
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)

SS-EN ISO 14708-4:2022
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)

SS-EN ISO 14708-6:2022
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)

SS-EN ISO 5832-6:2022
Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)

SS-EN ISO 9713:2022
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)

SS-EN ISO 10993-9:2021
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

SS-EN ISO 10993-12:2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

SS-EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

SS-EN ISO 16061:2021
Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

SS-EN ISO 5840-2:2021
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)

SS-EN ISO 5840-1:2021
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)

SS-EN ISO 5840-3:2021
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)

SS-EN ISO 22442-1:2020
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

SS-EN ISO 22442-2:2020
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

SIS-ISO/TS 21726:2020
Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of extractable substances from medical devices (ISO/TS 21726:2019)

SS-EN ISO 25539-2:2020
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)

SS-EN ISO 10993-18:2020
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

SS-EN ISO 16054:2019
Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)

SS-EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

SS-EN ISO 10993-16:2017
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

SS-EN ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

SS-EN ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)

SS-EN ISO 7198:2017
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)

SS-EN ISO 21535:2009/A1:2016
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)

SS-EN 45502-1:2015
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

SS-EN ISO 10993-3:2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

SS-EN ISO 21536:2009/A1:2014
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)

SS-EN ISO 14602:2011
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

SS-EN ISO 10993-13:2010
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

SS-EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

SS-EN 12006-3+A1:2009
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

SS-EN ISO 21534:2009
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

SS-EN ISO 10993-14:2009
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

SS-EN ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)

SS-EN 45502-2-1:2004
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhytmia (cardiac pacemakers)

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Working group 3 workgroups

SIS/TK 340/AG 01, Kliniska prövningar

SIS/TK 340/AG 02, Biologisk säkerhet

SIS/TK 340/AG 03, Implantat

Participants 20 companies and organizations

ACR Consulting SL, Madrid

Aurevia, Kista

Essity Hygiene and Health AB, Mölndal

Gambro Lundia AB, Lund

GBA Key2Compliance AB, Nacka Strand

KF Toxicology Consulting AB, Mölnlycke

Lunds Universitet, Lund

Maquet Critical Care AB, Solna

Mediteq Svenkebo AB, Göteborg

MissionTech AB, Lidingö

Mölnlycke Health Care AB, Mölndal

Nipro Nordics AB, Stockholm

Region Skåne, Lund

RISE Research Institutes of Sweden AB, Borås

Scandinavian Real Heart AB, Västerås

SenzaGen AB, Lund

Sveriges Tandläkarförbund, Stockholm

Veranex Sweden AB, Mölndal

Wellspect AB, Mölndal

WL Gore & Associates Scandinavia AB, Mölndal

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International participation 53 international committees

SIS/TK 340/AG 01, Kliniska prövningar:

CEN/TC 206, Biological and clinical evaluation of medical devices

ISO/TC 194/WG 4, Clinical investigation and evaluation of medical devices in humans

SIS/TK 340/AG 02, Biologisk säkerhet:

CEN/TC 206, Biological and clinical evaluation of medical devices

ISO/TC 194, Biological and clinical evaluation of medical devices

ISO/TC 194/SAG, Strategic Advisory Group

ISO/TC 194/WG 1, Systematic approach to biological evaluation and terminology

ISO/TC 194/WG 10, Implantation

ISO/TC 194/WG 11, Allowable limits for leachable substances

ISO/TC 194/WG 12, Sample preparation and reference materials

ISO/TC 194/WG 13, Toxicokinetics

ISO/TC 194/WG 14, Material characterization

ISO/TC 194/WG 15, Strategic approach to biological assessment

ISO/TC 194/WG 16, Pyrogenicity

ISO/TC 194/WG 17, Nanomaterials

ISO/TC 194/WG 18, Attributes of medical devices relevant to biological risk assessment

ISO/TC 194/WG 19, Tissue product safety

ISO/TC 194/WG 2, Degradation aspects related to biological testing

ISO/TC 194/WG 3, Animal protection aspects

ISO/TC 194/WG 4, Clinical investigation and evaluation of medical devices in humans

ISO/TC 194/WG 5, Cytotoxicity

ISO/TC 194/WG 6, Mutagenicity, carcinogenicity and reproductive toxicity

ISO/TC 194/WG 7, Systemic toxicity

ISO/TC 194/WG 8, Irritation, sensitization

ISO/TC 194/WG 9, Effects on blood

SIS/TK 340/AG 03, Implantat:

CEN/CLC/JTC 16, Active Implantable Medical Devices

CEN/TC 285, Non-active surgical implants

ISO/TC 150, Implants for surgery

ISO/TC 150/SC 1, Materials

ISO/TC 150/SC 1/WG 3, Ceramics

ISO/TC 150/SC 1/WG 4, Metals

ISO/TC 150/SC 1/WG 5, Plastics

ISO/TC 150/SC 2, Cardiovascular implants and extracorporeal systems

ISO/TC 150/SC 2/WG 1, Cardiac valves

ISO/TC 150/SC 2/WG 3, Vascular prostheses

ISO/TC 150/SC 2/WG 4, Blood gas exchangers

ISO/TC 150/SC 2/WG 5, Renal replacement, detoxification and apheresis

ISO/TC 150/SC 2/WG 6, Vascular device-drug combination products

ISO/TC 150/SC 2/WG 7, Cardiovascular absorbable implants

ISO/TC 150/SC 4, Bone and joint replacements

ISO/TC 150/SC 4/WG 1, Mechanical testing

ISO/TC 150/SC 4/WG 3, Wear

ISO/TC 150/SC 4/WG 4, General requirements

ISO/TC 150/SC 6, Active implants

ISO/TC 150/SC 6/JWG 1, Joint ISO/TC 150/SC 6 - IEC/SC 62D WG: Cardiac pacemakers and implantable defibrillators

ISO/TC 150/SC 6/JWG 2, JWG between ISO/TC 150/SC 6 and IEC/SC62B: Effects of magnetic resonance imaging on active implantable medical devices

ISO/TC 150/SC 6/WG 3, Cochlear implants

ISO/TC 150/SC 6/WG 4, Implantable infusion pumps

ISO/TC 150/SC 7, Tissue-engineered medical products

ISO/TC 150/SC 7/WG 1, Management of risk

ISO/TC 150/SC 7/WG 3, Tissue-engineered medical products for skeletal tissues

ISO/TC 150/WG 10, Use and retrieval of surgical implants

ISO/TC 150/WG 12, Implant coatings

ISO/TC 150/WG 7, Fundamental standards

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Subjects

Health care technology (11) Biological evaluation of medical devices (11.100.20)

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CEN & ISO Meetings
ISO/TC 150 - Implants for surgery
ISO/TC 194 - Biological and clinical evaluation of medical devices
CEN/TC 285 - Non-active surgical implants
CEN/TC 206 - Biological and clinical evaluation of medical devices

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Contact

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

Jenny Aromaa
Project manager
jenny.aromaa@sis.se

Mattis Rundgren
Project coordinator
mattis.rundgren@sis.se

Lars Magnus Bjursten
Chairman
Region Skåne