New work items Komitee 179

Medizintechnik

Medical technology

Document number Starting date
CEN/TS 16945:2016 2016-05-18

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma

EN ISO 15195 2019-02-06

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

EN ISO 20186-1 2019-03-27

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)

EN ISO 20186-3 2019-08-13

Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO/FDIS 20186-3:2019)

EN ISO 20186-2 2019-03-27

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)

EN ISO 20166-2 2018-12-19

Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)

EN ISO 20166-3 2019-01-23

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)

EN ISO 6710 2017-09-06

Single-use containers for human venous blood specimen collection (ISO 6710:2017)

EN ISO 20166-1 2018-12-19

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)

EN ISO 20184-1 2018-12-19

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)

EN ISO 20184-2 2018-12-12

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)

EN ISO 20776-1 2018-09-18

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO/DIS 20776-1:2018)

EN ISO 17511 2019-06-06

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO/DIS 17511:2019)

EN ISO 22870 2016-11-30

Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)

EN ISO 7864 2016-08-31

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

EN ISO 9626 2016-08-31

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

EN ISO 11608-4 2016-10-07

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 ISO 6009 2016-08-31

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

EN ISO 7886-1 2018-03-28

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017)

EN ISO 20695 2019-03-11

Enteral feeding systems - Design and testing (ISO/DIS 20695:2018)

EN ISO 7886-3 2018-08-02

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO/DIS 7886-3:2016)

EN ISO 11608-7 2017-08-02

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)

EN ISO 1135-3 2017-02-22

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

EN ISO 80601-2-56 2017-07-26

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)

EN ISO 8536-13 2016-10-19

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)

EN ISO 8536-14 2018-02-07

Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)

EN ISO 7199 2017-01-25

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)

EN ISO 23500-1 2019-03-20

Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)

EN ISO 8871-5 2016-11-23

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)

EN ISO 22610 2017-03-27

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO/DIS 22610:2015)

CEN/TR 455-5 2017-11-15

Medical gloves for single use - Guidance for selection

EN ISO 8637-1 2017-09-06

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

EN ISO 8637-2 2018-08-22

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)

EN ISO 20696 2018-07-04

Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2018-09)

EN ISO 20697 2018-07-04

Sterile drainage catheters and accessory devices for single use (ISO 20697:2018, Corrected version 2018-09)

EN ISO 7886-4 2019-03-06

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

EN ISO 10555-1/A1 2017-12-20

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements - Amendment 1 (ISO 10555-1:2013/Amd 1:2017)

EN ISO 3826-1 2019-07-23

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

EN ISO 8536-4 2019-07-18

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO/FDIS 8536-4:2019)

prEN ISO 22413 rev 2016-01-27

Transfer sets for pharmaceutical preparations -- Requirements and test methods

EN 455-3/A1 2017-01-19

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

EN ISO 10993-6 2016-12-14

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

EN ISO 10993-7 2016-11-28

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

EN ISO 10993-5 2017-02-09

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

EN ISO 10993-4 2017-10-18

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

EN ISO 10993-11 2018-05-30

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

EN ISO 10993-1 2018-05-26

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/FDIS 10993-1:2018)

EN ISO 10993-9 2019-07-20

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

EN ISO 10993-15 2019-06-13

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

EN ISO 10993-16 2017-12-06

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

EN ISO 10993-18 2019-06-20

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO/FDIS 10993-18:2019)

EN ISO 80601-2-70 2018-05-03

Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apneoa breathing therapy equipment (ISO/DIS 80601-2-70:2013)

EN ISO 5366 2016-10-26

Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)

EN ISO 5361 2016-09-28

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)

EN ISO 5364 2016-09-28

Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)

EN ISO 9170-1/A1 2017-05-30

Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO/FDIS 9170-1:2017)

EN ISO 19054/A1 2016-12-07

Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)

EN ISO 10524-2 2019-01-30

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2018)

EN ISO 10524-3 2019-01-30

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO 10524-3:2019)

EN ISO 17510 2018-05-03

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories

EN ISO 10524-1 2019-01-30

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2018)

EN ISO 80601-2-55 2018-02-28

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)

EN ISO 80601-2-61 2019-01-30

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02)

EN ISO 5359/A1 2017-11-29

Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases - Amendment 1 (ISO 5359:2014/Amd 1:2017)

EN ISO 18082/A1 2017-08-30

Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases - Amendment 1 (ISO 18082:2014/Amd 1:2017)

EN ISO 14607 2018-05-16

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

EN ISO 7198 2017-03-01

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

EN ISO 25539-1 2017-03-15

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

EN ISO 5840-3 2019-04-08

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO/DIS 5840-3:2019)

EN ISO 21535/A1 2016-12-07

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

EN ISO 16054 2019-07-17

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

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