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Number of results 439

UNE
In force
2024-06-05

Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas without mechanical action - Test method and requirements without mechanical action (phase 2, step 2)

UNE
In force
2024-05-22

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

UNE
In force
2024-05-22

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)

UNE
In force
2024-01-17

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

UNE
In force
2023-12-01

Chemical disinfectants and antiseptics - Information on the preparation of spores and determination/exclusion of sporistatical activity (Endorsed by Asociación Española de Normalización in December of 2023.)

UNE
In force
2023-10-18

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

UNE
In force
2023-07-12

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

UNE
In force
2023-06-01

Laboratory glassware - Petri dishes (ISO 13132:2023) (Endorsed by Asociación Española de Normalización in June of 2023.)

UNE
In force
2023-04-12

Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics

UNE
In force
2022-10-01

Chemical disinfectants and antiseptics - Interpretation of water controls in EN 16615:2015 (Endorsed by Asociación Española de Normalización in October of 2022.)

UNE
In force
2022-09-21

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)

UNE
In force
2022-07-27

Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity

UNE
In force
2022-07-27

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

UNE
In force
2022-05-25

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

UNE
In force
2022-03-16

Chemical disinfectants and antiseptics - Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

UNE
In force
2022-02-16

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

UNE
In force
2022-01-19

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

UNE
In force
2022-01-19

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

UNE
In force
2021-10-13

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

UNE
In force
2021-10-06

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

UNE
In force
2021-09-22

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

UNE
In force
2021-05-01

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by Asociación Española de Normalización in May of 2021.)

UNE
In force
2021-02-10

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 20776-1:2019, including Corrected version 2019-12)

UNE
In force
2021-01-20

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

Number of results 439