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11.100.20 Biological evaluation of medical devices

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Released: 2014-06-26
14/30264453 DC
BS ISO 16782. Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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English
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Released: 2017-02-20
17/30344601 DC
BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process
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English
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Released: 2018-06-26
18/30344902 DC
BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
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English
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Released: 2018-05-04
18/30354689 DC
BS EN ISO 10993-9. Biological evaluation of medical devices Part 9. Framework for identification and quantification of potential degradation products
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English
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Released: 2018-05-02
18/30354781 DC
BS EN ISO 10993-15. Biological evaluation of medical devices Part 15. Identification and quantification of degradation products from metals and alloys
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English
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Released: 2018-08-16
18/30355036 DC
BS EN ISO 10993-7 AMD1. Biological evaluation of medical devices Part 7. Ethylene oxide sterilization residuals
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English
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Released: 2018-08-15
18/30358832 DC
BS EN ISO 10993-18. Biological evaluation of medical devices Part 18. Chemical characterization of medical device materials within a risk management process
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English
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Released: 2018-07-06
18/30370871 DC
BS EN ISO 20776-1. 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
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English
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Released: 2018-08-15
18/30375452 DC
BS EN ISO 22442-1. Medical devices utilizing animal tissues and their derivatives Part 1. Application of risk management
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English
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Released: 2018-11-28
18/30380349 DC
BS ENISO 22442-2. Medical devices utilizing animal tissues and their derivatives Part 2. Controls on sourcing, collection and handling
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English
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Released: 2019-05-13
19/30372368 DC
BS EN ISO 10993-23. Biological evaluation of medical devices Part 23. Tests for irritation
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English
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Released: 2019-05-13
19/30376763 DC
BS EN ISO 10993-12. Biological evaluation of medical devices Part 12. Sample preparation and reference materials
LANGUAGE
English