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11.100.20 Biological evaluation of medical devices
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24/30482475 DC
BS EN ISO 10993-2 Biological evaluation of medical devices Part 2: Animal welfare requirements
BS EN ISO 10993-2 Biological evaluation of medical devices Part 2: Animal welfare requirements
Released: 2024-11-11
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BS EN ISO 10993-15:2023
Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys
Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys
Released: 2023-05-24
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24/30475247 DC
BS EN ISO 10993-4:2017/Amd 1 Biological evaluation of medical devices Part 4. Selection of tests for interactions with blood. Amendment 1
BS EN ISO 10993-4:2017/Amd 1 Biological evaluation of medical devices Part 4. Selection of tests for interactions with blood. Amendment 1
Released: 2024-03-11
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23.53 USD
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25/30482510 DC
BS EN ISO 10993-16 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-16 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
Released: 2025-12-08
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BS EN ISO 10993-6:2026 - TC
Tracked Changes. Biological evaluation of medical devices Tests for local effects after implantation
Tracked Changes. Biological evaluation of medical devices Tests for local effects after implantation
Released: 2026-06-04
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611.53 USD
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BS EN ISO 14155:2026 - TC
Tracked Changes. Clinical investigation of medical devices for human subjects. Good clinical practice
Tracked Changes. Clinical investigation of medical devices for human subjects. Good clinical practice
Released: 2026-05-05
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660.24 USD
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BIP 0113:2012
Guide to European medical device trials and BS EN ISO 14155
Guide to European medical device trials and BS EN ISO 14155
Released: 2012-06-13
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78.47 USD
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26/30546338 DC
BS EN ISO 10993-4 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
BS EN ISO 10993-4 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
Released: 2026-07-01
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PD ISO/TR 15499:2016
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Released: 2017-01-31
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DD ISO/TS 10993-20:2006
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
Released: 2006-09-29
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BS EN ISO 10993-16:2017
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
Released: 2020-03-30
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313.88 USD
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