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Standards [CURRENT]

UNE-EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Edition 2018-12-26

Standards [CURRENT]

UNE-EN ISO 10993-12

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Edition 2022-02-16

Standards [CURRENT]

UNE-EN ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
Edition 2010-11-17

Standards [CURRENT]

UNE-EN ISO 10993-14

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
Edition 2009-09-09

Standards [CURRENT]

UNE-EN ISO 10993-15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
Edition 2024-01-17

Standards [CURRENT]

UNE-EN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Edition 2018-05-16

Standards [CURRENT]

UNE-EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
Edition 2024-05-22

Standards [CURRENT]

UNE-EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Edition 2021-01-20

Standards [CURRENT]

UNE-EN ISO 10993-18/A1

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)
Edition 2024-05-22

Standards [CURRENT]

UNE-EN ISO 10993-23

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Edition 2021-10-13

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