SURGICAL AND MEDICAL DEVICES

UNE-EN ISO 14971:2012

UNE-EN ISO 14971:2012

Superseded Historical

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

€134.00

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UNE-EN 455-1:2020

UNE-EN 455-1:2020

Superseded Historical

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

€53.00

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UNE-EN ISO 7886-2:2020

UNE-EN ISO 7886-2:2020

Active Most Recent

Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)

€76.00

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UNE-EN ISO 7886-3:2020

UNE-EN ISO 7886-3:2020

Active Most Recent

Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)

€74.00

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UNE-EN ISO 10993-18:2021

UNE-EN ISO 10993-18:2021

Active Most Recent

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

€132.00

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UNE-EN 13623:2021

UNE-EN 13623:2021

Active Most Recent

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems - Test method and requirements (phase 2, step 1)

€90.00

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UNE-EN ISO 8536-12:2021

UNE-EN ISO 8536-12:2021

Active Most Recent

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

€69.00

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UNE-EN ISO 10993-23:2021

UNE-EN ISO 10993-23:2021

Active Most Recent

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

€129.00

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UNE-EN ISO 20417:2021

UNE-EN ISO 20417:2021

Active Most Recent

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)

€130.00

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UNE-EN ISO 22442-1:2022

UNE-EN ISO 22442-1:2022

Active Most Recent

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

€91.00

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UNE-EN ISO 22442-2:2022

UNE-EN ISO 22442-2:2022

Active Most Recent

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

€73.00

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UNE-EN ISO 10993-12:2022

UNE-EN ISO 10993-12:2022

Active Most Recent

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

€80.00

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UNE-EN ISO 11138-8:2022

UNE-EN ISO 11138-8:2022

Active Most Recent

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)

€61.00

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UNE-EN ISO 22413:2022

UNE-EN ISO 22413:2022

Active Most Recent

Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)

€69.00

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UNE-EN ISO 10993-9:2022

UNE-EN ISO 10993-9:2022

Active Most Recent

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

€69.00

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