UNE - Spanish national standards

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UNE-ISO/TR 10989:2014IN (19.11.2014)

UNE-ISO/TR 10989:2014IN (19/11/2014)

Reference materials - guidance on, and keywords of, RM categorization

Available languages: Spanish, English

Available design: electronic design (pdf), Print design

from 75.10 USD more info
UNE-CEN/TS 1099:2009EX (24.6.2009)

UNE-CEN/TS 1099:2009EX (24/06/2009)

Plywood - Biological durability - Guidance for the assessment of plywood for use in different use classes

Available languages: English, Spanish

Available design: electronic design (pdf), Print design

from 59.60 USD more info
UNE-EN ISO 10991:2023 (1.11.2023)

UNE-EN ISO 10991:2023 (01/11/2023)

Microfluidics - Vocabulary (ISO 10991:2023) (Endorsed by Asociación Espanola de Normalización in November of 2023.)

Available languages: English

Available design: electronic design (pdf), Print design

from 74.00 USD more info
UNE-EN ISO 10993-1:2026 (28.10.2026)

UNE-EN ISO 10993-1:2026 (28/10/2026)

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)

Available languages: English, Spanish

Available design: electronic design (pdf), Print design

from 131.40 USD more info
UNE-EN ISO 10993-10:2023 (18.10.2023)

UNE-EN ISO 10993-10:2023 (18/10/2023)

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

Available languages: English, Spanish

Available design: electronic design (pdf), Print design

from 135.80 USD more info
UNE-EN ISO 10993-11:2018 (26.12.2018)

UNE-EN ISO 10993-11:2018 (26/12/2018)

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

Available languages: English, Spanish

Available design: electronic design (pdf), Print design

from 108.20 USD more info
UNE-EN ISO 10993-12:2022 (16.2.2022)

UNE-EN ISO 10993-12:2022 (16/02/2022)

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

Available languages: English, Spanish

Available design: electronic design (pdf), Print design

from 90.60 USD more info
UNE-EN ISO 10993-12:2022/A1:2026 (6.5.2026)

UNE-EN ISO 10993-12:2022/A1:2026 (06/05/2026) Change

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)

Available languages: English, Spanish

Available design: electronic design (pdf), Print design

from 61.90 USD more info
UNE-EN ISO 10993-13:2010 (17.11.2010)

UNE-EN ISO 10993-13:2010 (17/11/2010)

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

Available languages: English, Spanish

Available design: electronic design (pdf), Print design

from 79.60 USD more info
UNE-EN ISO 10993-14:2009 (9.9.2009)

UNE-EN ISO 10993-14:2009 (09/09/2009)

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

Available languages: English, Spanish

Available design: electronic design (pdf), Print design

from 74.00 USD more info
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