Buscador de normas

Estado: Active / 2022-09

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022

Estado: Active / 2022-04

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021); German version EN ISO 20776-2:2022

Estado: Active / 2022-03

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021

Estado: Active / 2021-12

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN EN ISO 10993-17 (2009-08).

Estado: Active / 2021-10

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

Estado: Active / 2021-10

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/DAM 1:2021); German and English version EN ISO 10993-18:2020/prA1:2021 / Note: Date of issue 2021-09-17*Intended as an amendment to DIN EN ISO 10993-18 (2021-03).

Estado: Active / 2021-08

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020 / Note: Applies in conjunction with DIN EN ISO 14971 (2020-07).

Estado: Active / 2021-08

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

Estado: Active / 2021-05

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020

Estado: Active / 2021-05

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020

Estado: Active / 2021-04

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

Estado: Active / 2021-03

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020 / Note: To be amended by DIN EN ISO 10993-18/A1 (2021-10).

Estado: Active / 2020-12

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 (ISO 20776-1:2019, including Corrected version 2019-12); German version EN ISO 20776-1:2020

Estado: Active / 2020-04

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2020); German and English version prEN ISO 10993-2:2020 / Note: Date of issue 2020-02-28*Intended as replacement for DIN EN ISO 10993-2 (2006-10).

Estado: Active / 2020-04

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020); German and English version prEN ISO 10993-10:2020 / Note: Date of issue 2020-03-13*Intended as replacement for DIN EN ISO 10993-10 (2014-10).

Estado: Active / 2019-03

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018

Estado: Active / 2018-09

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018

Estado: Active / 2018-05

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018); German and English version prEN ISO 10993-15:2018 / Note: Date of issue 2018-04-20*Intended as replacement for DIN EN ISO 10993-15 (2009-10).

Estado: Active / 2018-02

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017

Estado: Active / 2017-12

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017

Estado: Active / 2017-09

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016

Estado: Active / 2015-02

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014

Estado: Active / 2014-10

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013 / Note: To be replaced by DIN EN ISO 10993-10 (2020-04).

Estado: Active / 2014-06

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)

Estado: Active / 2010-11

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

Estado: Active / 2009-10

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009

Estado: Active / 2009-10

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000); German version EN ISO 10993-15:2009 / Note: DIN EN ISO 10993-15 (2001-11) remains valid alongside this standard until 2010-03-21.*To be replaced by DIN EN ISO 10993-15 (2018-05).

Estado: Active / 2009-08

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 / Note: DIN EN ISO 10993-14 (2002-05) remains valid alongside this standard until 2010-03-21.

Estado: Active / 2009-08

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009 / Note: DIN EN ISO 10993-17 (2003-06) remains valid alongside this standard until 2010-03-21.*To be replaced by DIN EN ISO 10993-17 (2021-12).

Estado: Active / 2006-10

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); German version EN ISO 10993-2:2006 / Note: To be replaced by DIN EN ISO 10993-2 (2020-04).

Estado: Tramitación / 2022-11-29

Evaluación biológica de productos sanitarios. Parte 2: Requisitos relativos a la protección de los animales. (ISO 10993-2:2022)

Estado: Tramitación / 2022-01-09

Evaluación biológica de productos sanitarios. Parte 17: Evaluación del riesgo toxicológico de los componentes de los productos sanitarios. (ISO/DIS 10993-17:2021)

Estado: Tramitación / 2021-10-09

Evaluación biológica de productos sanitarios. Parte 18: Caracterización química de materiales de productos sanitarios dentro de un proceso de gestión de riesgos. Modificación 1: Determinación del coeficiente de incertidumbre (ISO 10993-18:2020/DAM 1:2021).

Estado: Tramitación / 2020-04-05

Evaluación biológica de productos sanitarios. Parte 10: Ensayos de sensibilización cutánea. (ISO/DIS 10993-10:2020).

Estado: Tramitación / 2018-07-02

Evaluación biológica de productos sanitarios. Parte 15: Identificación y cuantificación de los productos de degradación de metales y aleaciones. (ISO/DIS 10993-15:2018)

Estado: Withdrawn / 2022-09

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008

Estado: Withdrawn / 2022-09

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008, Corrigendum to DIN EN ISO 10993-7:2009-02, German version EN ISO 10993-7:2008/AC:2009

Estado: Withdrawn / 2022-09

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018 / Note: Date of issue 2018-07-13

Estado: Withdrawn / 2022-04

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO/DIS 20776-2:2021); German and English version prEN ISO 20776-2:2021 / Note: Date of issue 2021-05-07

Estado: Withdrawn / 2022-03

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009); German version EN ISO 10993-9:2009

Estado: Withdrawn / 2022-03

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2018); German and English version prEN ISO 10993-9:2018 / Note: Date of issue 2018-04-20

Estado: Withdrawn / 2021-10

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO/DIS 10993-23:2019); German and English version prEN ISO 10993-23:2019 / Note: Date of issue 2019-07-05

Estado: Withdrawn / 2021-08

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012

Estado: Withdrawn / 2021-08

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2019); German and English version prEN ISO 10993-12:2019 / Note: Date of issue 2019-07-05

Estado: Withdrawn / 2021-05

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009

Estado: Withdrawn / 2021-05

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017 / Note: Date of issue 2017-03-24

Estado: Withdrawn / 2021-04

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018); German and English version prEN ISO 22442-2:2018 / Note: Date of issue 2018-11-02

Estado: Withdrawn / 2021-04

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2018); German and English version prEN ISO 22442-1:2018 / Note: Date of issue 2018-07-27

Estado: Withdrawn / 2021-03

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009 / Note: DIN EN ISO 10993-18 (2005-10) remains valid alongside this standard until 2010-03-21.

Estado: Withdrawn / 2021-03

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO/DIS 10993-18:2018); German and English version prEN ISO 10993-18:2018 / Note: Date of issue 2018-08-03