Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)
€145.00
Clinical investigation of medical devices for human subjects - Good clinical practice
€20.00
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
€140.00
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
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO/DIS 10993-23:2019); German and English version prEN ISO 10993-23:2019
€179.53
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
€185.05
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024
€150.65
Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices
€115.00
Medical devices utilizing animal tissues and their derivatives Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids Part 1: Terminology and general requirements for nucleic acid quality evaluation
€155.00
Biological evaluation of medical devices Part 55: Interlaboratory study on cytotoxicity
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood Part 1: Isolated RNA
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood Part 2: Isolated DNA
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood Part 3: Preparations for analytical CTC staining
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids Part 3: Interpretation and reports
