AAMI/ISO TIR10993-19:2020
Current
The latest, up-to-date edition.
Biological evaluation of medical devices— Part 19: Physico-chemical, morphological and topographical characterization of materials
English
18-12-2023
This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices.
| DocumentType |
Test Method
|
| ISBN |
9781570208812
|
| Pages |
27
|
| ProductNote |
This standard also refers to ISO 10993-1, ISO 10993-9, ISO 10993-15
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| EN 455-3:2023 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| ISO 16610-21:2011 | Geometrical product specifications (GPS) — Filtration — Part 21: Linear profile filters: Gaussian filters |
| ISO 22442-1:2007 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
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