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AAMI/ISO TIR10993-19:2020

Current

Current

The latest, up-to-date edition.

Biological evaluation of medical devices— Part 19: Physico-chemical, morphological and topographical characterization of materials

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

18-12-2023

$299.55
Including GST where applicable

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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