Standard

ISO/TS 10993-19:2020

Mar 2020 Current

Existing or new amendments and versions must be purchased separately.

Language English French

Services Online + Pdf CHF 101.00 Online CHF 87.00

There are no extended editions available for this standard

There are no available corrigendum or amendments for this standard. Any future corrigendum and amendments will be added automatically for subscribers.

Abstract

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. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness. This document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, which are covered in ISO 10993‑9, ISO 10993‑13, ISO 10993‑14 and ISO 10993‑15. Chemical characterization of materials is covered by ISO 10993‑18. The ISO 10993 series is not applicable when the material or device is not in contact with the body directly or indirectly.

Products specifications

Standard from ISO
Published: March 12 2020
Edition: 2
Document type: TS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.20
International TC: ISO/TC 194

Product Relations

Adopted by: XP ISO/TS 10993-19:2022
Revises: ISO/TS 10993-19:2006

ISO/TS 10993-19:2020

Create subscription