DPS
Drejtoria e Përgjithshme e Standardizimit
Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri
Main menu

SSH EN ISO 10993-17:2009

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 17: Vërtetimi i limiteve të lejueshme për substancat e filtrueshme (ISO 10993-17:2002)

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
17 qer 2009
95.99 Withdrawal of Standard   14 gush 2024

General information

95.99     14 gush 2024

DPS

DPS/KT 206

European Norm

11.100.20  

anglisht  

Buying

Shfuqizuar

Language in which you want to receive the document.

Scope

ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
ISO 10993-17:2002 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. ISO 10993-17:2002 does not address the potential for exposure from such sources.

Related directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

Të harmonizuara
90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara
2007/47/EC

Direktiva 2007/47/EC e Parlamentit Europian dhe e Këshillit të 5 shtator 2007 amendon Direktivën e Këshillit 90/385/EEC mbi përafrimin e ligjeve të Shteteve Anëtare në lidhje me pajisje medicinale aktive transplatuese, Direktiva e Këshillit 93/42/EEC në lidhje me pajisjet mjekësore dhe Direktivën 98/8/EC në lidhje me vendosjen e produkteve biocide në treg

Life cycle

NOW

WITHDRAWN
SSH EN ISO 10993-17:2009
95.99 Withdrawal of Standard
14 gush 2024

REVISED BY

WITHDRAWN
SSH EN ISO 10993-17:2004

PUBLISHED
SSH EN ISO 10993-17:2023

Related project

Adopted from EN ISO 10993-17:2009