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UNE-EN ISO 10993-12:2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

Available format(s)

Hardcopy , PDF

Superseded date

16-02-2022

Superseded by

UNE-EN ISO 10993-12:2022

Language(s)

Spanish, Castilian, English

Published date

27-02-2013

€88.80
Excluding VAT

Descrive requisiti e dà guida sulle procedure Essere seguito nella preparazione dei campioni e nella selezione Di materiali di riferimento per verifica di dispositivo medica in biologico Sistemi in conformità con uno e più parti dell'ISO 10993 Serie.

Committee
CTN 111
DocumentType
Standard
Pages
32
PublisherName
Asociacion Espanola de Normalizacion
Status
Superseded
SupersededBy
Supersedes

ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO Guide 33:2015 Reference materials — Good practice in using reference materials
ISO Guide 35:2017 Reference materials — Guidance for characterization and assessment of homogeneity and stability
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO Guide 30:2015 Reference materials — Selected terms and definitions
CFR 40(PTS700-789) : JUL 2016 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
NFS 90 701 : 1988 MEDICO-SURGICAL EQUIPMENT - BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES
ISO Guide 34:2009 General requirements for the competence of reference material producers

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