UNE-EN ISO 10993-12:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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)
Hardcopy , PDF
16-02-2022
Spanish, Castilian, English
27-02-2013
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Superseded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 |
Standards | Relationship |
ONORM EN ISO 10993-12 : 2012 | Identical |
DIN EN ISO 10993-12:2012-10 | Identical |
ISO 10993-12:2012 | Identical |
NBN EN ISO 10993-12 : 2012 | Identical |
NEN EN ISO 10993-12 : 2012 | Identical |
NS EN ISO 10993-12 : 2012 | Identical |
I.S. EN ISO 10993-12:2012 | Identical |
SN EN ISO 10993-12 : 2012 | Identical |
UNI EN ISO 10993-12 : 2012 | Identical |
BS EN ISO 10993-12:2012 | Identical |
EN ISO 10993-12:2012 | Identical |
NF EN ISO 10993-12 : 2012 | Identical |
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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