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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
Hardcopy , PDF
Spanish, Castilian, English
27-02-2013
16-02-2022
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 |
Asociación Española de Normalización
|
| Status |
Superseded
|
| Standards | Relationship |
| DIN EN ISO 10993-12:2012-10 | Identical |
| EN ISO 10993-12:2012 | Identical |
| NS EN ISO 10993-12 : 2012 | Identical |
| ISO 10993-12:2012 | Identical |
| BS EN ISO 10993-12:2012 | Identical |
| I.S. EN ISO 10993-12:2012 | Identical |
| NF EN ISO 10993-12 : 2012 | Identical |
| NEN EN ISO 10993-12 : 2012 | Identical |
| NBN 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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