UNE-EN ISO 10993-12:2013

Superseded

View Superseded by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Superseded date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

Language(s)

Spanish, Castilian, English

Published date

27-02-2013

Publisher

Asociacion Espanola de Normalizacion

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Status	Superseded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	UNE-EN ISO 10993-12:2022
Supersedes	UNE-EN ISO 10993-12:2009

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
DIN EN ISO 10993-12 E : 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