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UNE-EN ISO 15189:2023/A11:2024
Medical laboratories - Requirements for quality and competence
UNE-EN ISO 15189:2023
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
UNE-EN ISO 15223-1:2022
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
UNE-ISO 15190:2022
Medical laboratories — Requirements for safety
UNE-EN ISO 15378:2018
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
UNE-EN 15224:2017
Quality management systems - EN ISO 9001:2015 for healthcare
UNE-EN ISO 22870:2017
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
UNE-CEN/CLC Guide 6:2014
Guidelines for standards developers to address the needs of older persons and persons with disabilities (Endorsed by AENOR in February of 2015.)
UNE-EN ISO 15189:2013
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
UNE 179005:2011
Quality criteria for dental insurance
UNE 179001:2011
Quality in dental surgeries and dental services. General requirements.
UNE-EN 15986:2011
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNE-EN ISO 22442-3:2008
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
ASTM F640 - 23
Standard Test Methods for Determining Radiopacity for Medical Use
ASTM E2891 - 20
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
NF EN ISO 14375
Emballages non refermables à l'épreuve des enfants pour produits pharmaceutiques - Exigences et essais
AFNOR SPEC X50-231+A1
Centres de beauté et de bien-être - exigences et recommandations pour l'hygiène et la prévention des risques sanitaires
AFNOR SPEC S99-910
Services de médecine et chirurgie esthétique non opératoires - Exigences et recommandations pour l'hygiène et la prévention des risques sanitaires en période de déconfinement de Covid-19
NF EN ISO 15195
Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage utilisant des procédures de mesure de référence
NF S99-170
Maintenance des dispositifs médicaux - Système de management de la qualité pour la maintenance et la gestion des risques associés à l'exploitation des dispositifs médicaux
UNE-EN ISO 15378:2018/A1:2024
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)
ISO 8284:2024
Traditional Chinese medicine — Simplified accelerated stress simulation methods
ISO/TS 23824:2024
Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology
ISO 15189:2022
Medical laboratories — Requirements for quality and competence