GETINGE Lucea 50 Notice D'utilisation page 20

Introduction
1
Normes appliquées
Référence
Regulation 1907/2006
US California proposi-
tion 65 Act
Directive 2018/851
Directive 94/62/EC
SJ/T 11365-2006
Tab. 6 : Normes et réglementations environnementales
Pays
Argentina
Australia
Brazil
Brazil
Canada
China
EU
Japan
South Korea
South Korea
South Korea
Switzerland
Taiwan
UK
Tab. 7 : Conformité aux normes relatives au marché
20 / 60
Année Intitulé
2006 Enregistrement, évaluation et autorisation des substances
chimiques, ainsi que les restrictions applicables à ces sub-
stances
1986 The Safe Drinking Water and Toxic Enforcement Act of 1986
2018 Gestion des déchets
1994 Emballage et Gestion des déchets
2006 Administrative Measure on the Control of Pollution caused
by Electronic Information Products Chines RoHS (Restriction
of Hazardeous Substances)
Référence Année
Dispocision 2002
2318/2002
TGA 236-2002 2019
RDC 665/2022 2022
RDC 185/2001 2001
SOR/98-282 2022
Regulation n°739 2021
Regulation 2017
2017/745/EU
MHLW Ordi- 2021
nance: MO n°169
Act 14330 2016
Decree 27209 2016
Rule 1354 2017
RS (Odim) 2020
812.213
TPAA 2018
2018-01-31
Act 2021
Intitulé
Administración Nacional de Medicamentos, Ali-
mentos y Tecnología Médica - Registro de pro-
ductos Medicas - Reglamento
Therapeutic Goods (Medical Devices) Regula-
tions 2002. Statutory Rules No. 236, 2002 made
under the Therapeutic Goods Act 1989
GMP Requirements for Medical Devices and IVDs
Technical regulation about the registration of me-
dical products at ANVISA, as well as its alteration,
revalidation, or cancellation
Medical Devices Regulations
Regulation for the Supervision and Administration
of Medical Devices
Medical Devices Regulations
Ministerial Ordinance on Standards for Manufac-
turing Control and Quality Control for Medical De-
vices and In-Vitro Diagnostics
Medica Device Act
Enforcement Decree of Medicl Act
Enforcement Rule of the Medical Act
Medical Devices Ordinance (MedDO) of 1 July
2020
Taiwanese Pharmaceutical Affairs Act
Medical Devices Regulations 2002 n°618
LUCEA 50-100
IFU 01741 FR 11