GETINGE LUCEA 10 Notice D'utilisation page 16

Introduction
1
Normes appliquées
Pays
Argentina
Australia
Brazil
Brazil
Canada
China
EU
Japan
South Korea
South Korea
South Korea
Switzerland
Taiwan
UK
USA
USA
Tab. 8 : Conformité aux normes relatives au marché
Autres informations (pour Chine uniquement)
适用规格型号：Lucea 10 rail version; Lucea 10 desk version; Lucea 10 mobile version; Lucea 10
wall version, Lucea 40 mobile version, Lucea 40 Ceiling-mounted version
产品名称：手术辅助照明灯
规格型号：见标签
序列号：见标签
生产日期：见标签
性能结构及组成：通常由光源、灯架等组成。预期供手术辅助照明用，为不具备自动防故障功能的
照明灯具，不能单独用于手术。不具有无影效果。
预期用途：用于手术室手术辅助照明。
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Référence Année
Dispocision 2002
2318/2002
TGA 236-2002 2019
RDC 665/2022 2022
RDC 185/2001 2001
SOR/98-282 2021
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
21CFR Part 7 2017
21CFR Subchap-
ter H
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
Title 21--Food And Drugs
Chapter I--Food And Drug Administration Depart-
ment Of Health And Human Services
Subchapter A -- General
PART 7 - Enforcement policy
- Title 21--Food And Drugs
Chapter I--Food And Drug Administration Depart-
ment Of Health And Human Services
Subchapter H -- Medical Devices
LUCEA 10-40
IFU 01701 FR 12