EN 45502-1:1997

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

This Part 1 of EN 45502 specifies requiremnets that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The test that are specified in EN 45502 are type tests and are to be carries out on samples of a device to show compliance. This Part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources ( for example by gas pressure or by springs.). This Part of EN 45502 is also applicable to some non-implantable parts and accessories of the devices (see note 1). NOTE 1: The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICES may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non- implantable parts and accessories if they could affect safety or performance of the implantable device. NOTE 2: The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3: In this European Standard, terms printed in SMALL CAPITAL LETTERS are used as defined in clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

Aktive implantierbare medizinische Produkte - Teil 1: Allgemeine Festlegungen für die Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu stellende Informationen

Dieser Teil 1 von En 45502 legt Anforderungen fest, die im allgemein für AKTIVEIMPLANTIERBARE MEDIZINISCHE PRODUKTE (AIMP) gelten. Für besondere Arten von AIMP werden diese wesentlichen Anforderungen durch die Anforderunge besonderer Normen ergänzt oder modifiziert, die die zusätlichen Teile dieser Norm bilden.Die Prüfungen, die in dieser EN 45502 festgelegt sind, sind Typprüfungen und an Prüflingen eines Produktes durchzuführen, um die Einhaltung der Anforderungfestzustellen.

Dispositifs médicaux implantables actifs - Partie 1: Règles générales de sécurité, marquage et informations fournies par le fabricant

Cette partie de la EN 45502 spécifie les exigences généralement applicables aux DISPOSITIF MEDICAUX IMPLANTABLES ACTIFS (DMIA). Les exigences essentielles rela-tives à des types spéciaux de DMIA sont complétées ou modifiées par les exi- gences des normes particulières, qui sont regroupées dans les parties addition- nelles. Les essais spécifiés dans la EN 45502 sont des essais de type et doiventêtre effectués sur des échantillons d'un dispositif pour vérifier la conformité.Cette partie est applicable aux DMIA, qui sont alimentés électriquement et à ceux qui fonctionnent à partir d'autres sources d'énergie (gaz pressurisé ...)

Aktivni medicinski pripomočki za vsaditev - 1. del: Splošne zahteve za varnost, označevanje in informacije, ki jih priskrbi proizvajalec

General Information

• Status: Withdrawn
• Publication Date: 26-Aug-1997
• Withdrawal Date: 28-Feb-1998
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/CLC/JWG AIMD - CEN/CLC_JWG_AIMD
• Drafting Committee: CEN/CLC/JWG AIMD - CEN/CLC_JWG_AIMD
• Parallel Committee: CENCLC/JWG AIMD - CENCLC_JWG_AIMD
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 20-Apr-2018
• Completion Date: 20-Apr-2018
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Mandate: BC/CLC/02-89 - BC/CLC/02-89
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN 45502-1:2000 - Active implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer

Relations

• Replaced By: EN 45502-1:2015 - Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
• Effective Date: 28-Jan-2023

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aktive implantierbare medizinische Geräte -- Teil 1: Allgemeine Festlegungen für die Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu stellende InformationenDispositifs médicaux implantables actifs -- Partie 1: Règles générales de sécurité, marquage et informations fournies par le fabricantActive implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 45502-1:1997SIST EN 45502-1:2000en01-april-2000SIST EN 45502-1:2000SLOVENSKI
STANDARD



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