This part of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL 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 ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 2 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can 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 the safety or performance of the implantable device. NOTE 3 In this part of EN 45502, 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.
Số hiệu tiêu chuẩn
EN 45502-1
Tên tiêu chuẩn
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Ngày phát hành
2015-05-00
Tiêu chuẩn tương đương
BS EN 45502-1 (2015-06-30), IDT * NEN-EN 45502-1:2015 en (2015-06-01), IDT
Tiêu chuẩn liên quan
EN ISO 13485 (2012-02) *
EN ISO 15223-1 (2012-07) *
ISO 7000*ISO 7000-DB (2014-01) *
ISO 8601 (2004-12) * EN 50061 (1988-07) * EN 60068-2-14 (2009-07) * EN 60068-2-27 (2009-05) * EN 60068-2-47 (2005-06) * EN 60068-2-64 (1994-06) * EN 60068-2-64 (2008-09) * EN 60601-1 (2006-10) * EN 60601-1/A1 (2013-10) * EN 62127-1 (2007-10) * EN 62304 (2006-07) * EN 62366 (2008-01) * EN ISO 10993-1 (2009-06) * EN ISO 10993-9 (2009-12) * EN ISO 11135-1 (2007-05) * EN ISO 11137-1 (2006-04) * EN ISO 11137-2 (2013-06) * EN ISO 11607-1 (2006-04) * EN ISO 14155 (2011-10) * EN ISO 14937 (2009-10) * EN ISO 14971 (2012-07) * EN ISO 17665-1 (2006-08) * ISO/TS 10974 (2012-05) * ISO/TR 14283 (2004-07) * 90/385/EWG (1990-06-20) * 96/29/EG (1996-05-13) * 1999/519/EGEmpf (1999-07-12) * 2001/83/EG (2001-11-06) * AAMI TIR42 (2010) * FIPS PUB 199 (2004-02)
Từ khóa
Atmospheric pressure * Biocompatibility * Biological hazards * Catheters * Circuits * Clinics * Damage * Defibrillators * Definitions * Determinations * Discharge * Disposables * Electric fields * Electrical appliances * Electrical components * Electricity * Electrodes * Electromagnetic * Electrostatics * Gas pressure * Graphic symbols * Handling * Heat * Hospitals * Implants (surgical) * Information * Information supplied by the manufacturer * Ionizing radiation * Jets * Marking * Medical equipment * Medical sciences * Osmotic pressure * Packages * Patients * Performance * Protection * Safety * Safety requirements * Specification (approval) * Sterility * Surgical implants * Temperature * Testing