SS-EN-45502-1 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

SS-EN-45502-1 - 2015 EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:


This Part 1 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 1 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 1 of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES. 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.

To find similar documents by classification:

11.040.01 (Medical equipment in general)

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)


Active implantable medical devices

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems

ISO-10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

IEC-60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

ORDER

Price:

$223.05        


Want this as a site license?



Designation Name

SS-EN 45502-1:2015

Revision Level

2015 EDITION

Status

Current

Publication Date

Sept. 16, 2015

Language(s)

English

Page Count

72

International Equivalent

EN 45502-1:2015(IDT)