BS EN 60601-2-18:2015
Current
The latest, up-to-date edition.
Medical electrical equipment Particular requirements for the basic safety and essential performance of endoscopic equipment
Hardcopy , PDF
English
30-11-2015
| Committee |
CH/62/4
|
| DevelopmentNote |
Supersedes 94/507140 DC, 99/562488 DC and BS 4824(1972). (12/2002) Supersedes BS 5724-2.18(1997) & 07/30166679 DC. (11/2015)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include:
- alignment of requirements with IEC 60601-1:2005;
- inclusion of essential performance requirements;
- the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard;
- reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.
| Standards | Relationship |
| EN 61935-2:2005 | Identical |
| DIN EN 60601-2-18:2016-10 | Identical |
| IEC 60601-2-18:2009 | Identical |
| I.S. EN 60601-2-18:2015 | Identical |
| EN 60601-2-18:2015 | Identical |
| IEC 61935-2:2005 | Identical |
| UNE-EN 60601-2-18:2016 | Identical |
| IEC 60601-2-37:2007+AMD1:2015 CSV | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| IEC 60601-2-57:2011 | Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
| ISO 8600-1:2015 | Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements |
| EN 60601-2-57:2011 | Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| EN 60601-2-37:2008/A1:2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
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