Logo
Login Sign Up
Current Consolidated

BSI BS EN 60601-1-6:2010+A2:2021

Medical electrical equipment -- General requirements for basic safety and essential performance. Collateral standard: Usability
Best Price Guarantee
Instant

$310.76

2-5 Days

$310.76

SAVE 10%

$559.37


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


View in Library
or
British Standards Institution Logo

BSI BS EN 60601-1-6:2010+A2:2021

Medical electrical equipment -- General requirements for basic safety and essential performance. Collateral standard: Usability

PUBLISH DATE 2021
PAGES 26
BSI BS EN 60601-1-6:2010+A2:2021

1.1 * Scope

This International Standard specifies a process for a manufacturer to analyse, specify, A2_startdevelop and evaluate the usabilityA2_end, as it relates to basic safety and essential performance of medical electrical equipment, hereafter referred to as me equipment.

This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.

A2_start If the usability engineering process detailed in this collateral standard has been complied with, then the usability of me equipment as it relates to basic safety and essential performance is presumed to be acceptable, unless there is objective evidence to the contrary.

NOTE Such objective evidence can subsequently originate from post-production surveillance. A2_end

1.2 Object

The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.

1.3 Related standards

1.3.1 IEC 60601‑1

For me equipment, this collateral standard complements IEC 60601‑1.

When referring to IEC 60601‑1 or to this collateral standard, either individually or in combination, the following conventions are used:

  • 'the general standard' designates IEC 60601‑1 aloneA2_start, including any amendmentsA2_end;

  • 'this collateral standard' designates IEC 60601‑1‑6 aloneA2_start, including any amendmentsA2_end;A1_end

  • 'this standard' designates the combination of the general standard and this collateral standard.

1.3.2 Particular standards

A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.

SDO BSI: British Standards Institution
Document Number EN 60601-1-6
Publication Date Aug. 13, 2021
Language en - English
Page Count
Revision Level 2
Supercedes
Committee CH/62/1
Loading...

Failed to load document history.

Publish Date Document Id Type View