BS EN 60601-1-8:2007
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Standard No.

BS EN 60601-1-8:2007

Release Date

2007

Published By

British Standards Institution (BSI)

Status

Be replaced 2007-11

Replace By

BS EN 60601-1-8:2007+A1:2013

Latest

BS EN 60601-1-8:2007+A2:2021

Replace

BS EN 60601-1-8:2004

Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS.

BS EN 60601-1-8:2007 Referenced Document

• IEC 60417 
• IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-18 Update
• IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability*， 2024-04-18 Update
• ISO 3744:1994 Acoustics - Determination of sound power levels of noise sources using sound pressure - Engineering method in an essentially free field over a reflecting plane
• ISO 7000:1989 Graphical symbols for use on equipment; index and synopsis

BS EN 60601-1-8:2007 history

• 2021 BS EN 60601-1-8:2007+A2:2021 Medical electrical equipment - General requirements for basic safety and essential performance. Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• 2017 BS EN 60601-1-8:2007+A11:2017 Medical electrical equipment-General requirements for basic safety and essential performance. Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• 2007 BS EN 60601-1-8:2007+A1:2013 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• 2007 BS EN 60601-1-8:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• 2004 BS EN 60601-1-8:2004 Medical electrical equipment. General requirements for safety. Collateral standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems