Product Info

2
Edition：A0
Thank you for choosing Infrared thermometer. The product combined the newest
technology and had passed related certification test.With its unique technology ,it can get
stable and accurate measurement result every time.This product will self test and display
the current room temperature when starting up to ensure the accuracy of the measurement.
This product is suitable for home or hospital to measure and monitor human body
temperature，and suitable for people of all ages.
Measurement site of this product :auditory meatus
Referent Standards and Documents
No
.
Standard Name
Reference No.
1
Medical Device Quality System for the regulation
requirement
EN ISO13485: 2003
2
Medical device risk management to medical devices
application
EN ISO14971: 2012
3
Symbol for the label of medical devices
EN 980: 2008
4
Term, symbol and information of medical device—
information of medical device manufacturer offering
EN 1041: 2008
5
Medical electrical equipment – Part 1: General
requirements for safety
EN60601-1:
2006/AC:2010
6
Medical electrical equipment – Part 1-2: General
requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests
EN 60601-1-2: 2007
7
Medical electrical equipment -- Part 1-11: General req
uirements for basic safety and essential performance -
- Collateral standard: Requirements for medical electric
al equipment and medical electrical systems used in t
he home healthcare environment
IEC60601-1-11:2010
8
Medical device software – Software life-cycle processes
EN 62304: 2006/AC:
2008
9
Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential performance –
Collateral standard: Usability
EN 60601-1-6: 2010
10
Medical electrical equipment – Part 1-8: General
requirements for safety – Collateral standard: General
requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical
systems
EN 60601-1-8: 2004
/A1:2006
11
Medical devices – Application of usability engineering to
medical devices
EN62366: 2008
12
Council Directive 93/42/EECof 14 June 1993 concerning
medical devices
OJ L 169 of 12 July 1993 (including Directive 2007/47/EC )
MDD 93/42/EEC