EN ISO 14971:2012 / ISO 14971:2007 Medical
devices - Application of risk management to
medical devices
EN 1041:2008 Information supplied by the
manufacturer of medical devices
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical
electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
EN 60601-1:2006/ IEC 60601-1:2005+A1:2012
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
EN 60601-1-11:2010/ IEC 60601-1-11:2015
Medical electrical equipment - Part 1-11: General
requirements for basic safety and essential
performance - Collateral standard: Requirements
for medical electrical equipment and medical
electrical systems used in the home healthcare
environment
EN ISO 15223-1:2016/ ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling
and information to be supplied.
Part 1 : General requirements
EN ISO 81060-1:2012 Non-invasive sphygmomanometers
-Part 1: Requirements and test methods for non
-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive
sphygmomanometers-Part 3: Supplementary
requirements for electro-mechanical blood pressure
measuring systems
IEC 80601-2-30:2013 Medical electrical equipment
-Part 2-30: Particular requirements for the basic
safety and essential performance of automated
non-invasive sphygmomanometers
Risk
management
Labeling
User manual
General
Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Complied Standards List
Contact Information
Manufactured by:
Company:
Address:
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
FCC Statement
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation.
For more information about our products, please contact us by
mail,you can get customer service, usual problems and customer
download, Lifehood will serve you anytime.
If any quality questions or confusion, feel free to contact us :
HONGKONG XUHUA INDUSTRIAL CO., LTD.
RM 605, 6/F DAVID HSE 8-20 NANKING ST JORDAN KL, HONGKONG
E-mail: [email protected]
34
35
CONTACT INFORMATION
COMPLIED STANDARDS LIST
