Tensiometro Who

WHO_TS_61_MDs_web.
xlsx 49
NAME, CATEGORY AND CODING

WHO Category / (under development)
1
Code
2 Generic name Sphygmomanometer
Specific type or aneroid
3
variation (optional)
4 GMDN name Sphygmomanometer, aneroid
5 GMDN code 16156
02 Anaesthetic and respiratory devices , 04 Electro mechanical medical devices , 11
6 GMDN category Assistive products for persons with disability
7 UMDNS name Sphygmomanometers, Aneroid
8 UMDNS code 16156
UNSPS code
9
(optional)
Alternative name/s Blood pressure meters (sphygmomanometers); Blood pressure manometer; Aneroid
10 sphygmomanometer
(optional)
Alternative code/s MS 30892; MS 43524; S 43839
11
(optional)
12 Keywords (optional) blood pressure, non-invasive, BP set, NIBP, auscultation
Measures blood pressure non-invasively by displaying the pressure in a cuff wrapped around
GMDN/UMDNS a patient’s arm. The systolic and diastolic pressure is usually assessed by listening to
13 Korotkoff sounds generated by arterial blood flow using a stethoscope simultaneously.
definition (optional)
PURPOSE OF USE
Clinical or other Physical examination, Diagnosis hypertention, Monitoring
14
purpose
Level of use (if Health center, district hospital, provincial hospital, specialized hospital
15
relevant)
Clinical all area
16 department/ward(if
relevant)
Overview of Inflatable rubber cuff surrounded by durable, flexible cover that can be easily fastened round
upper arm
17 functional Aneroid pressure gauge displaying cuff pressure
requirements Pumping bulb and valve allowing adjustment up and down of cuff pressure
TECHNICAL CHARACTERISTICS
Detailed Cuff arm fixing method to allow ease of use, ease of cleaning and low attraction of dirt;
requirements Washable size adjustable cuff (one size fits all).
Pressure gauge to allow reading of pressure to 2mmHg accuracy
18 Maximum pressure to be at least 300mmHg
Gauge body to allow recalibration of readings, yet in normal operation be sealed and secure
19 Displayed parameters mmHg

User adjustable
20
settings
PHYSICAL/CHEMICAL CHARACTERISTICS
Rubber tubes to be detachable from other parts, allowing periodic cutting of decayed ends
Components(if relevant)
Gauge body to include clip for mounting on cuff
Tube length to be greater than 30cm
21 Cuff surround to be removable and washable
To be supplied in protective, reclosable container
portable
22 Mobility, portability(if relevant)
23 Raw Materials(if relevant) N/A
1
WHO_TS_61_MDs_web.xlsx 49
UTILITY REQUIREMENTS
Electrical, water
24 and/or gas supply (if
relevant)
2
ACCESSORIES, CONSUMABLES, SPARE PARTS, OTHER COMPONENTS

Accessories (if
25
relevant)
Sterilization process
for accessories (if
26
relevant)
Consumables /
27 reagents (if relevant)
28 Spare parts (if relevant)

29 Other components (if relevant)
PACKAGING
Sterility status on N/A
30
delivery (if relevant)
31 Shelf life (if relevant) N/A
Transportation and N/A
32
storage (if relevant)
Labelling (if relevant) N/A
33
ENVIRONMENTAL REQUIREMENTS
Context-dependent Capable of being stored continuously in ambient temperature of 0 to 50 deg C and relative
humidity of 15 to 90%.
34 requirements Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative
humidity of 15 to 90%.
TRAINING, INSTALLATION AND UTILISATION

Pre-installation
35 requirements(if
relevant)
Requirements for
36 commissioning (if
relevant)
Training of user/s (if Training of users in operation and basic maintenance shall be provided
37
relevant)
38 User care(if relevant)
WARRANTY AND MAINTENANCE
39 Warranty
40 Maintenance tasks
Type of service
41
contract
42 Spare parts availability post-warranty
43 Software / Hardware upgrade availability
DOCUMENTATION
Documentation User, technical and maintenance manuals to be supplied in ************** language.
requirements Certificate of calibration and inspection to be provided.
List to be provided of equipment and procedures required for local calibration and routine
maintenance
44 List to be provided of important spares and accessories, with their part numbers and cost.
Contact details of manufacturer, supplier and local service agent to be provided
3
DECOMMISSIONING
Estimated Life Span 10 years
45
SAFETY AND STANDARDS

46 Risk Classification Class A (GHTF Rule 4);Class II (USA); Class I (EU, Japan, Canada and Australia)
Regulatory Approval Should be FDA, CE or UL approved product.
47 / Certification
International ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for
standards regulatory purposes (Australia, Canada and EU)
ISO 14971:2007 Medical devices -- Application of risk management to medical devices IEC
60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety -
Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility -
48 Requirements and tests
IEC 80601-2-30:2009 (Part 2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers)
ISO 81060-1:2007 (Part 1: Requirements and test methods for non-automated measurement
type)
ISO 81060-2:2013 (Part 2: Clinical investigation of automated measurement type)
ISO/IEEE 11073-10407:2010 (Part 10407: Device specialization -- Blood pressure monitor)
OIML R16-2:2002 Non-invasive automated sphygmomanometers
Reginal / Local ANSI/AAMI SP10:2002 & ANSI/AAMI SP10:2002/A1:2003 ( Manual, electronic or automated
49 Standards sphygmomanometers)
JIS T 1115:2005 Non-invasive Automated Sphygmomanometers
Regulations US regulations
21 CFR part 820
21CFR part 870.1130 Noninvasive blood pressure measurement system
50
JP regulations
MHLW Ordinance No.169
16156000 Aneroid sphygmomanometer

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WHO_TS_61_MDs_web.

NAME, CATEGORY AND CODING

19 Displayed parameters mmHg

ACCESSORIES, CONSUMABLES, SPARE PARTS, OTHER COMPONENTS

28 Spare parts (if relevant)

TRAINING, INSTALLATION AND UTILISATION

SAFETY AND STANDARDS

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