General requirements for testing ME Euippment

***Type tests***
--Clause 4--
1. If one test which has cleared our product then you do not have any need to
further proceed on other tests.
2.First do risk analysis then determine which test has need to be performed.

***Number of samples***
1.On a Sample(type tests will be performed:multiple samples can be tested)

***Ambient temprature, humidity and atmospheric pressure***

1.Test conditions will be changed according to the requirement.

2.Might be shielded to save from other environmental changes.

***Other Conditions***
1.Least favourable conditions.
2.forseable misuse(must be according to the specs which have been defined).

***Supply voltage,type of current,nature of supply and frequency***

1.test results must consider the necessary deviations into account.(and it is least
favourable mens voltage).
2.you do have tests measurements which are less favourable in terms of frequency
range.
3.It must have been designed for more than one rated voltage.
4.Accompanying documents must be covered in it.
5.If it is mentioned that it has to given more than one power spply then you have
to give it.

***Repairs and modifications***

1.During test if failure has occured then made another sample and perform only
those particular tests which comes in aid to failure of our sample.

***Humidity preonditioning treatment***

1.Humididty Preconditioning treatment(components which are effected by climate
conditioning)
2.ME equipment shall be placed to temprature before moving it into the humidity
treatment.(temprature maintained in the range of 20 to 32).

**Sequence of test**
1. Test must be in order that it does not effect the other tests.

**Determination of appliad parts and accessible parts**

1.Apllied parts(Identification from accompanying documents)
2.Accessible parts(test finger(through test or through inspection)
3.Accessibility is detetrmined through standard test finger.(Finger is bent toward
or made in straight posiition with respect to ME equipment for all position of me
equipment).
4.Test with standard test finger is performed after testing ME with the straight
test finger.(force 30N)
5.**ME** must have bendig angle of 90 degree with 0 to 10 degree tolerance.( The
test finger is taken from IEC 60950-1)

6.**Test Hook**( ME opennings is tested with the test hook)

7.**Actuating mechanisms**
analysis related to pulse oximeter
1.Type of tests
**Functional Testing**(Prepare Test Equipment,Adjust Oxygen Levels)
**Accuracy Testing**
**callibration testng**
**performance testing**
**Battery Life Testing**
**Environmental Testing**
**Electromagnetic Compatibility (EMC) Testing**(Identify the EMC standards,Set up a
controlled testing environment)
**safety testing**

2. Number of samples required

Regulatory Requirements,Testing Standards and Variability and Complexity

3.Ambient temperature, humidity, atmospheric pressure

Pulse oximeters typically function well within a range of 10°C to 40°C (50°F to
104°F)
Pulse oximeters are often designed to operate within a humidity range of 10% to 95%
relative humidity.
Most pulse oximeters are not significantly affected by changes in atmospheric
pressure within normal ranges at ground level.

4.Other Conditions
Low oxygon levels(hypoxic gas mixture),User Interface and Usability.

5.Supply voltages( technical documentation), type of current(no need ), nature of

supply, frequency(technical documentation)

6.Humididty Preconditioning testing(Understand Specifications and

Standards,Preparation of Testing Environment,Select Humidity Levels,Place the Pulse
Oximeter,Monitoring and Data Collection)

7.Sequence tests
Functional Testing,Accuracy Testing,Calibration Testing and Performance Testing

8.test hook(Simulating Oxygen Levels)

9.Test Finger(Prepare the Test Finger,Understand the Relevant Standards,Examine

Accessibility and Compare with Standards)

10.Actuating Mechanisms(Buttons,Touchscreens and Rotary Controls)