Answers - Legal

The AS/NZ 3760 : 2003 is document written by Standards Australia that specifies the procedures and criteria f

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

or the in-service safety inspection and testing of electrical equipment which is designed for connection by a

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

flexible cord. It also applies to cord extension sets, portable outlet devices, portable residual current dev

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ices. Appendices include detailed test methods.

1. Visual Inspection

The most important test is a Vi

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ual Inspection of the device, especially its lead/s. Cords should be firmly anchored in plugs, connections ma

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e solidly with no frayed ends. Copper terminals should be clean and not pitted.

There should be no sign of h

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

eat or melting of plugs. Leads should be visually inspected for their entire length to ensure that there are

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

o cuts, cracks or breaks. This test alone represents 80% of the testing process.

2. Polarity

A Pola

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ity test is done on leads, power boards, etc, and is functional check that Active, Neutral and especially Ear

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

th are not incorrectly wired.

3. Insulation Resistance

This test is important on appliances which c

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

me in contact with water such as pumps, cleaning and cooking appliances etc, but must be performed on all ite

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

s. This will reveal if there are any hairline cracks or cuts in the lead which will result in a low insulatio

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

n resistance.

4. Earth Resistance

This test will pass a larger current (up to 25 Amp) through the le

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

d to ensure the earth wire has a strong connection.

5. Earth Leakages/ Touch Leakage

A leakage test

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

must be preformed on a circuit that must be energizing to be switched on. i.e. circuits with electronic switc

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

hes. The appliance is tested under load and the amount of current that leaks from the circuit is tested

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

. The Tag Itself

A tag will be applied to the plug end of the appliance’s lead. It will clearly state th

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

date of the test, date it is due to be retested, and who tested it.

7. Database

A complete test re

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

cord will be databased, including; the asset id; test results; sites and locations; retest date; asset descri

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

tion, make, and serial number; and any additional notes that our test and tagging specialists wish to include

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.answers.org.ua/article/131323/answers-ASNZ-3760-2003-InService-Safety-Inspection-and-Testing-of-Electrical-Equipment.html">AS/NZ 3760: 2003 In-Service Safety Inspection and Testing of Electrical Equipment</a>

BB link (for phorums):
[url=http://www.answers.org.ua/article/131323/answers-ASNZ-3760-2003-InService-Safety-Inspection-and-Testing-of-Electrical-Equipment.html]AS/NZ 3760: 2003 In-Service Safety Inspection and Testing of Electrical Equipment[/url]

Like all mediums, radio has various structural characteristics that make certain times of the year more or less favorable for advertising performance. Knowledge about these aspects of radio advertising is of tremendous value in maximizing campaign profitability and achieving long term success.

There is a plethora of help (many books, SBA loans and educational programs, support groups, etc.) for those who want to start a business but far less help for those who are at the exit side of their careers. Yet, creating an exit strategy is equally important. Time (years) and creative thought should be devoted to it while advice from professionals with expertise can make the transition easier and more profitable.

The escrow is the good faith deposit that is made by a buyer. If you are the buyer then you are the one that is providing this deposit. If you are the seller, then you will be receiving these funds.

Tags

Links

Answers - AS/NZ 3760: 2003 In-Service Safety Inspection and Testing of Electrical Equipment

Related Articles: