Eleven Notified Bodies signed Code of Conduct

A first group of Notified Bodies has signed the voluntary Code of Conduct for Medical Device Notified Bodies. The Code of Conduct is an initiative to improve harmonised implementation of the European directives, creating a more level playing field for manufacturers. The initiative of this
NB Plus Group has received strong support from various stakeholders.

As a voluntary initiative the Code of Conduct aims at establishing a uniform basis for the assessment, surveillance and certification of medical device manufacturers and medical devices under the European directives MDD and AIMD. The General Statement and the General Principles specify criteria such as the qualification and experience of assessment personnel and the minimum time required for various conformity assessment processes.

The signatories of the Code of Conduct express the necessity of strict and uniform quality control of the Notified Bodies in the Medical Device sector. Through voluntary harmonisation, they support the European legislative framework on an operational level, to improve consistency of conformity assessment operation hence creating a more level playing field for manufacturers and increasing trust in the European regulatory system for medical devices.

To read more on the topic please visit: http://www.tuvps.co.uk/home-psuk/company/tuev-news/eleven-notified-bodies-signed-code-of-conduct

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You mentioned imported components in a product - if they are not CE marked in their own right (e.g. a PSU) are you saying I definitely can't use it in a larger product, or if I have the product data, can I make my own assessment?

If you use a component or sub-assembly that is subject to CE marking then it should be made available to you with the appropriate CE marking and Declaration of Conformity supported by a Technical File. You can use it but you take responsibility for the compliance of that component or sub-assembly within the complete product. Be aware however that this is not always very straightforward; i.e. you may have an EMC failure as a result of this part or you may have to obtain detailed constructional information which you may not have access to.

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How do military standards and testing differ to the commercial EMC test standards?

The driving force behind Commercial Test Standards and testing is EU legislation. The driving force behind Military testing is usually contractual requirement. Different areas of the world have different military test standards, the UK has Def Stan, the US has Mil Std. In addition to this there are product specific military standards, EFA for Euro fighter as an example and also product family specs such as the RTCA specs for airborne equipments and systems so in that way there are similarities to Commercial standards.

In general the military test standards, while quoting similar tests to the Commercial ones, tend to be to severer levels to ensure that the equipment is fit for purpose in its intended environment with additional specialist tests that commercial specs don’t cover.

As an example, a multi role piece of military communications equipment intended for land force and naval use as well as being aircraft mountable would require testing to a complete Def Stan suite of tests to ensure that it was fit for purpose in all 3 environments. It may also require some additional tests from the RTCA specs to ensure that the equipment met the airborne equipment requirements and if this equipment was also being marketed to other countries that had adopted the Mil Std approach then a gap analysis of the tests that had been carried out compared to the Mil Std requirement would need to be done and any Mil Std test differences would also need to be addressed.

In addition to this, many larger military systems and installations require an amount of commercial testing in addition to the Military testing carried out. The Type 45 destroyer was required to meet both Def Stan requirements and also some commercial maritime test standards as well.

 

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Ishan Palit appointed CEO of Product Services Division, TÜV SÜD

Ishan Palit will assume responsibility as Chief Executive Officer for the Product Services Division at TÜV SÜD AG with effect from 1 August 2011. The international provider of testing, inspection, training and certification services has focused its global portfolio for product and food safety under the umbrella of this Division. Ishan Palit succeeds Dirk Eilers, who was promoted to the Board of Management of TÜV SÜD AG in 2010.

Ishan Palit (43) joined TÜV SÜD in 1994 as General Manager of the group's operations in India. In 1999 Palit was appointed Managing Director of TÜV SÜD South Asia. In this function he was responsible for the activities of the TÜV SÜD Group in India and Sri Lanka. Under his leadership, sales revenue tripled and operations expanded to 30 branches and laboratories throughout India, Bangladesh and Sri Lanka. In October 2009 Ishan Palit was promoted to Chief Executive Officer of TÜV SÜD Asia Pacific, where his main responsibilities included business development in the Asia Pacific region. In the future, Palit will be responsible for the global strategy of the Product Services Division. He will report to TÜV SÜD Member of the Board of Management, Dirk Eilers. Commenting on his new appointment, Ishan Palit said: "Global supply chains are getting more complex every day. This poses a challenge to our customers in ensuring quality and safety as well as social and environmental accountability. In order to serve our customers in every location where they need to manage these challenges, we will continue to invest aggressively in our testing, inspection and auditing capabilities worldwide."


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If I have a prototype battery that needs to be UN tested how do I actually transport it to the test lab?

You may transport samples for test but restrictions will apply.
The quantity you can ship will be restricted to 12 batteries per package.
Each battery must be individually packed completely in cushioning material that is not conductive or combustible.
The batteries must be placed in boxes made of metal, plastic or plywood that meets packing group 1 requirements; this is highest level. Once the battery has been proven to meet the UN Manual of Test and Criteria packing group 2 is acceptable (medium risk).
When packaged the packing shall prevent accidently short circuiting of the packs.

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Does an accelerated humidity test produce the same failure modes as long term testing and what is the acceleration factor?

Humidity tests can be accelerated by increases in humidity, temperature or pressure. If there is a significant level of acceleration not all failures are likely to be representative. Accelerated tests are a good way of getting information quickly. They uncover failure modes allowing them to be addressed earlier in the product development process. This is why they can be termed “accelerated” tests. The tests generally do not provide a satisfactory quantitative indication of the expected life.

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­We have a product with a 3.1 Wh lithium ion battery in it. Should it be packaged with a label saying li-ion included?­

Yes you need to indentify that the lithium ion battery is being transported in the package.

Details include:

·         Lithium ion battery contained inside package

·         The package must be handled with care and that flammability hazard exists if package is damaged.

·         Special procedures that are to be followed in the event the package is dropped such as visual inspection and repacking if required.

·         Telephone number for additional information

·         Label as below

As the Wh rating of the pack is below 100Wh the battery is classified as excepted from fully regulated Class 9 requirements, the battery still needs to meet UN Manual of Test & Criteria requirements however and other applicable requirements.

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