CE marking

Small size, ruggedness, simple cabling and the ability to operate the equipment under adverse conditions in the field has also been design goals. The system should also conform with the regulations necessary for the CE-marking (i. e. standards and directives for EMC, Electrical Safety and Machine Safety). 

The modules are attributed in function of the different levels of risk inherent to the products. After having applied the modules applicable to a given product, the manufacturer issues a declaration of conformity and affixes the CE-marking. 

As a general rule all products covered by the New Approach directives must bear the CE-marking which symbolises conformity of the products to the requirements of the directive including the relevant certification procedures. The main principles which are basic to the application of the CE-marking can be summarised as follows ... 

The affixing of any other marking liable to deceive third parties as to the meaning and form of the CE-marking must be prohibited ... 

The affixing of the CE-marking to a product which is not covered by any of the directives providing for its fixing must be regarded as a case of abuse. 

Under the New Approach Member States shall not prohibit, restrict or impede the placing on the market or putting into service of products which comply with the directives and bear the CE-marking. Member States have also the obligation to take all appropriate measures to ensure that the products placed on the market do not endanger the health and safety of persons. 

Where a Member State ascertains tliat a product, bearing the CE-marking and used in accordance with its intended use, is liable to endanger the safety of persons or health, it shall take all appropriate measures to withdraw such a product from the market. That Member State shall immediately Inform the Commission which is obliged to investigate whether or not the measure is justified. Where the Commission considers that the measure is justified, it shall immediately inform the Member State which took the initiative and also the other Member States. This entails that the other Member States must also take action against the product concerned. That latter disposition is referred to as the safeguard clause. 

Technical requirements Sound engineering practice, essential requirements tarticle 3t The directive includes a particular technical requirement with respect to equipment which presents only a minor pressure hazard. For such equipment the essential requirements and the certification procedures are not applicable. Instead the so-called sound engineering practice of one of the Member States must be applied. That practice must ensure that design and manufacture takes into account all relevant factors influencing safety during the intended lifetime. The equipment must be accompanied with adequate instruetions for use and must bear the identification of the manufacturer. The CE-marking shall not be applied for such equipment. 

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

Aqueous ceric solutions are widely used as oxidants in quantitative analysis they can be prepared by the oxidation of Ce ( cerous ) solutions with strong oxidizing agents such as peroxodisulfate, S20g ", or bismuthate, BiOg". Complexation and hydrolysis combine to render (Ce" +/Ce +) markedly dependent on anion and acid concentration. In relatively strong perchloric acid the aquo ion is present but in other acids coordination of the anion is likely. Also, if the pH is increased, hydrolysis to... 

When the directives were introduced, they were applied to both new and existing devices. Thus, all device manufacturers are required to establish conformity with essential requirements, so that they can apply the CE Mark of conformity and legally market their products in the EU. 

The CE Mark is not specific to medical devices, but is used generally to indicate to European consumers that a product conforms to applicable European performance and safety requirements. It can be found on electrical equipment, children s toys and safety equipment, among other products. 

Before a device can be legally placed on the market in Europe, it must go through an appropriate conformity assessment process to establish that it meets all the essential requirements of the applicable directive. This enables the manufacturer to make a formal declaration of conformity and apply the CE mark of conformity to the device. The manufacturer, or an authorised representative (EC Rep), who takes on the responsibilities imposed by the directives on behalf of the manufacturer, must be established in the EU. 

An overview is presented of the CE marking requirements for manufacturers of medical devices, the role of EU Notified Bodies and third party approval and the provision of relevant data to the manufacturers of medical devices. 

Certificates issued by the British Board of Agrement (BBA) cover new or innovative construction products not covered by existing British Standards and Codes of Practice. These certificates, which are the result of assessment by BBA based on manufacturers information and on independent testing, also provide information on projected lifetimes. In future, under the European Construction Products Directive, product performance details including durability will be given on the label of each CE marked product. An example of how this is applied will be described in the next section. 

Beyond perfonnance optimization, issues relative to packaging and the need for compliance with certain safety and electronics regulatory codes are cited as reasons for a customized solution. In the latter case, a systems approach is required, especially when attempting to meet the code or performance requirements for compliance with European Certification (CE) mark or electrical and fire safety codes such as National Eire Prevention Association (NFPA) and CENELEC (European Committee for Electrotechiucal Standardization). Off-the-shelf electronics may provide the necessary performance characteristics for generic applications, and their use eliminates large expenses related to product development, plus the associated time delays. Photonics-related components are solely addressed in this section because they are used to customize instruments for application-specific systems. 

A new device that is specifically made in accordance with a duly qualified medical practitioner s written prescription and which gives, under the practitioner s responsibility, specific design characteristics, and is intended for the sole use of a particular patient is permitted to be marketed without CE marking imder provisions referring to custom-made devices. The prescription may be made by any person authorised by virtue of their professional qualifications to do so. Mass produced devices that need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices. 

The system or procedure pack must not bear additional CE marking and must be accompanied by the original manufacturers information. The declaration must be kept for 5 years. 

Where the above conditions are not met, as in cases where the system or procedure pack incorporates devices that do not bear CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack must be treated as a device in its own right and the appropriate conformity assessment procedure must be followed. 

The Directives provide that devices may be placed on the market and put into service only if they comply with the requirements laid down in the Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. Devices, other than devices that are custom-made or intended for clinical investigations, that are considered to meet the essential requirements set out in Annex I of the relevant Directive must bear the CE marking of conformity when they are placed on the market. ... 

The CE marking of conformity, as specified in MDD Annex XII, must appear in a visible, legible and indelible form on the device or its... 

A device, either CE marked or non-CE marked, is proposed for a new purpose or function. 

Clinical investigation will also be required where a CE marked device is to be used for a new purpose. 

The ECMRA applies to medical devices manufactured in the EC, Australia and New Zealand. It recognises the competence of designated conformity assessment bodies (CABs) in the EC to undertake conformity assessment of medical devices to Australian regulatory requirements, and the competence of the TGA to undertake assessment of medical devices for compliance with the requirements for certification (CE Marking) for entry onto the EC market. 

Devices incorporating animal-derived tissues, radioactive materials, in vitro diagnostics and devices manufactured in other countries, such as the United States (even those devices that have CE marking) are excluded. 

In Europe, prior to the CE mark, medical devices were registered in individual countries, each having a set of specific registration requirements. In June 1993, the Council of European Communities issued the medical device directive (MDD), which has been transposed into national laws throughout the EC. The purpose of adoption of the MDD was to allow the health care industry to benefit from the advantages of a single European market and allow products to circulate freely in the EC without additional technical constraints issued by the various member states. 

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

Most on-line analyzers are installed as permanent fixtures. Bearing this in mind, environmental issues associated with temperature and vibration become more critical, and the requirement for conformance to safety standards may be enforced by the need for system certification. The latter requires an assessment of the working environment, and the potential for fire and/or explosion hazard, relative to the anticipated presence of flammable vapors or gases. Safety hazard and local electrical design code compliance, which includes CE Mark for Europe, Canadian Standards Association (CSA) for Canada,... 

Fig. 1.84. Summary of the results of three runs, which are differentiated by the control pressure 1, no pressure control 2, pressure controlled at 0.36 mbar 3, pressure controlled at 0.20 mbar. The graphs show T ce marked as 1,2, 3 and Tpr marked as 12, 3 in the upper drawing. In the lower drawing, the DR are marked as 1, 2, 3 and the pch as 1, 2, 3. The increase in the product temperature (T ) and decrease of chamber pressure (pch) depend on the chamber pressure, because Ktot is pressure-dependent and Tsh has been programmed up to +30°C in such a way that the control pressure has never been exceeded. In...

Continuing with the above example of ER3 of the European Construction Products Directive horizontal emissions test methods (i.e., applicable to multiple product types) have been developed by CEN and ISO for compliance with the CPD and are now available as parts 6, 9,10 and 11 of EN/ISO standard 16000 (see Table 6.1). Furthermore, a program of work led by CEN TC351 has now been instigated under European Council Mandate M/366 to amalgamate and validate these standards. Once this work is completed (estimated 2010) it is understood that chemical emissions testing will become a mandatory part of CE marking for construction products. 

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