Conformity Assessment Procedures

The conformity assessment procedure for the proof of the compliance of explosion-protected equipment and protective systems to be supplied with the regulations of the directive is described in annex 11, article 8 of the directive. 

Depending on equipment group, category and design of equipment and protective systems, the conformity assessment procedure defines 

In accordance with the conformity assessment procedure the protective systems have to be subjected to an EC-type examination according to annex III of the directive by a Notified Body. 

Notified Bodies are national testing authorities, which have been notified by the respective member state of the European Community for the execution of the proceedings in the context of the conformity assessment procedure. The Notified Bodies and their identification numbers have to be iirformed to the European Commission. 

Vacuum pumps on which various electrical and non-electrical equipment or accessories can be installed are regarded as non-electrical 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. 

The purpose of all the conformity assessment procedures is to ensure that the device as designed and as subsequently manufactured will meet the essential requirements. For most devices where Notified Body involvement is required, the manufacturer may choose between the strategies of relying on the application of appropriate quality systems or independent testing to demonstrate this. 

Assembling technical documentation that provides evidence of conformity with the essential requirements is a fundamental part of all conformity assessment procedures. The appropriate essential requirements annex may be used as a checklist, against which documents demonstrating the adopted solutions may be identified... 

Risk Clinical Data Authorisation of Clinical Investigations Instructions for Use Conformity Assessment Procedure... 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

Depending on the class of the device, a manufacturer may be able to choose between a number of alternative conformity assessment procedures in the assessment of whether a medical device conforms to the essential requirements. Although the rules should be considered in detail in each case, the basic options might be summarised as follows ... 

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. 

One of the following two conformity assessment procedures may be followed for devices covered by Annex II ... 

The publication of BS EN ISO 9001 2000 has implications for Council Decision 93/465/EEC of July 22, 1993 concerning the modules for the various phases of conformity assessment procedures and the mles for affixing and using the CE conformity marking, which are intended to be used in the technical harmonization directives. It is important to note that the modules used in individual technical harmonization directives may vary in some respects compared to those described in Council Decision 93/465/ECC. In all cases, it is the annex of the applicable directive(s) that is legally binding. The principles set out in this foreword remain valid regardless of these variations. 

The Directive classifies the pressure equipment into four categories (I, II, III, IV) dependent on the level of risk presented by the pressure (Figure 4.17). Category IV represents the highest risk. The category of the pressure equipment is established from one of the nine tables in Annex II of the Directive. The categories determine the Conformity Assessment Procedures to be used. 

Thus, in the language of the new TBT agreement, when a government acts to accept a voluntary standard to make it mandatory, the resulting document is a technical regulation. A measure used to ascertain compliance with a standard or technical regulation is a conformity assessment procedure. 

Federal Register April 10,1998 (Volume 63, Number 69). Mutual Recognition of the FDA and European Community Member State Conformity Assessment Procedures Pharmaceutical GMP Inspection Reports, Medical Device Quality System Evaluation Reports, and Certain Medical Device Premarket Evaluation Reports. 

Directive 93/465/EEC, dated 1993-07-22, gives a survey of the different modules (called A. .. H) for conformity assessment procedures (Fig. 3.2). A short description of these modules is given in Table 3.9. Obviously, module B... 

The different combinations of modules for conformity assessment procedures are summarized in Table 3.10. 

The United Nations Economic Commission for Europe (UN/ECE) model, with its Common Regulatory Objective, international standards to be referenced and conformity assessment procedures provides a possible framework for the establishment of equivalence. 

CE Marking Directive 93/68/EEC states that the choice of conformity assessment procedures must not lead to a lowering of safety standards of electrical equip-ment/products, which have already been established throughout the Community. Alternatives to European standards are possible in the case where no European harmonized standard exists. Conformity to International standards (i.e., lEC) or European national standards (i.e., DIN, BS, NF) is sometimes an acceptable alternative, but in this case the manufacturer must be able to demonstrate conformity with the ERs of the directives and at the same time not fall below the minimum acceptable criteria. The General Product Safety Directive 92/59/EEC allows the use of EU national standards when no European harmonized standards exist. This alternative may be needed as a transitional measure until a European standard is published (see General Product Safety in Chapter 2). This approach is not recommended when European harmonized standards exist, especially if a product becomes suspect, since... 

The objecCive of a conformity assessment procedure is to give users, consumers, and authorities assurance that products conform to the various requirements as expressed in the directives ... 

FIGURE 2-5 General Guidelines for Use of Conformity Assessment Procedures... 

The essential objective of a conformity assessment procedure is to enable the authorities to ensure that products placed on the market conform to the requirements expressed in the directives and, these products must meet the high level of safety that the directives seek for a given product or product sector. There are seven modules in 93/465/EEC, and the generic directives (LVD, EMC, etc.) or product-specific directives (machinery, etc.) will set the range of choices that may be considered, as follows ... 

The Conformity Assessment Procedures and Rules for CE Marking Directive 93/465/EEC... 

European Harmonized Standards play a key role, not just because they significantly simplify the conformity assessment procedures (Article 10.1 of the directive) if used in full, but also because they provide by consent, a unique, harmonized, technical solution that has been based on an EMC analysis. This means that, even if those standards are not used (they are voluntary) in the design and manufacture of the apparatus, manufacturers should take them into account when performing their analysis. ... 

Conformity assessment procedure for a safety component to include ... 

---