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GSM Certification R&TTE Directive for GSM products
Nick Xu, Ph.D Nick_xu@sgs.com

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R&TTE Directive for GSM products (I)
Precaution: This document can not replace the R&TTE directive in its full scope.
The intention is to give an extract of the most important steps in terms of testing, documentation and product marking with special attention to GSM terminal equipment. We strongly recommend involved persons to go directly to the directive, especially to learn about the legal obligations. Of course CETECOM is ready to advice all our customers for a better understanding of the directive. The directive can be downloaded from CETECOM’s web site: http://www.cetecom.com

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R&TTE Directive for GSM products (II)
The most important changes to the “old” TTE directive (1): ? R&TTE concentrates on the basic “essential requirements”.
– Heavily reduced compared to TTE – No requirements concerning network interoperability except for justified cases if they are raised from the EC Commission
? “A piece of wood would fulfil all R&TTE essential requirements!”

? R&TTE includes the essential requirements regarding EMC, Safety and Health.
– This means that all these can be declared to be fulfilled by one (R&TTE) Declaration of Conformity.

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R&TTE Directive for GSM products (III)
The most important changes to the “old” TTE directive (2): ? Possibility for Complete Self Assessment under the manufacturer’s responsibility.
– No third party involved, neither for testing nor for certification, if harmonized standards are available and applied to the product to prove fulfillment of the essential requirements. Only for products being or containing radio transmitters, a Notified Body needs to be involved only if harmonized standards are not available, not applicable at all or only applicable in parts.

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R&TTE Directive for GSM products (IV)
The R&TTE conformity assessment procedures There are four (4) conformity assessment modules described in annexes 2 to 5 of the directive. Annex 2 as minimum required procedure is part of Annex 3, which itself is a part of Annex 4. Annex 5 is an outstanding procedure describing the possibility of having a “Full Quality Assurance System” making the other annexes obsolete.

Annex 2 Annex 5 Annex 3 Annex 4
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R&TTE Directive for GSM products (V) Annex 2 – Internal production control
? Applicability: Mandatory to all products under R&TTE ? Main contents:
– Documentation set (technical product documents, applied standards, test reports/evidence.) – Declaration of Conformity. (DoC) – Product marking with “CE”. – Retention of documents (e.g. for market surveillance actions by regulatory authorities.) – Manufacturer to take measures that manufacturing process ensures the product’s compliance to technical documentation and to the essential requirements.

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R&TTE Directive for GSM products (VI) Annex 3 – Annex 2 plus “Specific radio test suites”
? Applicability: Mandatory to all products being or containing radio transmitters. ? Main contents:
– Manufacturer to perform specific radio test suites
? (1) according to harmonized standards - or ? (2) as identified by NB

– Manufacturer to declare that specific radio tests where applied successfully. – In the second case: Manufacturer to complete the CE mark by the EC identifier of the NB, e.g. CE0682.

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R&TTE Directive for GSM products (VII) Annex 4 – Annex 3 plus “TCF”
? Applicability: Mandatory to all products being or containing radio transmitters if harmonized standards are not applied or are only applied in parts. For other products under R&TTE, Annex 4 is optional. ? Main contents:
– Manufacturer to prepare a TCF containing
? documentation as for annex 2 - or ? declaration for specific radio test suites as for annex 3.

– Manufacturer to provide the TCF to one or more NBs.

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R&TTE Directive for GSM products (VIII) Annex 5 – “Full Quality Assurance system”
? Applicability: optional for all products falling under R&TTE ? Describes the possibility for the manufacturer to have an assessed full quality assurance (FQA) system (for design, manufacturing and product inspection) as basis for the DoCs that are issued for products when bringing it to the market. ? A FQA system allows the manufacturer to completely self-assess the conformance of those products for which the system has been assessed by a NB to be sufficient.

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R&TTE Directive for GSM products (IX) – Routes to the market
Manufacturer

Essentials: Safety, EMC, Health, Protection of the Frequency Spectrum

Yes

Radio Transmitter

No

Essentials: Safety, EMC, Health, Protection of the Frequency Spectrum

Harmonized Standard

Yes

No
Annex IV or Annex V

Annex III or Annex IV or Annex V

Annex II or Annex IV or Annex V

MARKET
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R&TTE Directive for GSM products (X) What is the choice for GSM terminals?
? To implement a FQA according to Annex 5 or following the Annex 4 procedure would be the maximum solution. ? Applying Annex 4 means that a NB as 3rd party makes a technical and completeness check of the manufacturer’s TCF parts against the essential requirements and provides an independent official statement.

We strongly recommend Annex 4 as the safest way to ensure compliance with the R&TTE essential requirements.
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R&TTE Directive for GSM products (XI) Partial conclusion
GSM terminals: ? are subject to R&TTE. ? are RF transmitters and therefore fall under Annex 3 as a minimum. ? may be assessed without involvement of a NB because harmonized standards covering the essential requirements are available, i.e. have been published in the Official Journal of the European Commission.

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R&TTE Directive for GSM products (XII) Harmonized standards
? Safety – EN 60950 ? EMC – EN 301 489-1 (generic part) – EN 301 489-7 (specific part for GSM terminals) ? Use of spectrum – EN 301 511 ? Health – EN 50360 / 50361 (SAR) To find the latest published list of harmonized standards: http://europa.eu.int/comm/enterprise/rtte/harstand.htm
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R&TTE Directive for GSM products (XIII) Some observations:
? In principle the R&TTE leaves it up to the manufacturer to decide which standard to finally apply or which method to choose to assess conformity against the single essential requirements. ? However, it shall be sufficiently explained in the documentation how conformance is proven by the selected test method if other than those described in the harmonized standards are applied for the testing.

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R&TTE Directive for GSM products (XIV)

TO DO list
? The manufacturer must affix the CE marking on the product. ? The manufacturer must make a declaration of conformity. ? The manufacturer must establish the technical documentation with the following contents… (and keep it for 10 years after production stop!)

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R&TTE Directive for GSM products (XV) Technical documentation for Annex 2 (I)
? General description of the product. ? Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. ? Descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product. ? A list of the standards referred to in Article 5, applied in full or in part and/or descriptions and explanations of the solutions adopted to meet the essential requirements of the Directive where such standards referred to in Article 5 have not been applied or do not exist.

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R&TTE Directive for GSM products (XVI) Technical documentation for Annex 2 (II)
? Results of design calculations made, examinations carried out, etc. ? Test reports. ? Copy of the Declaration of Conformity.

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R&TTE Directive for GSM products (XVII) Annex 2 (continued)
?The manufacturer must take all necessary measures so that the manufacturing process ensures compliance of the products with: 3 the technical documentation (as listed above) - and 3 with the applicable requirements of the R&TTE.

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R&TTE Directive for GSM products (XVIII) Annex 3
? The manufacturer must perform all applicable essential radio test suites according ? to a standard harmonized under R&TTE or alternatively ? as identified by a NB (obsolete if EN 301 511 is applied). ? The manufacturer must declare that the specific radio tests have been carried out successfully (that the product is conforming to the specific radio test suite s) ? Affix the EC identifier of the NB to the product in the second case above (as a NB is involved)

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R&TTE Directive for GSM products (XIX) Annex 4
? The manufacturer must establish the TCF, containing
– technical documentation, according to annex 2 – declaration of conformity to specific radio test suites, according to annex (and keep it ready until 10 years after production stop)

? The manufacturer must present this TCF to one or more NBs. ? The manufacturer must wait for the opinion of the NB regarding the TCF for 4 weeks max. after provision of the TCF. Then the manufacturer may launch the product to the market after it has been marked accordingly.
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R&TTE Directive for GSM products (XX)
USER INFORMATION ? The manufacturer must provide information to the user regarding correct operation of the product according to the declared intended purpose together with the declaration of conformity with the essential requirements (as integral of the manual) ? For telecommunications terminal equipment, sufficient information must be provided about the interface of the public telecommunications network to which the product is intended to be connected.
For all apparatus that information must be prominently displayed . Note: For GSM Terminals this requirement should be fulfilled when in formation is given that the product is a GSM terminal for use in public GSM 9 00 and/or 1800 networks.

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R&TTE Directive for GSM products (XXI) The role of the NB
From a strictly regulatory view the role of a NB is limited to the following scope: ? Identifying the specific radio test suites applicable to RF transmitters within the Annex 3 procedure if there is no harmonized standard available containing those tests. ? Review of the TCF within Annex 4 and (optional) issue of an “opinion“ to it within 4 weeks after reception of the TCF. Information to other NBs about the reception of the TCF. The TCF review includes according to the current understanding also the TCF parts covering the essential requirements for EMC, Safety and Health. ? Proceeding applications for assessment of “Full Quality Assurance Systems“ according to Annex 5, i.e. doing the assessment and follow up control.
Of course, CETECOM’s NB understands that the scope of its work i s far beyond those limited regulatory tasks. (See CETECOM’s support for R&TTE)

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R&TTE Directive for GSM products (XXII) IMEI allocation
All relevant information will be notified to BABT UK for input t o the CEIR (Central Equipment Identity Register of the GSM Association ).
Requests for IMEI allocations could be managed by a test house or directly to BABT UK, who is appointed for GSM IMEI allocations by the GSM Association.

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R&TTE Directive for GSM products (XXIII) Documents issued by a NB
Only one of the following documents are foreseen to be issued by a NB under the R&TTE Directive:
? Notification letter containing the specific radio test suites applicable to RF transmitters as identified within Annex 3 procedure. ? Issue of an “opinion“ letter concerning a TCF within Annex 4. ? Issue decisions about the assessment of FQA systems. That’s it as far as given by the R&TTE. A “Type Examination Certificate“ or a “Confirmation of Administrative Approval“ with reference to the old TTE directive may not be issued by NB’s anymore since April 8, 2000. Neither is that allowed with reference to the R&TTE. NB’s are even not allowed to make updates to existing Certificates issued under the former TTE regime.
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R&TTE Directive for GSM products (XXIV) Process
The Annex 4 procedure foresees that a manufacturer provides the TCF to a Notified Body. ? The Notified Body will – as officially accepted, independent 3rd party – review the TCF, check the completeness and the consistency of the TCF parts by it’s technical and regulatory competence. ? The Notified body will issue an independent opinion to the manufacturer about the sufficiency of the TCF and the manufacturer’s measures documented therein for the fulfillment of the R&TTE requirements. (Some NBs, in addition, issue a “Certificate of Conformance“ to those standards applied for the R&TTE conformity assessment when the relevant test reports are part of the TCF).
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R&TTE Directive for GSM products (XXV)

TCF route: benefits
? To have the NB’s technical and regulatory competence available. ? To have the NB’s independent view. More results will be seen when: ? applying for product authorization in non -EC countries. ? requesting acceptance to private certification schemes (e.g. GCF). ? requesting acceptance to the customer.

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R&TTE Directive for GSM products (XXVI) Third Party Lab Services
- A 3rd party independent testing service against GSM standards including complete coverage of the GCF requirements. - Assessment of EMC, Safety and Health essential requirements. - To handle the Certificates of Conformity to single standards or groups of standards, to specific network interface specifications, to R&TTE requirements, to GCF requirements, etc. - TCF service: Guidance for assembly of the TCF parts, or complete creation of TCFs including an additional “Certificate of Conformance“. - Technical and regulatory consultancy.

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Market Surveillance under the R&TTE Directive (XV)

Better Ways
Preventative measures: Making all information which necessary to bring compliant products to the market easy available to manufacturers Even better: To convince manufacturers that they will be more successful on the long run when their products are compliant.

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