marking of conformity assessment

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Marking of Conformity Assessment MIC MRA International Workshop 30 th March 2012 Jan Coenraads [email protected] 003XY1234 AC111234003 3521

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Page 1: Marking of Conformity Assessment

Marking of Conformity Assessment

MIC MRA International Workshop 30th March 2012 Jan Coenraads [email protected]

RT

003XY1234

AC111234003

3521

Page 2: Marking of Conformity Assessment

Comparison of Conformity Assessment

Certification Certification

SDoC SDoC Reg

Certification

Dec RT

003XY1234

AC111234003

SDoC Reg

Dec

SDoC SDoC Federal/ NO State/Yes LVD

Radio Act, Telecom Business Act

R&TTE Directive

CFR47

Voluntary

R&TTE

EMC

SDoC DoC

EMC Directive

LVD Directive

Electric Safety Law

CFR47

3521 3521

Page 3: Marking of Conformity Assessment

The MRA Contracts for EU Regulation

Japan EU: R&TTE Directive USA EU: R&TTE Directive + EMC Directive Canada R&TTE Directive & EMC Directive Australia R&TTE Directive & EMC Directive New Zealand R&TTE Directive & EMC Directive Switzerland R&TTE Directive & EMC Directive

But Special situation being in Europe

Page 4: Marking of Conformity Assessment

The MRA Players outside the EU

CAB’s USA R&TTED 19 EMCD 26 Japan R&TTED 2 EMCD MRA n.a. Canada R&TTED 1 EMCD 0 Australia R&TTED 0 EMCD 1 New Zealand R&TTED 0 EMCD 1 Switzerland R&TTED 0 EMCD 7 (EU total R&TTED 73 EMCD 198)

Notifying Authorities USA NIST Japan Ministry of Internal Affairs & Communications (MIC) Canada Department of Industry Canada

Accreditation Bodies USA NVLAP & A2LA Japan JAB?

Page 5: Marking of Conformity Assessment

Applicable EU legislation Which legislation applies to a product?

• For most electrical and electronics products EMC + LVD apply except for: Radio and Telecommunications Terminal Equipment (as they fall

under the R&TTE Directive)

When EMC risks are benign (in which case the EMC Directive does NOT apply)

When products are outside the voltage range of the LVD (in which case the LVD does NOT apply)

• Other Directives MAY apply instead: Sector specific (e.g. marine equipment , medical equipment)

• Other Directives MAY apply on top: E.g. RoHS, WEE and specific chemical legislation

Page 6: Marking of Conformity Assessment

Marking Items covered

1. Classified Radio Devices 2. Alert Sign 3. Notification 4. Declaration of Conformity 5. EU Type Certificate (NEW) 6. CE Mark A lot of confusion between 1, 2 and 3! For 5 see yesterday’s presentation

Page 7: Marking of Conformity Assessment

Classified Radio devices – Current situation Commission Decision 2000/299/EC, based on R&TTE Directive Art. 4.1, classifies radio equipment into 2 Classes: -‘Class 1’, including radio equipment and terminals which can be placed on the market and put into service without restrictions -‘Class 2’, including radio equipment for which Member States apply restrictions to the placing on the market or the putting into use. Class 2 equipment shall be marked with the ‘Alert Sign’

Page 8: Marking of Conformity Assessment

The Commission needs to publish on the EU website an indicative and non-exhaustive list of equipment

falling within the 2 classes. This has been implemented under the form of a

publication of ‘subclasses’, later transferred to the ERO website.

http://www.ero.dk/rtte

R&TTED Art. 6.4 obliges Manufacturers to notify to EU MS their intention to place on the market radio

equipment using frequency bands whose use is not harmonised throughout the EU.

Note: Classification and Notification follows different

procedures

Page 9: Marking of Conformity Assessment

A CLASS 2 identifier has to be placed on the product, on the accompanying documents and on the packaging. This identifier has to be accompanied by following information: Information on the actual restriction for use (on the product, on the accompanying documents or on the packaging): EXAMPLES ► Equipment may not be operated ► A license is needed to operate the equipment ► A certificate is needed to operate the equipment ► Equipment has to be registered before operation ► Equipment may only be operated indoor ► Equipment may not be operated within 3km from an airport…; ► List of the countries where the equipment may be used (with or without restriction) on the packaging of the equipment; ETC, ETC

Page 10: Marking of Conformity Assessment

CE Marking CE marking shall be affixed only by:

- manufacturer, or - authorized representative in EU (if mandated to do so)

The affixing of the CE marking on products not covered by the appropriate Directive & Affixing of misleading marks/signs similar to CE is prohibited!!

By affixing the CE marking, the manufacturer indicates his responsibility for product conformity with all relevant legislative requirements, among others - Compliance with essential requirements - fulfilling of the administrative provisions (EU DoC) - satisfactory results of properly chosen conformity assessment procedures - providing necessary information for users and for the MSA

MS shall provide for penalties in case of infringements of the CE marking

For R&TTED the NB Number must be added when a NB or CAB has been used. For R&TTED the Alert Sign, if applicable, shall also be added. For EMCD and LVD both requiremenst not applicable!

Page 11: Marking of Conformity Assessment

4 possible Marking Appearances (based on NEW EMC and R&TTE Directive proposal)

R&TTED: Harmonised standards applied for radio aspects, no user restrictions, no NB used. EMCD: any module followed, NB could have been used. LVD: applicable.

R&TTED: Harmonised standards applied for radio aspects, user restrictions, NB not used. EMCD and LVD: this is not applicable.

R&TTED: Harmonised standards for radio aspects not applied or module B/C applied for other aspects, user restrictions, NB used

EMCD and LVD: this is not applicable.

3521

3521 R&TTED: Harmonised standards for radio aspects not applied or module B/C applied for other aspects , no user restrictions, NB used

EMCD and LVD: this is not applicable.

Page 12: Marking of Conformity Assessment

Extra Information on the R&TTED DoC

Apart from the information given in yesterdays presentation on the new DoC structure, the R&TTED DoC must contain the following additional information for radio equipment:

• Frequency band(s) or discrete frequencies in which the equipment operates (not necessary for those licensed frequencies where the equipment operates under the control of a network) • Radio-frequency power linked to the frequency band(s)

Page 13: Marking of Conformity Assessment

The simplified EU DoC accompanies each product and states: Hereby, [Name of manufacturer, or authorised representative, or importer, or distributor, as applicable], declares that this [type of equipment] is in compliance with the essential requirements and other relevant provisions of Directive XXXX/XX/EC. This simplified EU DoC shall be translated into the official language(s) of the MS in which market the product is placed or made available. In practice this would mean for the whole of the EU: 20 languages

Simplified DoC for R&TTED

Page 14: Marking of Conformity Assessment

The product has: 1. The full EU DoC in one of the official languages of the EU

+ the simplified EU DoC in all languages, or

2. The simplified DoC + directly followed by the exact address (Internet webpage or email address) where the full EU DoC can be obtained.

The full EU DoC, available at that exact address, shall be in one of the official languages of the EU.

The advantage of method 2? Any change in the Full DoC text does not require changes

for the documentation with the product!

2 Options available for R&TTED DoC

Page 15: Marking of Conformity Assessment

MSA requests for DoC

Following a request from a Member State Authority, the manufacturer shall provide a copy of the full EU DoC translated into the language of that Member State.

Page 16: Marking of Conformity Assessment

End of Presentation

Any QUESTIONS ??

Thank you for your attention