Radio Approvals for Europe: the R&TTE Directive and the US ... › ... › 2001symposium › rttedirective.pdf · Directive). 10/23/2000 11 Placing on the Market • Article 6 Requirements

1

9/20/2000

Radio Approvals for Europe:the R&TTE Directive and theUS-EU MRA

Presented by:

Todd RobinsonCKC Laboratories, Inc.

October 3, 20002001 RMCEMC Symposium on

Electromagnetic Compatibility

10/23/2000 2

Background - The New Deal

• In April 2000, Directive 99/5/EC (the Radioand Telecommunications TerminalEquipment Directive - R&TTE) drasticallychanged the manner in which radioequipment was placed on the Europeanmarket.

10/23/2000 3


Notified Body and CABProvision of US/EU MRA• In January 2001 (actually began May

2001), Conformity Assessment Bodies(CABs), began the Phase 2 of the MutualRecognition Agreement between the UnitedStates and the European Union (US-EUMRA).

2

10/23/2000 4


Open Area Area Test Site(OATS) performing RFEmissions Testing in

Tillamook, OR

Therefore, a ConformityAssessment Body(CAB), that is properlyaccredited, can act as aNotified Body under theprovisions of the R&TTEDirective

10/23/2000 5

Overview

In the Directive• Essential

Requirements.• Testing and

EvaluationRequirements.

• EU Agency andNational AgencyNotificationRequirements.

Specialized Test Set forRadio Equipment

10/23/2000 6

Overview

How It’s Working• Shortage of

HarmonizedStandards

• “Extra”Requirements ofNationalAuthorities.

• Certification ProjectExamples

RF Immunity Testing Facilityfor Radio Equipment

3

10/23/2000 7

R&TTE Essential Requirements

Article 3 -• 3.1(a) Protection of the health and safety of

the user or any other person, including thesafety objectives of the Low VoltageDirective, 73/23/EEC, but with no voltagelimit.

• 3.1(b) Protection requirements of the EMCDirective, 89/336/EEC (emissions andimmunity).

10/23/2000 8


• 3.2 Radio equipment must effectively usethe spectrum allocated to terrestrial, spaceradio communications and orbital resourcesas to avoid harmful interference.

• 3.3 (a-b) Essential requirements forTelecom Terminal Equipment (TTE).

• 3.3 (c-f) Potentially applies to all R&TTEequipment for personal privacy, fraudprotection, access to emergency servicesand disabled user access.

10/23/2000 9

Placing on the Market

• In addition to the essential requirements,Article 6 of the R&TTE Directive puts thefollowing obligations on the manufacturer,his authorised representative or the personresponsible for placing the product on themarket:

1 Apply the conformity assessment procedures(Annexes II - V) of the Directive.

2 Add Declaration of Conformity (DoC) to theproduct.

4

10/23/2000 10


• Article 6 Requirements (continued):3 Affix the appropriate CE marking.4 The destination of the apparatus indicated so the

the product is used for its intended purpose.5 Information shall be given on the installation and

maintenance (Article 6 (1) of the Directive).6 Identification of the apparatus by means of type,

batch and/or serial numbers.7 The name of the manufacturer (Article 12 (4) of the

Directive).

10/23/2000 11


• Article 6 Requirements (continued):8 For radio equipment:

i information about the intended purpose must beon the packaging and in the instructions.

i this information shall be sufficient to identifywhere the equipment is intended to be used

9 The marking on the apparatus shall identify:i potential restrictions of usei potential requirements to hold a ministerial

licence.

10/23/2000 12


Article 6 Requirements (continued):Letters of Notification . . .iWhen using frequency bands that are not

harmonized, the manufacturer must notifyeach Member State of the intention to placeradio equipment on its national market.

iImportant radio characteristics aredescribed the letter of Notification and theidentification number of the CAB (NotifiedBody) referred to in Annex IV or V.

5

10/23/2000 13


Article 6 Requirements (continued)Letters of Notification . . .iRoughly 1/2 of the Member States are

requiring additional applications to besubmitted with the ‘Letter of Notification.’

iImportant Note: manufactures aresubmitting Member State ‘Letters ofNotification’ after receiving the ‘Letter ofOpinion’ (Annex IV) from a CAB (NotifiedBody).

10/23/2000 14


Article 6 Requirements (continued):Letters of Notification . . .i ‘Letters of Notification’ shall be given no

less than four weeks in advance of the startof placing on the market.

i A Member State may, in certain cases,prevent these products from being placedon its market. (e.g. Article 3.3).

10/23/2000 15

Conformity Assessment

Article 10: The manufacturer must applyan adequate and permissible conformityassessment procedure whichdemonstrates compliance of the apparatuswith all relevant requirements in theR&TTE Directive. These procedures areidentical in all Member States andConformity Assessment Bodies (CABs)functioning as Notified Bodies, such asCKC Laboratories.

6

10/23/2000 16


Article 10 describes equipment categories andtells manufactures which procedural Annexescan be used to demonstrated compliance.

Open Area Test Site(OATS) for EMC andTransmitter Testing

10/23/2000 17


iThe provisions of the Low Voltage andEMC Directives no longer apply directly toradio apparatus.

iHowever, for receivers, the procedures ofthe LVD and EMC Directives can be usedas an alternative to the conformityprocedures of the R&TTE Directive.

10/23/2000 18


iReceiving parts of radio equipment aresubject to the procedures outlined inAnnexes II, IV or V.

iSpecial Note: Article 10.5 of the EMCDirective no longer applies to radioequipment: a notified body is no longerneeded for EMC approval or receivers.EMC Directive Article 10.2 can be used analternative compliance route for R&TTEDEssential Requirement, Article 3.1(b).

7

10/23/2000 19


• Transmitters, where harmonizedstandards can be utilized, shouldfollow the procedures outlined inAnnexes III, IV or V at the choice ofthe manufacturer.

• Transmitters, where harmonizedstandards cannot be applied or onlyutilized in part, should follow theprocedures outlined in Annexes IV orV at the choice of the manufacturer.

10/23/2000 20


Annex II - Internal Production Control• This procedure is the easiest and less

stringent procedure that can be used fortelecommunications terminal equipment notcontaining any radio transmitter and forradio receivers .

Transmitters:“Not Applicable”

10/23/2000 21


Annex III - Specific Apparatus TestsAnnex III includes Annex II, plus:• All essential radio tests relevant to the

product, typically including: power output,antenna terminal conducted bandwidth,temperature and spurious emissionsmeasurements.

• If harmonized standards cannot be appliedin full, then a notified body must be involvedto create a test plan to comply with Article3.2, “Use of Spectrum” requirements.

8

10/23/2000 22


Annex III (continued):• In creating the test plan or making other

judgements, the notified body mustconsider any of previous decisions made byany notified body.

• The manufacturer then declares thatrelevant radio tests have been carried outand that the apparatus complies with theessential requirements. If a notified bodyhas been used, the notified body numbermust to be affixed to the marketed product.

10/23/2000 23


Annex IV Technical Construction Filei Can be used for transmitters that do not

have any applicable harmonized standardsor that cannot fully apply Harmonisedstandards (Example: applicable,harmonized EMC standard but noapplicable, harmonized “Use of Spectrum”standard).

i Annex III Requirements (previous slides).

10/23/2000 24


Annex IV (continued)i TCF Consisting of - Annex II, point 4

technical documentation, the Declaration ofConformity to the specific radio tests.

i The manufacturer must present this file toone or more notified bodies.

i If the Notified Body (or CAB) considers thatthe requirements of the Directive have notbeen met, then they can issue a letter ofopinion stating such within 4 weeks.

9

10/23/2000 25


Annex IV (continued)i Upon receipt of the Letter of Opinion or if

the CAB (Notified Body) doesn’t issue aLetter of Opinion within 4 weeks, themanufacture can place on the market.

i In reality, many CABs and Notified Bodiesare issuing Letters of Opinion as a normalcourse of action, whether negative orpositive.

i Files kept for 10 years after last production.

10/23/2000 26


Annex V Full Quality Assurancei This procedure can be applied to all R&TTE

equipment.i This procedure can only be used by

manufacturers operating an approved qualitysystem for design, manufacture, finalproduct inspection and testing.

i Not yet a popular R&TTE conformity route.

10/23/2000 27

Marking the Product

Annex VIIi To remain in proportion with the Directive’s

renderings.i No less than 5 mm unless not possible on

the apparatus.i Should be on data plate and packaging.i Frequency information where applicable.i Notified Body number (per Annex IV).i Class 2 “alert symbol” if applicable.

10

10/23/2000 28

Marking the Product

Class 2 Alert Symboli Article 12.1: radio equipment needs a class

identifier where it has been assigned.i The EC established the identifier 4-6-2000.i Class 2 devices, those operating with

restriction, shall be identified with the alertsymbol. Many Class 2 devices operate atfrequencies not usable in all countries. A listof Class 2 devices can be found at:

Http://europa.eu.int/comm/enterprise/ rtte/listreq.htm

10/23/2000 29

Marking the Product

Example Equipment Marking

CE, Notified Body Number, Class 2 Alert.

10/23/2000 30

Example Conformity Steps

Typical R&TTE Radio Certification• CAB (Notified Body) constructs test plan

using harmonized EMC and non-harmonized TX characteristics standards.

• Testing performed at a qualified laboratoryand results submitted to CAB (NotifiedBody). Note: many CABs (Notified Bodies)may require that testing is performed by aproperly accredited laboratory.

11

10/23/2000 31


Typical R&TTE Radio Certification(continued)• A Letter of Opinion issued by CAB (Notified

Body) within 4 weeks (usually within 1week).

• Letters of Notification sent to MemberStates along with any applications requiredby given Member States.

• The Device is place on the EU market.

10/23/2000 32

Current R&TTE Issues

• Publication 2001/C 105/02 lists standardsthat are currently harmonized under theR&TTE Directive.

• GSM Cellular devices is the only “major”device category that can fully applyharmonized standards. Many moreharmonized EMC and “Use of Spectrum”standards are in the works!

• Most devices have applicable harmonizedstandards only for EMC and therefore musthave the involvement of a Notified body perAnnexes III, IV or V.

10/23/2000 33


• Many Existing EMC standards for RadioEquipment have been replaced by a single,multi-part standard, EN 301 489-xx, with“dates of withdraw” during 2002 and 2003.

• SAR/MPE Exposure requirements are beingdeveloped to meet the health aspects ofArticle 3.19(a). The EC produced CouncilRecommendation 99-519 on EMF between 0Hz and 300GHz and has also producedprEN50371 concerning exposure limits in thefrequency range between 10 MHz and 300GHz.

12

10/23/2000 34

References

• “Directive 1999/45/EC of the European Parliamentand of the Council of 9 March 1999” (R&TTEDirective).

• “ETSI EG 201 450 v1.1.1 (2000-09), Guidance forthe identification of Harmonized Standards and/orother technical specifications for Radio Equipmentand Telecommunications Terminal Equipment(R&TTE) covering requirements under Article 3.1of Directive 1999/5/EC.”

• “2001/C 105/02 Publication of titles and referencesof harmonised standards under the Directive”(1999/45/EC)

1

9/20/2000

Radio Approvals for Europe:the R&TTE Directive and theUS-EU MRA

Presented by:

Todd RobinsonCKC Laboratories, Inc.

October 3, 20002001 RMCEMC Symposium on

Electromagnetic Compatibility

10/23/2000 2


• In April 2000, Directive 99/5/EC (the Radioand Telecommunications TerminalEquipment Directive - R&TTE) drasticallychanged the manner in which radioequipment was placed on the Europeanmarket.

10/23/2000 3


Notified Body and CABProvision of US/EU MRA• In January 2001 (actually began May

2001), Conformity Assessment Bodies(CABs), began the Phase 2 of the MutualRecognition Agreement between the UnitedStates and the European Union (US-EUMRA).

2

10/23/2000 4


Open Area Area Test Site(OATS) performing RFEmissions Testing in

Tillamook, OR

Therefore, a ConformityAssessment Body(CAB), that is properlyaccredited, can act as aNotified Body under theprovisions of the R&TTEDirective

10/23/2000 5

Overview

In the Directive• Essential

Requirements.• Testing and

EvaluationRequirements.

• EU Agency andNational AgencyNotificationRequirements.

Specialized Test Set forRadio Equipment

10/23/2000 6

Overview

How It’s Working• Shortage of

HarmonizedStandards

• “Extra”Requirements ofNationalAuthorities.

• Certification ProjectExamples

RF Immunity Testing Facilityfor Radio Equipment

3

10/23/2000 7


Article 3 -• 3.1(a) Protection of the health and safety of

the user or any other person, including thesafety objectives of the Low VoltageDirective, 73/23/EEC, but with no voltagelimit.

• 3.1(b) Protection requirements of the EMCDirective, 89/336/EEC (emissions andimmunity).

10/23/2000 8


• 3.2 Radio equipment must effectively usethe spectrum allocated to terrestrial, spaceradio communications and orbital resourcesas to avoid harmful interference.

• 3.3 (a-b) Essential requirements forTelecom Terminal Equipment (TTE).

• 3.3 (c-f) Potentially applies to all R&TTEequipment for personal privacy, fraudprotection, access to emergency servicesand disabled user access.

10/23/2000 9


• In addition to the essential requirements,Article 6 of the R&TTE Directive puts thefollowing obligations on the manufacturer,his authorised representative or the personresponsible for placing the product on themarket:

1 Apply the conformity assessment procedures(Annexes II - V) of the Directive.

2 Add Declaration of Conformity (DoC) to theproduct.

4

10/23/2000 10


• Article 6 Requirements (continued):3 Affix the appropriate CE marking.4 The destination of the apparatus indicated so the

the product is used for its intended purpose.5 Information shall be given on the installation and

maintenance (Article 6 (1) of the Directive).6 Identification of the apparatus by means of type,

batch and/or serial numbers.7 The name of the manufacturer (Article 12 (4) of the

Directive).

10/23/2000 11


• Article 6 Requirements (continued):8 For radio equipment:

i information about the intended purpose must beon the packaging and in the instructions.

i this information shall be sufficient to identifywhere the equipment is intended to be used

9 The marking on the apparatus shall identify:i potential restrictions of usei potential requirements to hold a ministerial

licence.

10/23/2000 12


Article 6 Requirements (continued):Letters of Notification . . .iWhen using frequency bands that are not

harmonized, the manufacturer must notifyeach Member State of the intention to placeradio equipment on its national market.

iImportant radio characteristics aredescribed the letter of Notification and theidentification number of the CAB (NotifiedBody) referred to in Annex IV or V.

5

10/23/2000 13


Article 6 Requirements (continued)Letters of Notification . . .iRoughly 1/2 of the Member States are

requiring additional applications to besubmitted with the ‘Letter of Notification.’

iImportant Note: manufactures aresubmitting Member State ‘Letters ofNotification’ after receiving the ‘Letter ofOpinion’ (Annex IV) from a CAB (NotifiedBody).

10/23/2000 14


Article 6 Requirements (continued):Letters of Notification . . .i ‘Letters of Notification’ shall be given no

less than four weeks in advance of the startof placing on the market.

i A Member State may, in certain cases,prevent these products from being placedon its market. (e.g. Article 3.3).

10/23/2000 15


Article 10: The manufacturer must applyan adequate and permissible conformityassessment procedure whichdemonstrates compliance of the apparatuswith all relevant requirements in theR&TTE Directive. These procedures areidentical in all Member States andConformity Assessment Bodies (CABs)functioning as Notified Bodies, such asCKC Laboratories.

6

10/23/2000 16


Article 10 describes equipment categories andtells manufactures which procedural Annexescan be used to demonstrated compliance.

Open Area Test Site(OATS) for EMC andTransmitter Testing

10/23/2000 17


iThe provisions of the Low Voltage andEMC Directives no longer apply directly toradio apparatus.

iHowever, for receivers, the procedures ofthe LVD and EMC Directives can be usedas an alternative to the conformityprocedures of the R&TTE Directive.

10/23/2000 18


iReceiving parts of radio equipment aresubject to the procedures outlined inAnnexes II, IV or V.

iSpecial Note: Article 10.5 of the EMCDirective no longer applies to radioequipment: a notified body is no longerneeded for EMC approval or receivers.EMC Directive Article 10.2 can be used analternative compliance route for R&TTEDEssential Requirement, Article 3.1(b).

7

10/23/2000 19


• Transmitters, where harmonizedstandards can be utilized, shouldfollow the procedures outlined inAnnexes III, IV or V at the choice ofthe manufacturer.

• Transmitters, where harmonizedstandards cannot be applied or onlyutilized in part, should follow theprocedures outlined in Annexes IV orV at the choice of the manufacturer.

10/23/2000 20


Annex II - Internal Production Control• This procedure is the easiest and less

stringent procedure that can be used fortelecommunications terminal equipment notcontaining any radio transmitter and forradio receivers .

Transmitters:“Not Applicable”

10/23/2000 21


Annex III - Specific Apparatus TestsAnnex III includes Annex II, plus:• All essential radio tests relevant to the

product, typically including: power output,antenna terminal conducted bandwidth,temperature and spurious emissionsmeasurements.

• If harmonized standards cannot be appliedin full, then a notified body must be involvedto create a test plan to comply with Article3.2, “Use of Spectrum” requirements.

8

10/23/2000 22


Annex III (continued):• In creating the test plan or making other

judgements, the notified body mustconsider any of previous decisions made byany notified body.

• The manufacturer then declares thatrelevant radio tests have been carried outand that the apparatus complies with theessential requirements. If a notified bodyhas been used, the notified body numbermust to be affixed to the marketed product.

10/23/2000 23


Annex IV Technical Construction Filei Can be used for transmitters that do not

have any applicable harmonized standardsor that cannot fully apply Harmonisedstandards (Example: applicable,harmonized EMC standard but noapplicable, harmonized “Use of Spectrum”standard).

i Annex III Requirements (previous slides).

10/23/2000 24


Annex IV (continued)i TCF Consisting of - Annex II, point 4

technical documentation, the Declaration ofConformity to the specific radio tests.

i The manufacturer must present this file toone or more notified bodies.

i If the Notified Body (or CAB) considers thatthe requirements of the Directive have notbeen met, then they can issue a letter ofopinion stating such within 4 weeks.

9

10/23/2000 25


Annex IV (continued)i Upon receipt of the Letter of Opinion or if

the CAB (Notified Body) doesn’t issue aLetter of Opinion within 4 weeks, themanufacture can place on the market.

i In reality, many CABs and Notified Bodiesare issuing Letters of Opinion as a normalcourse of action, whether negative orpositive.

i Files kept for 10 years after last production.

10/23/2000 26


Annex V Full Quality Assurancei This procedure can be applied to all R&TTE

equipment.i This procedure can only be used by

manufacturers operating an approved qualitysystem for design, manufacture, finalproduct inspection and testing.

i Not yet a popular R&TTE conformity route.

10/23/2000 27

Marking the Product

Annex VIIi To remain in proportion with the Directive’s

renderings.i No less than 5 mm unless not possible on

the apparatus.i Should be on data plate and packaging.i Frequency information where applicable.i Notified Body number (per Annex IV).i Class 2 “alert symbol” if applicable.

10

10/23/2000 28

Marking the Product

Class 2 Alert Symboli Article 12.1: radio equipment needs a class

identifier where it has been assigned.i The EC established the identifier 4-6-2000.i Class 2 devices, those operating with

restriction, shall be identified with the alertsymbol. Many Class 2 devices operate atfrequencies not usable in all countries. A listof Class 2 devices can be found at:

Http://europa.eu.int/comm/enterprise/ rtte/listreq.htm

10/23/2000 29

Marking the Product

Example Equipment Marking

CE, Notified Body Number, Class 2 Alert.

10/23/2000 30


Typical R&TTE Radio Certification• CAB (Notified Body) constructs test plan

using harmonized EMC and non-harmonized TX characteristics standards.

• Testing performed at a qualified laboratoryand results submitted to CAB (NotifiedBody). Note: many CABs (Notified Bodies)may require that testing is performed by aproperly accredited laboratory.

11

10/23/2000 31


Typical R&TTE Radio Certification(continued)• A Letter of Opinion issued by CAB (Notified

Body) within 4 weeks (usually within 1week).

• Letters of Notification sent to MemberStates along with any applications requiredby given Member States.

• The Device is place on the EU market.

10/23/2000 32


• Publication 2001/C 105/02 lists standardsthat are currently harmonized under theR&TTE Directive.

• GSM Cellular devices is the only “major”device category that can fully applyharmonized standards. Many moreharmonized EMC and “Use of Spectrum”standards are in the works!

• Most devices have applicable harmonizedstandards only for EMC and therefore musthave the involvement of a Notified body perAnnexes III, IV or V.

10/23/2000 33


• Many Existing EMC standards for RadioEquipment have been replaced by a single,multi-part standard, EN 301 489-xx, with“dates of withdraw” during 2002 and 2003.

• SAR/MPE Exposure requirements are beingdeveloped to meet the health aspects ofArticle 3.19(a). The EC produced CouncilRecommendation 99-519 on EMF between 0Hz and 300GHz and has also producedprEN50371 concerning exposure limits in thefrequency range between 10 MHz and 300GHz.

12

10/23/2000 34

References

• “Directive 1999/45/EC of the European Parliamentand of the Council of 9 March 1999” (R&TTEDirective).

• “ETSI EG 201 450 v1.1.1 (2000-09), Guidance forthe identification of Harmonized Standards and/orother technical specifications for Radio Equipmentand Telecommunications Terminal Equipment(R&TTE) covering requirements under Article 3.1of Directive 1999/5/EC.”

• “2001/C 105/02 Publication of titles and referencesof harmonised standards under the Directive”(1999/45/EC)

Documents

Radio Approvals for Europe: the R&TTE Directive and the US ... › ... › 2001symposium › rttedirective.pdf · Directive). 10/23/2000 11 Placing on the Market • Article 6 Requirements