Compliance for...Technology Projects 872 Active Projects Some Projects IT Device: >$3.0 M Pledged...
Transcript of Compliance for...Technology Projects 872 Active Projects Some Projects IT Device: >$3.0 M Pledged...
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Compliance for
s
Mike Violette, P.E. Steve Koster, Washington Laboratories, Ltd
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Washington Labs & ACB EMC, Environmental, Product Safety &
Radio Frequency Expertise Commercial Consumer Defense & Aerospace Energy Wireless Certifications
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15,000+ projects since 1989 NASA Raytheon US Army, Air Force & Navy General Electric Westinghouse Hughes Network System Applied Physics Laboratory Exelon 35+ Nuclear Power Plants Research Universities Over 500 individual clients
WL Project Experience
Partner Laboratory
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Agenda
Your Presenters
Mike Violette President, WLL Director ACB
Steve Koster Vice-President, WLL
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Agenda
Overview • Background: Mike Violette • Regulatory Overview US/CN: Steve Koster
• Technical Requirements • Measurements
• Regulatory Overview EU: Mike Violette • Regulatory Overview Asia/Aus: Mike Violette
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Agenda
Overview • Background: Mike Violette • Regulatory Overview N.A.: Steve Koster
• Technical Requirements • Measurements
• Regulatory Overview EU: Mike Violette • Regulatory Overview Asia: Mike Violette
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Kickstarter Phenomenom Some Background - Crowdsourcing • $1 Billion pledged ($380M in 2013) • 7.6 Million backers (>200 Countries + Territories) • “Rewards” depending on pledged amount, timing
• Technology, Publishing, Theater, Games
Post cards to Rock and Roll
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Some Projects Dreamers I ($34,000 pledged)
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Dreamers II
($5600 pledged)
Some Projects
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Innovators
($1.3M pledged)
Some Projects
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Innovators
Streaming video: $8.6M pledged, 10X Goal!
Some Projects
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Technology Projects
872 Active Projects
Some Projects
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IT Device: >$3.0 M Pledged 11,860 Backers USA 2676 UK 442 Germany 347 Canada 262 Australia 256 Netherlands 142 Switzerland 111 France 105
Example Project
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Backers
Japan 104 Norway 77 Singapore 65 Russia 56 Italy 53 Sweden 53 Belgium 49 Spain 48 Austria 40
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Backers
… Libyan Arab Jamahiriya 1 Tanzania 1 Panama 1 Nigeria 1 New Caledonia 1 French Polynesia 1 Georgia 1
84 Countries!
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Why Are We Here? Compliance? What could go wrong?
• Electrical Safety • Mechanical Safety • Biological • Radio spectrum • Materials selection • APPROVALS
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Compliance? • What Needs to Go Right?
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Compliance? • What Needs to go Right?
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Compliance Definitions - Consumer EMC: Electromagnetic Compatibility Spectrum: Wireless Transmitters Product Safety
Protection from Electrical, Mechanical, Fire and Chemical Hazards
Environmental: ROHS: Restriction on Hazardous Substances
WEEE: Waste Electrical and Electronics Equipment
REACH: Registration, Evaluation, Authorisation & Restriction of Chemicals
OTHER Toy Safety Explosive Atmospheres (ATEX) Pressure Vessels Automotive
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Safety Safety Issues
Mechanical Safety Electrical Safety
IEC60950 is dominant standard for IT
SAR & MPE (OET Supplement C, IEEE 1528, IEC 62209) Laser Safety FDA CDRH
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Compliance Definitions - Consumer
Declaration of Conformity (DoC, sDoC) • “Self-Certification” Third-Party Certification • CB Scheme Accreditation
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Compliance Definitions - Consumer
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North America Regulations • EMC: FCC & Industry Canada
– Intentional and Unintentional – Licensed and Unlicensed
• Safety: NEC & OSHA, Provincial, NOM • Medical: FDA 510(k) Premarket Notification • Laser: FDA CDRH
Regulatory Requirements
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EUROPE
Directives: EMC Directive Low Voltage Directive Medical Device Directive Machinery Directive Radio and Telecommunications Terminal Equipment Directive => “RED”
Self-Declaration allowed for many products “Essential Requirements” Notified Body for certain classes (notably medical and some
telecom and some machinery)
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EUROPEAN DIRECTIVES Low Voltage (2006/95/EC) > 2014/35/EU Simple Pressure Vessels (2009/105/EU) Toy Safety (2009/48/EC) Construction Products (89/106/EEC) Amended by 93/68/EEC *EMC (2004/108/EC) > 2013/30/EU *Machinery (2006/42/EC) Personal Protective Equipment (89/686/EEC) Non-Automatic Weighing Instruments (90/384/EEC) Amended by 93/68/EEC Gas Appliances (2009/142/EC) Hot Water Boilers (92/42/EEC) Amended by 93/68/EEC *Medical Devices (2007/47/EC) Explosive Atmospheres (94/9/C) > 2014/34/EU Recreational Craft (94/25/EEC) Automotive (2007/46/EC) and others *Active Implantable Medical Devices (90/385/EEC) *Radio and Telecommunications Terminal Equipment Directive (1995/5/EC) > 2014/53/EU WEEE (2012/95/EU) ROHS Directive (2011/65/EC)
* Contain EMC Provisions
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“Electrical and Electronic Equipment”
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EU Environmental Directives
ROHS: Restriction on Hazardous Substances (RoHS) Minimize hazardous metals in landfills: Pb, Hg, Cd, Hexavalent Chromium, Polybrominated Biphynels, Polybrominated Diphenyl
Ethers
WEEE: Waste Electrical and Electronic Equipment Recycling and disposing of electrical equipment REACH: Registration, Evaluation, Authorization and
Restriction of Hazardous Chemicals
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Other Markets?
• Country-by-country specific • Most countries regulate radio spectrum • Many countries regulate product safety • Some countries (and the EU) regulate
materials in products
Regulatory Requirements
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Compliance Strategies Determine target market(s) requirements Refer to International Standards (International Electro-technical Commission) IEC Source components that are already approved
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Agenda
Overview • Background: Mike Violette • Regulatory Overview US/CN: Steve Koster
• Technical Requirements • Measurements
• Regulatory Overview EU: Mike Violette • Regulatory Overview Asia: Mike Violette
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• Code of Federal Regulations Title 47: – Part 2: General Requirements
» §2.1091, §2.1093 * – Part 15, Unlicensed – Part 22, 24: Licensed
» Cellular devices – Part 87, 90: Licensed
» Marine, Land-Mobile *SAR: ANSI C95.1-1991: Non-ionizing Radiation Hazards
US Regulations
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Industry Canada Requirements • ICES-CS03: Unintentional Emitters
• Digital Apparatus • RSS-GEN: Overall • RSS-119: Licensed
• Land mobile • RSS-210: Unlicensed
• Short range, low power
• “Most” technical requirements harmonized with FCC
Canada
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Compliance For Wireless Equipment
Two Main Areas for EMC • Conducted and Radiated Emissions
– (FCC, IC, RTTE)
• Conducted and Radiated Immunity (For Europe)
ALSO: Network connection protocols for Mobile Devices (cellular devices)
•CTIA, PTCRB (Cellular Telecommunications Industry Association PCS Type Certification Review Board)
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FCC Authorizations
FCC has authority over radio spectrum since 1934 “to make available…a rapid, efficient, nationwide, and worldwide wire and radio communication service…for the purpose
of the national defense…”
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Federal Communications Commission • Responsible for integrity of the airwaves • Use of spectrum • Licensing and operation of RF systems • Certification • Database of thousands of products:
• Frequency • Power • Limitations on Use • Responsible Party
• RF Safety
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FCC Equipment Authorizations Verification: least-interfering equipment
Class A Digital Devices Radio receivers
Declaration of Conformity (DOC) Class B Digital Devices (computers & peripherals)
Certification Intentional Transmitters (unlicensed and licensed)
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IC Authorization Industry Canada has overview Authority on
Spectrum Similar technical limits and rules “Verification” for digital devices Certification for radio transmitters
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Wireless Explosion
FCC Certifications in 2000: 4,011 devices FCC (+TCB) Certifications in 2014: 19,000+ Power levels from mW to hundreds of watts Unlicensed low power proliferating Broadband technologies expanding Frequency Allocations expanding
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Grant of Equipment Authorization
Transmitter
Grantee Frequency & Power Grant Notes
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FCC ID Provides Device Details
FCC ID: AAAAAnnnnnnnnnnnnnn
AAAAA: is Grantee Code from FCC. Identifies the responsible party (Grantee)
nnnnnnnnnnnnnn: is from Manufacturer https://fjallfoss.fcc.gov/oetcf/eas/reports/GenericSearch.cfm
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FCC Database
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FCC CFR 47 Regulations
Part 2 General Requirements Part 5 Experimental Radio Service Part 15 Subpart C, D, and E Unlicensed Low
Power Transmitters Part 20 Common Carrier Part 21 Domestic Public Service Part 22 Public Mobile Service Part 24 Licensed PCS
http://www.gpoaccess.gov/ecfr/
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FCC CFR 47 Regulations
Part 25 Satellite Communication Services Part 26 General Wireless services Part 27 Miscellaneous Wireless Services Part 68 Telecom Services Part 73 Education Services Part 74 Television Broadcast Part 80 Maritime Service
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FCC CFR 47 Regulations
Part 87 Aviation Part 90 Private Land Mobile Part 95 Personal Radio Service Part 97 Amateur Radio Part 100 Digital Satellite Broadcast (Eliminated and
now requirements are in Part 25) Part 101 Fixed Microwave
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KDB
FCC’s Knowledge Database system Most topics have some sort of guidance or
KDB written about them https://apps.fcc.gov/oetcf/kdb/index.cfm
IC accepts guidance from most of these KDBs
KDB system is used to ask the FCC about any non-standard test methods
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Permit But Ask (PBA)
Limits on TCBs: PCB PBA: Typically “New Technologies” If your device is on the PBA list
If guidance is clear, such as confidentiality of a photo or user manual, then TCB can guide
If the PBA is due to test procedures, you will typically need to contact the FCC through the KDB system to resolve all testing issues before testing begins
Submit your KDB communication with the FCC, to the TCB at the time of Certification
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Technical Requirements
Applies to ALL Devices
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Unlicensed versus Licensed Licensed devices are more regulated and
are protected Unlicensed devices are unprotected. Some
historical basis in the Industrial Scientific and Medical (ISM) Bands (13.56 MHz, 2.4 GHz, e.g.,)
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Unlicensed Examples WiFi Bluetooth Cordless phones Remote control devices (most) UWB devices Spread Spectrum UNII Unlicensed use is UNPROTECTED
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Licensed Devices Land mobile radio Cellular telephones (blanket license) Broadcast transmitters (*Docket 20780 ca 1979) Business radio applications Radars Licensed Use is PROTECTED
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Part 2 of the FCC Rules covers general regulations & Filing procedures which apply to all other rule parts
About 15 different radio service rule Parts which require equipment authorization
Technical standards for licensed equipment are
found in the various radio service rule parts (e.g. Part 22, Part 24, Part 25, Part 80, and Part 90, etc.)
Technical standards for unlicensed equipment are found in Part 15
General Rules (CFR 47)
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Best place to find up-to-date Rules FCC OET - http://transition.fcc.gov/oet/info/rules/
General Rules
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47 CFR Parts 2.1046 - 2.1055 Tests required for all Devices*
2.1046 - RF power output 2.1047 - Modulation Characteristics 2.1049 - Occupied Bandwidth 2.1051 - Conducted Spurious Emissions 2.1053 - Radiated Spurious Emissions 2.1055 - Frequency Stability: Temperature & Voltage *unless the specific Rule part doesn’t call these out For example, there are no limits for Stability in Part 15
General Rules
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IC Radio Standard Specifications RSS GEN RSS 102: RF Exposure RSS 210: License Free RSS 220: UWB
Forty Titles in all
http://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/h_sf06129.html
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Measurement Standards ANSI C63.4–2009/2003: “Methods of Measurement of
Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz”
ANSI C63.10—2009: “Standard for testing Unlicensed Wireless Devices”
TIA-603D: “Land Mobile FM Or PM Communications Equipment Measurement And Performance Standards”
FCC Rules, Regulations and special procedures DTS, UNII, MMWave, FHSS procedures etc,
• FCC e-mail service for publications and notices. [email protected]
(ANSI C63.26: Draft: Licensed Devices)
Status here: http://www.c63.org/documents/misc/matrix/c63_standards.htm
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Unlicensed Devices (a closer look) FCC Part 15 https://apps.fcc.gov/oetcf/eas/ Year 2011 Grants: • 4412 digital transmission (DTS) • 2514 spread spectrum (DSS) • 1761 low power communications (DXX)
About 1/3 of the total Authorizations (20,360) …Let’s look at the unlicensed requirements…
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FCC Part 15.15: Technical Requirements
“Good Design.” Emissions < Limits No adjustments by User allowed (power, frequency
are fixed) Operators of Part 15 devices must cease operation
if interference is caused to authorized users Operators must “accept” interference
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
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Part 15 labeling (KDB 784748) Declaration of Conformity: Section 15.19(b) FCC Logo, Trade Name and Model number must
be on device
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Part 15 labeling (KDB 784748) LABEL or statement shall be etched, engraved,
stamped, indelibly printed, or permanently affixed to a permanently attached part of the equipment, and be visible at the time of purchase on the exterior of the equipment enclosure.
Cannot be located on removable part (battery cover, for example)
Electronic Labeling is now allowed for devices with an integrated screen
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Application Items Cover Letters (e.g., Agent Authorization) Request for Confidentiality (if desired) Test Report from Lab Modifications Performed During the Testing User’s Manual Theory of Operation, Schematics and Block
Diagram Test Setup Photograph & Internal/External Photograph FCC ID Label Artwork & Position on Device Attestation Statements (such as conditions of
installation)
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IC Application Process Apply the right RSS Collect all the technical documents required for
certification and submit them to a CB CB reviews the application and uploads all the
documentation to the IC website CB’s own Certificate received from the CB
• IC places details of the certification on their own website, after they have completed their review
• Radio Equipment List (REL)
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Hearing Aid Compatibility
Mobile Phone Requirements Cell phone providers are obligated to provide a
certain portion of their product line that satisfy HAC requirements
Two or fewer models: Not required. Three of more: Offer at least one Beginning September 8, 2012: Big guys must offer
one ANSI C63.19
New Version
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Part 15 Intentional Radiators Most consumer devices are
unlicensed Part 15 covers these transmitters
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title47/47tab_02.tpl
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15C Intentional Radiators
RFID
FM Radio
Remote Control
RFID
Bluetooth, 802.11
Vehicle ID
Vehicle Radar
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15E UNII
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15F UNII
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15.203 Antenna Requirements
An intentional radiator shall be designed to ensure that no antenna other than that furnished by the responsible party shall be used with the device. Unique connector Permanently affixed and/or Professional Installation* *Attestation and Justification
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What is a Modular Approval?
• The intent of modular approvals for part 15 devices. – “Pre-approved device” can be used in other
products – Ideal for Kickstarters! – Must pay attention to some details…
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Finally…… You have received your FCC Grant and
your IC Certificate….. FCC: Start shipping! (once you have taken
care of any other authorizations) IC: Wait…a little: (watch the IC website for
your certification to appear)
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Agenda
Overview • Background: Mike Violette • Regulatory Overview N.A.: Steve Koster
• Technical Requirements • Measurements
• Regulatory Overview EU: Mike Violette • Regulatory Overview Asia/Aus: Mike Violette
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TERMS & DEFINITIONS
European Directive Legal Document adopted by EC Council of Ministers Must be adopted into National Law by each EC member state Does not call out technical standards; refers to private
standards-making bodies to draw up product standards European Norm (EN)
Harmonized Standard: Common Standard used for determining conformity
• Committee process • ENs based on existing standards (CISPR, IEC)
Must be adopted into National
CE: Communaute Europeenne
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DIRECTIVES
Anti-discrimination measures Environment Intellectual property Privacy and data protection Weights and measures Information technology related Rail transport Road transport Pharmaceuticals Culture “Television without Frontiers” Accounting, Auditing and Management Control
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DIRECTIVES
Active Implantable Medical Devices Directive Airborne noise emitted by household appliances directive Appliances burning gaseous fuels directive Battery directive (2006/66/EC in force from 6 September 2006) Cableway installations designed to carry persons directive Colours for use in foodstuffs (1994/36/EC 30 June 1994) Construction Products Directive Dangerous Preparations Directive (1999/45/EC in force from 30 July 2002) Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels directive ("Boilers directive") Electromagnetic compatibility directive ("EMC directive") Energy efficiency requirements for ballasts for fluorescent lighting directive Energy efficiency requirements for household electric refrigerators, freezers and combinations thereof directive Equipment and protective systems intended for use in potentially explosive atmospheres (94/9/EC "ATEX directive") Explosives for civil uses directive Food supplements directive (2002/46/EC 10 June 2002) General product safety directive In vitro diagnostic medical devices directive Interoperability of trans-European conventional rail system directive Interoperability of trans-European high-speed rail system directive Landfill Directive Lifts Directive Low voltage Directive Machinery directive Marine equipment directive
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DIRECTIVES
Medical devices directive Minimum requirements for improving the safety and health protection of workers potentially at risk from explosive
atmospheres (99/92/EC "ATEX directive") Noise emission in the environment by equipment for use outdoors directive Non-automatic weighing instruments directive Packaging and packaging waste directive Personal protective equipment directive ("PPE directive") Pressure Equipment Directive Product liability directive Promotion of electricity produced from renewable energy sources ("Renewables Directive") Promotion of cogeneration based on a useful heat demand in the internal energy market (2004/8/EC "CHP Directive") Promotion of the use of biofuels and other renewable fuels for transport Radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity directive
(1999/5/EC "R&TTE Directive") Recreational Craft Directive Registration, Evaluation and Authorisation of Chemicals ("REACH directive") Restriction of Hazardous Substances Directive (RoHS) ("RoHS directive") Restrictions on marketing and use of certain dangerous substances and preparations directive ("Azocolourants
directive") Safety of toys directive Simple pressure vessel directive Tobacco Advertising Directive (IP/02/1788) Transportable pressure equipment directive Water Framework Directive
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COMPLIANCE WITH DIRECTIVES
Product-Specific Standards or use
Generic Standards Use Generic Requirements if Product-Specific
Standards do not exist Conformity Assessment Options
Declaration of Conformity Technical File Preparation
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CE Marking
Implementation of the CE Marking: Must be affixed to:
• Product • Packaging • Instructions for use, OR • Guarantee certificate
Can be used with other marks providing they do not reduce the visibility and legibility of the mark
The marking may include: • The identification of a notified body
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Enforcement
New Legislative Framework (NLF) • Came into force January 2010 • mandates is that all countries in Europe must perform
market surveillance Manufacturers meeting a lot more resistance and problems
when selling into Europe, towards the end of 2010. Devices have been refused entry into countries for things
like..... • No Alert Symbol on a WLAN device. • Unable to contact the DoC signatory. • DoC not provided in the local language. • CE Mark not appearing on the packaging.
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Toy Safety Directive
Defined as "products designed or intended, whether or not exclusively, for use in play by children under 14 years of age“
Chemical Choking Hazards Heavy metals limits Allergenic Fragrances CE Declaration of Conformity
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THE EMC DIRECTIVE
“Electrical Apparatus” Covered • Exceptions: components, large installations and
devices that must comply with other Directives that address EMC (e.g., telecommunications)
Member states adopt ENs Penalties for non-compliance
Country-by-Country basis. • Example: UK Requirements:
– Fines up to £5000 – Up to 3 months imprisonment for misuse of CE mark – Forfeiture of equipment
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Low Voltage Directive
For products intended for connection to Mains voltages from 50 - 1000VAC and 75-1500VDC. Generally for ITE, household products, office or laboratory equipment For products where hazards are primarily electrical in nature. Documented internal QUALITY ASSURANCE system required. Technical File (TF) required
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R&TTE Directive
• Applies to Radio and Telecommunications Terminal Equipment intended for use in all 27 EU member states and 3 EFTA countries (EEA countries).
• Soon to be replaced (April 2016) by Radio Equipment Directive
• Applies to Licensed and Unlicensed Devices
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Recycling
Waste Electrical and Electronic Equipment Directive (WEEE) 2002/96/EC.
10 Categories for reporting Large household appliances Small household appliances IT and telecommunications equipment Consumer equipment Lighting equipment Electrical and electronic tools Toys, leisure and sports equipment Medical devices Monitoring and control instruments Automatic dispensers
• Set targets for recycling and recovery targets for all types of electrical goods, with a minimum rate of 4 kilograms per person by 2009
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Restrictions on Hazards
RoHS: 2011/65/EU Electronic Trash: 50 million tons a year worldwide
paints and pigments PVC (vinyl) cables as a stabilizer (e.g., power cords, USB cables) solders printed circuit board finishes, leads, internal and external interconnects glass in television and photographic products (e.g., CRT television screens and camera lenses) metal parts lamps and bulbs Batteries
China, Japan, S. Korea, Turkey have enacted legislation
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Restrictions on Hazards
Restricted Substances Lead (Pb) Mercury (Hg) Cadmium (Cd) Hexavalent chromium (Cr6+) Polybrominated biphenyls (PBB) Polybrominated diphenyl ether (PBDE)
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Some Other Markets
Regulatory regimen depends on a number of factors: Development of the country Size of market Protection of local industries
• China • Brazil
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Mutual Recognition Arrangements
MRAs allow the acceptance of test data across economies Sector-dependent
US-EU MRA √ √ √ √ √ APEC TEL MRA √ √ US-Japan MRA √ √ √ √ √ US-Canada √ √ √ √ CITEL (Latin & S. American): ⊗ √ √ √ √: Well-implemented √ : Not well-implemented
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Agenda
Overview • Background: Mike Violette • Regulatory Overview N.A.: Steve Koster
• Technical Requirements • Measurements
• Regulatory Overview EU: Mike Violette • Regulatory Overview Asia/Aus: Mike Violette
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Japan Product Compliance
Wireless & International Approvals
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Radio Approvals Mandatory
Four main classes of products: 1. License-free (very low power) 2. Unlicensed (BT, cordless phones, WLAN) 3. Licensed 4. Special* *Only MIC can approve
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Regulations and Specifications
Japan Radio Law (Number 131): Procedure (akin to Part 2 of FCC) http://www.soumu.go.jp/main_sosiki/joho_tsusin/eng/Resources/laws/2003RL.pdf
Ordinances Technical Requirements Regulation 18: http://www.tele.soumu.go.jp/resource/e/equ/tech/orre.pdf
Telec Summary of Technical Requirements Association of Radio Industries and Businesses (ARIB)
Procedures
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Core Review Items 1. Transmitter
• Rated output power • Available type of emissions and frequency range • Oscillation • Modulation
2. Device Information • Manufacturer’s name • Model name
3. Antenna • Model name and configuration • Gain
4. Information on associated/ancillary equipment 5. Drawings
• System diagram References & Supporting Documentation
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2400-2483.5 MHz Limits
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Very Low Power Transmitters
License-exempt, certification exempt
μV/m
1000
100
10
1
35 μV/m
500 μV/m
1.5
500 μV/m
32.2MHz
100 kHz 1 MHz 10 100 1 GHz 10 100 1000~
Test Method: http://www.tele.soumu.go.jp/j/material/dwn/kouzi2.pdf (in Japanese only)
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Modular Approvals: “Independent of Host’ Modular type device can be approved under the following
conditions: 1. Equipment must have:
1. Antenna, high frequency section, modulation section, auxiliary equipment (indicator, etc) and a control section (including power supply).
2. The control section may include external equipment which is supposed to be connected to the control part under certain interface conditions.
2. If the equipment is supposed to be installed in a host, it must be “easily disconnected”
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Application Requirements ACB-Japan-Application-Form ACB-Japan-Application-Form-Letters (on your letterhead)
Includes Power or Attorney Construction Protection Confirmation
ACB-Japan-Statement-of-Quality-System-and-Confirmation-Method-Example (on your letterhead)
ACB-Japan-Technical-Type-Specification (as applicable) Form-No-1 (PHS, DSRC, 50GHz convenience radio, etc.) From-No 2 (radio navigation, radio location) Form-No 3 (CB, cordless phones, special low power radio, LP security, LP data,
digital cordless phone, land mobile station PHS, land mobile SDRC, 5GHz wireless access, UWB etc)
Form-No 4 (amateur band) Form-No 5 (earth station or portable mobile earth station)
Note: only some of these forms are currently used under scope B1. Make sure you choose the right form. If you have questions, please contact us.
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Other Documentation Block diagram External photos Internal photos Label information Operational description Schematics Parts list Rf exposure information (Currently Japan is considering how to
approach rf exposure) Test report along with test setup photos Manual and other pertinent user information
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Labeling
1. The Giteki Mark must be greater than 3 mm. The mark may be placed in the manual if the device is smaller than 6X6 mm. 2. Put “R” in the square as shown in the figure above. 3. Certified Type Number specific to the device
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Certificate
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EMC For ITE, emissions are voluntary. Voluntary
Control Council on Interference (VCCI) Primarily applied to consumer products Company using VCCI mark must be a member Test Laboratory must also be a member
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Safety Devices may have to comply with “Electrical Appliance and Material Safety Law” - Ministry of Economy Trade and Indust - Specified Electrical Appliances and Materials (Category A and B)
http://www.meti.go.jp/english/policy/economy/consumer/pse/02.htm http://www.meti.go.jp/english/policy/economy/consumer/pse/03.htm
Third-party laboratory
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China Approvals
China
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Two principal approvals: CCC Mark: Electrical Safety & EMC Specific Product Categories http://export.gov/china/doingbizinchina/eg_cn_031011.asp
Radio Transmitters Radio Transmission Type Approval Network Attachment License (cellular devices) State-designated Laboratory
China
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Necessary Information: All the usual bits
• Samples for testing • Instructions • Application forms, etc.
Recent changes allow for modular approvals
ACB has Agent services in Beijing
China
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Aus/NZ Approvals
Australia/New Zealand
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Regulatory Compliance Mark Replaces the C-Tick Covers all EMC and Safety Requirements Electrical Equipment Safety System Depends on Category (Declared or non-Declared)
ACMA Radio Equipment Telecommunications Equipment A-Tick (RCM will replace A-Tick in transition)
Australia/New Zealand
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Declaration of Conformity Compliance Folder Registration Supplier
Australia/New Zealand
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Other Things to Think About… Medical Device Approvals? Food-handling/processing? Toy Safety? Energy Efficiency Compliance EnergyStar
Compliance for Kickstarters
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Summary Success Strategies Define the largest market Use IEC Standards or Equivalents Use pre-approved components REQUIRE approvals for sourced items Check sources carefully (Documentation, certifications, materials) Leverage approvals
CB Scheme (IECEE)
Compliance for Kickstarters