Compliance for

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Mike Violette, P.E. Steve Koster, Washington Laboratories, Ltd Washington Labs & ACB EMC, Environmental, Product Safety & Radio Frequency Expertise Commercial Consumer Defense & Aerospace Energy Wireless Certifications WL Project Experience 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

Partner Laboratory Agenda

Your Presenters

Mike Violette Steve Koster President, WLL Vice-President, WLL Director ACB 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

Agenda

Overview • Background: Mike Violette • Regulatory Overview N.A.: Steve Koster • Technical Requirements • Measurements • Regulatory Overview EU: Mike Violette • Regulatory Overview Asia: Mike Violette

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

Some Projects Dreamers I ($34,000 pledged)

Some Projects Dreamers II ($5600 pledged)

Some Projects Innovators ($1.3M pledged)

Some Projects Innovators Streaming video: $8.6M pledged, 10X Goal!

Some Projects Technology Projects 872 Active Projects

Example Project 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 Backers

Japan 104 Norway 77 Singapore 65 Russia 56 Italy 53 Sweden 53 Belgium 49 Spain 48 Austria 40

Backers

… Libyan Arab Jamahiriya 1 Tanzania 1 Panama 1 84 Countries! Nigeria 1 New Caledonia 1 French Polynesia 1 Georgia 1

Why Are We Here? Compliance? What could go wrong? • Electrical Safety • Mechanical Safety • Biological • • Materials selection • APPROVALS

Compliance? • What Needs to Go Right?

Compliance? • What Needs to go Right?

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

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

Compliance Definitions - Consumer Declaration of Conformity (DoC, sDoC) • “Self-Certification” Third-Party Certification • CB Scheme Accreditation

Compliance Definitions - Consumer

Regulatory Requirements 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

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) 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 “Electrical and Electronic Equipment” 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

Regulatory Requirements

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 Compliance Strategies Determine target market(s) requirements

Refer to International Standards (International Electro-technical Commission) IEC

Source components that are already approved

Agenda

Overview • Background: Mike Violette • Regulatory Overview US/CN: Steve Koster • Technical Requirements • Measurements • Regulatory Overview EU: Mike Violette • Regulatory Overview Asia: Mike Violette

US Regulations

• 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

Canada 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 Compliance For Wireless Equipment Two Main Areas for EMC • Conducted and Radiated Emissions – (FCC, IC, RTTE) • Conducted and Radiated Immunity (For ) ALSO: Network connection protocols for Mobile Devices (cellular devices) •CTIA, PTCRB (Cellular Telecommunications Industry Association PCS Type Certification Review Board) 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…”

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 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) IC Authorization Industry Canada has overview Authority on Spectrum Similar technical limits and rules “Verification” for digital devices Certification for radio transmitters 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 Grant of Equipment Authorization

Transmitter

Grantee Frequency & Power Grant Notes 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

FCC Database FCC CFR 47 Regulations

http://www.gpoaccess.gov/ecfr/ 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 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 FCC CFR 47 Regulations

Part 87 Aviation Part 90 Private Land Mobile Part 95 Personal Radio Service Part 97 Part 100 Digital Satellite Broadcast (Eliminated and now requirements are in Part 25) Part 101 Fixed Microwave

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

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

Technical Requirements

Applies to ALL Devices 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.,) Unlicensed Examples WiFi Bluetooth Cordless phones Remote control devices (most) UWB devices Spread Spectrum UNII Unlicensed use is UNPROTECTED Licensed Devices Land mobile radio Cellular telephones (blanket license) Broadcast transmitters (*Docket 20780 ca 1979) Business radio applications Radars

Licensed Use is PROTECTED General Rules (CFR 47) 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 Best place to find up-to-date Rules FCC OET - http://transition.fcc.gov/oet/info/rules/

General Rules 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

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 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 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… 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. Part 15 labeling (KDB 784748) Declaration of Conformity: Section 15.19(b) FCC Logo, Trade Name and Model number must be on device

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 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) 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) 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 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

15C Intentional Radiators

RFID

Remote Control

FM Radio RFID

Bluetooth, 802.11

Vehicle ID

Vehicle Radar 15E UNII 15F UNII 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 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… 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) 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

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 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 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

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 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 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 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.

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

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 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 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 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 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 Restrictions on Hazards

Restricted Substances Lead (Pb) Mercury (Hg) Cadmium (Cd) Hexavalent chromium (Cr6+) Polybrominated biphenyls (PBB) Polybrominated diphenyl ether (PBDE) Some Other Markets

Regulatory regimen depends on a number of factors: Development of the country Size of market Protection of local industries • • Brazil 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 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

Wireless & International Approvals

Japan Product Compliance

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 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 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 2400-2483.5 MHz Limits Very Low Power Transmitters

License-exempt, certification exempt

μV/m

1000 500 μV/m 500 μV/m 100 35 μV/m

10

32.2MHz 1.5 1 100 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) Modular Approvals: “Independent of Host’ Modular type device can be approved under the following conditions: 1. Equipment must have: 1. Antenna, 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” 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.

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

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 Certificate 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 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 China

China Approvals

China 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 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 Australia/New Zealand

Aus/NZ Approvals

Australia/New Zealand 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 Declaration of Conformity Compliance Folder Registration Supplier Compliance for Kickstarters Other Things to Think About… Medical Device Approvals? Food-handling/processing? Toy Safety? Energy Efficiency Compliance EnergyStar

Compliance for Kickstarters 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) Thank you!

Q&A

Mike Violette [email protected] M: +1 240 401-1388

Steve Koster [email protected]