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by Gin-Shian Lou DGT,Chinese Taipei Email:james@dgt.tw May 11, 2005

Approval Regulatory Framework. by Gin-Shian Lou DGT,Chinese Taipei Email:james@dgt.gov.tw May 11, 2005. Outlines.  Approval Regulatory Overview  Approval Regulatory Schema  Low Power RF Devices Technical Regulations  Terminal Equipment Technical Regulations

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by Gin-Shian Lou DGT,Chinese Taipei Email:james@dgt.tw May 11, 2005

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  1. Approval Regulatory Framework by Gin-Shian LouDGT,Chinese TaipeiEmail:james@dgt.gov.tw May 11, 2005

  2. Outlines Approval Regulatory Overview  Approval Regulatory Schema Low Power RF Devices Technical Regulations Terminal Equipment Technical Regulations Conformity Assessment Scheme Conformity Assessment Requirements  Marking Requirements  Market Surveillance and Enforcement Mutual Recognition of Test Report Mutual Recognition of Certification

  3. §48 §48 §49, 50 §49, 50 1999 電信法 §46 §46 §39 §39 §42 §44 §42 §44 Approval Regulatory Overview (1/9) Equipment Approval Related Articles in Telecom Act ISM General Requirements Controlled Radio Equipment General Requirements 2003 Telecommunications Act Station General Requirements Network Equipment General Requirements TTE Approval Authority TTE General Requirements

  4. Approval Regulatory Overview (2/9) Telecommunications Act Equipment Approval Related Articles Article 49 Article 50 Article 42 Article 44 Telecommunications Terminal Equipment Controlled Telecommunications Radio Frequency Device

  5. Approval Regulatory Overview (3/9) Article 42, Telecommunications Act (1/2) The telecommunications terminal equipment for connection to the telecommunications machinery and line facilities of a Type I telecommunications enterprise shall conform to technical specifications, and be certified and approved before import and sale. The technical specifications shall be prescribed and announced by the Directorate General of Telecommunications (DGT).  The DGT shall enact regulations regarding the compliance approval mode and procedure of the telecommunications terminal equipment, the issuance, renewal, replacement and termination of the certificate of approval, and the embossment, marking and use of Approval Label, as well as the regulations with respect to the supervision and administration of compliance approval. The aforementioned technical specifications must ensure the following:

  6. Approval Regulatory Overview (4/9) Article 42, Telecommunications Act (2/2) The connection shall not damage telecommunications machinery and line facilities of Type I telecommunications enterprise, or malfunction of the said facilities.  Any nuisance shall not be caused to other users of the telecommunication machinery and line facilities of a Type I telecommunications enterprise. The demarcation of responsibility between the telecommunications machinery and line facilities of a Type I telecommunications enterprise and the terminal equipment connected by users shall be clearly stipulated.  Ensure electromagnetic compatibility to harmonize and effective use of the radio spectrum.  Ensure electrical safety to prevent harm to network operator personnel or users.

  7. Approval Regulatory Overview (5/9) Article 44, Telecommunications Act The DGT or the certification bodies commissioned by the DGT shall be responsible for compliance approval of telecommunications terminal equipment. Regulations governing the qualifications, the scope and limitations of delegated power, cancellation or termination of the commission, and supervision related to the commission of the aforementioned certification bodies shall be enacted by the DGT.

  8. Approval Regulatory Overview (6/9) Article 49, Telecommunications Act (1/2) To ensure national security and maintain the orderly sequence of radio waves, permission to manufacture, import, install or possess controlled telecommunications radio frequency devices shall be obtained from the MOTC; the model numbers and quantities of such devices manufactured or imported shall be reported to the MOTC for further reference. Regulations governing the operation permit of manufacture or import of controlled telecommunications radio frequency devices, the issuance, renewal, replacement and termination of operation license, administration of manufacture, import, installation and possession of the said devices, and other related matters shall be enacted by the MOTC.

  9. Approval Regulatory Overview (7/9) Article 49, Telecommunications Act (2/2)  No controlled telecommunications radio frequency device shall be manufactured, imported, sold or publicly displayed unless it has received type approval and recognition of inspections. However, the manufacture of such devices in connection with academic studies, technological research and developments or experiments, as well as uses exclusively for exportation, re-importation after exportation and other uses permitted by the MOTC of such devices are exempted. The items of controlled telecommunications radio frequency devices mentioned in the first paragraph shall be announced by the MOTC.

  10. Approval Regulatory Overview (8/9) Article 50, Telecommunications Act Technical specifications for controlled telecommunications radio frequency device shall be mandated and announced by the DGT. In the event that national standards are already in place, said standards shall prevail. Regulations governing the compliance approval mode and procedure of the devices mentioned in the preceding paragraph, the issuance, renewal, replacement and termination of inspection or compliance approval or certificate of approval, the affixing, embossment and use of the inspection Approval Label, as well as regulations related to the supervision and administration of inspection shall be enacted by the DGT.

  11. Approval Regulatory Overview (9/9) Article 50, Telecommunications Act The DGT or the certification bodies engaged by the DGT shall conduct the compliance approval on of the controlled telecommunications radio frequency devices. Rules governing the qualifications of the said certification bodies, the delegated power, cancellation or termination of the engagement, and supervision related to the engagement shall be enacted by the DGT. The inspection and technical specifications as prescribed in Article 42 shall apply to controlled telecommunications radio frequency devices that are used in telecommunications terminal equipment.

  12. Approval Regulatory Schema • Compliance Approval Regulations on Controlled Telecommunications Radio-Frequency Devices • Compliance Approval Regulations of Telecommunications Terminal Equipment Compliance Approval requirements • Administration Regulations of Regulatory Certification Body for Controlled Telecommunications Radio-Frequency Devices • Administration Regulations of Regulatory Certification Body for Telecommunications Terminal Equipment • Administrative Regulations on the Controlled Telecommunications Radio-Frequency Devices • Administrative Regulations on Low Power Radio Waves Radiated Devices • Administrative Regulations on Radio Waves of Industrial, Scientific, Medical Equipment Telecom Act Regulatory requirements Technical requirements • LP Device: LP0002(1) • TTE: PSTN(5); ISDN(1); PLMN(8); S-PCN(1)

  13. Low Power RF Devices Technical Regulations (1/5)  Regulations: Administrative Regulations on the Controlled Telecommunications Radio-Frequency Devices  Administrative Regulations on Low Power Radio Waves Radiated Devices  Compliance Approval Regulations onControlled Telecommunications Radio-Frequency Devices  Technical Specifications: LP0002: Low Power RF DevicesTechnical Specifications

  14. Low Power RF Devices Technical Regulations (2/5) Article 3,Administrative Regulations on the Controlled Telecommunications Radio-Frequency Devices • The controlled telecommunications devices(CTD) indicate those authorized radio frequency devices specified in the Section 4, Article 49 of the Telecommunications Act. • Two Types for above Radio Equipment: • 1) A License to operate a radio apparatus: Pursuant to paragraph 6 of Article 14, Article 47, Article 46 of ACT • 2) License Exempt to operate a radio apparatus: through conformity Assessment Process • Ex: Low Power License-Exempt Radio communication Devices

  15. Low Power RF Devices Technical Regulations (3/5) Article 10,Administrative Regulations on the Controlled Telecommunications Radio-Frequency Devices The controlled telecommunications radio frequency devices shall not be manufactured, imported, sold or publicly displayed if they acquired neither type approvals nor recognition of inspections. However, the manufacture, exportation only and other purposes permitted by the MOTC for those devices in connection with academic studies, technological researches and developments, or experiments are ruled out.

  16. Low Power RF Devices Technical Regulations (4/5) Article 4,Administrative Regulations on Low Power Radio Waves Radiated Devices The Low Power RF Device means the controlled telecommunications radio-frequency devices in compliance with “Low-power Radio-frequency Devices Technical Specifications” Article 5,Administrative Regulations on Low Power Radio Waves Radiated Devices The compliance approval of low power radio-frequency devices shall be conducted pursuant to ”Compliance Approval Regulations on Controlled Telecommunications Radio Frequency Devices” and “Low-power Radio-frequency Devices Technical Specifications”. A certificate of approval will be issued to the applicant while DGT or regulatory certification body (RCB) approves the low power radio-frequency devices in accordance with the regulations specified in the preceding Paragraph. The format of certificate is defined and determined by DGT.

  17. Low Power RF Devices Technical Regulations (5/5) Article 10,Administrative Regulations on Low Power Radio Waves Radiated Devices The manufacturer, importer or supplier of low-power radio-frequency devices shall print the requirements stipulated in Article 12, 14 on the operation manual or instruction guide. Article 12,Administrative Regulations on Low Power Radio Waves Radiated Devices Without permission granted by the DGT, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to a approved low power radio-frequency devices. Article 14,Administrative Regulations on Low Power Radio Waves Radiated Devices The low power radio-frequency devices shall not influence aircraft security and interfere legal communications; If found, the user shall cease operating immediately until no interference is achieved.

  18. Terminal Equipment Technical Regulations (1/9) Regulation:  Compliance Approval Regulations of Telecommunications Terminal Equipment Technical Specifications: • PLMN01: GSM 900 and DCS1800 Mobile Equipment • PLMN02: 1900MHz Digital Low Tier PHS Radio Terminal Equipment • PLMN03: 1900MHz Digital Low Tier PACS Radio Terminal Equipment • PLMN04: Trunked Radio Terminal Equipment • PLMN05: Mobile Data Radio Terminal Equipment • PLMN06: Paging Receiver Radio Terminal Equipment • PLMN07: 1880-1895MHz Wireless Private Branch Exchange and Radio Terminal Equipment • PLMN08: The Third Generation Mobile Telecommunication Terminal Equipment • PSTN01: Terminal Equipment for Connection to Public Switched Telephone Network • RTTE01: 2.4GHzRadio-frequency Telecommunications Terminal Equipment • ADSL01: Asymmetric Digital Subscriber Line Terminal Equipment and POTS Splitter • ID0002: DS1 Equipment Type Approval Guidelines • IT0002: CT-2 Wireless Private Branch Exchange System Equipment Type Approval Guidelines • IS6100: ISDN Terminal Equipment • IS2019: 1.6/2.4 GHz Satellite Personal Communications Networks (S-PCN) Mobile Earth Stations (MESs) Technical Requirements and Type Approval Guidelines

  19. Terminal Equipment Technical Regulations (2/9) ◎ Definition of TTE Article 2,Compliance Approval Regulations of Telecommunications Terminal Equipment The Telecommunications Terminal Equipment mentioned herein shall refer to any digital or analog equipment that interfaces with the end point of the Public Switched Telecommunications Network by using wireless or wired transmission media and conducts communications by means of optical or electromagnetic wave.

  20. Terminal Equipment Technical Regulations (3/9) ◎ Principle of TTE Technical Specifications Article 4,Compliance Approval Regulations of Telecommunications Terminal Equipment • The relevant TTE technical specifications shall be formulated and announced in public by the DGT • The aforementioned technical specifications shall not only contain test items and standards, but also ensure the following: • The connection should not damage telecommunications network facilities of Type I telecommunications enterprises, or malfunction the said facilities. • Any nuisance shall not be caused to other users of the telecommunications network facilities of Type I telecommunications enterprises. • The demarcation of responsibility between the telecommunications network facilities of Type I telecommunications enterprises and the terminal equipment connected by users shall be clearly clarified. • The connection of TTE shall ensure it is normally interfaced with the telecommunications network facilities of Type I telecommunications enterprises. • Ensure Electro-Magnetic Compatibility (hereinafter as EMC) to harmonize and effective use of the radio spectrum. • Ensure electrical safety to prevent harm to network operator personnel or users.

  21. Terminal Equipment Technical Regulations (4/9) ◎ Essential Requirements of TTE • Harm to network and users Limit to • Electrical safety • Electromagnetic Compatibility

  22. Terminal Equipment Technical Regulations (5/9) ◎ EMC/Electrical Safety Requirements for TTE Article 4,Compliance Approval Regulations of Telecommunications Terminal Equipment The test items relating to EMC and electrical safety of TTE and date of enforcement shall be announced in public by the DGT. EMC test : All TTE are requested to conduct EMC test to CNS 13438 from June 28, 2002. •  Electrical Safety test : Up to now, the following TTE are requested to conduct Electrical Safety test to CNS 14336 from June 28, 2002. • xDSL • IP Phone • Cable Modem • DS1 TTE • Cellular Phone (IEC/EN 60950, Jan 7, 2004)

  23. Terminal Equipment Technical Regulations (6/9) ◎SAR Requirements for TTE (1/4) Enforcement Date: From July 1, 2001on, Marking warnings on cellular phone, measuring the SAR values and posting the SAR values of cellular phone were mandated by DGT. That is, since July 1, 2001, applicants for compliance approval of cellular phones are required to submit SAR test reports or verdict data to the DGT. (Ref: Specific Absorption Rate,SAR) SAR standards: • 2G Cell Phone(PLMN 01, Section 3); 3G Cell Phone(PLMN 08, Section 3.1.2) • The DGT adopts the same SAR limits “1.6 W/kg, as measured over 1 gram of human tissue” as the FCC and IEEE does. Meanwhile, the DGT adopts the required measurements procedure for the standard, such as FCC Part 2.1093, FCC OET Bulletin 65(Supplement C), ANSI/IEEE C95.1 and ANSI/IEEE C95.3, Std. 1528-200x or the ANSI/IEEE relevant latest requirements.

  24. Terminal Equipment Technical Regulations (7/9) ◎SAR Requirements for TTE(2/4)  The SAR test report shall contain the followings: 1. Equipment name, brand name and model number. 2. Testing facility connection diagram and description. 3. Name, brand name and model number of test instruments. 4. Test items and standards. 5. Test data and verdict of test results. 6. Date of acceptance and completion of testing.

  25. Warning: ”For Reducing RF Influence, Use Properly “ Labeling method: Label accordingly on handset, carton, or in user’s manual. RF Exposure Warning Label SAR label content: “ SAR limit 1.6 W/Kg; after testing value: W/Kg” Labeling method: Label accordingly on handset, carton, or in user’s manual. SAR Label Terminal Equipment Technical Regulations (8/9) ◎SAR Requirements for TTE(3/4)  RF Exposure Warning Label: (PLMN01, Section 3.9; PLMN08, Section 3.1.2)  Label requirements and Format

  26. Terminal Equipment Technical Regulations (9/9) ◎SAR test reports how to be accepted by the DGT(4/4) For Domestic testing labs: The test report shall be issued by the testing labs with the SAR scope accredited by the CNLA and comply with the SAR requirements of the DGT. For Foreign testing labs: The test report shall be issued by the testing labs with the SAR scope accredited by the third party and comply with the SAR requirements of the DGT. For MRA CAB: The test report shall be issued by the testing labs with the SAR scope accredited by its Accreditation Body, designated by its Designating Authority as a MRA CAB and comply with the SAR requirements of the DGT.

  27. Conformity Assessment Schema Designating Authority/Regulator [DGT] Appointed/Designated Accredited/Designated Product Certification Accreditation Body [TAF/CNAB] Comply with ISO/IEC Guide 61 Testing Lab Accreditation Body [TAF/CNLA] Comply with ISO/IEC Guide 58 CNLA:Chinese National Laboratory Accreditation CNAB:Chinese National Accreditation Board Accredited Accredited Testing Labs Comply with ISO/IEC 17025 Certification Bodies Comply with ISO/IEC 17025& ISO/IEC Guide 65 CABs TAF:Taiwan Accreditation Foundation

  28. Conformity Assessment Requirements (1/12 ) ◎Regulations Amendments  Regulations amended ( Coming into force in Nov. 2004): Compliance Approval Regulations on Controlled Telecommunications Equipment Compliance Approval Regulations of Telecommunications Terminal Equipment  Outline of the amendment SDoC (Supplier’s Declaration of Conformity) is introduced as conformity assessment requirements.  Foreign manufacturers can directly apply for compliance approval.  Electronic Filing Systemfor the public to submit application package is introduced.

  29. Supplier Declaration of Compliance (SDoC) Certification (Type Approval) Technical Regulations Conformity Assessment Requirements (2/12 ) ◎Two Types of Conformity Assessment Process for TTE and LP

  30. Conformity Assessment Requirements (3/12 ) ◎Definition of Type Approval and SDoC for TTE and LP • Type Approval: • Apply to the approval procedure by the manufacturer, importer or distributor in accordance with the brand name, model number of TTE/LP that shall be submitted to the Directorate General of Telecommunications or DGT recognized certification bodies. • Supplier Declaration of Conformity(SDoC)： • A process in which the Declaring Party has the TTE/LP tested and declare in a signed application form accompanying with the required document to RCB that the TE complies with the appropriate technical standards.

  31. Conformity Assessment Requirements (4/12 ) ◎Category of Compliance Approval for TTE and LP Category of Compliance Approval Sale use Private use SDoC Approval by Piece Type Approval (For LP device only)

  32. Conformity Assessment Requirements (5/12 ) ◎Compliance Approval Requirementsfor TTE and LP

  33. Conformity Assessment Requirements (6/12 ) ◎Elements of Test Reportfor TTE and LP • The test report includes: • Color photographs larger than 4Rof the unit to show details of external appearance and internal construction • Name, trade name, model number of equipment • Name and address of applicant • Name and address of testing lab • Unique identity for test report and page test report • Testing instrument connection diagram and description • Name, trade and model number of testing facilities as well as date of calibration and period of validity • date of calibration and period of validity • Technical regulations be performed • Test items and its standards • Verdict of test results • Date of acceptance and completion of testing

  34. Conformity Assessment Requirements (7/12 ) ◎Technical Requirements for TTE and LP • TTE and CTD both shall comply with the test items and standards as specified in the relevant technical specifications; where the test items and standards are not available, testing shall be performed in accordance with the following order: • Ⅰ. National standards • Ⅱ. Standards specified by the international standard organization • Ⅲ. Standards specified by the regional standard organization • National Standards: CNS • International Standards: ITU-T; ITU-R; ISO; IEC; JTC1 • Regional Standard: ETSI; ANSI; TTC; CEN; T1

  35. Applicant RTL Equipment Sample Testing RCB 1.Application Form 2.Copies of related identification documents 3.Technical documents Accept application and charge approval fees Test Report Is the application package complete and adequate? Supplement within 1 months on receipt of notification from RCB No Supplement within prescribed time frame Is the supplement complete and adequate Yes Yes Yes No No Turn down the application Equipment conformity assessment Fail Applicant will receive notification of failure and shall apply for secondary review within 2 months Pass Application for secondary review within prescribed time frame Pass secondary review? Yes Yes Issue certificate of approval No No Turn down the application Conformity Assessment Requirements (8/12 ) ◎Conformity Assessment Procedurefor TTE and LP (Sale Use)

  36. RCB Applicant Accept Application and charge approval fees 1.Application Form 2.Equipment sample 3.Copies of related identification documents 4.Technical documents Is the application package complete and adequate? Supplement within 1 months on receipt of notification from RCB No Supplement within prescribed time frame Yes Yes Is the supplement complete and adequate No No Yes Turn down the application Applicant will receive notification of failure and shall apply for secondary review within 2 months Equipment conformity assessment Fail Pass Application for secondary review within prescribed time frame Pass secondary review? No Issue Certificate of approval and label No Turn down the application Conformity Assessment Requirements (8/12 ) ◎Conformity Assessment Procedurefor TTE and LP (Private Use)

  37. Conformity Assessment Requirements (9/12 ) ◎SDoCfor TTE and LP • Planning to the products apply SDoC: • The products has short life cycle. • The Products has stable quality and low Safety risks. • Less impact on consumers • Starting with small area of products, to see the knowledge and cooperation manufacturers, importers and distributors have to meet the certification regulations. • The items of equipment and date of implementation applicable to the SDoC procedure will be announced by the DGT. It is expected to put into force in the end of 2005.

  38. Conformity Assessment Requirements (10/12 ) ◎SDoC and Registration Requirements for TTE and LP • Equipment testing must be performed by DGT recognized testing laboratories • Compliance Folder are kept by RCB. • Sample equipment, testing software and special testing facilities are kept by Declaring Party for 5 years until the equipment doesn’t be manufactured or imported • The Equipment models will be registered by RCB.

  39. Conformity Assessment Requirements (11/12 ) ◎SDoC and Registration Procedurefor TTE and LP(1/2) • Submission to RCB • Registration application form • User Manuel • Spec. document • Circuit diagram or Block diagram • Test report • Certificate of establishment for legal entity • Operation certificate of CTD (Foreign manufacturers are exempted) • Other documents specified by DGT • 5 Compact Discs including the above information • Registration fee

  40. XXXyyyRFDzzzz-x XxxYYyyy=z Conformity Assessment Requirements (12/12 ) ◎SDoC and Registration Procedurefor TTE and LP (2/2) • Declaring Party action • Label the Equipment • Distribute the Equipment for market • RCB action • Review for completeness • Grant Certificate of SDoC • Register Equipment on the List • SDoC Mark showed as below: X : RCB Identification xx : Year Identification YY : Equipment Category yyy : Serial No. z : Identify as series products XXX: RCB Identification yyy : Year Identification zzzz: Serial No. x : Identify as series products, a-z

  41. Marking Requirements (1/6) ◎Label Requirements • The exclusive right of use relating to Approval Label belongs to the one who has been granted the certificate of approval. • When the certificate holder agrees to empower its approval label to others with respect to the same brand name and model number and submits a signed consent statement accompanying with the required documents to the DGT, the DGT will send an acknowledgement to the original party after reviewing the material submitted. • Certified equipment shall bear the identifying marks for market. • The identifying marks shall be affixed to the certified equipment.

  42. Marking Requirements (2/6) ◎Label Empowerment Process • Submission by Certificate Holder • Authorization Letter • Compliance Approval Certificate or SDoC Certificate • Legal Entity Certificate of Authorized Party • RCB action • Review for completeness • Send acknowledgement to the original certificate holder

  43. AxxYYyyy/z XxxYYyyy-z Marking Requirements (3/6) ◎TTE Approval Mark -For Sale Use: X : RCB Identification xx : Year Identification YY : Equipment Category yyy : Serial No. z : Identify as series products -For Private Use: A : stand for “DGT” xx : Year Identification YY : Equipment Category yyy : Serial No. z : Certified regulatory station of DGT N: Northern Regional Station; C: Central Regional Station; S: Southern Regional Station

  44. XXXyyyLPDzzzz-x DGTxxxLPDyyyy DGTxxxLPDyzzzz Marking Requirements (4/6) ◎Low Power RF Devices Approval Mark -For Sale Use: XXX: RCB Identification yyy : Year Identification zzzz: Serial No. x : Identify as series products, a-z -For Approval by Piece: xxx : Year Identification yyyy: Serial No. -For Private Use: xxx : Year Identification y : Certified regulatory station of DGT zzzz: Serial No.

  45. Marking Requirements (5/6) ◎Warning Label (Indoor Wireless TTE products) ◎Warning Label (Cellular Phone)

  46. Market Surveillance (1/3) • There's a requirement specified that RCBs are to perform some surveillance of the products they certify • Each RCB is required to have a market surveillance program in place to monitor all of the products it certifies • RCB is being carried out surveillance program mandatory • Each RCB needs to define what market surveillance it plans to perform and that DGT would assess each RCB's plan every year.

  47. Market Surveillance (2/3) • DGT/RCB determine whether a certified equipment maintains conformity with technical standards and the identity by sampling in the market. • Surveillance Method • Electric Characteristics Test • Examine conformity with the technical regulations • Comparison and Verification • Identity with color photographs

  48. Market Surveillance (3/3) • Performed by DGT • Randomly • In response to complaints • Performed by RCBs • For apparatus that they have certified • May result in testing to technical specifications • Fines will be applied

  49. Mutual Recognition of Test Report (1/5) ◎ Phase I of MRA implementation Recognized Testing Lab (RTL)Designation Criteria • Legal entity which has the technical competence to perform the tests • Accredited with ISO/IEC 17025 • Demonstration of technical competence in performing the tests. • Technological knowledge and experience of relevant product • Familiar with legislative, regulatory and administrative provisions

  50. Mutual Recognition of Test Report (2/5) ◎ Phase I of MRA implementation Domestic RTL Designation Process • Submit application package to CNLA • CNLA will review the application package. If it is acceptable, the process for the accreditation will be undertaken by CNLA • CNLA will issue a RTL accreditation certificate to applicant if competent and submit the accredited testing lab list to DGT for RTL designation and recognition. • DGT will make this public on its website (www.dgt.gov.tw)

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