SKR001 (V9) Regulatory Assurance Certification
Seagate Singapore Design Centre, SingaporeSKR001 (V9)RegulatoryAssurance CertificationDO NOT DUPLICATECONTROLLED COPYThis document has been issued electronically.Only the original recipient of the document will be notified with revision information.Issue Date: 26 Feb 2019Revision 9.3SKR001 (V9)Certification Package Revision 9.3Page 1 of 16
Safety CertificationTest Objective:Verifies that product meets the required Safety requirements as stipulated by UL, and TUV Safety Agencies; andalso European Directives: ndUL 60950-1, 2 Edition, 2014-10-14TUV EN60950-1, IEC 60950-1Test Description:The product was submitted to and tested by the safety agencies.The product is certified for cUL mark through UL Korea under Underwriter Laboratories (UL) file E190397.Attached is the Certificate of Compliance to apply the cUL mark.The product is certified for TUV SUD mark through TUV SUD Korea Corporation. Attached is the TUV SUDCertificate.Pass/Fail Criteria:Product meets the stipulated Safety requirements.Product:Product Name: Hard Disk DriveConclusion:The unit passed the above safety tests and standards. Due to similarities in the hard disk drives, it was onlynecessary to test one model in order to pass for all models.Agency / StandardsUL60950-1TUV EN60950-1, IEC 60950-1SKR001 (V9)Certification Package Revision 9.3ConclusionApproved to BearAgency’s MarksCompliance with applicable cULCompliance with IEC60950,Compliance with EN60950Page 2 of 16
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ElectroMagnetic CompatibilityTest Objective:Verify that the product, which is an internal computer peripheral with no direct connection to external I/O or power,meets applicable EMC emission and immunity standards when installed in a representative host system. This isdone by verifying that the product, in the system, complies with the appropriate limits for FCC, CE Mark, Ctick(RCM), and VCCI. For FCC, applicable limits are found in CFR 47, Part 15, Subpart B, Class B, and for CE, Ctick(RCM), and VCCI are found in EN 55032 Class B. Immunity requirements for CE Marking are defined in EN55024Test Description:Testing is performed with the drive installed in representative host system. The host system in this case, is aNotebook laptop or Desktop and the drive is exercised random write/read mode for all testing. The drive ismonitored for correct operation throughout the testing.Emission testing (performed at a 10m Chamber) and immunity testing are performed at an EMC facility, which hasbeen certified by SAC-SINGLAS.Emission testing consists of the following:1.2.3.4.5.6.Conducted emissions, 150 kHz to 30 MHz, 110 Vac/60 Hz (FCC)Conducted emissions, 150 kHz to 30 MHz, 230 Vac/50 Hz {CE, C-tick(RCM), VCCI}Radiated emissions, 30 MHz to 1 GHz, 10-meter antenna distanceRadiated emissions, 1 GHz to 6 GHz, 3-meter antenna distanceAC power line harmonics, per EN61000-3-2 : 2014AC power line flicker, per EN61000-3-3: 2013Immunity testing includes the following:1.2.3.4.5.6.7.Electrostatic discharge per IEC 61000-4-2 (Level B)Radiated RF field immunity per IEC 61000-4-3 and EN 50204 (Level A)Electrical Fast Transient/Burst per IEC 61000-4-4 (Level B)Surge Immunity per IEC 61000-4-5 (Level B)Conducted RF Immunity per IEC 61000-4-6 (Level A)Power Frequency H-field Immunity per IEC 61000-4-8 (Level A)Voltage Dips and Interrupts per IEC 61000-4-11 (Level B, C)Pass/Fail Criteria:For immunity testing, the drive must meet different levels of performance (A, B or C) for the various RFenvironments to which it is exposed. These are defined as follows:Performance Level A - no degradation in performance, no loss of dataPerformance Level B - degraded performance acceptable provided that 1) no data is lost and 2) unit self-recoverswithout user intervention after the RF environment has been withdrawnPerformance Level C - reset acceptable, user intervention acceptable provided that unit suffers no permanentdamage.Product:Product Name: Hard Disk DriveSKR001 (V9)Certification Package Revision 9.2Page 8 of 16
Conclusion:No modifications were made to pass. No Specification deviations, additions to or exclusions from were performed.Due to similarities in the drives, the test conclusions are applicable to hard disk drive.StandardApproved to BearCE & RCM MarksResultEN 55032:2015EN 61000-3-2: 2014EN 61000-3-3: 2013EN 55024: 2010IEC 61000-4-2: 2008IEC 61000-4-3: 2010IEC 61000-4-4: 1995IEC 61000-4-5: 1995IEC 61000-4-6: 1996IEC 61000-4-8: 1993IEC 61000-4-11: st Data:EMC Immunity Test ResultsSpecificationElectrostatic DischargeTest MethodTest ConditionsComplianceEFT/BurstSurge ImmunityIEC 61000-4-2IEC-61000-4-3EN 50204IEC 61000-4-4IEC 61000-4-5Conducted RF ImmunityIEC 61000-4-6Power Frequency MagneticField ImmunityIEC 61000-4-81 Amp / meter, 3 axes, 50 Hz and 60HzCompliantVoltage Dips and InterruptsIEC 61000-4-110% open and short for 5 seconds, 40% for 0.1second, 70% for 0.01 secondCompliantRF Radiated ImmunitySKR001 (V9)Certification Package Revision 9 .24 kV Contact / HCP, VCP / 8 kV AirCompliant80 - 1000 MHz, 3 V/m, 80% 1 kHz AMCompliant0.5 kV I/O, 1 kV AC mains2 kV comm. mode, 1 kV diff. mode, AC mains150 kHz to 80 MHz, 3 Vrms, 80% 1 kHz AM,power and I/OCompliantCompliantCompliantPage 10 of 16
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Seagate Singapore Design Centre, SingaporeSKR004(V11 3D/4D)RegulatoryAssurance CertificationDO NOT DUPLICATECONTROLLED COPYThis document has been issued electronically.Only the original recipient of the document will be notified with revision information.Issue Date: 7 Jan 2020Revision 6.1Page 1 of 17
Safety CertificationTest Objective:Verifies that product meets the required Safety requirements as stipulated by UL, and TUV Safety Agencies; andalso European Directives: UL 60950-1TUV EN 60950-1, IEC 60950-1, EN 62368-1, IEC 62368-1Test Description:The product was submitted to and tested by the safety agencies.The product is certified for cUL mark through UL Korea under Underwriter Laboratories (UL) file E190397.Attached is the Certificate of Compliance to apply the cUL mark.The product is certified for TUV SUD mark through TUV SUD Korea Corporation. Attached is the TUV SUDCertificate.Pass/Fail Criteria:Product meets the stipulated Safety requirements.Product:Product Name: Hard Disk DriveConclusion:The unit passed the above safety tests and standards. Due to similarities in the hard disk drives, it was onlynecessary to test one model in order to pass for all models.Agency / StandardsUL60950-1TUV EN 60950-1, IEC 60950-1TUV EN 62368-1, IEC 62368-1ConclusionApproved to BearAgency’s MarksCompliance with applicable cULCompliance with IEC60950,EN60950, IEC62368,EN62368Page 2 of 17
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ElectroMagnetic CompatibilityTest Objective:Verify that the product, which is an internal computer peripheral with no direct connection to external I/O or power,meets applicable EMC emission and immunity standards when installed in a representative host system. This isdone by verifying that the product, in the system, complies with the appropriate limits for FCC, CE Mark, Ctick(RCM), and VCCI. For FCC, applicable limits are found in CFR 47, Part 15, Subpart B, Class B, and for CE, Ctick(RCM), and VCCI are found in EN 55032 Class B. Immunity requirements for CE Marking are defined in EN55024Test Description:Testing is performed with the drive installed in representative host system. The host system in this case, is aNotebook laptop or Desktop and the drive is exercised random write/read mode for all testing. The drive ismonitored for correct operation throughout the testing.Emission testing (performed at a 10m Chamber) and immunity testing are performed at an EMC facility, which hasbeen certified by SAC-SINGLAS.Emission testing consists of the following:1.2.3.4.5.6.Conducted emissions, 150 kHz to 30 MHz, 110 Vac/60 Hz (FCC)Conducted emissions, 150 kHz to 30 MHz, 230 Vac/50 Hz {CE, C-tick(RCM), VCCI}Radiated emissions, 30 MHz to 1 GHz, 10-meter antenna distanceRadiated emissions, 1 GHz to 6 GHz, 3-meter antenna distanceAC power line harmonics, per EN61000-3-2 : 2014AC power line flicker, per EN61000-3-3: 2013Immunity testing includes the following:1.2.3.4.5.6.7.Electrostatic discharge per IEC 61000-4-2 (Level B)Radiated RF field immunity per IEC 61000-4-3 and EN 50204 (Level A)Electrical Fast Transient/Burst per IEC 61000-4-4 (Level B)Surge Immunity per IEC 61000-4-5 (Level B)Conducted RF Immunity per IEC 61000-4-6 (Level A)Power Frequency H-field Immunity per IEC 61000-4-8 (Level A)Voltage Dips and Interrupts per IEC 61000-4-11 (Level B, C)Pass/Fail Criteria:For immunity testing, the drive must meet different levels of performance (A, B or C) for the various RFenvironments to which it is exposed. These are defined as follows:Performance Level A - no degradation in performance, no loss of dataPerformance Level B - degraded performance acceptable provided that 1) no data is lost and 2) unit self-recoverswithout user intervention after the RF environment has been withdrawnPerformance Level C - reset acceptable, user intervention acceptable provided that unit suffers no permanentdamage.Product:Product Name: SKR004 (V11 3D/4D)Page 10 of 17
Conclusion:No modifications were made to pass. No Specification deviations, additions to or exclusions from were performed.Due to similarities in the drives, the test conclusions are applicable to hard disk drive.StandardApproved to BearCE & RCM sPassEN 55032:2015 - Class BEN 61000-3-2: 2014EN 61000-3-3: 2013EN 55024: 2010IEC 61000-4-2: 2008IEC 61000-4-3: 2010IEC 61000-4-4: 1995IEC 61000-4-5: 1995IEC 61000-4-6: 1996IEC 61000-4-8: 1993IEC 61000-4-11: 1994Test Data:EMC Immunity Test ResultsSpecificationElectrostatic DischargeTest MethodTest ConditionsComplianceEFT/BurstSurge ImmunityIEC 61000-4-2IEC-61000-4-3EN 50204IEC 61000-4-4IEC 61000-4-5Conducted RF ImmunityIEC 61000-4-6Power Frequency MagneticField ImmunityIEC 61000-4-81 Amp / meter, 3 axes, 50 Hz and 60HzCompliantVoltage Dips and InterruptsIEC 61000-4-110% open and short for 5 seconds, 40% for 0.1second, 70% for 0.01 secondCompliantRF Radiated Immunity4 kV Contact / HCP, VCP / 8 kV AirCompliant80 - 1000 MHz, 3 V/m, 80% 1 kHz AMCompliant0.5 kV I/O, 1 kV AC mains2 kV comm. mode, 1 kV diff. mode, AC mains150 kHz to 80 MHz, 3 Vrms, 80% 1 kHz AM,power and I/OCompliantCompliantCompliantPage 11 of 17
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Seagate Singapore Design Centre, SingaporeSKR002 (V11 1/2D)RegulatoryAssurance CertificationDO NOT DUPLICATECONTROLLED COPYThis document has been issued electronically.Only the original recipient of the document will be notified with revision information.Issue Date: 7 Jan 2020Revision 5.1SKR002 (V11 1/2D)Certification Package Revision 5.1Page 1 of 4
Safety CertificationTest Objective:Verifies that product meets the required Safety requirements as stipulated by UL, and TUV Safety Agencies; andalso European Directives: UL 60950-1TUV EN 60950-1, IEC 60950-1, EN 62368-1, IEC 62368-1Test Description:The product was submitted to and tested by the safety agencies.The product is certified for cUL mark through UL Korea under Underwriter Laboratories (UL) file E190397.Attached is the Certificate of Compliance to apply the cUL mark.The product is certified for TUV SUD mark through TUV SUD Korea Corporation. Attached is the TUV SUDCertificate.Pass/Fail Criteria:Product meets the stipulated Safety requirements.Product:Product Name: Hard Disk DriveConclusion:The unit passed the above safety tests and standards. Due to similarities in the hard disk drives, it was onlynecessary to test one model in order to pass for all models.Agency / StandardsUL60950-1TUV EN 60950-1, IEC 60950-1TUV EN 62368-1, IEC 62368-1ConclusionApproved to BearAgency’s MarksCompliance with applicable cULCompliance with IEC60950,EN60950, IEC62368,EN62368SKR002 (V11 1/2D)Certification Package Revision 5.1Page 2 of 4
ElectroMagnetic CompatibilityTest Objective:Verify that the product, which is an internal computer peripheral with no direct connection to external I/O or power,meets applicable EMC emission and immunity standards when installed in a representative host system. This isdone by verifying that the product, in the system, complies with the appropriate limits for FCC, CE Mark, Ctick(RCM), and VCCI. For FCC, applicable limits are found in CFR 47, Part 15, Subpart B, Class B, and for CE, Ctick(RCM), and VCCI are found in EN 55032 Class B. Immunity requirements for CE Marking are defined in EN55024Test Description:Testing is performed with the drive installed in representative host system. The host system in this case, is aNotebook laptop or Desktop and the drive is exercised random write/read mode for all testing. The drive ismonitored for correct operation throughout the testing.Emission testing (performed at a 10m Chamber) and immunity testing are performed at an EMC facility, which hasbeen certified by SAC-SINGLAS.Emission testing consists of the following:1.2.3.4.5.6.Conducted emissions, 150 kHz to 30 MHz, 110 Vac/60 Hz (FCC)Conducted emissions, 150 kHz to 30 MHz, 230 Vac/50 Hz {CE, C-tick(RCM), VCCI}Radiated emissions, 30 MHz to 1 GHz, 10-meter antenna distanceRadiated emissions, 1 GHz to 6 GHz, 3-meter antenna distanceAC power line harmonics, per EN61000-3-2 : 2014AC power line flicker, per EN61000-3-3: 2013Immunity testing includes the following:1.2.3.4.5.6.7.Electrostatic discharge per IEC 61000-4-2 (Level B)Radiated RF field immunity per IEC 61000-4-3 and EN 50204 (Level A)Electrical Fast Transient/Burst per IEC 61000-4-4 (Level B)Surge Immunity per IEC 61000-4-5 (Level B)Conducted RF Immunity per IEC 61000-4-6 (Level A)Power Frequency H-field Immunity per IEC 61000-4-8 (Level A)Voltage Dips and Interrupts per IEC 61000-4-11 (Level B, C)Pass/Fail Criteria:For immunity testing, the drive must meet different levels of performance (A, B or C) for the various RFenvironments to which it is exposed. These are defined as follows:Performance Level A - no degradation in performance, no loss of dataPerformance Level B - degraded performance acceptable provided that 1) no data is lost and 2) unit self-recoverswithout user intervention after the RF environment has been withdrawnPerformance Level C - reset acceptable, user intervention acceptable provided that unit suffers no permanentdamage.Product:Product Name: SKR002 (V11 1D / 2D)SKR002 (V11 1/2D)Certification Package Revision 5.0Page 3 of 4
Conclusion:No modifications were made to pass. No Specification deviations, additions to or exclusions from were performed.Due to similarities in the drives, the test conclusions are applicable to hard disk drive.StandardApproved to BearCE & RCM sPassEN 55032:2015 – Class BEN 61000-3-2: 2014EN 61000-3-3: 2013EN 55024: 2010IEC 61000-4-2: 2008IEC 61000-4-3: 2010IEC 61000-4-4: 1995IEC 61000-4-5: 1995IEC 61000-4-6: 1996IEC 61000-4-8: 1993IEC 61000-4-11: 1994Test Data:EMC Immunity Test ResultsSpecificationElectrostatic DischargeTest MethodTest ConditionsComplianceEFT/BurstSurge ImmunityIEC 61000-4-2IEC-61000-4-3EN 50204IEC 61000-4-4IEC 61000-4-5Conducted RF ImmunityIEC 61000-4-6Power Frequency MagneticField ImmunityIEC 61000-4-81 Amp / meter, 3 axes, 50 Hz and 60HzCompliantVoltage Dips and InterruptsIEC 61000-4-110% open and short for 5 seconds, 40% for 0.1second, 70% for 0.01 secondCompliantRF Radiated ImmunitySKR002 (V11 1/2D)Certification Package Revision 5.04 kV Contact / HCP, VCP / 8 kV AirCompliant80 - 1000 MHz, 3 V/m, 80% 1 kHz AMCompliant0.5 kV I/O, 1 kV AC mains2 kV comm. mode, 1 kV diff. mode, AC mains150 kHz to 80 MHz, 3 Vrms, 80% 1 kHz AM,power and I/OCompliantCompliantCompliantPage 4 of 4
Supplier’s Declaration of ConformityDeclaration of Conformity as a registered and responsible supplier under theAustralian Communications and Media Authority (ACMA) regulatory arrangementsfor Regulatory Compliance Mark (RCM) and it’s placement.Responsible Supplier Name: Seagate Technology Australia Pty LtdResponsible Supplier Number: E806Seagate Technology Australia Pty. LimitedLevel 7, 91 Phillip StPARRAMATTA NSW 2150AUSTRALIADeclare under our sole responsibility that the following product(s):Hard Disk Data Storage DriveModel: SKR002to which this declaration relates is in conformity with the following standard(s):TitleTest RegulationAustralian/New Zealand StandardAS/NZS CISPR 32 : 2015(Name of the Authorized Person)(Title of the Authorized Person)(Date of Issue)(Signature)8th August 2016Sam ZavagliaSenior Field Applications Engineer
Reg Model: STR00C(MakaraBP, SATA, 6TB)RegulatoryAssurance CertificationJuly 1, 2019Rev EDO NOT DUPLICATECONTROLLED COPYThis document has been issued electronically.Only the original recipient of the document willbe notified with the revision informationAuthor: Regulatory Assurance
Reg Model: STL010(Cimarron, SATA)RegulatoryAssurance CertificationNovember 27, 2019Rev 1.3DO NOT DUPLICATECONTROLLED COPYThis document has been issued electronically.Only the original recipient of the document willbe notified with the revision informationAuthor: Regulatory Assurance
IEC 61000-4-3: 2010 . IEC 61000-4-4: 1995 . IEC 61000-4-5: 1995 . IEC 61000-4-6: 1996 . IEC 61000-4-8: 1993 . IEC 61000-4-11: 1994 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass . Test Data: EMC Immunity Test Resu
A formal Regulatory Management System [RMS] can help with: reduction of regulatory burden on citizens and firms improvement of regulatory quality identification of best choice of policy options Comprised of four elements: 1. regulatory quality tools 2. regulatory processes 3. regulatory institutions 4. regulatory policies 16
Page 1 of 9 Rapid Regulatory Courses in HealthStream Getting Started Tip Sheet Please note: Everyone is required to take two compliance trainings titled: Rapid Regulatory Compliance: Non-clinical I Rapid Regulatory Compliance: Non-clinical II Depending on your position at CHA, you may have more courses on your list. One must complete them all.File Size: 1MBPage Count: 9Explore furtherRapid Regulatory Compliance: Clinical II - KnowledgeQ .quizlet.comRapid Regulatory Compliance: Clinical I - An HCCS .quizlet.comRapid Regulatory Compliance: Non-clinical II-KnowledgeQ .quizlet.comThe Provider Compliance Tip fact sheets are now available .www.cms.govRapid Regulatory Compliance - Non-Clinical - Part Istudyres.comRecommended to you b
Auditing and Assurance Services Week 2 1. ASSURANCE What is assurance and what are the different types and levels of assurance? Five elements: Three-parties relationships, subject matter, suitable criteria, sufficient appropriate evidence, written assurance report T
critical issues the University has established a Quality Assurance Directorate, which is mandated to develop a Quality Assurance Framework and a Quality Assurance Policy. The Quality Assurance Framework would clearly spell out the Principles, Guidelines and Procedures for implementing institutional quality assurance processes.
Certification is a process to check the quality assurance system. It helps en-sure the essential components of the quality assurance system are present and functioning properly, resulting in the highest probability of meeting specifications and building a success-ful project. Therefore, certification
Key words: regulation, regulatory quality, regulatory burden, regulatory management system, regulatory impact analysis, regulatory impact statement, cost of doing business . P a g e 792 . competitiveness, erodes public trust in government and encourages corruption in public institutions and public processes [OECD 2010].
Previous or current experience in regulatory affairs (minimum two years) may be taken into account in assessing entry . requirements of companies in filling regulatory and quality assurance roles. The impetus for the development of this . MASTERS IN MEDICAL TECHNOLOGY REGULATORY AFFAIRS. CERTIFICATION NFQ Level 9 - 90 credits PROGRAMME COSTS
A02 x 2 One mark for the purpose, which is not simply a tautology, and one for development. e.g. The Profit and Loss Account shows the profit or loss of FSC over a given period of time e.g. 3 months, 1 year, etc. (1) It describes how the profit or loss arose – e.g. categorising costs between cost of sales and operating costs/it shows both revenues and costs (1) (1 1) (2) 3(b) AO2 x 2 The .
