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1、ATTEENTIION:- TThiss taablee liist conntaiins thee RMM taablees ffromm thhe IIEC 606601-1:220055 trrf vverssionn g.- TThiss RMM taablee liist is inttendded to be useed iin tthe folllowwingg waay:aa) MManuufaccturrer willl ffilll ouut OONLYY THHE FFIRSST CCOLUUMN Doocummentt Reef iin RRMF“ and send b
2、ack the word document to the test engineer.b) The test engineer will verify the correctness of the “Document Ref in RMF” and transfer it in the IEC 60601-1 trf.c) Then the test engineer will evaluate the RMF and “verdict” the results. Please find a “wrong” and “right” filled out sample of a single R
3、M-table as guidance how to fill out the RM-tables correctly:4.2“WROONG” exaamplle oof ffillled outt RMM REESULLTS TABBLE:Clauuse of ISOO 1449711Docuumennt RRef. inn RMMF (Doccumeent No. & parragrraphh)Resuult - RRemaarkssVerddictt3.3aaSee RM-fille 3.5eeSee RM-fille 4.1See RM-fille 4.2See RM-fille 4.
4、3See RM-fille 4.4See RM-fille 5See RM-fille 6.1See RM-fille 6.2See RM-fille 6.3See RM-fille 6.4See RM-fille 6.5See RM-fille 6.6See RM-fille 6.7See RM-fille 7See RM-fille 4.2“RIGGHT” exaamplle oof ffillled outt RMM REESULLTS TABBLE:Clauuse of ISOO 1449711Docuumennt RRef. inn RMMF (Doccumeent No. & pa
5、rragrraphh)Resuult - RRemaarkssVerddictt3.3aa9806640000000_RMMF cchappterr 4 pagge 2233.5ee9806640000000_RMMF cchappterr 5 pagge 3344.19806640000000_RMMF cchappterr 2 pagge 0084.29806640000000_RMMF cchappterr 3 pagge 114fff4.39806640000000_ARR01_0011 RA rref # 11.000a4.49806640000000_ARR02_0011 RMMS
6、RA rref # 11.000a59806640000000_ARR02_0011 RMMSRA rref # 11.000a6.1See 6.22 too 6.76.29806640000000_ARR02_0011 RMMSRA rref # 11.000a6.39806640000000_VAA01_0011 Chheckklisst6.49806640000000_ARR02_0011 RMMSRA rref # 11.000a6.59806640000000_ARR02_0011 RMMSRA rref # 11.000a6.69806640000000_ARR02_0011 RM
7、MSRA rref # 11.000a6.79806640000000_RMMF cchappterr 111 paage 104479806640000000_RMMF cchappterr 122 paage 1077STARRT tto ffilll ouut bby tthe mannufaactuurerr:Manuufaccturrer:Devvicee unnderr Teest:Datee off coomplletiion of firrst collumnn:4.2RM RRESUULTSS TAABLEE: RRiskk Maanaggemeent Proocesss f
8、for ME Equuipmmentt orr MEE Syysteems Clauuse of ISOO 1449711Docuumennt RRef. inn RMMF (Doccumeent No. & parragrraphh)Resuult - RRemaarkssVerddictt3.3aa3.5ee4.14.24.34.456.16.26.36.46.56.66.774.3RM RRESUULTSS TAABLEE: EEsseentiial PerrforrmannceClauuse of ISOO 1449711Docuumennt RRef. inn RMMF (Doccu
9、meent No. & parragrraphh)Resuult - RRemaarkssVerddictt4.24.34.456.26.36.4Notee: 66.2 to 6.44 noot ppartt off IEECEEE TRRF vverssionn G, buut rrequuireed bby IISO 149971.4.5RM RRESUULTSS TAABLEE: EEquiivallentt Saafetty ffor ME Equuipmmentt off MEE SyysteemClauuse of ISOO 1449711Docuumennt RRef. inn
10、RMMF (Doccumeent No. & parragrraphh)Resuult - RRemaarkssVerddictt4.24.34.456.26.36.46.5Not apppliccablle ffor equuivaalennt ssafeety.N/A4.6RM RRESUULTSS TAABLEE: MME EEquiipmeent or sysstemm paartss coontaactiing thee paatieentClauuse of ISOO 1449711Docuumennt RRef. inn RMMF (Doccumeent No. & parrag
11、rraphh)Resuult - RRemaarkssVerddictt4.24.34.456.26.36.46.54.7RM RRESUULTSS TAABLEE: SSinggle Fauult Conndittionn foor MME EEquiipmeentClauuse of ISOO 1449711Docuumennt RRef. inn RMMF (Doccumeent No. & parragrraphh)Resuult - RRemaarkssVerddictt4.24.34.44.8RM RRESUULTSS TAABLEE: CCompponeentss off MEE
12、 EqquippmenntClauuse of ISOO 1449711Docuumennt RRef. inn RMMF (Doccumeent No. & parragrraphh)Resuult - RRemaarkssVerddictt4.24.34.456.26.36.46.54.9RM RRESUULTSS TAABLEE: UUse of commponnentts wwithh hiigh-inttegrrityy chharaacteerissticcsClauuse of ISOO 1449711Docuumennt RRef. inn RMMF (Doccumeent No. & parragrraphh)Resuult - RRemaarkssVerddictt4.24.34.456.26.36.46.5N/A5.1RM RRESUULTSS TAABLEE: TTypee TeestssClauuse of ISOO 1449711Docuumennt RRef. inn RMMF (Doccumeent No. & parragrraphh)Resuult - RRemaarkssVerddictt4.24.34.45.4 a)RM RRESUULTSS TAABLEE: OOtheer CCondditiions
