List of recognised standards - Brasil - IMDRF

1 Status: 2014-SeptemberPLEASE FILL IN: IF YES = Y FOR NO = N FOR Partial = PPLEASE FILL IN: IF YES = Y FOR NO = N FOR Partial = PIF "Y" OR "P" PLEASE ADD THE NATIONAL/REGIONAL REFERENCE FILL IN: PLEASE FILL IN: Document Reference PublicationStatus N-Standard, N-E -Draft, VN-E predraft, English Title recognised ?

2 Y-fully, P-partial,N-NOMandatory ? Y-fully, P-partial,N-NONational ReferencePublication date of the national standardRecognition Number, if availableIEC 60118-0 1983N Measurement of electroacoustical characteristics YYThere is no national referenceIN n 09/13 IEC 60118-0 AMD 1 1994-01N Hearing aids; part_0: measurement of electroacoustical characteristics; amendment_1 YYThere is no national referenceIN n 09/13 IEC 60118-1 1995-04N Hearing aids_- Part_1: Hearing aids with induction pick-up coil input IEC 60118-1 AMD 1 1998-07N Hearing aids_- Part_1: Hearing aids with induction pick-up coil input.

3 Amendment_1 IEC 60118-1 Edition 1999-01N Hearing aids_- Part_1: Hearing aids with induction pick-up coil input IEC 60118-12 1996-09N Hearing aids_- Part_12: Dimensions of electrical connector systems IEC 60118-13 2011-04N Electroacoustics_- Hearing aids_- Part_13: Electromagnetic compatibility (EMC) YYThere is no national referenceIN n 09/13 IEC 60118-14 1998-02N Hearing aids_- Part_14: Specification of a digital interface device IEC 60118-15 2012-02N Electroacoustics_- Hearing aids_- Part_15: Methods for characterising signal processing in hearing aids with a speach-like signal IEC 60118-2 1983N Hearing aids.

4 Part 2 : Hearing aids with automatic gain control circuits IEC 60118-2 AMD 1 1993-02N Hearing aids; part_2: hearing aids with automatic gain control circuits; amendment_1 IEC 60118-2 AMD 2 1997-05N Hearing aids_- Part_2: Hearing aids with automatic gain control circuits; Amendment_2 BrasilIEC 60118-4 2006-10N Electroacoustics_- Hearing aids_- Part_4: Induction loop systems for hearing aid purposes_- Magnetic field strength IEC 60118-5 1983N Hearing aids.

5 Part 5 : Nipples for insert earphones IEC 60118-6 1999-06N Hearing aids_- Part_6: Characteristics of electrical input circuits for hearing aids IEC 60118-7 2005-10N Electroacoustics_- Hearing aids_- Part_7: Measurement of performance characteristics of hearing aids for production, supply and delivery quality assurance purposes YYThere is no national referenceIN n 09/13 IEC 60118-8 2005-10N Electroacoustics_- Hearing aids_- Part_8: Methods of measurement of performance characteristics of hearing aids under simulated in situ working conditions IEC 60118-9 1985N Hearing aids.

6 Part 9 : Methods of measurement of characteristics of hearing aids with bone vibrator output IEC 60318-4 2010-01N Electroacoustics_- Simulators of human head and ear_- Part_4: Occluded-ear simulator for the measurement of earphones coupled to the ear by means of ear insertsIEC 60335-2-52 2005-10N Household and similar electrical appliances_- Safety_- Part_2-52: Particular requirements for oral hygiene appliances IEC 60335-2-52 AMD 1 2008-04N Household and similar electrical appliances_- Safety_- Part_2-52: Particular requirements for oral hygiene appliances.

7 Amendment_1 IEC 60335-2-52 Edition 2008-07N Household and similar electrical appliances_- Safety_- Part_2-52: Particular requirements for oral hygiene appliances IEC 60336 2005-04N Medical electrical equipment_- X-ray tube assemblies for medical diagnosis_- Characteristics of focal spots IEC 60336 Corrigendum 1 2006-05N Medical electrical equipment_- X-ray tube assemblies for medical diagnosis_- Characteristics of focal spots; Corrigendum_1 IEC 60522 2003-12N Determination of the permanent filtration of X-ray tube assemblies IEC 60526 1978N High-voltage cable plug and socket connections for medical X-ray equipment IEC 60526 Corrigendum 1 2010-04N High-voltage cable plug and socket connections for medical X-ray equipment IEC 60580 2003-09N Medical electrical equipment_- Dose area product meters

8 IEC 60601 -1 2005-12N Medical electrical equipment_- Part_1: General requirements for basic safety and essential performance YYABNT NBR IEC 60601 -12010IN n 09/13 IEC 60601 -1 Corrigendum 1 2006-12N Medical electrical equipment_- Part_1: General requirements for basic safety and essential performance; Corrigendum_1 YYABNT NBR IEC 60601 -12010IN n 09/13 IEC 60601 -1 Corrigendum 2 2007-12N Medical electrical equipment_- Part_1: General requirements for basic safety and essential performance.

9 Corrigendum_2 YYABNT NBR IEC 60601 -12010IN n 09/13 IEC 60601 -1 Interpretation Sheet 1 2008-04N Medical electrical equipment_- Part_1: General requirements for basic safety and essential performance YYABNT NBR IEC 60601 -12010IN n 09/13 IEC 60601 -1 Interpretation Sheet 2 2009-01N Medical electrical equipment_- Part_1: General requirements for basic safety and essential performance_- Interpretation sheet_2 YYABNT NBR IEC 60601 -12010IN n 09/13 IEC 60601 -1-1 2000-12N Medical electrical equipment_- Part_1-1: General requirements for safety.

10 Collateral standard: Safety requirements for medical electrical systems YYABNT NBR IEC 60601 -1-12004IN n 09/13 IEC 60601 -1-10 2007-11N Medical electrical equipment_- Part_1-10: General requirements for basic safety and essential performance_- Collateral Standard: Requirements for the development of physiologic closed-loop controllers YYABNT NBR IEC 60601 -1-102010IN n 09/13 IEC 60601 -1-11 2010-04N Medical electrical equipment_- Part_1-11: General requirements for basic safety and essential performance_- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment YYABNT NBR IEC 60601 -1-112012IN n 09/13 IEC 60601 -1-11 Corrigendum 1 2011-04N Medical electrical equipment_- Part_1-11: General requirements for basic safety and essential performance_- Collateral standard.