국가별적용규격 매트릭스 _ 범용초음파영상진단장치 < 목차 > 머리말 1 Ⅰ. 목적 2 Ⅱ. 국가별표준기관 9 III. 범용초음파영상진단장치적용규격매트릭스현황 9 출처 - 21

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1 국가별적용규격 매트릭스 _ 범용초음파영상진단장치 < 목차 > 머리말 1 Ⅰ. 목적 2 Ⅱ. 국가별표준기관 9 III. 범용초음파영상진단장치적용규격매트릭스현황 9 출처 - 21

2 국가별적용규격매트릭스 본매트릭스는의료기기설계 개발진행시편의성을도모하고자작성된것으 로써일반적인국가별규격요구사항을기술하고있습니다. 본매트릭스에작성 된규격번호및발행일자는규격의이해를돕기위하여작성된것으로법적효 력이있는사항이아니며, 실제국가별적용규격홈페이지에들어가셔서확인 하시는것을권고드립니다. 또한, 현재까지의업데이트된정보에근거한것이므로새로운규격이업데이트 가될경우또는관련규정의개정에따라추후변경될수있습니다 - 1 -

3 국가별적용규격매트릭스 Ⅰ. 목적 본매트릭스는의료기기설계 개발진행시편의성을도모하고자작성된것으로써 국제표준기준주요국가 ( 미국, 유럽, 브라질등 ) 들의규격적용시점, 발행일자, 만료 일자, 유의사항등에대한정보가포함되어있다. Ⅱ. 국가별표준기관 - 2 -

4 국가별적용규격매트릭스 Ⅱ. 국가별표준기관 - 3 -

5 국가별적용규격매트릭스 Ⅱ. 국가별표준기관 - 4 -

6 국가별적용규격매트릭스 Ⅲ. 범용초음파영상진단장치적용규격매트릭스현황 < 국제규격 > 분류규격번호규격 / 가이드라인명발행일자 전기기계적안전성 / 전자파 ¹)IEC :2005 +AMD1:2012 Medical electrical equipment Part 1: General requirement for basic IEC :2005 safety and essential performance ²)IEC :2014 IEC :2007 IMedical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests 위험관리 ISO 14971:2007 Medical devices - Application of risk management to medical devices ³)ISO 780:2015 Graphical symbols for handling and storage of packages 공통 표시기재 소프트웨어 ⁴)ISO :2016 ISO :2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements ⁵IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice ⁶)ISO7010:2011/ Amd7:2016 ⁷)IEC62304:2006+AMD1 :2015 IEC 62304:2006 Graphical symbols Safety colors and safety signs Registered safety signs Medical device software - Software life cycle process 품질시스템 ISO 13485:2016 Medical devices - Quality management systems -- Requirements for regulatory purposes ISO 13485: ⁸)IEC : AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC :

7 사용자적합성 ⁹)IEC62366:2007 +AMD1: IEC62366:2007 Medical devices - Application of usability engineering to medical devices ¹⁰)IEC : 임상 ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical practice 아래규격은해당제품이환자몸에접촉하는경우, 해당제품의악세서리가멸균되는경우반드시적용합니다. 분류규격번호규격 / 가이드라인명발행일자 생체적합성 ISO series Tests demonstrating cytotoxicity, irritation, biocompatibility, sensitization, where applicable, according to ISO ISO :2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products 선택 멸균 ISO :2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process ISO :2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 아래규격은해당의료기기에만적용되는제품별규격입니다. 분류규격번호규격 / 가이드라인명발행일자 범용초음파영상진단장치 기본안전 / 필수성능 IEC :2007+AMD1:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment IEC :

8 < 유럽규격 > 공통 분류규격번호규격 / 가이드라인명발행일자적용일자만료일자 전기기계적안전성 / 전자파 ¹¹)EN :2006+A1:2013 EN :2006+A11:2011 Medical electrical equipment Part 1: General requirement for basic safety and essential performance _ EN :2015 Medical electrical equipment Part 1-2: General requirement for basic safety and essential EN :2007 performance Collateral standard: Electromagnetic compatibility Requirements and tests Medical devices - Application of risk management to medical devices _ 위험관리 ¹²)EN ISO 14971:2012 표시기재 품질시스템 EN ISO 780:2015 EN 1041:2008+A1:2013 EN ISO :2016 EN ISO 7010:2012/A7:2017 Graphical symbols for handling and storage of packages Information supplied by the manufacturer of medical devices Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements Graphical symbols Safety colors and safety signs Registered safety signs EN ISO 13485:2016 Medical devices - Quality management systems EN ISO 13485:2012 Requirements for regulatory purposes 소프트웨어 사용자적합성 EN 62304:2006+A1: EN 62304:2006 Medical device software - Software life cycle process EN :2010+A1:201 5 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability _ EN : EN 62366:2008+A1: EN 62366:2008 Medical devices Application of usability engineering to medical devices EN : _ - 7 -

9 임상 EN ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice MEDDEV 2.12/2 Rev.2 Post Market Clinical Follow-up Studies MEDDEV Rev.4+H11 Clinical Evaluation: A guide for manufacturers and notified bodies MEDDEV 2.12/1 Rev.8 Guidelines on a Medical Devices Vigilance System _ 아래규격은해당제품이환자몸에접촉하는경우, 해당제품의악세서리가멸균되는경우반드시적용합니다. 선택 분류 규격번호 규격 / 가이드라인명 발행일자 적용일자 만료일자 Tests demonstrating cytotoxicity, irritation, 생체적합성 ISO series biocompatibility, sensitization, where applicable, _ according to ISO EN ISO Sterilization of medical devices Microbiological :2006/AC:2009 methods Part 1: Determination of a population ISO :2006 of microorganisms on products Sterilization of medical devices Microbiological 멸균 ISO :2009 methods Part 1: Determination of apopulation of microorganisms on products Sterilization of health care products Moist heat EN ISO :2006 Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 아래규격은해당의료기기에만적용되는제품별규격입니다. 분류규격번호규격 / 가이드라인명발행일자적용일자만료일자 범용초음파영상진단장치 기본안전 / 필수성능 EN :2008+A1:2015 EN :2008+A11:2011 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

10 < 미국규격 > 분류규격번호규격 / 가이드라인명발행일자 AAMI ANSI ES :2005 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment Part 1: General requirement for basic safety and essential performance 전기기계적안전성 / 전자파 AAMI ANSI IEC :2014 ¹³)AAMI ANSI IEC : 2007/(R)2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests 공통 위험관리 표시기재 AAMI ANSI ISO 14971:2007/(R)2010 AAMI ANSI ISO :2016 Medical devices - Application of risk management to medical devices Graphical symbols for electrical equipment in medical practice 소프트웨어 AAMI ANSI IEC 62304:2006 Medical device software - Software life cycle process 품질시스템 21 CFR 820 사용자적합성 AAMI ANSI IEC 62366:2007/(R)2013 AAMI ANSI IEC :2015 Medical devices - Quality management systems - Requirements for regulatory purposes Medical devices - Application of usability engineering to medical devices

11 아래규격은해당제품이환자몸에접촉하는경우, 해당제품의악세서리가멸균되는경우반드시적용합니다. 분류규격번호규격 / 가이드라인명발행일자 생체적합성 AAMI ANSI ISO series Tests demonstrating cytotoxicity, irritation, biocompatibility, sensitization, where applicable, according to ISO _ AAMI ANSI ISO :2009(R)2014 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products 선택 멸균 AAMI ANSI ISO :2006(R)2011 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process AAMI ANSI ISO :2006(R)2013 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

12 < 브라질규격 > 공통 분류규격번호규격 / 가이드라인명발행일자 ¹⁴)ABNT NBR IEC Equipamento eletromédico :2010 Emenda Parte 1: Requisitos gerais para segurança básica e desempenho essencial 1:2016 전기기계적안전성 / 전자파 위험관리 표시기재 품질시스템 사용자적합성 ABNT NBR IEC :2010 Errata 1:2013 ABNT NBR ISO 14971:2009 ABNT NBR ISO :2015 ABNT NBR ISO 13485:2016 ABNT NBR IEC :2011 Errata1:2013 ABNT NBR IEC :2011 Version Corrected:2013 ABNT NBR IEC 62366:2010 Emenda 1:2016 ABNT NBR IEC 62366:2016 Equipamento eletromédico Parte 1-2: Requisitos gerais para segurança básica e desempenho essencial - Norma colateral: Compatibilidade eletromagnética - Requisitos e ensaio Produtos para a saúde Aplicação de gerenciamento de risco a produtos para a saúde Produtos para a saúde Símbolos a serem utilizados em rótulos, rotulagem e informações a serem fornecidas de produtos para saúde Parte 1: Requisitos gerais Produtos para saúde Sistemas de gestão da qualidade Requisitos para fins regulamentares Equipamento eletromédico Parte 1-6: Requisitos gerais para segurança básica e desempenho essencial Norma colateral: Usabilidade Produtos para a saúde Aplicação da engenharia de usabilidade a produtos para a saúde 임상 ABNT NBR 14155:2010 Alumínio e suas ligas Tratamento de superfície Camada de anodização dura Determinação da microdureza

13 아래규격은해당제품이환자몸에접촉하는경우, 해당제품의악세서리가멸균되는경우반드시적용합니다. 분류규격번호규격 / 가이드라인명발행일자 생체적합성 ABNT ANSI ISO series Tests demonstrating cytotoxicity, irritation, biocompatibility, sensitization, where applicable, according to ISO _ 선택 멸균 ABNT NBR ISO :2010 Esterilização de produtos para saúde Vapor Parte 1: Requisitos para o desenvolvimento, validação e controle de rotina nos processos de esterilização de produtos para saúde 아래규격은해당의료기기에만적용되는제품별규격입니다. 분류규격번호규격 / 가이드라인명발행일자적용일자만료일자 범용초음파영상진단장치 기본안전 / 필수성능 ABNT NBR IEC :2016 Equipamento eletromédico Parte 2-37: Requisitos particulares para a segurança básica e o desempenho essencial dos equipamentos médicos de monitoramento e diagnóstico por ultrassom

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16 참고문헌

17 국가별매트릭스적용규격매트릭스 발행연월 : 2018년 09월편집위원 : 산업정보팀발행처 : 우 ) 서울특별시구로구디지털로 30길 28 마리오타워 2층 208호문의처 : 산업정보팀 (Tel ~4411)

ISO17025.PDF

ISO17025.PDF ISO/IEC 17025 1999-12-15 1 2 3 4 41 42 43 44, 45 / 46 47 48 49 / 410 411 412 413 414 5 51 52 53 54 / 55 56 57 58 / 59 / 510 A( ) ISO/IEC 17025 ISO 9001:1994 ISO 9002:1994 B( ) 1 11 /, / 12 / 1, 2, 3/ (