의료기기 기준규격

이제 우리는 세계를 향해 마음을 활짝 열고 ‘ 세계 속의 한국 ’ 을 구현해야 합니다. 이로써 인류의 공동번영과 전 세계적 범위 에서의 국익을 동시에 추구해야 합니다. 표준 이를 위해 우리 국민은 사유의 틀을 국제무 대로 확대해야 하고 우리 사회는 여러 방면 에서 국제적 표준에 접근해야 할 것입니다. 이것 또한 우리 자신에 대한 존경심과 자긍 심을 바탕에 두어야 가능하다고 봅니다 년 11 월 10 일

Documents, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context Documents, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context STANDARDS ISO/IEC WTO Documents, approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory Documents, approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory KS A0001 주어진 상황에서 최적상태의 달성을 위해 공통적이고 반복적인 용도, 규칙, 가이드, 또는 행위와 그 결과에 대한 특성을 제공하는, 합의에 의해 개발되 고 공인기관에 의해 승인된 문서 주어진 상황에서 최적상태의 달성을 위해 공통적이고 반복적인 용도, 규칙, 가이드, 또는 행위와 그 결과에 대한 특성을 제공하는, 합의에 의해 개발되 고 공인기관에 의해 승인된 문서

일반적 합의, 기술, 관습이 공인기관에 의해 정립된 것 품질, 가치, 범위, 무게 질량 등의 측정을 위한 원칙이 공인기관에 의해 정립된 것 Dictionary Something 합의에 의해 제정 공인기관에서 승인 주어진 상황에서 최적상태의 달성을 목적으로 공통적이고 반복적인 사용 규칙, 가이드, 특성을 제공 ISO / IEC Document 제품 · 공정 · 서비스 WTO Document 제품 · 공정 · 방법 관습, 가치 Document 에서 Something 으로 공인기관에서 승인 준수여부는 비강제적 공통적이고 반복적인 사용 규칙, 가이드, 특성을 제공

  사회 경제적 효율 향상의 수단   산업발전 기반   교역증대와 무역자유화의 기반

  압도적인 시장점유로 실질적으로 정립된 규격 * 예 ) MS Windows, VHS 등   규격의 결정자 : 시장 ( 대량의 특허료 수입 가능 )   공공이익을 목적으로 설립한 표준화기구가 제정한 규격 * 예 ) ISO, IEC, ITU ( 국가규격의 경우 : ANSI, KS, JIS 규격 등 )   규격의 결정자 : 표준화 기관 ( 해당 committee)   특정단체 이익 확보를 목적으로 설립한 포럼 등에서 제정한 규격 * 예 ) W3C, OASIS, OMG, UDDI 등   규격의 결정자 : 포럼 or 컨소시엄 ( 해당 committee) 공적규격 (De Jure) 공적규격 (De Jure) 사실상규격 (De Facto) 사실상규격 (De Facto) 포럼 규격 ( or 사실상 규격 ) 포럼 규격 ( or 사실상 규격 ) 성립 과정에 따른 분류

규격의 영역에 따른 분류 사내규격 단체규격 국가규격 지역규격 국제규격

기능에 따른 분류 Basic safety standards (also known as horizontal standards) :Standards indicating fundamental concepts, principles and requirements with regard to general safety aspects applicable to all kinds or a wide range of products and/or processes (e.g., standards concerning risk assessment and control of medical devices). Basic safety standards (also known as horizontal standards) :Standards indicating fundamental concepts, principles and requirements with regard to general safety aspects applicable to all kinds or a wide range of products and/or processes (e.g., standards concerning risk assessment and control of medical devices). Group safety standards (also known as semi-horizontal standards): Group safety standards (also known as semi-horizontal standards): Standards indicating aspects applicable to families of similar products and/or processes making reference as far as possible to basic safety standards (e.g., standards concerning sterile medical devices, electrically-powered medical devices or risk of infection due to IVD reagents) Group safety standards (also known as semi-horizontal standards): Group safety standards (also known as semi-horizontal standards): Standards indicating aspects applicable to families of similar products and/or processes making reference as far as possible to basic safety standards (e.g., standards concerning sterile medical devices, electrically-powered medical devices or risk of infection due to IVD reagents) Product safety standards Product safety standards (also known as vertical standards) Standards indicating necessary safety aspects of specific productsand/or processes, making reference, as far as possible, to basic safety standards and group safety standards (e.g., standards for infusion pumps, for anaesthetic machines, for blood glucose meters for self testing or specifications detailing technical product requirements for certain IVD devices). Product safety standards Product safety standards (also known as vertical standards) Standards indicating necessary safety aspects of specific productsand/or processes, making reference, as far as possible, to basic safety standards and group safety standards (e.g., standards for infusion pumps, for anaesthetic machines, for blood glucose meters for self testing or specifications detailing technical product requirements for certain IVD devices).

Regulation that provides technical requirements, either directly or by referring to or incorporating the content of a standard, technical specification or code of practice Regulation that provides technical requirements, either directly or by referring to or incorporating the content of a standard, technical specification or code of practice Technical Regulation ISO/IEC WTO Documents which lay down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory Documents which lay down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory

기 술 규정 규 격 Harmonized standards Harmonized standards Voluntary standards Technical Regulations 자발적 (Voluntary) KATS / MIC 산업표준화법 / 전기통신기본법 KS 22,058 종 / KICS 457 종 강제적 (Mandatory) 19 개 부처 86 개 개별법령 19,000 여종 성격 시행 기관 법적 근거 보유 현황

229 16, / 1963 일반분야 100 5, / 1963 전기 ∙ 전자분야 설립 / 가입 연도 ISOIEC 회원국 총규격수 T/C 구 분

About ISO ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO is a network of the national standards institutes of 157 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. non-governmental organizationISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations. consensusTherefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.

ISO's name always ISOBecause "International Organization for Standardization" would have different acronyms in different languages ("IOS" in English, "OIN" in French for Organisation internationale de normalisation), its founders decided to give it also a short, all- purpose name. They chose "ISO", derived from the Greek isos, meaning "equal". Whatever the country, whatever the language, the short form of the organization's name is always ISO.

Proposal stage 제 안 단 계제 안 단 계신규 업무 항목 제안 NP Preparatory stage 준 비 단 계준 비 단 계작업 초안 WD Committee stage 위원회단계위원회 초안 CD Enquiry stage 질 의 단 계질 의 단 계질의안 ( 국제규격안 ) DIS Approval stage 승 인 단 계승 인 단 계최종 국제규격안 FDIS Publication stage 출 판 단 계출 판 단 계국제규격 ISO

ISO TC (Medical Device) NO Technical committee TC106Dentistry TC121Anaesthetic and respiratory equipment TC150Implants for surgery TC168Prosthetics and orthotics TC170Surgical instruments TC194Biological evaluation of medical devices TC198Sterilization of health care products

ISO TC106 (Dentistry) NOSubcommitteeSTD SC 1Filling and restorative materials13 SC 2Prosthodontic materials29 SC 3Terminology20 SC 4Dental instruments58 SC 6Dental equipment18 SC 7Oral care products6 SC 8Dental implants6

IEC TC (Medical Device) NO Technical committee TC1Terminology TC62Electrical equipment in medical practice SC62A Common aspects of electrical equipment used in medical practice SC62B Diagnostic imaging equipment SC62C Equipment for radiotherapy, nuclear medicine and radiation dosimetry SC62D Electromedical equipment TC66 Safety of measuring, control and laboratory equipment TC76Optical radiation safety and laser equipment TC87Ultrasonics

Location: Geneva, Switzerland Established: 1 January 1995 Created by: Uruguay Round negotiations ( ) Membership: 152 countries on 16 May 2008 Administering WTO trade agreements Forum for trade negotiations Handling trade disputes Monitoring national trade policies Technical assistance and training for developing countries Cooperation with other international organizations

Free Trade Fair Trade Multilateralism Non-Discrimination principle

무역상대국간에 서로 상이한 technical regulation, standard, conformity assesment procedure 등을 채택함 으로써 무역에 있어서 제품의 자유로운 이동을 저해하 는 제반 장애요소 무역상대국간에 서로 상이한 technical regulation, standard, conformity assesment procedure 등을 채택함 으로써 무역에 있어서 제품의 자유로운 이동을 저해하 는 제반 장애요소 TBT (Technical Barrier to Trade) TBT (Technical Barrier to Trade) The agreement on TBT The agreement on TBT 무역에 있어서 unnecessary obstacle 을 만들지 않도록 준수할 의무 무역에 있어서 unnecessary obstacle 을 만들지 않도록 준수할 의무

공산품 수산품 식의약품 농산품 National Inquiry Point 외교통상부

의료기기 기준규격 국가기준규격 국제기준규격 국내외 공인된 시험규격 국내외 공인된 시험규격 의료기기기술문서등심사에관한규정

의료용산소발생기 등 57 품목 주사기 등 61 품목 IEC IEC ISO10993 생물학적안전에관한공통기준규격 전자파안전에관한공통기준규격 전기기계적안전에관한공통기준규격 전기기계적안전에관한공통기준규격 의료기기기준규격 전자의료기기기준규격

핵심인프라 기술의 정의 핵심기술 소프트 인프라 Head/Heart 감 성감 성 2000 년대 2000 년대 문화, 영화, 표 준 신산업 ( 지능 형 ) IT ㆍ S/W ㆍ 바이오 Head/Head ’90 년대 사 람사 람 지식 인프라 Head/Hammer 중화학, 자동차 조선 ’80 년대 설비 ( 장치 ) 기술 인프라 Head/Hand 섬유산 업 조립산 업 ~ ’70 년대 Skill 토목 인프라

감사합니다.