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Standarder Udviklingssurvey Nr Standarder Udviklingssurvey nr. 3 – 2015 Fokus: Produktstandarder og processtandarder 2142.1.15 We help ideas meet the real world / MADEBYDELTA.COM DELTA DELTA hjælper sine kunder med effektiv anvendelse af avancerede teknologier, der skal opnå kommerciel succes i en kompleks verden. Vi laver design, udvikling, test, certificering og rådgivning inden for elektronik, mikroelektronik, softwareteknologi, lys, optik, akustik, vibration og sensorsystemer. DELTA er ét af Europas førende udviklingshuse samt et af de ni Godkendte Teknologiske Serviceinstitutter (GTS) i Danmark. Vores 250 medarbejdere i Danmark, Sverige og Storbritannien samarbejder med kunder i over 50 lande. Læs mere om DELTA på www.delta.dk. Copyright © 2015 DELTA. NO WARRANTY This DELTA material is furnished on an “AS-IS” basis. DELTA can in no way and under no circumstances be held responsible for the use, construction, interpretation or any other kind of implication of the contents or context of this report by subscribers of any other party. Internal use: Permission to reproduce this document and to prepare derivative works from this document for internal use is granted, provided the copyright and “No Warranty” statements are included with all reproductions and derivative works. External use: This document may be reproduced in its entirety, without modification, and freely distributed in written or electronic form without requesting formal permission. Permission is required for any other external and/or commercial use. Sammendrag For de fleste produkter, særligt for medicinsk og trådløst udstyr, er der mange krav, som produktet skal leve op til, før det kan lance- res på markedet. Kravene kan opfyldes på flere måder, men den sikreste og mest effektive er gennem anvendelse af standarder. Det kan være standarder, der dikterer krav til produktets specifikationer (produktstandarder), krav til hvordan produktet er udviklet (processtandarder), og krav til hvordan teknologien er implementeret (teknologi standarder). I denne 3. udgave af surveyet går vi et niveau dybere i forhold til, hvilke standarder der er nyttige. Der er i dette survey udvalgt 6 hovedområder af standarder, der har stort potentiale for danske virksomheder og ikke mindst små og mellemstore virksomheder. For hvert hovedområde er udviklingen beskrevet for det seneste år, og der er givet et bud på udviklingen af standarderne på kortere og længere sigt. Formålet med dette survey er at give danske virksomheder et overblik over, hvilke standarder der findes og inspirere til at bruge dem. Gennem anvendelse af standarder vil virksomhederne kunne stå stærkere med hensyn til efterlevelse af produkt- og proces- krav i standarder og dermed kunne agere på de markeder, der er reguleret. Nøgleord: Standarder, ISO, IEC, ITU, CEN, CENELEC og ETSI. Summary Most products, and especial medical and wireless devices, must conform with many requirements prior to market launch. Fulfilment of the requirements may be accomplished in many ways, however, the safest and most efficient way is using standards. It may be standards that dictate requirements for the product's specifications (product standards), requirements for how the product is devel- oped and requirements for how the technology is implemented. In this 3rd version of the survey we describe which standards are beneficial in relation to product development (process standards). In this survey 6 main groups of standards, that have great potential for Danish companies and especially SMEs, are selected. For each family, the development for the past year is described and a suggestion for the development of the standards for the shorter and longer term is given. The purpose of this survey is to provide Danish companies with an overview of the standards that exist and inspire to use them. This will help companies to be stronger in terms of compliance with product requirements and process requirements of the standards, and thus be able to act in the markets that are regulated. Keywords: Standards, ISO, IEC, ITU, CEN, CENELEC and ETSI. Indholdsfortegnelse 1 Indledning .......................................................................................................................................................................................5 1.1 Tak ............................................................................................................................................................................................ 5 1.2 Definitioner og akronymer ......................................................................................................................................................... 5 2 Introduktion .....................................................................................................................................................................................7 2.1 Nationale og internationale parter i udvikling af standarder ...................................................................................................... 7 2.2 Organisering og udvikling af standarder ................................................................................................................................... 8 2.3 Nationale og internationale krav ................................................................................................................................................ 9 2.4 Anvendelse af standarder: CE-mærkning ............................................................................................................................... 11 2.5 Anvendelse af standarder: Læsning ....................................................................................................................................... 16 3 Medico ..........................................................................................................................................................................................17 3.1 Introduktion ............................................................................................................................................................................. 17 3.2 Oversigt ................................................................................................................................................................................... 18 3.3 EN ISO 13485:2012 Medical Devices - Quality Management System ................................................................................... 18 3.4 EN 62366:2008 Medical Devices – Application of usability engineering to medical devices .................................................. 19 3.5 EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices ................................................ 20 3.6 IEC 62304:2006 Medical device software – Software life cycle processes ............................................................................ 20 3.7 IEC 60601-1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance 21 3.8 IEC/TR 80002-1:2009 Medical device software – Part 1: guidance on the application of ISO 14971 to medical device software ............................................................................................................................................................................................. 23 3.9 Anvendelse af standarderne og godkendelse ......................................................................................................................... 23 4 Produktudvikling ...........................................................................................................................................................................25 4.1 Introduktion ............................................................................................................................................................................. 25 4.2 Oversigt ................................................................................................................................................................................... 25 4.3 Hvordan hænger de forskellige standarder sammen .............................................................................................................. 27 4.4 Livscyklusstandarder ............................................................................................................................................................... 28 4.5 Modenhed – Evne til produktudvikling .................................................................................................................................... 30 4.6 Produktkvalitet ......................................................................................................................................................................... 35 4.7 Udviklingen de seneste år ....................................................................................................................................................... 40 4.8 Udviklingen på kortere og længere sigt ................................................................................................................................... 40 5 Pålidelighed ..................................................................................................................................................................................41 5.1 Introduktion ............................................................................................................................................................................
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