Skip to content
Please enter a keyword to search

  • VDI 5702 Blatt 1:2017-04

    Current The latest, up-to-date edition.

    Medical device software - Medical SPICE Process assessment model

    Available format(s):  Hardcopy, PDF

    Language(s):  German - English

    Published date:  01-04-2017

    Publisher:  Verlag des Vereins Deutscher Ingenieure

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    Preliminary note
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Abbreviations
    5 Overview of the process
      assessment model
    6 The process dimension and
      process performance indicators
      (level 1)
    7 Process capability indicators
      (level 1 to 5)
    Annex A - Conformity of the
              process assessment model
    Annex B - Work product characteristics
    Annex C - Reference mappings
    Annex D - Relation with IEC/TR 80002-3
    Annex E - References to terms and definitions
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives a detailed description of the structure and key components of the process assessment model, which includes two dimensions: a process dimension and a capability dimension.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 33020:2015 Information technology Process assessment Process measurement framework for assessment of process capability
    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    ISO/IEC 15504-4:2004 Information technology Process assessment Part 4: Guidance on use for process improvement and process capability determination
    IEC TR 80002-3:2014 Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO/IEC 33001:2015 Information technology Process assessment Concepts and terminology
    DIN EN 62366 : 2016 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    VDE 0750-101 : 2016 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    ISO/IEC 33003:2015 Information technology Process assessment Requirements for process measurement frameworks
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO/IEC 15504-2:2003 Information technology Process assessment Part 2: Performing an assessment
    VDE 0750-241 : 2016 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO/IEC 33002:2015 Information technology Process assessment Requirements for performing process assessment
    ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    DIN EN 62304 : 2016 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO/IEC 15504-1:2004 Information technology Process assessment Part 1: Concepts and vocabulary
    VDE 0750-1 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
    ISO/IEC 33004:2015 Information technology Process assessment Requirements for process reference, process assessment and maturity models
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective