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VDI 5702 Blatt 1:2017-04

Current
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

04-01-2017

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

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.

DocumentType
Standard
Pages
180
PublisherName
Verlag des Vereins Deutscher Ingenieure
Status
Current
Supersedes

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

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