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Standards and Safety Aspects for Medical Devices in the Field of Neurorehabilitation

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Neurorehabilitation Technology

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Abstract

An overview of standards and safety aspects for medical devices in the field of neurorehabilitation is given as a snapshot in time. Common basic safety principles for medical devices and international applicable standards for medical devices, especially in the context of neurorehabilitation, are summarized. Trends and ongoing international activities in standardization and regulatory framework are described. This chapter could help start-up companies for medical devices or researchers which think about the commercialization of their results for a better understanding of the actual situation of Standards and Safety Aspects for Medical Devices in the Field of Neurorehabilitation and how these standards should be integrated in a process of medical devices development.

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References

  1. Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices; Publication of titles and references of harmonized standards under the directive 2010/C 183/03. Amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007.

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  3. ISO Guide 63.

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  10. IEC 62304:2006; Medical device software—software life cycle processes.

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  14. IEC 60601-1-11:2015 RLV; Medical electrical equipment; general requirements for basic safety and essential performance; collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

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Author information

Authors and Affiliations

  1. Department of Quality Management, Hocoma AG, Industriestrasse 4, 8604, Volketswil, Switzerland

    Burkhard Zimmermann

  2. IISART, Zürich, Zürich, Switzerland

    Burkhard Zimmermann

Authors
  1. Burkhard Zimmermann
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Corresponding author

Correspondence to Burkhard Zimmermann .

Editor information

Editors and Affiliations

  1. Department of Mechanical and Aerospace Engineering, Department of Anatomy and Neurobiology, Department of Biomedical Engineering, Department of Physical Medicine and Rehabilitation, University of California at Irvine, Irvine, California, USA

    David J. Reinkensmeyer

  2. Spinal Cord Injury Center, University Hospital Balgrist, Zürich, Switzerland

    Volker Dietz

Appendices

Appendix I: Overview of the Currently Published IMDRF/ (GHTF) Documents [June 2016]

  • IMDRF/MDSAP WG/N3 FINAL:2016 (Edition 2) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

  • IMDRF/RPS WG/N19 FINAL:2016 Common Data Elements for Medical Device Identification

  • IMDRF/MDSAP WG/N8 FINAL:2015 Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations

  • IMDRF/MDSAP WG/N24 FINAL:2015 Medical Device Regulatory Audit Reports

  • IMDRF/SaMD WG/N23 FINAL:2015 Software as a Medical Device (SaMD): Application of Quality Management System

  • IMDRF/NCAR WG/N14 FINAL:2015 Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form

  • IMDRF/SaMD WG/N12 FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

  • IMDRF/MDSAP WG/N11 FINAL:2014 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization

  • IMDRF/RPS WG/N13 FINAL:2014 In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)

  • IMDRF/RPS WG/N9 FINAL:2014 Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC)

  • IMDRF/MDSAP WG/N3 FINAL:2013—See also Edition 2

    • Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

  • IMDRF/MDSAP WG/N4 FINAL:2013 Competence and Training Requirements for Auditing Organizations

  • IMDRF/MDSAP WG/N5 FINAL:2013 Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations

  • IMDRF/MDSAP WG/N6 FINAL:2013 Regulatory Authority Assessor Competence and Training Requirements

  • IMDRF/UDI WG/N7 FINAL:2013 UDI Guidance: Unique Device Identification (UDI) of Medical Devices

  • IMDRF/SaMD WG/N10 FINAL:2013 Software as a Medical Device (SaMD): Key Definitions

  • IMDRF/MC/N39 FINAL:2015 IMDRF Strategic Plan 2020

  • IMDRF/MC/N16 FINAL:2014 IMDRF Document Format and Style Guide

  • IMDRF/MC/N17 FINAL:2014 IMDRF Document Template

  • IMDRF/MC/N18 FINAL:2014 IMDRF Presentation Template

  • IMDRF/MC/N2 FINAL:2014 (Edition 2) MDRF Standard Operating Procedure

  • IMDRF/MC/N1 FINAL:2014 (Edition 3) IMDRF Terms of Reference

  • IMDRF/MDSAP WG/N29 FINAL:2015 Clarification of the Term “Legal Entity” for MDSAP Recognition Purposes

  • IMDRF/NCAR WG/N30 FINAL:2015 Medical Devices: Post-Market Surveillance - IMDRF National Competent Authority Report (NCAR) Pilot Plan

  • IMDRF/NCAR WG/N31 FINAL:2015 Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material

  • IMDRF/RPS WG/N32 FINAL:2015 Strategic Assessment of Electronic Submission Messaging Formats

  • IMDRF/MC/N34 FINAL:2015 Statement regarding Use of ISO 14971:2007 “Medical devices - Application of risk management to medical devices”

  • IMDRF/MC/N35 FINAL:2015 Statement regarding Use of IEC 62304:2006 “Medical device software—Software life cycle processes”

  • IMDRF/MC/N36 FINAL:2015 Statement regarding Use of IEC 60601-1 “Medical electrical equipment—Part 1: General requirements for basic safety and essential performance”

  • IMDRF/MC/N37 FINAL:2015 Statement regarding Use of ISO 10993-1:2009 “Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process”

  • IMDRF/MC/N38 FINAL:2015 Statement regarding Use of ISO 11137-1:2006 “Sterilization of health care products—Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”

  • IMDRF/RPS WG/N26 FINAL:2015 (Edition 2) IMDRF Table of Contents (ToC) Pilot Plan

  • IMDRF/MC/N25 FINAL:2015 Statement regarding Use of ISO 14155:2011 “Clinical investigation of medical devices for human subjects – Good clinical practice”

  • IMDRF/Standards WG/N15 FINAL:2014 Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014

  • IMDRF/MDSAP WG/N22 FINAL:2014 MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes

  • IMDRF/RPS WG/N20 FINAL:2014 Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS

  • IMDRF/RPS WG/N21 FINAL:2014 RPS Beta Testing Document

Appendix II: Overview of the Currently Published MEDDEV Documents [March 2015]

 

Title

Date

2.1 Scope, field of application, definition

MEDDEV 2.1/1 Definitions of “medical devices”, “accessory” and “manufacturer”

April 1994

MEDDEV 2.1/2 rev.2 Field of application of directive “active implantable medical devices”

April 1994

MEDDEV 2.1/2.1 Treatment of Computers Used to Program Implantable Pulse Generators

February 1998

MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative

December 2009

MEDDEV 2.1/4 Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment

March 1994

For the relation between the MDD and directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009

MEDDEV 2.1/5 Medical devices with a measuring function

June 1998

MEDDEV 2.1/6 Qualification and Classification of stand alone software

January 2012

2.2 Essential requirements

MEDDEV 2.2/1 rev.1 EMC requirements

February 1998

MEDDEV 2.2/3 rev.3 “Use by”-date

June 1998

MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products

January 2012

2.4 Classification of MD

MEDDEV 2.4/1 rev.9 Classification of medical devices

June 2010

2.5 Conformity assessment procedure

General rules

Quality assurance

Regulatory auditing of quality systems of medical device manufacturers (See document in the GHTF-Global Harmonization Task Force)

June 2016

MEDDEV 2.5/3 rev.2 Subcontracting quality systems related

June 1998

MEDDEV 2.5/5 rev.3 Translation procedure

February 1998

MEDDEV 2.5/6 rev.1 Homogenous batches (verification of manufacturers’ products)

February 1998

Conformity assessment for particular groups of products

MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants

July 1998

MEDDEV 2.5/9 rev.1 Evaluation of medical devices incorporating products containing natural rubber latex

February 2004

MEDDEV 2.5/10 Guideline for Authorised Representatives

January 2012

2.7 Clinical investigation, clinical evaluation

MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified bodies

Appendix 1: clinical evaluation on coronary stents

December 2009

December 2008

MEDDEV 2.7/2 rev. 2 Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC

September 2015

MEDDEV 2.7/3 rev. 3 Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC - SAE reporting form

May 2015

The new SAE reporting form will be taken in use 1 September 2016 at the latest.

MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies

December 2010

2.10 Notified bodies

MEDDEV 2.10/2 rev.1 Designation and monitoring of notified bodies within the framework of EC directives on medical devices Annex 1, Annex 2, Annex 3, Annex 4

April 2001

2.12 Market surveillance

MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System January 2013

I. MEDDEV 2.12/1 rev.8 – Latest Version Forms MEDDEV 2.12/1 rev. 7 MIR and FSCA are still valid

Active PDF forms How to use FSCA and MIR forms Manufacturer Incident Report – MIR Field Safety Corrective Action – FSCA MIR and FSCA xml files

Please note: Some browser plugins are not compatible with PDF forms. If you have problems opening these forms, please save them to your computer and open them from there.

Other forms and templates Field Safety Notice Template Trend Report Periodic Summary Report

EU Vigilance Pilot on Trending – Additional MIR Form EU Vigilance Pilot MIR form EU Vigilance Pilot MIR Step-by-Step Guide EU Vigilance Pilot Toolkit for Users

II. Device Specific Vigilance Guidance

DSVG 00 Introduction to Device Specific Vigilance Guidance DSVG 01 Cardiac Ablation Vigilance Reporting Guidance

 

MEDDEV 2.12/2 rev.2 Post Market Clinical Follow-up studies

January 2012

2.13 Transitional period

MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05)

August 1998

As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009

 

2.14 IVD

MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for manufacturers and notified bodies

January 2012

MEDDEV 2.14/2 rev.1 Research Use Only products

February 2004

MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices

January 2007

Form for the registration of manufacturers and devices In Vitro Diagnostic Medical DeviceDirective, Article 10

January 2007

MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP

January 2012

2.15 Other guidances

MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the medical device directives

December 2008

  • Guidance Notes for Manufacturers of Class I Medical Devices endorsed by the MDEG on December 2009

  • Guidance Notes for Manufacturers of Custom-Made Medical Devices endorsed by the MDEG on June 2010

  • Guidance document on Dir. 2005/50/EC endorsed by the MDEG on December 2006

  • Informative document of the Commission’s services on placing on the market of medical devices (16 November 2010)

  • Information on the relation between the revised Directives 90/385/EEC and 93/42/EEC concerning (active implantable) medical devices and Directive 2006/42/EC on machinery (21 August 2009)

  • Information on the relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment (21 August 2009)

  • Informative document of the Commission’s services on implementation of directive 2007/47/EC amending directives 90/385/EEC, 9342/EEC and 98/8/EC (5 June 2009)

  • Information on the Medical Devices Directives in relation to medical device own brand labellers (4 February 2008)

Appendix III: Overview of the Currently Published IEC TC 62 (SC 62A and SC 62D) [June 2016]

  • IEC TR 60513:1994

  • Edition 2.0

  • Fundamental aspects of safety standards for medical electrical equipment

  • IEC 60601-1:2015 SER

  • Edition 1.0

  • Medical electrical equipment - ALL PARTS

  • IEC 60601-1:2005+AMD1:2012 CSV

  • Edition 3.1

  • Medical electrical equipment—Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1:2005+AMD1:2012 CSV/COR1:2012

  • Edition 3.1

  • Corrigendum 1—Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1:2005

  • Edition 3.0

  • Medical electrical equipment—Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1:2005/ISH1:2008

  • Edition 3.0

  • Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1:2005/ISH2:2009

  • Edition 3.0

  • Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1:2005/ISH3:2013

  • Edition 3.0

  • Interpretation sheet 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1:2005/COR1:2006

  • Edition 3.0

  • Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1:2005/COR2:2007

  • Edition 3.0

  • Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1:2005/AMD1:2012

  • Edition 3.0

  • Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1:2005/AMD1:2012/COR1:2014

  • Edition 3.0

  • Corrigendum 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1-2:2014

  • Edition 4.0

  • Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

  • IEC 60601-1-6:2010+AMD1:2013 CSV

  • Edition 3.1

  • Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

  • IEC 60601-1-6:2010

  • Edition 3.0

  • Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

  • IEC 60601-1-6:2010/AMD1:2013

  • Edition 3.0

  • Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

  • IEC 60601-1-8:2006+AMD1:2012 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

  • IEC 60601-1-8:2006

  • Edition 2.0

  • Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

  • IEC 60601-1-8:2006/AMD1:2012

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

  • IEC 60601-1-9:2007+AMD1:2013 CSV

  • Edition 1.1

  • Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

  • IEC 60601-1-9:2007

  • Edition 1.0

  • Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

  • IEC 60601-1-9:2007/AMD1:2013

  • Edition 1.0

  • Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

  • IEC 60601-1-10:2007+AMD1:2013 CSV

  • Edition 1.1

  • Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

  • IEC 60601-1-10:2007

  • Edition 1.0

  • Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

  • IEC 60601-1-10:2007/AMD1:2013

  • Edition 1.0

  • Amendment 1 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

  • IEC 60601-1-11:2015

  • Edition 2.0

  • Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

  • IEC 60601-1-11:2015 RLV

  • Edition 2.0

  • Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

  • IEC 60601-1-12:2014

  • Edition 1.0

  • Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

  • IEC TR 60601-4-2:2016

  • Edition 1.0

  • Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

  • IEC TR 60601-4-3:2015

  • Edition 1.0

  • Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

  • IEC TR 60878:2015

  • Edition 3.0

  • Graphical symbols for electrical equipment in medical practice

  • IEC TR 60930:2008

  • Edition 2.0

  • Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems

  • IEC TR 61258:2008

  • Edition 2.0

  • Guidelines for the development and use of medical electrical equipment educational materials

  • IEC TR 62296:2009

  • Edition 2.0

  • Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements

  • IEC 62304:2006+AMD1:2015 CSV

  • Edition 1.1

  • Medical device software - Software life cycle processes

  • IEC 62304:2006

  • Edition 1.0

  • Medical device software - Software life cycle processes

  • IEC 62304:2006/AMD1:2015

  • Edition 1.0

  • Amendment 1 - Medical device software - Software life cycle processes

  • IEC TR 62348:2012

  • Edition 2.0

  • Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

  • IEC 60601-2-2:2009

  • Edition 5.0

  • Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

  • IEC 60601-2-2:2009/COR1:2014

  • Edition 5.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

  • IEC 60601-2-3:2012+AMD1:2016 CSV

  • Edition 3.1

  • Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment

  • IEC 60601-2-3:2012

  • Edition 3.0

  • Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment

  • IEC 60601-2-3:2012/AMD1:2016

  • Edition 3.0

  • Amendment 1 - Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment

  • IEC 60601-2-4:2010

  • Edition 3.0

  • Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

  • IEC 60601-2-5:2009

  • Edition 3.0

  • Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

  • IEC 60601-2-6:2012+AMD1:2016 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

  • IEC 60601-2-6:2012

  • Edition 2.0

  • Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

  • IEC 60601-2-6:2012/AMD1:2016

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

  • IEC 60601-2-10:2012+AMD1:2016 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

  • IEC 60601-2-10:2012

  • Edition 2.0

  • Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

  • IEC 60601-2-10:2012/AMD1:2016

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

  • IEC 60601-2-16:2012

  • Edition 4.0

  • Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

  • IEC 60601-2-18:2009

  • Edition 3.0

  • Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

  • IEC 60601-2-19:2009+AMD1:2016 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

  • IEC 60601-2-19:2009

  • Edition 2.0

  • Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

  • IEC 60601-2-19:2009/COR1:2012

  • Edition 2.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

  • IEC 60601-2-19:2009/AMD1:2016

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

  • IEC 60601-2-20:2009+AMD1:2016 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

  • IEC 60601-2-20:2009

  • Edition 2.0

  • Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

  • IEC 60601-2-20:2009/COR1:2012

  • Edition 2.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

  • IEC 60601-2-20:2009/COR2:2013

  • Edition 2.0

  • Corrigendum 2 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

  • IEC 60601-2-20:2009/AMD1:2016

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

  • IEC 60601-2-21:2009+AMD1:2016 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

  • IEC 60601-2-21:2009

  • Edition 2.0

  • Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

  • IEC 60601-2-21:2009/COR1:2013

  • Edition 2.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

  • IEC 60601-2-21:2009/AMD1:2016

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

  • IEC 60601-2-23:2011

  • Edition 3.0

  • Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

  • IEC 60601-2-24:2012

  • Edition 2.0

  • Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

  • IEC 60601-2-25:2011

  • Edition 2.0

  • Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

  • IEC 60601-2-26:2012

  • Edition 3.0

  • Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

  • IEC 60601-2-27:2011

  • Edition 3.0

  • Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

  • IEC 60601-2-27:2011/COR1:2012

  • Edition 3.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

  • IEC 60601-2-31:2008+AMD1:2011 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

  • IEC 60601-2-31:2008

  • Edition 2.0

  • Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

  • IEC 60601-2-31:2008/AMD1:2011

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

  • IEC 60601-2-34:2011

  • Edition 3.0

  • Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

  • IEC 60601-2-36:2014

  • Edition 2.0

  • Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

  • IEC 60601-2-39:2007

  • Edition 2.0

  • Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

  • IEC 60601-2-40:1998

  • Edition 1.0

  • Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyography and evoked response equipment

  • IEC 60601-2-41:2009+AMD1:2013 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

  • IEC 60601-2-41:2009

  • Edition 2.0

  • Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

  • IEC 60601-2-41:2009/AMD1:2013

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

  • IEC 60601-2-46:2010

  • Edition 2.0

  • Medical electrical equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating tables

  • IEC 60601-2-47:2012

  • Edition 2.0

  • Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

  • IEC 60601-2-49:2011

  • Edition 2.0

  • Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

  • IEC 60601-2-50:2009+AMD1:2016 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

  • IEC 60601-2-50:2009

  • Edition 2.0

  • Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

  • IEC 60601-2-50:2009/COR1:2010

  • Edition 2.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

  • IEC 60601-2-50:2009/AMD1:2016

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

  • IEC 60601-2-52:2009+AMD1:2015 CSV

  • Edition 1.1

  • Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

  • IEC 60601-2-52:2009

  • Edition 1.0

  • Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

  • IEC 60601-2-52:2009/COR1:2010

  • Edition 1.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

  • IEC 60601-2-52:2009/AMD1:2015

  • Edition 1.0

  • Amendment 1 - Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

  • IEC 60601-2-62:2013

  • Edition 1.0

  • Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

  • IEC TR 61289:2011

  • Edition 1.0

  • High frequency surgical equipment - Operation and maintenance

  • IEC TR 62653:2012

  • Edition 1.0

  • Guideline for safe operation of medical equipment used for haemodialysis treatments

  • IEC PAS 63023:2016

  • Edition 1.0

  • Medical electrical system - Input interface for haemodialysis equipment for use of external alarming device

  • IEC 80369-5:2016

  • Edition 1.0

  • Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

  • IEC 80601-2-30:2009+AMD1:2013 CSV

  • Edition 1.1

  • Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

  • IEC 80601-2-30:2009

  • Edition 1.0

  • Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

  • IEC 80601-2-30:2009/COR1:2010

  • Edition 1.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

  • IEC 80601-2-30:2009/AMD1:2013

  • Edition 1.0

  • Amendment 1 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers

  • IEC 80601-2-35:2009+AMD1:2016 CSV

  • Edition 2.1

  • Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

  • IEC 80601-2-35:2009

  • Edition 2.0

  • Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

  • IEC 80601-2-35:2009/COR1:2012

  • Edition 2.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

  • IEC 80601-2-35:2009/COR2:2015

  • Edition 2.0

  • Corrigendum 2 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

  • IEC 80601-2-35:2009/AMD1:2016

  • Edition 2.0

  • Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

  • IEC 80601-2-58:2014

  • Edition 2.0

  • Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

  • IEC 80601-2-59:2008

  • Edition 1.0

  • Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

  • IEC 80601-2-59:2008/COR1:2009

  • Edition 1.0

  • Corrigendum 1 - Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

  • IEC 80601-2-60:2012

  • Edition 1.0

  • Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

  • IEC 80601-2-71:2015

  • Edition 1.0

  • Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

  • ISO 80369-1:2010

  • Edition 1.0

  • Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements

  • ISO 80369-6:2016

  • Edition 1.0

  • Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications

  • ISO 80369-20:2015

  • Edition 1.0

  • Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methods

  • ISO 80601-2-12:2011

  • Edition 1.0

  • Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

  • ISO 80601-2-13:2011

  • Edition 1.0

  • Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

  • ISO 80601-2-13:2011/AMD1:2015

  • Edition 1.0

  • Amendment 1 - Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

  • ISO 80601-2-55:2011

  • Edition 1.0

  • Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

  • ISO 80601-2-56:2009

  • Edition 1.0

  • Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

  • ISO 80601-2-61:2011

  • Edition 1.0

  • Medical electrical equipment—Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

  • ISO 80601-2-67:2014

  • Edition 1.0

  • Medical electrical equipment—Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

  • ISO 80601-2-69:2014

  • Edition 1.0

  • Medical electrical equipment—Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

  • ISO 80601-2-70:2015

  • Edition 1.0

  • Medical Electrical Equipment–Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

  • ISO 80601-2-72:2015

  • Edition 1.0

  • Medical electrical equipment—Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

  • ISO 81060-1:2011

  • Edition 1.0

  • Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type

  • ISO 81060-2:2013

  • Edition 2.0

  • Non-invasive sphygmomanometers—Part 2: Clinical investigation of automated measurement type

Appendix IV: Guidelines About Software and Software Development Cycle

Appendix V: Additional Documents Published by IEEE

  • IEEE Recommended Practice for Software Requirements Specifications; Software Engineering Standard Committee of the IEEE Computer Society

  • IEEE Recommended Practice for Software Design Descriptions; Software Engineering Standard Committee of the IEEE Computer Society

  • IEEE Standard for Software Project Management Plans; Software Engineering Standard Committee of the IEEE Computer Society

  • IEEE Standard for Software Quality Assurance Plans; IEEE Computer Society; Software Engineering Standard Committee

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Zimmermann, B. (2016). Standards and Safety Aspects for Medical Devices in the Field of Neurorehabilitation. In: Reinkensmeyer, D., Dietz, V. (eds) Neurorehabilitation Technology. Springer, Cham. https://doi.org/10.1007/978-3-319-28603-7_13

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