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This is a preview click here to buy the full publication IEC 623661 Edition 1.0 201502 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical devices Part 1: Application of usability engineering to medical.

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The 62366–1:2015/AMD1:2020 requires that hazard-related scenarios of use are defined, but it does not require that primary operating functions are identified. Yet, other standards might require this.

IEC 62366 is the international standard that covers the application of usability engineering to medical devices. This standard helps medical device manufacturers consider human factors by offering a standardized process for analyzing, specifying, developing, and evaluating the usability of their medical device.

IEC 60601 series is widely recognized as the basic safety and essential performance standard for medical electrical equipment. IEC 62366 has established a broadly recognized process model for achieving and validating optimal usability of devices.

Summary of IEC 62366 The IEC 62366 standard aims to reduce errors caused by inadequate medical device usability. Such errors have become an increasing cause for concern. IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability.

Medical devices - Part 1: Application of usability engineering to medical devices. IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.

ISO 14791 is the overall risk management standard for medical devices, but it is not the only standard that concerns risk, medical devices and usability engineering. There are: Product standards that include primary operating functions of various types of medical devices.

The use specification, previously referred to as the application specification in IEC 62366:2007, is a document that provides a “summary of the important characteristics related to the context of use of the medical device” (IEC 62366-1:2015).

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232