IEC 62366-1-2015 pdf free download

IEC 62366-1-2015 pdf free download.Medical devices – Part 1: Application of usability engineering to medical devices.
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent
(in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography beginning on page 46
ISO 14971:2007, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purpose of this document, the terms and definitions given in ISO 14971:2007 and the following apply.
NOTE An index of defined terms is found beginning on page 49.
ABNORMAL USE conscious, intentional act or intentional omission of an act that is counter to or violates NORMAL USE and is also beyond any further reasonable means of USER INTERFACE-related RISK CONTROL by the MANUFACTURER
EXAMPLES Reckless use or sabotage or intentional disregard of information for SAFETY are such acts.
3.2 ACCOMPANYING DOCUMENTATION
materials accompanying a MEDICAL DEVICE and containing information for the USER or those accountable for the installation, use and maintenance of the MEDICAL DEVICE, particularly regarding safe use
Note 1 to entry: The ACCOMPANYING DOCUMENTATION can consist of the instructions for use, technical description, installation manual, quick reference guide, etc
Note 2 to entry: ACCOMPANYING DOCUMENTATION is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types
Note 3 to entry: MEDICAL DEVICES that can be used safely without instructions for use are exempted from having instructions for use by some authorities with jurisdiction.
(SOURCE: ISO 14971:2007, 2.1, modified — The term has been changed to refer to ‘documentation’ rather than document’, and in the definition ‘document’ has been replaced by material’, ‘OPERATOR’ has been deleted and notes to entry have been added.]
3.3 CORRECT USE
NORMAL USE without USE ERROR
Note I to entry: Deviation from instructions for use is only considered USE ERROR if it leads to a MEDICAL DEVICE response that is different than intended by the MANUFACTURER or expected by the USER.
Note 2 to entry: Figure 1 shows the relationships of the types of use.
3.4 EFFECTIVENESS
accuracy and completeness with which USERS achieve specified goals
Note 1 to entry: This is a different concept than ‘clinical effectiveness’.
[SOURCE: ISO 9241-11:1998, 3.2, modified — Added the note to entry.]IEC 62366-1 pdf download.