AAMI TIR55 : 2014

Name: AAMI TIR55 : 2014
Brand: AAMI
Price: 126.89 GBP

Superseded

View Superseded by

HUMAN FACTORS ENGINEERING FOR PROCESSING MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

25-01-2020

Language(s)

English

Published date

01-01-2017

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Definitions and abbreviations
3 A human factors engineering and design
controls approach to device processing
4 Design of devices for processing
5 Design of processing procedures
6 Design of processing instructions
7 Education, training, and competency
assessment tools
8 Validation
Bibliography

Gives guidance to medical device manufacturers from a human factors perspective on the aspects of product design; design of processing instructions for use (IFU); education and training design; and development, verification, and validation of the device processing process to meet the needs of personnel working in a health care facility processing environment.

DocumentType	Standard
Pages	32
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	AAMI TIR55:2014(R2017) AAMI TIR55 : 2015

ISO 9241-9:2000	Ergonomic requirements for office work with visual display terminals (VDTs) Part 9: Requirements for non-keyboard input devices
AAMI ST41 : 2008	ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
ANSI/AAMI ST58:2013(R2018)	CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
CFR 21(PTS800-1299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
AAMI TIR22 : 2007	GUIDANCE FOR ANSI/AAMI/ISO 11607, PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1 AND PART 2:2006
CFR 29(PT1910.1000 TO END) : 0	LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
AAMI TIR 12 : 2010	DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
ANSI/AAMI ST79:2017	COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI ST77 : 2013	CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
ISO 13407:1999	Human-centred design processes for interactive systems