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AAMI ST15883-2 : 2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.

Available format(s)

Hardcopy , PDF

Superseded date

05-09-2020

Language(s)

English

Published date

05-01-2013

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 15883-2:2006
U.S. Deviations to ISO 15883-2:2006
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical and control requirements
6 Testing for conformity
7 Information to be supplied by the manufacturer
Annex A (informative) - Summary of test programs
Bibliography

Describes particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anesthetic equipment, bowls, dishes and receivers, utensils and glassware.

Committee
WG 13
DocumentType
Standard
Pages
30
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

AAMI TIR34 : 2014 WATER FOR THE REPROCESSING OF MEDICAL DEVICES

BS 2745-3:1993 Washer-disinfectors for medical purposes Specification for washer-disinfectors except those used for processing human-waste containers and laundry
IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
ASTM F 593 : 2017 : REDLINE Standard Specification for Stainless Steel Bolts, Hex Cap Screws, and Studs
ISO 4017:2014 Fasteners Hexagon head screws Product grades A and B
EN 10088-2:2014 STAINLESS STEELS - PART 2: TECHNICAL DELIVERY CONDITIONS FOR SHEET/PLATE AND STRIP OF CORROSION RESISTING STEELS FOR GENERAL PURPOSES
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 5362:2006 Anaesthetic reservoir bags
ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
AAMI ST15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS

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