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ANSI/AAMI ST15883-2:2013(R2015) (ISO 15883-2:2006 MOD)

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

27-04-2023

Language(s)

English

Published date

23-11-2015

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
TC 198
DocumentType
Standard
ISBN
1-57020-481-0
Pages
30
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

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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$234.08
Including GST where applicable

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