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AAMI ST65 : 2008 : R2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
Available format(s)

Hardcopy , PDF

Superseded date

09-02-2021

Language(s)

English

Published date

01-01-2013

Glossary of equivalent standards
Committee representation
Foreword
Introduction: Need for the recommended practice
1 Scope
   1.1 General
   1.2 Inclusions
   1.3 Exclusions
2 Definitions, symbols, and abbreviations
3 Design consideration
   3.1 General ratio
   3.2 Work area design and functional work flow
        3.2.1 Definitions of work areas
        3.2.2 Design criteria for work areas
        3.2.3 Functional work flow patterns
        3.2.4 Traffic control
   3.3 Physical facilities: laundry area
        3.3.1 Space requirements
        3.3.2 Mechanical systems
        3.3.3 Floors, walls, ceilings, and vents
        3.3.4 Ventilation
        3.3.5 Temperature and humidity control
        3.3.6 Lighting systems
        3.3.7 Handwashing facilities
        3.3.8 Emergency eyewash/shower equipment
        3.3.9 Soil-sort area
        3.3.10 Chemical storage area
        3.3.11 Storage area for clean textile packs
        3.3.12 Housekeeping
   3.4 Physical facilities: surgical pack assembly area
        3.4.1 Space requirements
        3.4.2 Mechanical systems
        3.4.3 Floors, walls, ceilings, and vents
        3.4.4 Ventilation
        3.4.5 Temperature and humidity control
        3.4.6 Lighting systems
        3.4.7 Hand hygiene facilities
        3.4.8 Storage area for clean textile packs
        3.4.9 Surgical pack sterilization area
        3.4.10 Sterile storage area
        3.4.11 Housekeeping
4 Personnel considerations
   4.1 General rationale
   4.2 Qualifications
        4.2.1 Supervisors/managers
        4.2.2 Personnel
   4.3 Training and education
   4.4 Health and personal hygiene
   4.5 Attire
        4.5.1 General
        4.5.2 Personal protective equipment (PPE)
5 Receiving and handling of reusable surgical textiles
   5.1 General rationale
   5.2 Newly purchased items
        5.2.1 Identification and handling
        5.2.2 Washing
   5.3 Collecting and transporting soiled surgical textiles
        5.3.1 Collecting soiled surgical textiles at the
               point of use
        5.3.2 Transporting soiled surgical textiles
   5.4 Sorting of soiled textiles
        5.4.1 General considerations
        5.4.2 Pre-sort systems
        5.4.3 Post-sort systems
6 Laundry processing recommendations
   6.1 General rationale
   6.2 Washing
        6.2.1 Procedures
        6.2.2 Loading of washing equipment
        6.2.3 Steps in the washing process: laundry formulas
   6.3 Drying
        6.3.1 Procedures
        6.3.2 Equipment loading
        6.3.3 Steps in the drying process: drying formulas
   6.4 Process monitoring
        6.4.1 Rationale for process monitoring
        6.4.2 Process monitoring: supplies
        6.4.3 Process monitoring: equipment operation
        6.4.4 Process monitoring: finished products
7 Inspection, testing, and maintenance of laundered textiles
   7.1 General rationale
   7.2 Visual inspection
        7.2.1 Quality standards
        7.2.2 Stains
        7.2.3 Physical defects
        7.2.4 Chemical or thermal damage
        7.2.5 Foreign debris
        7.2.6 Labeling
        7.2.7 Tracking system
   7.3 Testing
        7.3.1 Test procedures
        7.3.2 Microbiological cleanliness
        7.3.3 Effective life
        7.3.4 Important functional attributes
   7.4 Maintenance
        7.4.1 Patching
        7.4.2 Mending
        7.4.3 Rewash
        7.4.4 Rejuvenation
        7.4.5 Retirement or alternate use
8 Preparation and packaging
   8.1 General rationale
   8.2 Procedures
   8.3 Folding
        8.3.1 General considerations
        8.3.2 Guidelines for folding gowns
        8.3.3 Guidelines for folding drapes
   8.4 Pack assembly
   8.5 Wrapping
   8.6 Labeling/identification of packs
9 Handling, transport, and storage of laundered textiles
   9.1 General rationale
   9.2 Procedures
   9.3 Personnel attire and hygiene
   9.4 Handling clean/sterile textiles
   9.5 Transport
        9.5.1 General considerations
        9.5.2 Method of transport
        9.5.3 Separation of clean/sterile and soiled textiles
        9.5.4 Laundry cart cleaning, disinfection, and loading
        9.5.5 Truck cleaning and loading
   9.6 Storage
        9.6.1 Storage conditions
        9.6.2 Storage shelving
        9.6.3 Stock rotation
10 Installation, operation, care, and maintenance of laundry
   equipment
   10.1 General rationale
   10.2 Documentation
        10.2.1 Identification
        10.2.2 Safety
        10.2.3 Manuals and installation/operating instructions
   10.3 Installation
        10.3.1 General considerations
        10.3.2 Utilities
   10.4 Operation
        10.4.1 General considerations
        10.4.2 Washing, extraction, and drying equipment
        10.4.3 Support systems
   10.5 Routine care and maintenance
        10.5.1 Routine care
        10.5.2 Scheduled (preventive) maintenance
        10.5.3 Unscheduled maintenance (repairs)
        10.5.4 Calibration
        10.5.5 Recordkeeping
11 Quality control
   11.1 General rationale
   11.2 General quality control criteria
        11.2.1 Functional performance criteria
        11.2.2 Verification of laundry processes
   11.3 Policies and procedures
   11.4 Barrier efficacy
   11.5 Tracking uses of reusable surgical textile products
   11.6 Process performance
        11.6.1 Quality assessment
        11.6.2 Quality process
12 Medical device regulatory considerations
Annexes
A - Examples of folding procedures
B - Bibliography

Describes guidelines for properly handling, processing, and preparing of reusable surgical textiles for use in health care facilities.

Committee
WG 83
DocumentType
Standard
Pages
69
ProductNote
Reconfirmed 2013
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
CFR 40(PTS100-149) : JUL 94 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
CFR 21(PTS170-199) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199
AAMI TIR 11 : 2005 SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
ISO 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
ANSI Z8.1 : 2006 AMERICAN NATIONAL STANDARD FOR COMMERCIAL LAUNDRY EQUIPMENT AND OPERATIONS - SAFETY REQUIREMENTS
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
RIA R15.06 : 1999 INDUSTRIAL ROBOTS AND ROBOT SYSTEMS - SAFETY REQUIREMENTS
CFR 40(PTS150-189) : JUL 2017 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
CFR 40(PTS260-299) : JUL 96 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
AAMI TIR22 : 2007 GUIDANCE FOR ANSI/AAMI/ISO 11607, PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1 AND PART 2:2006
NFPA 70 : 2017 NATIONAL ELECTRICAL CODE
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 Z358.1 : 2014 EMERGENCY EYEWASH AND SHOWER EQUIPMENT
ANSI/IES RP-29 : 2016 LIGHTING FOR HOSPITALS AND HEALTH CARE FACILITIES
ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
ANSI/AAMI ST8:2013(R2018) HOSPITAL STEAM STERILIZERS
ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
ANSI/AAMI PB70:2012 LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES

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