• AAMI ST65:2008(R2018)

    Current The latest, up-to-date edition.

    PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  06-09-2018

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

    General Product Information - (Show below) - (Hide below)

    Committee WG 83
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    AAMI ISO 11607-1 : 2006 : R2010 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
    14/30255135 DC : 0 BS EN ISO 11607-1:2009/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    ASTM F 2407 : 2006 : R2013 : EDT 1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
    17/30351717 DC : 0 BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    AAMI ST40 : 2004 : R2010 TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    AAMI ISO 11607-1 : 2006 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
    UNE-EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
    AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    DIN EN ISO 11607-2:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014)
    BS EN ISO 11607-2 : 2006 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
    AAMI ISO 11607-2:2006 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
    ASTM F 2407 : 2006 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    DIN EN ISO 11607-1:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
    17/30351720 DC : 0 BS EN ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
    AAMI TIR 11 : 2005 SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
    AAMI ISO 11607-2 : 2006 : R2010 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
    ANSI/AAMI PB70:2012 LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    CSA Z314.10.2 : 2015 LAUNDERING, MAINTENANCE, AND PREPARATION OF REUSABLE GOWNS, DRAPES, AND WRAPPERS FOR HEALTH CARE SETTINGS AND LAUNDRIES
    BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
    CSA ISO 11607-1 : 2016 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    AAMI ST91 : 2015 FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES
    ANSI/AAMI/ISO 11607-1:2006/(R)2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
    CSA ISO 11607-2 : 2016 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
    UNE-EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)
    UNI EN ISO 11607-1 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    BS EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
    AAMI TIR11:2005(R2015) SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
    04/30101211 DC : DRAFT APR 2004 ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    14/30255138 DC : 0 BS EN ISO 11607-2:2006/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
    I.S. EN ISO 11607-2:2017 & LC:2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006, INCLUDING AMD 1:2014)
    AAMI ST40 : 2004 TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    04/30101215 DC : DRAFT APR 2004 ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
    I.S. EN ISO 11607-1:2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)
    BS EN ISO 11607-1 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    UNI EN ISO 11607-2 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES

    Standards Referencing This Book - (Show below) - (Hide below)

    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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