AAMI ST65 : 2008 : R2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
Hardcopy , PDF
02-09-2021
English
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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