AAMI TIR 11 : 2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
Hardcopy , PDF
05-08-2020
English
01-01-2005
Glossary of equivalent standards
Committee representation
Acknowledgments
Foreword
1 Introduction and scope
2 Definitions of terms
3 Types of surgical protective materials
3.1 Introduction
3.2 Multiple-use materials
3.2.1 General considerations
3.2.2 Historical materials
3.2.3 Current materials
3.3 Single-use materials
3.4 Reinforcement of multiple-use and single-use products
4 Safety and performance characteristics
4.1 Introduction
4.2 Barrier effectiveness
4.2.1 Resistance to liquid and microbial penetration
4.2.2 Resistance to penetration by airborne,
aerosol-borne, or dry particles
4.3 Abrasion resistance
4.4 Strength
4.4.1 General considerations
4.4.2 Breaking strength
4.4.3 Tear strength
4.4.4 Puncture and tear resistance
4.5 Drapeability
4.6 Comfort
4.7 Staining, discoloration, and residues
4.8 Electrostatic properties
4.9 Flammability
4.10 Generation of particulates and visible lint
4.11 Shrinkage
4.12 Biocompatibility
4.13 Sterility assurance
4.14 Performance in use
4.15 Strike-through investigation
5 Product evaluation and selection of protective
apparel and surgical drapes
5.1 Introduction
5.2 Information from manufacturers and suppliers
5.3 Product evaluation
5.4 Cost comparisons
5.5 Staff input
5.6 Performance priorities in relation to product
function
5.7 Periodic reassessment
6 Guidelines for choosing levels of barrier
performance needed for particular health care
applications
6.1 Introduction
6.2 Exposure control plan
6.3 Classification and labeling of barrier
performance by manufacturers
6.4 Examples of possible barrier performance
levels for particular applications
6.5 Special considerations for isolation gowns
7 Care and handling of protective apparel and
surgical drapes
7.1 Introduction
7.2 General considerations
7.3 Handling of contaminated protective apparel
and surgical drapes at the point of use
7.4 Disposal of single-use products
7.5 Processing of multiple-use products
7.5.1 Quality assurance program
7.5.2 Tracking the number of uses
7.5.3 Laundering
7.5.4 Inspection, testing, folding, and assembly
Annexes
A - Historical background
B - Test methods
C - Bibliography
Covers selection and use of protective apparel and surgical drapes, including information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, choosing the level of barrier performance and care of protective apparel and drapes.
Committee |
PB
|
DocumentType |
Standard
|
Pages |
49
|
PublisherName |
Association for the Advancement of Medical Instrumentation
|
Status |
Superseded
|
SupersededBy |
AAMI ST65:2008(R2018) | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
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 |
AAMI ST65 : 2008 : R2013 | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
ANSI/AAMI PB70:2012 | LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES |
AAMI ST65 : 2008 | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
ASTM F 2407 : 2006 : R2013 : EDT 1 | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
TAPPI T 547 : 2012 | AIR PERMEANCE OF PAPER AND PAPERBOARD (SHEFFIELD METHOD) |
ASTM D 5733 : 1999 | Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Withdrawn 2008) |
ISO 13934-1:2013 | Textiles — Tensile properties of fabrics — Part 1: Determination of maximum force and elongation at maximum force using the strip method |
AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
ISO 13934-2:2014 | Textiles Tensile properties of fabrics Part 2: Determination of maximum force using the grab method |
ISO 9073-4:1997 | Textiles Test methods for nonwovens Part 4: Determination of tear resistance |
EN 20811:1992 | Textiles - Determination of resistance to water penetration - Hydrostatic pressure test |
CFR 16(PTS1000-END) : 0 | COMMERCIAL PRACTICES - FEDERAL TRADE COMMISSION - CONSUMER PRODUCT SAFETY COMMISSION |
ISO 9073-7:1995 | Textiles — Test methods for nonwovens — Part 7: Determination of bending length |
ASTM F 1342 : 2005 | Standard Test Method for Protective Clothing Material Resistance to Puncture |
AAMI ST65:2008(R2018) | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
ISO 9073-9:2008 | Textiles Test methods for nonwovens Part 9: Determination of drapability including drape coefficient |
ISO 22612:2005 | Clothing for protection against infectious agents Test method for resistance to dry microbial penetration |
BS 6909:1988 | Method for generation and counting of the airborne linting propensity of fabrics in the dry state |
NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
CFR 29(PT1910.1000 TO END) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
ASTM F 2101 : 2014 : REDLINE | TEST METHOD FOR EVALUATING THE BACTERIAL FILTRATION EFFICIENCY (BFE) OF MEDICAL FACE MASK MATERIALS, USING A BIOLOGICAL AEROSOL OF STAPHYLOCOCCUS AUREUS |
ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 11092:2014 | Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test) |
NFPA 702 : 1993 | RECOMMENDED PRACTICE FOR A FIELD MATCH FLAME TEST FOR TEXTILES AND FILMS |
ISO 9073-10:2003 | Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state |
ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
ASTM F 1868 : 2017 : REDLINE | Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate |
ASTM D 2582 : 2016 : REDLINE | Standard Test Method for Puncture-Propagation Tear Resistance of Plastic Film and Thin Sheeting |
ANSI/AAMI PB70:2012 | LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES |
ASTM D 737 : 2004 | Test Method for Air Permeability of Textile Fabrics |
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