AS 4381-2002

1 - AS 4381-2002 SINGLE-USE FACE MASKS FOR USE IN HEALTH CARE
4 - PREFACE
5 - CONTENTS
6 - 1 SCOPE
6 - 2 REFERENCED DOCUMENTS
6 - 3 DEFINITIONS
6 - 3.1 Bacterial filtration efficiency (BFE)
6 - 3.2 Differential pressure (delta P) (breathability)
6 - 3.3 Facial fit
7 - 3.4 Facing material
7 - 3.5 Filter
7 - 3.6 Fluid resistance
7 - 3.7 Headband
7 - 3.8 Loops
7 - 3.9 May
7 - 3.10 Multiple pack
7 - 3.11 Nose piece
7 - 3.12 Particle filtration efficiency
7 - 3.13 Shall
7 - 3.14 Should
7 - 3.15 Single-use
7 - 3.16 Store pack
7 - 3.17 Submicron (submicrometre)
7 - 3.18 Ties
7 - 3.19 Unit
8 - 4 DESIGN
8 - 5 MATERIALS
8 - 5.1 General
8 - 5.2 Facing material
8 - 5.3 Filter
8 - 5.4 Nose piece
8 - 5.5 Colourfastness
8 - 5.6 Harmful Effects
8 - 6 CONSTRUCTION
8 - 6.1 General
8 - 6.2 Fixation
8 - 6.2.1 General
8 - 6.2.2 Ties
8 - 6.2.3 Loops and headbands
8 - 6.2.4 Nose piece
9 - 6.2.5 Types of face masks
9 - 7 PHYSICAL REQUIREMENTS
9 - 7.1 Dimensions
9 - 7.2 Performance characteristics
9 - 7.2.1 General
10 - 7.2.2 Strength of ties and tie attachment
10 - 8 PACKAGING OF MASKS
10 - 8.1 Multiple pack
10 - 8.2 Store pack
10 - 9 MARKING
10 - 9.1 Multiple pack
10 - 9.2 Store pack
11 - APPENDIX A - MEANS OF DEMONSTRATING COMPLIANCE WITH THIS STANDARD
11 - A1 SCOPE
11 - A2 STATISTICAL SAMPLING
11 - A3 PRODUCT CERTIFICATION
12 - A4 SUPPLIER'S QUALITY SYSTEM
12 - A5 OTHER MEANS OF ASSESSMENT
12 - A6 ACCEPTABLE QUALITY LEVELS (AQLs)
13 - APPENDIX B - METHOD FOR DETERMINING BACTERIAL FILTRATION EFFICIENCY
13 - B1 SCOPE
13 - B2 PRINCIPLE
13 - B3 APPARATUS AND MATERIALS
13 - B4 SAMPLE PREPARATION
14 - B5 PROCEDURE
14 - B6 CALCULATION
14 - B7 REPORT
17 - APPENDIX C - METHOD FOR DETERMINING PARTICLE FILTRATION EFFICIENCY
17 - C1 SCOPE
17 - C2 PRINCIPLE
17 - C3 REAGENT
17 - C4 APPARATUS AND MATERIALS
17 - C5 PROCEDURE
18 - C6 CALCULATION
18 - C7 REPORT
19 - APPENDIX D - METHOD FOR DETERMINING DIFFERENTIAL PRESSURE (BREATHABILITY)
19 - D1 SCOPE
19 - D2 PRINCIPLE
19 - D3 APPARATUS
19 - D4 SAMPLE PREPARATION
19 - D5 PROCEDURE
20 - D6 CALCULATION
20 - D7 REPORT
22 - APPENDIX E - METHOD FOR DETERMINING FLUID RESISTANCE OF FLUID RESISTANT FACE MASKS
22 - E1 SCOPE
22 - E2 PRINCIPLE
22 - E3 REAGENT
22 - E3.1 Synthetic blood
23 - E3.2 Isopropanol
23 - E4 APPARATUS AND MATERIALS
26 - E5 TEST SPECIMENS
26 - E6 CONDITIONING OF TEST SPECIMENS
26 - E7 PREPARATION AND CLEANING OF TEST APPARATUS
28 - E8 PROCEDURE
29 - E9 REPORT
30 - APPENDIX F - METHOD FOR DETERMINING STRENGTH OF TIESAND TIE ATTACHMENT
30 - F1 SCOPE
30 - F2 PRINCIPLE
30 - F3 APPARATUS AND MATERIALS
30 - F4 PROCEDURE
30 - F5 REPORT

Specifies requirements for single-use face masks which are used in health care where it is necessary to keep cross-contamination between the health care worker and the patient to a minimum. The masks are intended for use in the operating room, and for medical and dental procedures and applications. Does not apply to situations where an additional degree of respiratory protection may be required from the risk of airborne transmission infection, e.g. TB and surgical plume.

This Standard sets out requirements for single-use face masks which are used in health care where it is necessary to keep cross-contamination between the health care worker and the patient to a minimum. The masks are intended for use in the operating room, and for medical and dental procedures and applications. The Standard does not apply to situations where an additional degree of respiratory protection may be required from the risk of airborne transmission infection, e.g. TB and surgical plume. NOTE: Alternative means of determining compliance with this Standard are given in Appendix A.

First published as AS 4381-1996.
Second edition 2002.