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ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, 2022
- ANSI/AAMI PB70:2022; Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
- Title page
- AAMI Standard
- Copyright information
- Contents
- Committee representation
- Acknowledgement
- Foreword
- Introduction
- 1 Scope [Go to Page]
- 1.1 General
- 1.2 Inclusions
- 1.3 Exclusions
- 2 Normative references
- 3 Definitions
- 4 Requirements [Go to Page]
- 4.1 Labeling requirements [Go to Page]
- 4.1.1 Device labeling
- 4.1.2 Package labeling
- 4.1.3 Technical information
- 4.1.4 Education
- 4.2 Performance requirements [Go to Page]
- 4.2.1 Barrier performance [Go to Page]
- 4.2.1.1 General
- 4.2.1.2 Classification levels of barrier performance
- 4.2.1.3 Non-protective products
- 4.2.1.4 Changes affecting barrier performance
- 4.2.2 Tracking mechanism for multiple-use products
- 4.2.3 Construction [Go to Page]
- 4.2.3.1 Surgical gowns
- 4.2.3.2 Surgical gowns–E
- 4.2.3.3 Isolation gowns
- 4.2.3.4 Surgical drapes and drape accessories
- 4.2.3.5 Other gowns (e.g., procedure gown)
- 4.2.3.6 Decontamination gown
- 4.2.3.7 Hoods
- 4.2.3.8 Toga
- 4.2.3.9 Other protective apparel items (e.g., aprons, footwear covers, sleeves, protective headwear such as hats and caps)
- 5 Tests [Go to Page]
- 5.1 Tests for the labeling requirements
- 5.2 Tests for the performance requirements [Go to Page]
- 5.2.1 Barrier performance [Go to Page]
- 5.2.1.1 Sampling
- 5.2.1.2 Barrier test methods for surgical gowns, isolation gowns, other gowns, other protective apparel, surgical drapes, and drape accessories
- 5.2.1.3 Non-protective products
- 5.2.1.4 Changes affecting barrier performance
- 5.2.2 Tracking mechanism for multiple-use products
- 5.2.3 Construction
- Annex A (informative) Rationale for the development and provisions of this standard [Go to Page]
- A.1 Need for the standard, history of development, and scope [Go to Page]
- A.1.1 Need for the standard and history of development
- A.1.2 Scope of the standard
- A.2 Normative references
- A.3 Definitions
- A.4 Requirements [Go to Page]
- A.4.1 Rationale for the labeling requirements [Go to Page]
- A.4.1.1 Device labeling
- A.4.1.2 Package labeling
- A.4.1.3 Technical information
- A.4.1.4 Education
- A.4.2 Rationale for the performance requirements [Go to Page]
- A.4.2.1 Barrier performance
- A.4.2.2 Tracking mechanism for multiple-use products
- A.4.2.3 Construction [Go to Page]
- A.4.2.3.1 Surgical gowns
- A.4.2.3.2 Surgical gowns–E (a surgical gown with extended critical zones)
- A.4.2.3.3 Isolation gowns
- A.4.2.3.4 Surgical drapes and drape accessories
- A.4.2.3.5 Other gowns (e.g., procedure gown, decontamination gown)
- A.4.2.3.6 Decontamination gowns
- A.4.2.3.7 Hoods
- A.4.2.3.8 Toga
- A.4.2.3.9 Other protective apparel items (e.g., aprons, footwear covers, sleeves, protective headwear such as hats and caps)
- A.4.2.3.10 The sterile field and the critical zone
- Annex B (informative) Examples of barrier performance classification of surgical gowns, surgical gowns-E, isolation gowns, other protective gowns, surgical drapes, hoods, togas, and other protective apparel
- Annex C (informative) Example of a sampling plan
- Annex D (informative) Rationale for changes to the 2012 edition of PB70
- Bibliography [Go to Page]
