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BSI 23/30457003 DC 2023

$13.70

BS EN 13795-2 Surgical clothing and drapes – Requirements and test methods – Part 2. Clean air suits

Published By Publication Date Number of Pages
BSI 2023 31
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PDF Catalog

PDF Pages PDF Title
1 30457003-NC.pdf
3 41_e_stf (3).pdf
7 1 Scope
2 Normative references
3 Terms and definitions
10 4 Performance requirements
11 5 Manufacturing and processing requirements and documentation
6 Information to be supplied with the product
6.1 Information to be supplied to the user
6.2 Information to be supplied to the processor
12 Annex A (normative)Testing
A.1 General
A.2 Test methods and conformance
A.2.1 Test method for evaluation of cleanliness microbial/bioburden
A.2.2 Test method for evaluation of particle release
13 A.2.3 Test method for evaluation of bursting strength in dry state
A.2.4 Test method for evaluation of tensile strength in dry state
A.2.5 Test method for evaluation of dry microbial penetration
A.2.6 Test method for evaluation of biocompatibility
14 A.3 Treatment of results
15 Annex B (informative)Rationales
B.1 General
B.2 Cleanliness – microbial
B.3 Particle release
16 B.4 Bursting strength – dry
B.5 Tensile strength – dry
B.6 Resistance to microbial penetration – dry
17 B.7 Labelling
B.8 Treatment of results
18 B.9 Flammability
B.10 Electrostatic discharge
19 Annex C (informative)Environmental impact
21 Annex D (informative)Guidance to users for selecting products
D.1 General
D.2 Performance levels
D.3 Functional design aspects
D.3.1 Size
D.3.2 Accessories
22 D.4 Comfort
D.4.1 General
D.4.2 Clean air suits
D.4.3 Practical trials
23 Annex E (informative)Functional design
E.1 General
E.2 Test method for measuring source strength
E.2.1 Dispersal chamber
24 E.2.2 Operating room
E.2.3 Measuring bacteria carrying airborne particles
E.2.4 Source strength
25 E.3 Use of source strength measurements
27 Annex ZA (informative)Relationship between this European standard and General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
BSI 23/30457003 DC 2023
$13.70