BS EN 13795-2:2019
$142.49
Surgical clothing and drapes. Requirements and test methods – Clean air suits
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 32 |
This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions |
| 12 | 4 Performance requirements |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 A.3 Treatment of results |
| 17 | Annex B (informative)Rationales B.1 General B.2 Cleanliness – microbial B.3 Particle release |
| 18 | B.4 Bursting strength – dry B.5 Tensile strength – dry B.6 Resistance to microbial penetration – dry |
| 19 | B.7 Labelling B.8 Treatment of results |
| 20 | B.9 Flammability B.10 Electrostatic discharge |
| 21 | Annex C (informative)Environmental aspects |
| 22 | 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 |
| 23 | D.4 Comfort D.4.1 General D.4.2 Clean air suits D.4.3 Practical trials |
| 24 | Annex E (informative)Functional design E.1 General E.2 Test method for measuring source strength E.2.1 Dispersal chamber |
| 25 | E.2.2 Operating room E.2.3 Measuring bacteria carrying airborne particles E.2.4 Source strength |
| 26 | E.3 Use of source strength measurements |
| 28 | Annex ZA (informative)Relationship between this European standard and the essential requirements of Directive 93/42/EEC [1993 OJ L 169] aimed to be covered |
