BS EN 13795-1:2019
$167.15
Surgical clothing and drapes. Requirements and test methods – Surgical drapes and gowns
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 36 |
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 surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, 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 surgical drapes and gowns and sets performance requirements for these products. EN 13795-1 does not cover requirements for resistance to penetration by laser radiation of products. Suitable test methods for resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810. EN 13795-1 does not cover requirements for incise drapes or films. EN 13795-1 does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment may cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this standard with respect to their use as surgical gowns and drapes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 9 | 1 Scope 2 Normative references |
| 10 | 3 Terms and definitions |
| 13 | 4 Performance requirements |
| 15 | 5 Manufacturing and processing requirements and documentation 6 Information to be supplied with the product 6.1 Information to be supplied to the user |
| 16 | 6.2 Information to be supplied to the processor |
| 17 | Annex A (normative)Testing A.1 General A.2 Test methods and conformance A.2.1 Test method for evaluation of cleanliness microbial/bioburden |
| 18 | A.2.2 Test method for evaluation of particle release A.2.3 Test method for evaluation of liquid penetration A.2.4 Test method for evaluation of bursting strength in dry and wet state |
| 19 | A.2.5 Test method for evaluation of tensile strength in dry and wet state A.2.6 Test method for evaluation of dry microbial penetration A.2.7 Test method for evaluation of wet microbial penetration A.2.8 Test method for evaluation of biocompatibility |
| 20 | A.3 Treatment of results |
| 21 | Annex B (informative)Rationales B.1 General B.2 Cleanliness – microbial B.3 Particle release |
| 22 | B.4 Resistance to liquid penetration |
| 23 | B.5 Bursting strength – dry and wet B.6 Tensile strength – dry and wet B.7 Resistance to microbial penetration – dry |
| 25 | B.8 Resistance to microbial penetration – wet B.9 Labelling |
| 26 | B.10 Treatment of results |
| 27 | Annex C (informative)Information on further characteristics C.1 Comfort C.2 Adhesion for fixation for the purpose of wound isolation C.3 Liquid control |
| 28 | C.4 Flammability C.5 Electrostatic discharge |
| 29 | Annex D (informative)Environmental aspects |
| 30 | Annex E (informative)Guidance to users for selecting products E.1 Performance levels E.2 Functional design E.2.1 General E.2.2 Critical and less critical areas |
| 31 | E.2.3 Size E.2.4 Accessories E.2.5 Comfort E.2.5.1 General E.2.5.2 Surgical gowns |
| 32 | E.2.5.3 Surgical drapes E.3 Practical trials |
| 33 | 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 |
