This standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products. EN 13795 does not cover requirements for flammability of products used in laser surgery. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.
Số hiệu tiêu chuẩn
prEN 13795
Tên tiêu chuẩn
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
Ngày phát hành
2009-10-00
Tiêu chuẩn tương đương
DIN EN 13795 (2009-10), IDT * 09/30190221 DC (2009-10-16), IDT * S97-165PR, IDT * OENORM EN 13795 (2009-12-01), IDT
Từ khóa
Accessories * Clinics * Cover cloths * Data of the manufacturer * Definitions * Enterprises * Hygiene * Information * Instructions for use * Medical devices * Medical equipment * Medical personnel * Medical products * Medical sciences * Medical technology * Occupational safety * Operation shirt * Patients * Production * Products * Public health * Specification (approval) * Surgery * Surgical equipment * Testing * Work clothes * Aids