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FprEN 13795

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

Số trang: 22
Ngày phát hành: 2010-11-00

Liên hệ
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 980 and EN 1041), concerning manufacturing and processing requirements. This European 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 European 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. 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
FprEN 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
2010-11-00
Trạng thái
Hết hiệu lực
Tiêu chuẩn tương đương
Tiêu chuẩn liên quan
Thay thế cho
prEN 13795 (2009-10)
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
Số hiệu tiêu chuẩn prEN 13795
Ngày phát hành 2009-10-00
Mục phân loại 11.140. Thiết bị bệnh viện
Trạng thái Có hiệu lực
Thay thế bằng
EN 13795 (2011-03)
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
Số hiệu tiêu chuẩn EN 13795
Ngày phát hành 2011-03-00
Mục phân loại 11.140. Thiết bị bệnh viện
Trạng thái Có hiệu lực
Lịch sử ban hành
EN 13795+A1 (2013-02)
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
Số hiệu tiêu chuẩn EN 13795+A1
Ngày phát hành 2013-02-00
Mục phân loại 11.140. Thiết bị bệnh viện
Trạng thái Có hiệu lực
* EN 13795 (2011-03)
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
Số hiệu tiêu chuẩn EN 13795
Ngày phát hành 2011-03-00
Mục phân loại 11.140. Thiết bị bệnh viện
Trạng thái Có hiệu lực
* FprEN 13795 (2010-11)
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
Số hiệu tiêu chuẩn FprEN 13795
Ngày phát hành 2010-11-00
Mục phân loại 11.140. Thiết bị bệnh viện
Trạng thái Có hiệu lực
* prEN 13795 (2009-10)
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
Số hiệu tiêu chuẩn prEN 13795
Ngày phát hành 2009-10-00
Mục phân loại 11.140. Thiết bị bệnh viện
Trạng thái Có hiệu lực
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 * Operation shirt * Patients * Production * Products * Public health * Specification (approval) * Surgery * Surgical equipment * Testing * Work clothes * Aids
Số trang
22