"European Standard for Surgical Gowns, Drapes and Clean Air Suites "

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. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.

"Single use sterile surgical rubber gloves - specification"

This International Standard specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove. This International Standard is intended as a reference for the performance and safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent handling, packaging, and storage procedures are outside the scope of this International Standard.

"Personal fall-arrest systems - Part 2. Lanyards and energy absorbers"

This part of ISO 10333 specifies requirements, test methods, instructions for use and maintenance, marking, labelling and packaging, as appropriate, for lanyards and energy absorbers. Lanyards and energy absorbers are used together as a connecting subsystem in personal fall-arrest systems (PFAS) which will be specified in a future International Standard (see ISO 10333-6 in the Bibliography). This part of ISO 10333 is applicable only to lanyards and energy absorbers limited to single-person use of a total mass not exceeding 100 kg. NOTE Users of fall-protection equipment whose total mass (including tools and equipment) exceeds 100 kg are advised to seek advice from the equipment manufacturer regarding the suitability of this equipment, which may need additional testing

"Personal fall-arrest systems -- Part 4: Vertical rails and vertical lifelines incorporating a sliding-type fall arrester"

This part of ISO 10333 specifies requirements, test methods, instructions for use and maintenance, marking, labelling and packaging, as appropriate, for vertical rails and vertical lifelines which incorporate a sliding-type fall arrester. When connected to a full-body harness as specified in ISO 10333-1, vertical rails and vertical lifelines which incorporate a sliding-type fall arrester constitute a personal fall-arrest system (PFAS), which will be specified in a future International Standard. Vertical rails and vertical lifelines which incorporate a sliding-type fall arrester in accordance with this part of ISO 10333 are limited to use by a single person of total mass not exceeding 100 kg.

"Personal fall-arrest systems - Part 6. System performance tests"

Specifies tests and requirements for complete personal fall arrest systems (PFAS) made up from specific combinations of components and subsystems selected from those conforming to the other parts of ISO 10333 and to ISO 14567, where it is both important and desirable to ascertain satisfactory system performance and interactive component compatibility. It includes PFAS performance tests using a rigid torso test mass as a surrogate for the faller. Examples of personal fall arrest systems, as well as descriptions of how components or subsystems may be connected together to constitute a system, are also given.