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Medical apparel and textiles

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This Technical Specification recommends characteristics, test methods and minimum performance specifications for unused textile for the healthcare and social service facilities (hospitals, residential care homes, etc.) to give a guidance on the suitability of products intended to be maintained by industrial laundering.

This Technical Specification is not applicable to surgical textiles under the Medical Devices Directive nor protective clothing under the PPE Directive.

These following documents are required to be enclosed to the product itself:

  • a reference to this technical specification;
  • material composition according to the European Directive;
  • any other agreed information between a supplier and a customer;
  • if a size is stated on a label, the sign must be legible throughout the whole product’s lifespan.

This standard is related to the industry specification: Textiles for healthcare and social services facilities – Technical Requirements OS P 80-07.


This Technical Specification is intended to assist healthcare organisations to select textiles and products produced from these textiles, which are intended to be maintained by industrial laundering.

It follows the Technical Specification CEN/TS 14237 Textiles for healthcare and social services facilities.

The aim is to ensure, together with CEN/TS 14237, the suitability of the products for the intended use.

Production technologies in laundries place a requirement for high performance characteristics on the textile and products to ensure sufficient lifespan of the textiles. That could lead to an increase of acquisition costs, therefore it is encouraged to carry on some trial processing in a prospective laundry, to better assess textile life and lifecycle costing.

Technical specification:

  • additional utility properties and tightened properties’ values (tables 1-6 of the Technical Specification);
  • requirements on the health harmlessness (table 7 of the Technical Specification);
  • an example of a material sheet (Annexe A of the Technical Specification);
  • additional testing provisions.

EN ISO 13688:2013 – PROTECTIVE CLOTHING – General requirements

This International Standard specifies general performance requirements for ergonomics, innocuousness, size designation, ageing, compatibility and marking of protective clothing and the pieces of information to be supplied by a manufacturer with a protective clothing.

This International Standard is only intended to be used in combination with other standards containing requirements for specific protective performance and not on a stand-alone basis.

EN 13795+A1 – 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

This European Standard specifies information to be supplied to users and a 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 for 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.


This International Standard specifies requirements for high visibility clothing which is capable to signal visually the user’s presence. The high visibility clothing is intended to provide conspicuity of the wearer in any light conditions for operators of vehicles or other mechanized equipment during daylight conditions and under illumination of headlights in the dark. Annex A defines other various factors that need to be considered. This International Standard is not applicable to medium and low risk situations. Performance requirements are included for colour and retroreflection as well as for minimum areas and the placement of materials in protective clothing. The following terms and definitions apply for the purposes of this document.

The basic material:
Colourful, highly noticeable fluorescent material that does not have to meet the requirements of this International Standard for retrospective material
Retroreflective material:
Material that has retroreflective properties and which does not have to comply with the requirements of this International Standard for the basic material
Material of combined properties:
Material with properties of the basic material and the retroreflective material as well

Minimum required area of the visible material in m²

MaterialGarment of 3rd ClassGarment of 2nd ClassGarment of 1st Class
Basic material0,80,50,14
Retroreflective material0,20,130,1
Material with combined properties--0,20
NOTE: Placing the garment to its class is determined according to the smallest area of the visible material.

The minimum required visible area, so that the garments could reach the classification according to table 1, can not be reduced or altered due to any logo, marking, labels, or the like.


This European Standard specifies the requirements and test methods for materials and the seams of clothing designed to give a protection against favourable weather conditions (rain, snow), mist and ground moisture.

Waterproofness is one of the most important properties and it is measured on the outer layer of the garment material. Tests are provided on new and provisionally modified test samples of the material on parts of the garments with seams.

Some waterproof materials do not release water vapour. However, other materials with combined properties resistant to water penetration and vapour permeability are available on the market. This property (low resistance to water vapours) increases the evaporation of sweat and therefore it significantly contributes to cooling the body. This is of high importance as it significantly contributes to the comfort increase and reduction of physiological stress and it prolongs the wearing time under certain climatic conditions.

The manufacturer has to supply the protective clothing with pieces of information in accordance with EN 343+A1, which are completed with this following information:

  • product label;
  • clothes’ dressing and undressing instructions if it is necessary;
  • necessary warnings about the improper use; the table A.1 must be included in the information manual in the case of water vapour resistance of the 1st Class;
  • detailed information, about a possible use and source release, is available.