AS NZS 4011.1:2014 pdf free

AS NZS 4011.1:2014 pdf free.Single-use medical examination gloves
This part of ISO 11193 specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over all or part of the glove.This part of ISO 11193 is intended as a reference for the performance and safety of rubber examination gloves. It does not cover the safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures.
NOTE 1 Powdered gloves are gloves where a powder has been applied on the gloves as a part of the manufacturing process, generally to facilitate donning. Powder-free gloves are gloves which have been manufactured without the deliberate application of powdered materials. Powder-free is also referred to as “powderless”， “no powder” or“non-powdered”, or other words to that effect.
NOTE 2 The cuff termination of the glove may be cut or in the form of a rolled rim.Gloves shall be manufactured from compounded natural rubber or nitrile rubber or polychloroprene rubber latex, or compounded styrene-butadiene rubber or thermoplastic-elastomer solution, or compounded styrene-butadiene rubber emulsion. To facilitate donning the gloves, any surface treatment, lubricant, powder or polymer coating may be used subject to compliance with ISO 10993.
Any pigment used shall be non-toxic. It is essential that substances used for surface treatment which are capable of being transferred are bio-absorbable.
Gloves as supplied to the user shall comply with the relevant part(s) of ISO 10993. The manufacturer shall make available to the purchaser, on request, data to support compliance with these requirements.
NOTE 1 Other suitable polymeric materials may be included in future parts of IsO 11193.
NOTE 2 It is recognized that some individuals may, over a period of time, become sensitized to a particular rubber compound (allergic reaction) and require gloves of an alternative formulation.
NOTE 3 Limits of extractable proteins, allergenic proteins, residual chemicals, endotoxins and residual powder in gloves may be specified in future editions of this part of Iso 11 193, subject to the availability of relevant ISO standard test methods.AS NZS 4011.1 pdf free.