September 24, 2020

Importing medical masks and respirators into the United Kingdom : Legal Regulations governing Type IIR Medical Masks

Surgical Face masks – Type IIR Applicable UK /EU law : Standards/Directives/Legislative requirements STANDARD / CERTIFICATION Surgical facemasks must conform to: BS EN 14683:2019 or any equivalent standard Medical face masks. 

 

Types :

  1. Surgical Type IIR face mask with loops/ties, no visor, no anti-fog strip
  2.  Surgical Type IIR face mask with loops/ties with no visor and anti-fogging strip
  3.  Surgical Type IIR face mask with loops/ties, with visor, with anti fogging strip

Medical Purpose:  Surgical face masks are medical devices covering the mouth, nose and chin, and should be worn during any activities where there is a risk of blood, body fluids, secretions or excretions splashing onto the wearer’s mouth or eyes.

Criteria  :

  • Mandatorily marked as a Type IIR Mask;
  • Must have a splash resistance pressure equal to or greater than 120mm Hg;
  • Must provide a bacterial filtration efficiency (BFE) of 98% or above;
  • Must be single use;
  • Each mask must dispense from packaging individually;
  •  Must be free from chemical smells, resulting from the manufacturing process, which prevent the end user from breathing comfortably;
  • Must have no residue left from the manufacturing process on the finished product which may lead to irritations on the skin; ● Must be close fitting in order to prevent venting (exhaled air ‘escaping’ at the sides of the mask);
  • The nose band must deform when pressed to mould over the nose and cheeks and must maintain its shape over time; and
  • The nose band must not kink or break when adjusted.

Legal Technical Requirements of Type IIR Masks which are ‘tie-back’ Masks. :

Such Masks should have integral ties long enough to go around an adult head whilst wearing a surgical cap;

  •  The upper tie must sit at the crown of the head;
  •  The lower tie must be positioned to allow it to be positioned behind the neck to hold the sides of the mask against the face of the user to prevent any gaping; and
  •  Straps and ties must not detach from the face mask when in use.

Legal Technical Requirements of Masks with ear loops :  

Have elastic ear loops; and   Ears loops must not detach from the face mask when in use.

As per the law, Masks with visors must:
● Not cause visual distortion for the wearer; and

● Have an anti-fog strip and be resistant to fogging. Masks with ties/ear loops and anti-fog strip must:

● Be resistant to fogging when worn by wearers of spectacles

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