European Keymark

The EU has defined the technical basis for offering the European Keymark. The first sector for which it has been developed is the electric domestic appliances. The announcement of the European Keymark also includes specific standards which will form the basis of compliance. All the standards recognized are part of the EN 60335 series which is on Safety of household and similar electrical appliances. The European Keymark is now offered to suppliers who wish to participate, however this mark is a purely voluntary mark. Products covered currently are:

• Vacuum-cleaners and water-suction cleaning appliances
  
• Electric irons
  
• Spin Extractors
  
• Dishwashers
  
• Washing machines, Tumbler-dryers, Cloths dryers and towel rails
  
• Electric shavers, hair clippers and similar appliances
  
• Toasters, grills, roasters and similar appliances
  
• Floor-treatment machines and wet-scrubbing machines
  
• Warming-plates and similar machines
  
• Frying pans, deep-fat fryers and similar appliances
  
• Electric Kitchen machines, Range hoods
  
• Appliances for heating liquids
  
• Appliances for skin or hair care
  
• Microwave ovens, Outdoor barbecues
  
• Clocks, Fans
  
• Ultra-violet and infra-red radiation skin treatment appliances
  
• Sewing machines
  
• Baftery chargers
  
• Room heaters, Humidifiers for heating and cooling
  
• Massage appliances
  
• Motor compressors, Safety isolating transformers
  
• Electric pumps, Electrical appliances for use with aquariums
  
• Air cleaning appliances
  
• Fixed immersion heaters

New Standards Recognized by EU

Active implantable medical devices:

EN 30993-11 = ISO 10993

Biological evaluation of medical devices. Part 11: Tests for - 11 systemic toxicity. 1995

Personal Protective Equipment.

EN 381-8		Protective clothing for users of hand-held chain-saws. Part 8: Test methods for chain-saw protective gaiters 1997
EN 381-9		Protective clothing for users of hand-held chain-saws. Part 9: Requirements for chain-saw protective gaiters 1997
EN 1868		Personal protective equipment against falls from a height. List of equivalent terms. 1997

Telecommunications terminal equipment:

TBR 25

Business telecommunications (BTC). 140 Mbits/s digital unstructured and structured leased lines (Dl4OU and D140S). Aftachment requirements for terminal equipment interface. 1997

Medical Devices:

EN 285		Sterilisation Steam sterilisers: large sterilisers 1996
EN 794-1		Lung ventilators. Part 1: Particular requirements for critical care ventilators 1997
EN 794-2		Lung ventilators. Part 2: Particular requirements for home care use 1997
EN 864		Medical electrical equipment: Capnometers for use with humans. Particular requirements 1996
EN 867-2		Non-biological systems for use in sterilisers. Part 2: Process indicators (Class A) 1997
EN 867-3		Non-biological systems for use in sterilisers. Part 3: Specification for Class B indicators for use in the Bowie and Dick test. 1997
EN 1089-3		Transportable gas cylinders. Cylinder identification. Part 3: Colour coding. 1997
EN 1280-1		Agent specific filling systems for anaesthetic vaporizers. Part 1: Rectangular keyed filling systems. 1997
EN 1282-2		Tracheostomy [sic] tubes. Part 2: Paediatric tubes. 1997
EN 1820		Anaesthetic reservoir bags. 1997
EN 8359= ISO 4135: 1995		Oxygen concentrators for medical use. Safety requirements. 1996
EN 60601-1-4= IEC 60601-1-4		Medical electrical equipment. Part 1: General requirements for safety. 4: Collateral standard: Programmable electrical medical systems. 1996

Foods

A proposal has been published in the Official Journal OJ C337, 7/11/1997 to extend existing harmonised European Product liability regulation to cover agricultural products. Although this new measure will not change approval requirements in the food sector, it will have a significant indirect effect. For the first time, suppliers of unprocessed agricultural products will be made subject to the harmonised product liability obligations which already apply throughout the rest of manufacturing industry.