What International and Harmonised Standards are relevant to Surgical Instruments?

There are no harmonised standards in place that Surgical Instruments can be assessed against to prove quality, specific to their functionality. Standards such as ISO 9001 and 13485 may be referenced, but they do not demonstrate quality, they signify a formalised quality system.  The BS 5194 standards document guidelines for each group of surgical
instruments, specification covered are:

• Steel Type
• Instrument Hardness
• Instrument Finish
• Corrosion Resistance

Any company selling surgical instruments, should address the following standards in their technical documentation:

• BS EN ISO 13485         2003    Medical devices – QMS – Requirements for
  regulatory purposes
• BS EN ISO 14971         2007    Medical devices – Application of risk
  management to medical devices
• 93/42/EEC       14/06/93         Official Journal of the European
  Communities – L169 volume 36
• 2007/47/EC     05/09/07         Amending Council Directive 93/42/EEC L
  247/21
• MEDDEV 2.12-1 rev 5 04/2007           Medical
  devices : Guidance document – Guidelines on a medical devices vigilance system
• MEDDEV 2.12-2          05/2004           Post Market Clinical Follow-up
• BS EN 980        2008    Graphical symbols for use in the labelling
  of medical devices
• BS EN 1041      2008    Information supplied by the manufacturer of
  medical devices
• BS 5194 Part 1 ISO 7153-1 1991 Surgical
  instruments. Specification for stainless steel
• BS 5194 Part 2            1989    Surgical instruments. Specification for
  instruments with pivot joints
• BS 5194 Part 3            1985    Surgical instruments. Specification for
  dissecting forceps
• BS 5194 Part 4            1985    Surgical instruments. Specification for
  scissors, shears & other jointed cutting instruments

All of these factors should be covered by the manufacturer, so adherence to these guidelines should be sought, when purchasing new instrumentation.