Specification for sterile epidural catheters and introducer needles for single use

Specification for sterile epidural catheters and introducer needles for single use

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What is BS 6196 - Sterile epidural catheters and introducer needles for single use about?

 BS 6196 is a European standard that specifies basic requirements, including requirements for packaging, epidural catheters and epidural introducer needles which are supplied sterile for single use.

Note: Equipment may be supplied separately or together in an epidural set.

Who is BS 6196 - Sterile epidural catheters and introducer needles for single use for?

BS 6196 on sterile epidural catheters and introducer needles for single use is useful for:

  • Manufacturers of epidural catheters and introducer needles for single use
  • Test centres or any person involved in the testing of sterile epidural catheters and introducer needles
  • Design engineers

Why should you use BS 6196 - Sterile epidural catheters and introducer needles for single use?

An epidural catheter is a flexible tube designed to introduce liquids into the epidural space. The epidural introducer needle is a rigid metal tube of suitable length to enable the introduction of an epidural catheter into the epidural space. It includes a hub and a formed end which may, by nature of its configuration, assist the deflection of the catheter.

BS 6196 guides you regarding the design and materials finish, packaging, and marking of sterile epidural catheters and introducer needles for single use to enhance their quality standards.

BS 6196 also guides you regarding the manufacturing of sterile epidural catheters, catheter stylets, sterile epidural introducer needles, and needle stylets by providing their size designation, properties, etc.

With obedience and compliance to BS 6196:1989, you can enhance the efficacy of sterile epidural catheters and introducer needles for single use.

What’s changed since the last update?

BS 6196:1989 supersedes BS 6196:1982, which has been withdrawn. BS 6196:1989has some technical changes with respect to BS 6196:1982. These include:

  • Requirements for freedom from biological hazards are introduced
  • The minimum length of the epidural catheter is not specified, to allow shorter catheters for specialized applications such as paediatric use. However, it is still recognized that epidural catheters for adult use should be at least 900 mm in length
  • Additional distance marks on the epidural catheter are introduced at the request of clinicians, who find them useful in fine adjustment of the extent of catheter insertion. A separate system of distance marking is introduced for catheters for paediatric use
  • A fixed length for the epidural introducer needle is not specified, to permit, at the request of clinicians, a range of lengths (in multiples of 10 mm) for particular applications such as paediatric use or use in obese patients