Sterilizing and disinfecting equipment for medical products - Specification for general requirements

Sterilizing and disinfecting equipment for medical products - Specification for general requirements

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1   Scope

This Part of BS 3970 specifies general requirements for sterilizers, including disinfectors, comprising a pressure-tight vessel capable of operating up to a design pressure of 6.0 bar4). These sterilizers and disinfectors are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes.

NOTE 1 Not all sterilizervessels specified by BS 3970 are required to withstand a design pressure of 6.0 bar. A lower design pressure appropriate to the particular sterilizer and the load to be processed may be specified in relevant subsequent Parts of BS 3970.

The requirements of this Part of BS 3970 apply to all sterilizers and disinfectors specified in subsequent Parts of BS 3970, except insofar as they may be modified or added to by a subsequent Part, in which case the requirements of the particular Part will apply.
Appendix A indicates the additional information that should be provided by the purchaser to the manufacturer.

NOTE 2 Purchasers ordering to this standard are advised to specify in their purchasing contract that the sterilizer manufacturer operate a quality system in accordance with the principles described in BS 5750-1. (Guidance on the application of BS 5750-1 is given in BS 5750-4.) In addition, the manufacturer is advised to check that each supplier of accessories, fittings and other materials similarly operates a quality system in accordance with the principles described in BS 5750.

NOTE 3 It is essential that a sterilizer should be used only for sterilizing the type of goods for which it is designed (see foreword). In selecting the appropriate sterilizer, reference should be made to the list of Parts of BS 3970 given in the foreword.

NOTE 4 The titles of the publications referred to in this standard are listed on page 41.