BS EN 285:2015 Sterilization – Steam sterilizers – Large sterilizers
BS EN 285 details requirements and tests for large steam sterilizers. The standard was revised to reference the relationship with Medical Devices Directive 93/42/EEC.
What is BS EN 285:2015?
This European standard specifies requirements and the relevant tests for large steam sterilizers, primarily used in healthcare for the sterilization of medical devices and their accessories. It applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
The test loads described in this standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.
BS EN 285:2015 doesn’t:
- Specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion
- Specify requirements for equipment intended to process biological waste or human tissues
- Describe a quality management system for the control of all stages of the manufacture of the sterilizer
What’s new on BS EN 285:2015?
BS EN 285 was fully revised. Some of the amendments are:
- Modified scope to differentiate small and large sterilizers by chamber size and to exclude equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion, and equipment intended to process pathogenic substances or human tissues
- Redrafted of clause 6 on instrumentation, indicating and recording devices
- Redrafted requirements on sound power and vibration are completely
- Redrafted requirements on safety, risk control and usability (Clause 11) including normative Annex F and reference to EN ISO 14971
- Revised and extended requirements on packaging and marking (Clause 12)
- Extended requirements on service and working environment (Clause 13)
- Redrafted requirements on test measurement equipment
- Revised and extended clauses on documentation and information
- Redrafted annex A on environmental aspects
- New normative Annex F on protective measures
- Revised Annex ZA relationship with the essential requirements of the Directive 93/42/ECC on Medical Devices including Tables ZA.1 and ZA.2
Who should use BS EN 285:2015?
BS EN 285 is relevant to:
- Testing laboratory that include sterilizers in their service
- Medical device manufacturers and installers that include sterilizers in their service
- Personnel responsible for the maintenance of sterilizers in hospitals and laboratories
- Personnel responsible for sterilization assurance